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HutchMed Anticipates Milestone Payment as Takeda Launches Fruzaqla in Japan for CRC
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is poised to receive a milestone payment from its partner Takeda (TYO: 4502), following the successful pricing approval and launch of Fruzaqla (fruquintinib) 1mg/5mg capsules in Japan. The drug is indicated for patients with previously treated metastatic colorectal cancer (CRC). Fruzaqla’s Approval…
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First Patient Dosed in Abbisko’s Phase II Trial of ABSK061 and ABSK043 in FGFR2/3 Altered Tumors
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in an open, multi-center Phase II study. The study is designed to assess the safety and efficacy of its investigational drugs ABSK061 combined with ABSK043, with or without chemotherapy, in patients with metastatic or unresectable solid…
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Bayer’s Nubeqa Files for FDA Approval in mHSPC
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German pharmaceutical company Bayer AG (ETR: BAYN) has announced that the US Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide) for review. Bayer is seeking approval for its androgen receptor inhibitor (ARi) in combination with androgen deprivation therapy (ADT) for the treatment…
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Pfizer and Flagship Pioneering Expand Partnership with Two New Biotechnology Agreements
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The billion-dollar, multi-program partnership between US pharmaceutical giant Pfizer (NYSE: PFE) and bioplatform innovation company Flagship Pioneering, initiated in July 2023, has expanded with two new additions. Ampersand Biomedicines and Montai Therapeutics, both Flagship-founded biotechs, have entered into agreements to identify targeted molecules aimed at treating obesity and non-small cell…
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Kura Oncology and Kyowa Kirin Ink Licensing Deal for Menin Inhibitor Ziftomenib
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US-based Kura Oncology, Inc. (NASDAQ: KURA) has entered into a licensing deal with Japan-headquartered Kyowa Kirin Co., Ltd. (TYO: 4151), granting Kyowa Kirin exclusive commercialization rights to Kura’s menin inhibitor ziftomenib outside of the United States. Kura retains the corresponding rights within the US. Financial Terms and MilestonesAccording to the…
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InxMed’s Ifebemtinib Earns Breakthrough Therapy Designation for NSCLC Treatment in China
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China-based InxMed (Nanjing) Co., Ltd has announced that the Center for Drug Evaluation of the National Medical Products Administration (NMPA) has granted a Breakthrough Therapy Designation (BTD) to its innovative small-molecule ifebemtinib (IN10018). The designation is for the use of ifebemtinib, a focal adhesion kinase (FAK) inhibitor, in combination with…
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Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC). Phase III Study Data Supports NDA FilingThe filing is supported by data from…
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Innovent Biologics’ IBI354 Earns Breakthrough Therapy Designation for Ovarian Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG: 1801) is set to obtain breakthrough therapy designation (BTD) for its antibody drug conjugate (ADC) IBI354, which targets HER2, for the treatment of platinum-resistant ovarian cancer. Phase I/II Clinical Study ResultsThe Phase I/II clinical study…
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Apeiron Therapeutics Initiates Phase Ia/B Study for GTA182 in Solid Tumors with MTAP Deficiency
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Apeiron Therapeutics, a biomarker-driven cancer therapy developer with operations in Shanghai, China, and San Francisco, US, has announced the enrollment of the first patient in the Phase Ia/B study for its investigational drug GTA182. The dosage escalation study aims to assess the safety, efficacy, and pharmacokinetics of the small molecule…
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NMPA Approves Alpha Biopharma’s Zorifertinib for First-Line NSCLC Treatment with CNS Metastases
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The National Medical Products Administration (NMPA) has granted approval to China-based Alpha Biopharma’s zorifertinib, commercially known as Zorifer, for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation and central nervous…
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Shanghai Junshi Biosciences Enters Licensing Agreement for Dual-Targeted Fusion Proteins
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a China-based biopharmaceutical company, has announced a licensing agreement with an undisclosed company due to commercial sensitivity and trade secret considerations. Exclusive Licensing Rights for Greater ChinaAccording to the agreement, Junshi Bio will secure exclusive licensing rights and sublicensing rights to…
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EMA’s CHMP Recommends Approval for MSD’s Keytruda Combo in Mesothelioma Treatment
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Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of its PD-1 inhibitor, Keytruda (pembrolizumab), in combination with pemetrexed plus…
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EMA’s CHMP Recommends Approval for BMS’s Opdivo/Yervoy Combo in mCRC
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Bristol-Myers Squibb’s (BMS, NYSE: BMY) anti-PD-1 drug Opdivo (nivolumab) in combination with the anti-CTLA-4 biologic Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch…
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Janssen-Cilag’s Lazcluze-Rybrevant Combo Receives Positive EMA Opinion for NSCLC Treatment
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Janssen-Cilag International NV, a subsidiary of the US pharmaceutical giant Johnson & Johnson (J&J; NYSE: JNJ), has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding the combination of Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). This combination therapy…
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Impact Therapeutics Secures $34.5 Million in Series D++ Financing for Senaparib Commercialization
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China-based biopharmaceutical company Impact Therapeutics has reportedly secured RMB 250 million (USD 34.5 million) in a Series D++ financing round, co-led by a globally renowned industry investment institution and a prominent insurance fund. The funds raised will be directed towards the commercialization of its core product, senaparib, a PARP1 inhibitor,…
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Sanofi’s Sarclisa Receives CHMP Recommendation for Newly Diagnosed Multiple Myeloma
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with…
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Merck Secures Exclusive Rights to LaNova’s PD-1/VEGF Bispecific Antibody LM-299
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US pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced a significant licensing agreement with Shanghai-based LaNova Medicines Ltd, a developer of innovative cancer therapies. This deal grants Merck exclusive global rights to develop, manufacture, and commercialize LaNova’s LM-299, a novel PD-1/VEGF bispecific antibody (BsAb), marking a…
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Sino Biopharmaceutical’s TQB3002 Receives FDA Clearance for Phase I Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based pharmaceutical company, has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its TQB3002. This is an in-house developed fourth-generation epidermal growth factor receptor (EGFR) inhibitor, marking a significant…
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Mabwell Bioscience Receives NMPA Approval for 9MW2821 Clinical Trials
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its antibody drug conjugate (ADC), 9MW2821. This drug targets Nectin-4 and will be evaluated in combination with programmed-death 1 (PD-1)…
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Jiangxi Jemincare’s JMX-2002 Liposome Injection Gets NMPA Clinical Clearance
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Jiangxi Jemincare Group, a China-based pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its JMX-2002 liposome injection. This innovative drug, known for its high efficiency and safety, is now set to commence clinical studies focusing on solid tumors, including non-small…
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Lion TCR Gains NMPA Approval for mRNA TCR-T Therapy GZL-016 in HCC
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Singapore-based clinical-stage biotechnology company Lion TCR, supported by Chinese investors, has secured tacit clinical approval from the National Medical Products Administration (NMPA) for its innovative therapy GZL-016. This approval marks a significant milestone in the development of mRNA T-cell receptor engineered T-cells (TCR-T) therapy aimed at treating hepatitis B virus-associated…
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ImmuneOnco Initiates Phase II Study for IMM27M in ER+ Advanced Breast Cancer
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a leading biopharmaceutical company specializing in immuno-oncology, has announced the commencement of a Phase II clinical study for its investigational drug, IMM27M, targeting estrogen receptor positive (ER+) advanced breast cancer following endocrine therapy failure or recurrence. This announcement coincides with the enrollment of…
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Novartis’ Pluvicto Accepted for Review by China’s NMPA for Prostate Cancer Treatment
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The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has accepted a marketing approval filing from Swiss pharmaceutical giant Novartis (NYSE: NVS) for its radioligand therapy (RLT), Pluvicto (177Lu vipivotide tetraxetan). This acceptance marks a significant step towards making this innovative treatment available to patients in…
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BioNTech Seals Acquisition of China’s Biotheus for Up to $950M
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China’s Biotheus Inc. has entered into a definitive acquisition agreement with Germany-based BioNTech SE (NASDAQ: BNTX), marking a significant expansion of BioNTech’s operations in China. The deal underscores BioNTech’s commitment to enhancing its research and development capabilities and production capacity in the region. Deal Terms and FinancialsUnder the agreement, BioNTech…
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Canhelp Genomics Partners with Mirxes to Expand Tumor Origin Testing in Southeast Asia
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Canhelp Genomics, a Chinese company specializing in oncology-focused molecular diagnostics, has formed a strategic partnership with Mirxes Singapore. Together, they will utilize their combined technological and operational strengths to offer solid tumor origin identification testing services to medical practitioners and patients in Singapore, Malaysia, Thailand, Indonesia, and the Philippines. Collaboration…
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ETERN Therapeutics’ ETS-006 Receives FDA Orphan Drug Designation for Pleural Mesothelioma
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ETERN Therapeutics, a Shanghai-based developer of small-molecule anti-tumor drugs, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its compound ETS-006. The designation is for the treatment of pleural mesothelioma (PM), a rare and aggressive form of cancer. Development and…
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Pfizer Partners with Beijing Mabworks and KYinno Biotechnology on Multiple Myeloma Treatments in China
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At the 7th China International Import Expo (CIIE), Chinese firms Beijing Mabworks Biotech Co., Ltd, and KYinno Biotechnology Co., Ltd, have jointly announced a cooperation Memorandum of Understanding (MoU) with global pharmaceutical leader Pfizer (NYSE: PFE). The collaboration focuses on the clinical development of innovative treatment solutions for patients with…
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Jiangsu Hengrui Medicine Receives NMPA Clearance for Multiple Clinical Trials of Oncology Drugs
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for a suite of drugs including HRS-2189, HRS-5041, HRS-1358, HRS-8080, SHR-8068, adebrelimab, and HRS-6209. The company is set to initiate an open, multi-center Phase…
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Alphamab Oncology Presents JSKN033 Phase I/II Study Results at SITC 2024
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Alphamab Oncology (HKG: 9966), a China-based biopharmaceutical company, has announced the presentation of the latest results from the Phase I/II study of its investigational drug JSKN033 at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024). The study focuses on patients with HER2-expressing advanced or metastatic…
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Sino Biopharmaceutical Ltd Receives NMPA Approval for KRAS G12C Inhibitor Garsorasib
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd. The drug is indicated for the treatment of patients with…
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Daiichi Sankyo and Alteogen Sign $300 Million Deal to Develop Subcutaneous Enhertu
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Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has entered into a potentially $300 million agreement with South Korean biotechnology firm Alteogen to develop a subcutaneous injection version of its cancer drug Enhertu, which is also in collaboration with AstraZeneca. This innovative step aims to enhance patient accessibility and…
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Dizal Pharmaceutical Submits NDA to FDA for Sunvozertinib as NSCLC Therapy
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a Chinese pharmaceutical company, has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for sunvozertinib, a targeted therapy for lung cancer. The company is seeking approval for the treatment of locally advanced or metastatic non-small…
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Nanjing Leads Biolabs Secures FDA Orphan Drug Designation for LBL-034 in Multiple Myeloma Treatment
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Nanjing Leads Biolabs Co., Ltd, a China-based biopharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its Category 1 drug LBL-034, which is intended for the treatment of multiple myeloma (MM). LBL-034: A Novel Bispecific Antibody Targeting GPRC5D…
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Novartis Forges Partnerships at CIIE to Strengthen Radioligand Therapy Ecosystem in China
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At the 7th China International Import Expo (CIIE), Swiss pharmaceutical giant Novartis (NYSE: NVS) announced strategic partnerships with US medical device and life sciences company GE Healthcare Technologies Inc., (NASDAQ: GEHC), and Chinese firms Shanghai Pharmaceuticals Holding Co., Ltd (HKG: 2607, SHA: 601607; SPH) and C.Q. Pharmaceutical Holding Co., Ltd…
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Ascentage Pharma to Present Olverembatinib and Lisaftoclax Clinical Data at ASH Annual Meeting
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China-based Ascentage Pharma (HKG: 6855) has announced that it will present the results of multiple clinical studies for its olverembatinib (HQP1351) and three clinical studies for its lisaftoclax (APG-2575) at the 66th American Society of Hematology (ASH) annual meeting. These presentations highlight the company’s commitment to advancing treatments for various…
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CStone Pharmaceuticals Presents CS5001 Clinical Data at the ASH Annual Meeting
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the presentation of the latest clinical data on CS5001, an anti-ROR1 antibody drug conjugate (ADC) for lymphoma, at the 66th American Society of Hematology (ASH) Annual Meeting. CS5001 is a leading asset in CStone’s Pipeline 2.0 and has shown significant promise in treating…
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Roche to Showcase 40+ Abstracts on Blood Disorders at ASH Annual Meeting
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced plans to present over 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The presentations will feature data on approved medicines Polivy (polatuzumab vedotin), Lunsumio (mosunetuzumab), and Columvi (glofitamab), including long-term follow-up and…
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BMS’s Opdivo Secures NMPA Approval for Urothelial Carcinoma Treatment
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with cisplatin and gemcitabine. This approval is for a first-line treatment of unresectable or metastatic urothelial carcinoma (UC). The Opdivo/chemo…
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Shanghai RMX Biopharma and PharmaEngine Ink Distribution Deal for Liporaxel in Taiwan
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Chinese firms Shanghai RMX Biopharma Co. Ltd., a subsidiary of Haihe Biopharma Co., Ltd., and PharmaEngine Inc. have entered into a distribution agreement concerning Liporaxel (paclitaxel oral solution). The agreement grants PharmaEngine exclusive rights to handle the new drug application (NDA) filing, sales, and marketing of Liporaxel in the Taiwan…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Clinical Study
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China-based biopharmaceutical company Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its category 1 innovative drug, chiauranib. The study will evaluate chiauranib in combination with a programmed-death (PD)-(ligand) 1 monoclonal antibody and chemotherapy as a…
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Novartis’ Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received acceptance for its clinical trial application for the investigational drug PIT565 from the China National Medical Products Administration (NMPA). PIT565 is a potential “first-in-class” trispecific antibody targeting CD3, CD19, and CD2, which Novartis is developing to treat B-cell malignancies. Preclinical research results…
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Shenzhen Chipscreen Biosciences’ Tivozanib Secures NMPA Approval for ES-SCLC Phase III Trial
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Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) has announced that the National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for Tivozanib in combination with PD-(L)1 monoclonal antibodies and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Tivozanib, a novel multi-target inhibitor developed…
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AbbVie Partners with EvolveImmune to Develop Immunotherapies for Cancer
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US pharmaceutical company AbbVie (NYSE: ABBV) has entered into a collaboration and option-to-license agreement with EvolveImmune Therapeutics, Inc., an immunotherapy platform company backed by industry giants including Pfizer (NYSE: PFE) and BMS (NYSE: BMY). The partnership will focus on leveraging EvolveImmune’s T-cell engager platform to develop novel antibody-based therapies for…
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CARsgen Therapeutics’ Suspended CAR-T Therapies Get FDA Green Light to Resume
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The US Food and Drug Administration (FDA) has removed the suspension on clinical studies for three chimeric antigen receptor (CAR)-T therapies developed by CARsgen Therapeutics Holdings Ltd (HKG: 2171), according to the company’s statement to the Hong Kong Stock Exchange. The therapies include CT053 (zevorcabtagene autoleucel), a BCMA-targeted CAR-T therapy…
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HutchMed to Receive $20 Million Milestone Payment from Takeda for Fruzaqla Sales
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is poised to receive a USD 20 million milestone payment from its Japanese partner Takeda (TYO: 4502; NYSE: TAK), following the achievement of over USD 200 million in sales of Fruzaqla (fruquintinib) for metastatic colorectal cancer (CRC). Fruquintinib, a selective oral inhibitor…
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CStone Pharmaceuticals’ Sugemalimab Wins UK Approval for NSCLC Treatment
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China-based CStone Pharmaceuticals (HKG: 2616) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for sugemalimab, in combination with platinum-based chemotherapy, as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This…
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Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Files for New Indication with China’s NMPA
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that the National Medical Products Administration (NMPA) in China has accepted for review another indication approval filing for its sacituzumab tirumotecan (SKB264/MK-2870). The new indication is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC)…
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Akeso Biopharma Initiates Phase III Clinical Trial for PD-1/VEGF Bispecific Antibody Combination
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first patient in a randomized, controlled, multicenter Phase III clinical study (AK117-302), assessing the combination of the innovative PD-1/VEGF bispecific antibody ivonescimab and its next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive…
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Novartis Secures FDA Accelerated Approval for Scemblix in Newly Diagnosed CML Patients
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Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its drug Scemblix (asciminib) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). This accelerated approval is supported by the…
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GSK Secures Global Rights to Chimagen Biosciences’ T Cell-Engager in $850 Million Deal
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UK pharmaceutical company GSK plc (NYSE: GSK) has entered into a licensing agreement with Chimagen Biosciences, securing all global rights to CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE). GSK will pay an upfront fee of USD 300 million and is committed to making success-based development and commercial…
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Merck and Moderna Launch Phase III Study for Individualized Neoantigen Therapy in Lung Cancer
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US pharmaceutical companies Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) and Moderna Inc. (NASDAQ: MRNA) have initiated the Phase III INTerpath-009 study to evaluate V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab). The study will focus on patients with resectable Stage…
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Merck’s Keytruda Gains Two Additional EU Indications for Gynecologic Cancer Treatment
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Merck, Sharp & Dohme Inc., known as MSD (NYSE: MRK), has received two additional indication approvals from the European Union for its immunotherapy drug Keytruda (pembrolizumab), increasing the total number of approved uses in the region to 30. The PD-1 inhibitor is now approved for use in combination with carboplatin…
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Jiangsu Hengrui Medicine Advances Clinical Trials for Cancer Therapies with NMPA Clearance
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received clinical clearance from China’s National Medical Products Administration (NMPA) for a suite of cancer treatments, including HRS-4642 (adebrelimab), SHR-1826, SHR-8068, and a bevacizumab biosimilar. The company is set to initiate a multi-center, open Phase Ib/II study to evaluate the safety, tolerability,…
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AstraZeneca’s Zoladex Receives NMPA Approval for Higher Dosage Form in Breast Cancer Treatment
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a UK-based pharmaceutical giant, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Zoladex (goserelin sustain-released implant) 10.8mg. This new dosage form is intended for use in premenopausal and perimenopausal women with breast cancer who can be…
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Wantai Biological’s P85 Ab Detection Kit Receives NMPA Approval for Nasopharyngeal Carcinoma Screening
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a Chinese pharmaceutical company, announced last week that it has received marketing approval from the National Medical Products Administration for its EB virus BNLF2b antibody (P85 Ab) detection kit, which utilizes the magnetic particle chemiluminescence method. This product is a collaborative…
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Chinese ADCs from Escugen, Hansoh, and MediLink Therapeutics Eye Breakthrough Designations in China
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The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has indicated on its website that three antibody drug conjugates (ADCs) from Chinese pharmaceutical companies are on track to receive breakthrough therapy designations (BTDs) in China. These include Shanghai Escugen’s ESG401, Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692)’s…
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LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
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BeiGene’s PD-1 Inhibitor Tevimbra Scores First US Prescription, Offers More Affordable Option
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BeiGene Ltd, a leading China-based biotechnology company (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has announced the first prescription of its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab), in the United States. This marks a significant milestone for the company as it expands its global reach. Tislelizumab received approval in the US…
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Shanghai MicroPort Initiates Pre-Marketing Clinical Study for Embolic Microspheres in Liver Cancer Treatment
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a Chinese medical technology company, has announced the commencement of a pre-marketing clinical study for its polyvinyl alcohol embolic microspheres. The company has completed the first pre-marketing clinical implantation in transcatheter arterial chemoembolization (TACE) surgery for left lobe lesions in patients with…
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Asieris Pharmaceuticals Gets FDA Green Light for USP1 Inhibitor APL-2302 in Advanced Solid Tumors
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Asieris Pharmaceuticals (SHA: 688176), a China-based specialist in urogenital cancer treatments, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its in-house developed ubiquitin specific peptidase 1 (USP1) inhibitor, APL-2302, for the treatment of advanced solid tumors. Preclinical studies have indicated that…
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Henlius Biotech Commences Global Phase III Trial for Serplulimab in First-Line Metastatic Colorectal Cancer
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the dosing of the first patient in a global, multi-center Phase III study for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10). The study combines serplulimab with bevacizumab and chemotherapy for the first-line treatment of…
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3SBio Secures Exclusive Rights to Commercialize Haihe’s Paclitaxel Oral Solution in China and Hong Kong
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Shanghai Haihe Pharmaceutical Co., Ltd and 3SBio Inc. (HKG: 1530), two Chinese pharmaceutical companies, have jointly announced a licensing agreement that grants 3SBio the exclusive rights to commercialize Haihe’s paclitaxel oral solution in mainland China and Hong Kong. According to the agreement, 3SBio will pay an undisclosed upfront sum along…
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Merck Acquires Modifi Biosciences to Target DNA Repair Defects in Cancer Therapies
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has bolstered its oncology pipeline through the acquisition of Modifi Biosciences, Inc., a biotechnology company specializing in direct DNA modification-enabled cancer therapeutics. This strategic move provides MSD with preclinical compounds aimed at exploiting DNA repair defects in…
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BeiGene’s Tevimbra Receives CHMP Recommendation for Expanded Use in G/GEJ and ESCC Cancers in EU
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an extension of authorization for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The expanded authorization covers…
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Sino Biopharmaceutical’s Anlotinib Receives Ninth Indication Approval from China’s CDE for Soft-Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company in China, has announced that it has received another indication approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its oral multi-target kinase inhibitor, anlotinib. The request is for anlotinib to be used in…
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Johnson & Johnson’s Akeega Approved in China as First Dual Action Tablet for mCRPC
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Johnson & Johnson (J&J, NYSE: JNJ), a leading US pharmaceutical company, has announced that China’s National Medical Products Administration (NMPA) has granted indication approval for Akeega (niraparib and abiraterone acetate), to be taken with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2…
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BeiGene’s Tevimbra Approved in China for NSCLC Patients as Neoadjuvant and Adjuvant Therapy
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has announced that it has received market approval in China for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The National Medical Products Administration (NMPA) has granted approval for tislelizumab in combination with platinum-containing chemotherapy as both neoadjuvant…
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Novartis’s Kisqali Receives Positive CHMP Opinion for Early Breast Cancer Treatment in the EU
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Kisqali (ribociclib), a CDK4/6 inhibitor, for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth…
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Astellas Pharma’s Vyloy Receives FDA Approval for Gastric Cancer Treatment in CLDN18.2 Positive Tumors
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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its drug Vyloy (zolbetuximab-clzb). The approval is for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally…
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Jiangsu Hengrui Medicine Initiates Phase III Clinical Trial for SHR-A1904 in Gastric Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has filed for a Phase III clinical study of its Claudin18.2-targeted antibody drug conjugate (ADC) SHR-A1904 on Clinicaltrials.gov. The study aims to enroll 524 patients with second-line recurrent or metastatic gastric cancer and is anticipated to…
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Jacobio Pharma’s G12C Inhibitor Gecirasib Earns Orphan Drug Designation in Europe for Pancreatic Cancer
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Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the European Medicine Agency (EMA) for its KRAS G12C inhibitor, glecirasib, for the treatment of pancreatic cancer. This designation follows previous awards for glecirasib, including ODD in the US and Breakthrough…
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Astellas Pharma’s Vyloy Receives FDA Approval for CLDN18.2 Positive Gastric Cancer Treatment
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Astellas Pharma (TYO: 4503) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Claudin18.2 (CLDN18.2) targeting antibody Vyloy (zolbetuximab) in combination with a fluoropyrimidine- and platinum-based chemotherapy regimen for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or…
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Kanghong Pharmaceutical’s NASH Drug KH629 Receives Clinical Trial Implicit Approval in China
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On October 18th, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China announced that Kanghong Pharmaceutical (SHE: 002773)’s Class 1 new drug, KH629 tablets, has been granted implicit approval for clinical trials for the treatment of adult non-alcoholic steatohepatitis (NASH).…
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Akeso Biopharma Launches Phase Ib/II Trial for Cadonilimab and AK112 in Pancreatic Cancer
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On October 17, ClinicalTrials.gov reported that Akeso Biopharma (HKG: 9926) has initiated a Phase Ib/II clinical study to evaluate the combination of Cadonilimab (CTLA-4/PD-1 dual antibody) and AK112 (Envafolimab, a PD-1/VEGF dual antibody) with chemotherapy as a first-line treatment for pancreatic cancer. The primary endpoints of the study include safety,…
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FDA Extends Review of Amgen’s Lumakras for KRAS G12C mCRC Treatment to January 2025
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On October 18, FirstWord reported that the U.S. FDA has extended the review period for Amgen (NASDAQ: AMGN)’s KRAS G12C inhibitor Lumakras (sotorasib) in combination with the anti-EGFR monoclonal antibody panitumumab for second-line treatment of KRAS G12C-mutated metastatic colorectal cancer (mCRC) by three months, pushing the decision date to January…
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Pfizer Partners with TRIANA Biomedicines to Develop Molecular Glue Degraders for Oncology and Other Diseases
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Pfizer (NSE: PFIZER), a leading US pharmaceutical company, has entered into a strategic partnership and licensing agreement with Massachusetts-based biotech firm TRIANA Biomedicines. The collaboration aims to develop innovative molecular glue degraders targeting a variety of diseases, with a focus on oncology, according to a press release from TRIANA. Under…
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Tencent Invests USD 30 Million in Early Cancer Detection Firm Insighta, Backed by Prenetics
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Prenetics Global Limited (NASDAQ: PRE), a prominent health sciences company with operations in the US and Hong Kong, China, has announced a significant investment of USD 30 million by Chinese internet conglomerate Tencent into Insighta, a Hong Kong-based company specializing in early cancer detection. Insighta represents a substantial joint venture…
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Chengdu Baiyu Pharmaceutical Strikes Licensing Deal with Novartis for Unannounced Anti-Tumor Asset
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Chengdu Baiyu Pharmaceutical Co., Ltd., a Chinese pharmaceutical company, has entered into a licensing agreement with Swiss pharmaceutical giant Novartis (NYSE: NVS), according to the Xinhua News Agency. Under this deal, Novartis will acquire the global exclusive rights to develop and commercialize one of Baiyu’s small molecule anti-tumor assets, the…
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Novocure’s Optune Lua Wins FDA Approval for mNSCLC Treatment in Combination with Immunotherapies
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Novocure (NASDAQ: NVCR), a Swiss firm renowned for its pioneering Tumor Treating Fields (TTFields) cancer therapy, has received marketing approval from the US Food and Drug Administration (FDA) for its Optune Lua device. This portable device is now cleared for use in combination with PD-1/PD-L1 inhibitors or docetaxel to treat…
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Alphamab Oncology and CSPC Pharma’s KN026 Phase III Trial for Breast Cancer Gets NMPA Approval
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Alphamab Oncology (HKG: 9966) and CSPC Pharma (HKG: 1093) have jointly announced that their Phase III clinical study application for the combination of HER2 bispecific antibody KN026 and nab-paclitaxel HB1801 (Study Protocol Number: KN026-004) has received approval from the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) for neoadjuvant…
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Shanghai Junshi Biosciences’ Toripalimab Wins Marketing Approvals in India and Hong Kong for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biotech company based in China, has announced that it has received marketing approvals in India and Hong Kong for its drug toripalimab, used for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The drug will be marketed under…
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Jiangsu Hengrui Resubmits Application for Camrelizumab Combo in HCC to FDA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has announced a new attempt at a market filing with the US Food and Drug Administration (FDA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as…
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Boehringer Ingelheim Partners with Circle Pharma to Develop First-in-Class Cyclin Inhibitor
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Boehringer Ingelheim (BI), a leading German pharmaceutical company, has announced a research collaboration and license agreement with Circle Pharma, a US-based firm. This strategic partnership aims to develop a first-in-class cyclin inhibitor, a novel approach that could halt the growth of cancer cells and offer new hope for patients struggling…
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Huadong Medicine Gets NMPA Green Light for BCMA-Targeted ADC HDM2027 Phase I/IIa Study
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I/IIa study for its drug candidate HDM2027 (HDP-101). This antibody drug conjugate (ADC), co-developed with Heidelberg Pharma, targets the B cell maturation…
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RemeGen’s Disitamab Vedotin Receives Priority Review for New Indication in Breast Cancer by China’s NMPA
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another indication approval filing for its drug candidate disitamab vedotin (RC48). The antibody-drug conjugate (ADC) has been granted priority review status. This…
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AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China
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AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit activating HER2 (ERBB2)…
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BMS’s Dual Immunotherapy Achieves Global First Approval for MSI-H/dMMR CRC in China
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On October 14, 2024, Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the National Medical Products Administration (NMPA) of China has approved a new indication for its dual immune combination therapy, Opdivo (nivolumab) and Yervoy (ipilimumab), for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or deficient…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for CD33-Targeting ADC in Acute Myeloid Leukemia
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Sichuan Biokin Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange as (SHA: 688506), has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its antibody-drug conjugate (ADC), BL-M11D1. This therapy targets CD33…
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Dizal Pharmaceutical’s Sunvozertinib Earns Breakthrough Designation for NSCLC from China’s NMPA
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This designation is in relation to the drug’s potential use as…
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Pfizer’s Talzenna Combo Shows Improved Survival in mCRPC Patients, According to TALAPRO-2 Study
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Pfizer Inc. (NYSE: PFE) has announced positive topline results regarding overall survival (OS) in the Phase III TALAPRO-2 study for Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, when combined with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI). This combination is used for the treatment of patients with…
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CSPC Pharma Initiates Phase III Trial for JMT101 in First-Line EGFR-Positive NSCLC Treatment
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has initiated a Phase III clinical study for its Category 1 drug JMT101. This study combines JMT101 with osimertinib (Tagrisso) and compares it against osimertinib alone in the first-line treatment of locally advanced or metastatic epidermal growth…
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KangaBio’s KGX101 Receives NMPA Approval for Clinical Trial in China
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KangaBio, a biopharmaceutical company based in Shanghai, has announced that its investigational new drug (IND) application for KGX101 has received clinical trial approval from the China National Medical Products Administration (NMPA). This Class 1 new drug, an IL-12 Fc fusion protein injection, is expected to be used for the treatment…
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Immupeutics Medicine Secures NMPA Approval for Personalized Liver Cancer Immunotherapy IPM001
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Immupeutics Medicine, a pioneer in tumor immunotherapy based in Beijing, has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its proprietary therapy, IPM001. This marks a significant step forward in the field of cancer treatment in China. IPM001 is a groundbreaking multi-antigen targeted…
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Coherent Biopharma’s CBP-1008 Earns FDA Fast Track for Platinum-Resistant Ovarian Cancer
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Coherent Biopharma Ltd, a specialist in bispecific-ligand drug conjugates (Bi-XDCs) with operations in Suzhou, China, has been granted fast-track status by the US Food and Drug Administration (FDA) for its investigational drug CBP-1008. This drug is indicated for the treatment of platinum-resistant ovarian clear cell carcinoma (OCCC), a particularly aggressive…
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Doma Biopharmaceutical Receives Green Light for Clinical Trial of Novel ADC DM001 Targeting Solid Tumors
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a biotech firm with a presence in China and the United States, has received approval from China’s National Medical Products Administration to commence a clinical study for its innovative Category 1 drug DM001. This bispecific antibody drug conjugate (ADC) is designed to target advanced or…
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Harbour BioMed’s Innovative Antibody Porustobart Shows Promise in Early Clinical Trials for Melanoma
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Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands, and Suzhou, China, has announced the publication of the Phase I clinical study results for its CTLA-4 antibody porustobart (HBM4003) in combination with Junshi Biosciences’ PD-1 inhibitor toripalimab. This combination is aimed at treating advanced…
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Sunvozertinib’s Companion Diagnostic Gets NMPA Nod, Fortifying Targeted Therapy Arsenal for NSCLC in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have announced a significant regulatory milestone in China’s precision medicine space. Their jointly developed companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), designed to pair with the targeted therapy sunvozertinib,…
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Nona Biosciences Partners with OverT Bio to Develop Next-Generation Cell Therapies for Solid Tumors
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Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Ltd (HKG: 2142), has entered into a partnership with US biotechnology company OverT Bio, Inc. to develop next-generation cell therapies targeting solid tumors. The collaboration will leverage Nona’s heavy-chain antibody (HCAb) Harbour Mice platform, with no financial specifics disclosed. Nona Bio’s HCAb…
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Merck’s Keytruda Meets Primary Endpoint in Phase III Study for Head and Neck Cancer
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US pharmaceutical giant Merck & Co., Inc. (MRK, NYSE: MRK) has announced that the Phase III KEYNOTE-689 study for its PD-1 inhibitor Keytruda (pembrolizumab) has met its primary endpoint of event-free survival (EFS) in patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell…
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CSPC Pharmaceutical’s ADC CPO301 Earns Second Fast-Track Designation in the US for NSCLC Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC) CPO301 has received another fast-track status in the United States for the treatment of non-small cell lung cancer (NSCLC). The EGFR targeted ADC has been granted this status for the treatment of epidermal growth…
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Ascentage Pharma Receives Approval for Two Phase III Trials of APG-2449 in NSCLC
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China-based biopharmaceutical company Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) to conduct two separate Phase III clinical studies assessing its investigational drug APG-2449. The trials will evaluate the FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI)…
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Innovent Biologics and ASK Pharma Forge Strategic Partnership for Limertinib in Lung Cancer Treatment
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China-based Innovent Biologics Inc. (HKG: 1801) and Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharma, SHE: 002755) have announced a strategic collaboration and licensing agreement focused on ASK’s limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) designed for lung cancer treatment. Under the terms of the deal,…
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MediLink Therapeutics Partners with Amgen for Clinical Trial in Small Cell Lung Cancer
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the…
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BeiGene Prices TEVIMBRA 10% Below Competitors Following FDA Approval for Esophageal Cancer Treatment
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the commercial availability of TEVIMBRA (Tislelizumab) in the United States following its approval by the FDA for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The drug received FDA approval in March…
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BMS Expands Opdivo Indication with FDA Approval for NSCLC Combo Therapy
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The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS, NYSE: BMY) Opdivo (nivolumab) for use in combination with platinum-based chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC), followed by Opdivo as an adjuvant treatment post-surgery. This decision…
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Akeso Biopharma’s PD-1/VEGF Bispecific Antibody Study Completes Enrollment
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On October 4, 2024, Summit Therapeutics (referred to as “Summit”), a partner of Akeso Biopharma (HKG: 9926), announced the completion of subject enrollment for the HARMONi study, which evaluates the PD-1/VEGF bispecific antibody, Ivociclib (also known as AK112). The international Phase III clinical study is led by Summit and investigates…
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FRα ADC Rina-S by Genmab Enters Late-Stage Clinical Trial Following ProfoundBio Acquisition
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Genmab A/S (NASDAQ: GMAB) has initiated a Phase III clinical trial for its FRα ADC candidate, Rina-S, as registered on ClinicalTrials.gov on October 1, 2024. The trial aims to enroll 530 patients with platinum-resistant advanced ovarian cancer to compare Rina-S head-to-head with chemotherapy, with an anticipated preliminary completion date in…
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Dizal Pharmaceutical’s Surufatinib Earns CDE Consideration for Breakthrough Therapy in EGFR exon20ins NSCLC
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Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China is considering its drug candidate DZD9008 for breakthrough therapy status. The drug is designed to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received…
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NMPA Clears AbbVie’s ABBV-706 for Clinical Trials Targeting SCLC and Neuroendocrine Tumors
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The China National Medical Products Administration (NMPA) has granted clinical trial approval to ABBV-706, a novel antibody-drug conjugate (ADC) developed by AbbVie (NYSE: ABBV), for the treatment of relapsed/refractory small cell lung cancer (SCLC) and other neuroendocrine tumors . ABBV-706 is a targeted therapy that binds to SEZ6, a protein…
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CStone Pharmaceuticals’ Partner HengRui Medicine Launches Phase III Trial for CTLA-4 Antibody in HCC
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CStone Pharmaceuticals (HKG: 2616), an innovation-driven biopharmaceutical company focused on the development of oncology drugs, announced today that its partner, HengRui Medicine, has initiated a Phase III clinical study for CS1002/SHR-8068 (an anti-CTLA-4 monoclonal antibody) in combination with adebrelimab and bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (HCC).…
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Akeso Biopharma’s Cadonilimab Secures NMPA Approval for Gastric Cancer Indication
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Akeso Biopharma Inc. (HKG: 9926) announced that its self-developed PD-1/CTLA-4 bispecific antibody, Cadonilimab injection (AK104), has been approved by the National Medical Products Administration (NMPA) in China for a new indication. This is the second indication for the product in China and is for the first-line treatment of patients with…
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Alphamab Oncology Strikes Licensing Deal with CSPC Pharma for HER2 Targeted ADC in China
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm CSPC Pharmaceutical Group Ltd (HKG: 1093). The deal grants CSPC exclusive license and sub-license rights to Alphamab’s JSKN003 in mainland China for development, sales, and commercialization related to oncology indications.…
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Sichuan Biokin’s Partner Bristol-Myers Squibb Gets FDA Nod for Bispecific ADC Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced that its U.S. partner Bristol-Myers Squibb has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/IIa study for BL-B01D1, an in-house developed bispecific antibody drug conjugate (ADC), in patients with advanced…
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Qilu Pharmaceutical’s QL1706 Receives NMPA Conditional Approval for Cervical Cancer Treatment
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its combination drug QL1706, comprising iparomlimab and tuvonralimab, has received conditional marketing approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer. QL1706 (PSB205), originally developed by the U.S. biotech Qilu Puget Sound Biotherapeutic…
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Shanghai Fosun Pharmaceutical Gets NMPA Clinical Clearance for Lymphoma Drug XS-04
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a prominent pharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational drug XS-04 for the treatment of hematologic malignancies. XS-04, an innovative small molecule drug developed…
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Jacobio Pharma Receives NMPA Approval for Pan-KRAS Inhibitor JAB-23E73 Clinical Trial
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its investigational drug JAB-23E73, a pan-KRAS inhibitor developed in-house. This follows prior clearance from U.S. authorities to initiate a Phase I/IIa study for…
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AstraZeneca’s Tagrisso Secures FDA Approval for Unresectable Stage III EGFRm NSCLC
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AstraZeneca (NASDAQ: AZN, LON: AZN), a UK-based pharmaceutical giant, has announced that it has received a new indication approval from the US Food and Drug Administration (FDA) for its non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The FDA has approved Tagrisso for the treatment of adult patients with unresectable,…
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FDA Panel Weighs in on Narrowing Use of PD-1 Inhibitors in Stomach and Esophageal Cancers
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The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) convened on September 26 to scrutinize the application of PD-1 inhibitors in oncology, particularly focusing on Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) and Merck, Sharp & Dohme’s (NYSE: MRK) Keytruda (pembrolizumab). The committee evaluated the risk-benefit profile of these drugs for…
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Zelgen Biopharmaceuticals Receives NMPA Approval for ZG005 Clinical Trial in Advanced Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase I/II clinical study for its pipeline drug candidate, ZG005, aimed at treating advanced solid tumors. ZG005 is an…
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Johnson & Johnson Reportedly Winding Down Cardiovascular and Metabolic Pharma Unit
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Johnson & Johnson (J&J; NYSE: JNJ), a healthcare giant in the U.S., is reportedly winding down its cardiovascular and metabolic pharmaceutical unit, as reported by Endpoints News. Insiders have indicated that J&J has issued notices to its sales, marketing, and medical affairs teams this week. The company has acknowledged the…
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Shanghai Haihe Pharmaceutical’s Oral Paclitaxel RMX3001 Wins NMPA Nod for Advanced Gastric Cancer
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Shanghai Haihe Pharmaceutical Co., Ltd from China and its South Korean partner Daehwa Pharmaceutical have received approval from the National Medical Products Administration (NMPA) for their co-developed paclitaxel oral solution RMX3001. This new drug is intended for use in patients with advanced gastric cancer who have experienced disease progression during…
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TJ Biopharma and Sanofi Ink Deal for Anti-CD73 Antibody Uliledlimab in Greater China
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TJ Biopharma, a biopharmaceutical company based in China, has entered into a licensing agreement with the French pharmaceutical giant Sanofi. This agreement grants Sanofi exclusive rights to develop, manufacture, and commercialize TJ Biopharma’s anti-CD73 antibody, uliledlimab (TJD5), in Greater China. As part of the deal, Sanofi will make an upfront…
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Nona Biosciences Partners with Alkyon Therapeutics to Develop Next-Generation Immunotherapies
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Nona Biosciences, a subsidiary of HBM Holdings Ltd (HKG: 2142), has entered into a strategic partnership with U.S. biotechnology company Alkyon Therapeutics, Inc. (AlkyonTx). The collaboration aims to develop next-generation immunotherapy and other targeted therapy applications, leveraging Nona’s proprietary Harbour Mice fully human antibody platform. The financial details of the…
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Junshi Biosciences’ Toripalimab Secures EC Nod for Two Cancer Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received two indication approvals from the European Commission (EC) for its PD-1 inhibitor, Loqtorzi (toripalimab). This marks a significant expansion of the drug’s utility in the European Union, where it can now be used in combination…
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Allist Pharma’s Partner Abbisko Receives NMPA Green Light for NSCLC Drug Trial
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for ABK3376, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This drug is co-developed with Allist Pharmaceuticals Inc., (SHA: 688578), and is intended…
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HBOW Bio’s First-in-Class Tumor Imaging Drug NC527-X Receives NMPA Clinical Trial Approval
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HBOW Bio, a precision oncology company supported by Sherpa Healthcare Partners, has secured clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate NC527-X. This first-in-class near-infrared fluorescence (NIRF) tumor imaging agent is recognized as the world’s first drug to harness low oxygen pathways for…
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Antengene’s Xpovio Receives NDA Approval in Thailand for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval in Thailand for its drug Xpovio (selinexor). This approval allows the use of Xpovio in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory…
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Wuhan YZY Biopharma Presents M701 Interim Results at 2024 ESMO Congress for NSCLC-Related Pleural Effusion
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the presentation of interim analysis results from a Phase Ib clinical study for its investigational drug M701 at the 2024 European Society of Medical Oncology (ESMO) Congress. M701 is a recombinant anti-EpCAM and CD3 human…
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Allist Pharmaceuticals’ EGFR Inhibitor AST2303 Approved for Clinical Trial in NSCLC by NMPA
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Allist Pharmaceuticals Inc. (SHA: 688578), a Shanghai-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its AST2303, an oral small molecule epidermal growth factor (EGFR) inhibitor, for adult patients with advanced non-small cell lung cancer (NSCLC) that carries the…
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Sanofi’s Sarclisa Secures FDA Approval for First-Line Multiple Myeloma Treatment
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Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib,…
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Janssen and Yuhan Halt Development of Next-Gen EGFR Inhibitor for NSCLC
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Yuhan, a South Korean pharmaceutical company, and its partner Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (J&J; NYSE: JNJ), have reportedly decided to halt the development of a next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for non-small cell lung cancer (NSCLC). This strategic…
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Sichuan Biokin’s Multi-Specific Antibody GNC-077 Gets NMPA Nod for Advanced Solid Tumor Clinical Trial
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to advance its drug candidate, GNC-077, into clinical trials for the treatment of advanced solid tumors. GNC-077 is a multi-specific antibody developed on…
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SciClone Pharmaceuticals Gets NMPA Approval for Phase III Study of First-in-Class SERD Orserdu
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SciClone Pharmaceuticals Inc. (HKG: 6600), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III bridging study for its drug Orserdu (elacestrant), the world’s first selective estrogen receptor degrader (SERD) originally developed by Eisai. The Phase III study, which is randomized,…
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ApolloBio’s HPV Therapeutic Vaccine VGX-3100 Gets NMPA Green Light for Clinical Trial
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ApolloBio Corp., a joint stock company of China’s leading cephalosporin manufacturer Shandong Jincheng Pharmaceutical and Chemical Co., Ltd (SHE: 300233), has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for VGX-3100. This drug, hailed as the world’s first therapeutic vaccine for human papillomavirus…
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Jacobio Pharma’s Pan-KRAS Inhibitor JAB-23E73 Clears FDA Hurdle for Clinical Trials
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has received the green light from the U.S. Food and Drug Administration (FDA) to commence a Phase I/IIa clinical study for its investigational new drug, JAB-23E73. This in-house developed pan-KRAS inhibitor has shown promise in simultaneously inhibiting both active and…
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Yantai Dongcheng Pharmaceutical’s 18F-LNC1007 Receives Clinical Clearance for Solid Tumor Diagnostics
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received clinical trial approval from the National Medical Products Administration (NMPA) for its 18F-LNC1007 injection, a novel radioactive diagnostic drug. This drug is designed to target fibroblast activating protein (FAP) and integrin alpha-v beta-3, which are biomarkers…
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Fosun Pharmaceutical’s PD-1 Inhibitor HanSiZhuang Recommended for Approval by EMA’s CHMP
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Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a leading pharmaceutical company in China, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang, in combination with carboplatin and…
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AstraZeneca’s HIMALAYA Trial Data Showcases Significant Survival Benefits for Liver Cancer Treatment at ESMO 2024
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At the European Society for Medical Oncology (ESMO) 2024 conference, AstraZeneca (NASDAQ: AZN, LON: AZN) presented updated data from the HIMALAYA Phase III trial, demonstrating sustained and clinically meaningful overall survival (OS) benefits for patients with unresectable hepatocellular carcinoma (HCC) who had not previously received systemic therapy and for whom…
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J&J’s Rybrevant Secures FDA Approval for EGFR/c-MET Non-Small Cell Lung Cancer Treatment
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Johnson & Johnson (J&J; NYSE: JNJ)has announced that the US Food and Drug Administration (FDA) has granted approval for its EGFR/c-MET bispecific antibody, Rybrevant (amivantamab-vmjw), in combination with standard chemotherapy, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor…
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Beijing’s Apollobio Receives NMPA Approval for HPV Therapeutic Vaccine VGX-3100
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Beijing’s Apollobio, has announced that the National Medical Products Administration (NMPA) has granted market approval for its innovative therapeutic vaccine VGX-3100. This vaccine, which targets HPV-16/18 related anal precancerous lesions, is a significant advancement in the treatment landscape for conditions associated with Human Papillomavirus (HPV). The vaccine’s approval follows a…
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MSD’s Keytruda Secures FDA Approval for First-Line Mesothelioma Treatment in Combination with Chemotherapy
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab). The approval allows for the use of Keytruda in combination with pemetrexed and platinum chemotherapy as a first-line treatment…
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AstraZeneca’s Tagrisso Achieves Milestones in Phase III LAURA Study for EGFR-mutated NSCLC at ESMO 2024
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Global pharmaceutical company AstraZeneca (NASDAQ: AZN, LON: AZN) has reported updated results from the Phase III LAURA study on its EGFR-tyrosine kinase inhibitor (EGFR-TKI), Tagrisso (osimertinib), at the 2024 European Society of Medical Oncology (ESMO) Congress. The study included data from the Chinese cohort, highlighting the drug’s efficacy in treating…
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Adagene’s ADG126 Shows Promising Results in Phase Ib/II Study for MSS CRC at ESMO 2024
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Adagene Inc. (NASDAQ: ADAG), a biopharmaceutical company dedicated to the discovery and development of innovative antibody-based therapies, has announced updated results from the Phase Ib/II study of its anti-CTLA-4 SAFEbody, ADG126 (Muzastotug), in combination with pembrolizumab for the treatment of advanced/metastatic microsatellite stable colorectal cancer (MSS CRC) at the 2024…
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Transcenta’s Osemitamab Combo Therapy Shows Promising Results in G/GEJ Cancer Treatment at ESMO 2024
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Transcenta Holdings Ltd (HKG: 6628), a leading biopharmaceutical company, has announced updated positive results from the cohort-G data of its drug candidate osemitamab (TST001) in combination with nivolumab and CAPOX for the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) cancer at the 2024 European Society of Medical Oncology…
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AstraZeneca’s Imfinzi-Imjudo Combo Sets New Longevity Benchmark in Liver Cancer Treatment
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has achieved a significant milestone with its drug combination of Imfinzi (durvalumab) and Imjudo (tremelimumab), used in the treatment of patients with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC). Data from the Phase III HIMALAYA trial, showcased at the 2024 European…
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BeiGene’s Tislelizumab Receives Israeli Nod for Oesophageal Cancer Treatment
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China-based biotech firm BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has been granted market approval in Israel for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The Israeli Ministry of Health has approved Tevimbra for use as a monotherapy second-line treatment for adult patients with unresectable or metastatic oesophageal squamous…
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Merck and Daiichi Sankyo’s HER3-DXd ADC Patritumab Deruxtecan Passes Phase 3 Trial After FDA Rejection
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Merck (NYSE: MRK) and Daiichi Sankyo (TYO: 4568) announced that their antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) has passed Phase 3 HERTHENA-Lung 02 study, months after the drug was rejected by the U.S. FDA due to manufacturing issues following its presentation at this year’s ESMO conference. The companies will discuss…
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Kangfang Biotech Presents Groundbreaking mCRC Treatment Data at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) debuted its independently developed PD-1/VEGF bispecific antibody, Yivoxi, in combination with or without the next-generation CD47 monoclonal antibody, Laifali, plus FOLFOXIRI as a first-line treatment for microsatellite stable (MSS) or proficient mismatch repair (pMMR) advanced metastatic…
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Kangfang Biotech’s Yivoxi Shows Promising Results in First-Line TNBC Treatment at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled for the first time the results of its independently developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination with chemotherapy for the first-line treatment of locally advanced unresectable or metastatic triple-negative breast cancer (TNBC). Preliminary data…
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Kangfang Biotech’s Yivoxi Shows Promising Results in Treating R/M HNSCC at ESMO Congress
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At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled the impressive Phase II clinical study results of its self-developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination or alone with the next-generation CD47 monoclonal antibody, Laifali, for the first-line treatment of PD-L1 positive (CPS≥1) recurrent…
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Shanghai Pharmaceuticals’ Dual-Targeting CAR-T Therapy Advances with IND Re-Acceptance
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Shanghai Pharmaceuticals Group Co., Ltd. (SHA: 601607)’s biotech subsidiary has announced that its investigational ‘CD19 and CD22 targeting chimeric antigen receptor T cell injection’ has received renewed acceptance for its Investigational New Drug (IND) application by the relevant authorities. Known under the development code B019, this cellular therapy candidate has…
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Novartis’ Cemiplimab Approved in China for Moderate-to-Severe Atopic Dermatitis
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Novartis (SWX: NOVN, NYSE: NVS)’s Chinese arm has announced that it has received approval from the National Medical Products Administration (NMPA) for its drug candidate, cemiplimab, to be used in the treatment of adults and children aged 12 and over with moderate-to-severe atopic dermatitis (AD). The drug, known as cemiplimab…
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Innovent Biologics Launches Phase I Clinical Trial for IBR822 Cell Injection Solution in Solid Tumors
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Innovent Biologics (Hangzhou) Co., Ltd (HKG: 1801, OTCMKTS: IVBXF), a biopharmaceutical company based in China, has announced the successful initiation of a Phase I clinical trial for its proprietary IBR822 cell injection solution at Zhejiang Cancer Hospital. The trial, led by Professor Song Zhengbo from Zhejiang Cancer Hospital, is conducted…
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Sanofi Secures Global Rights to Radioligand Therapy AlphaMexi in Deal with RadioMedix and Orano Med
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Sanofi (EPA: SAN; NASDAQ: SNY), a leading French pharmaceutical company, has entered into a significant licensing agreement with US biotechnology firm RadioMedix Inc. and French company Orano Med, securing global rights to a radioligand therapy (RLT). The agreement centers on AlphaMexi (212Pb-DOTAMTATE), a targeted alpha therapy (TAT) that utilizes a…
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Roche’s Tecentriq Hybreza Becomes First Subcutaneous Anti-PD-(L)1 Immunotherapy in the US
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Roche (SWX: ROG; OTCMKTS: RHHBY) , a leading Swiss pharmaceutical company, has secured US Food and Drug Administration (FDA) approval for its subcutaneous formulation of the programmed death-ligand 1 (PD-L1) inhibitor, Tecentriq Hybreza (atezolizumab, hyaluronidase). This new formulation has been approved for all 12 adult indications of intravenous Tecentriq, covering…
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Signet Therapeutics and Jennio Biotech Join Forces to Advance Tumor Immunotherapy
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Signet Therapeutics, a pioneering biopharmaceutical company in China specializing in cancer targeted therapies based on organoid disease models and artificial intelligence (AI), has entered into a strategic partnership with Guangzhou Jennio Biotech Co., Ltd. The collaboration aims to leverage organoid disease models and advance tumor immunotherapy drug development. Financial specifics…
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Carisma Therapeutics and Moderna Expand Partnership to Target Autoimmune Diseases with CAR-M Therapies
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Carisma Therapeutics Inc. (NASDAQ: CARM), a U.S.-based company specializing in chimeric antigen receptor (CAR) macrophage therapies, has announced an expansion of its collaboration with fellow U.S. firm Moderna Inc. (NASDAQ: MRNA). This strategic partnership extension will focus on the development of in vivo CAR macrophage and monocyte (CAR-M) therapies for…
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Qilu Pharmaceutical’s Iruplinalkib Shows Promising Results in Phase II Study for ALK+ NSCLC
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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has presented updated results from the Phase II INTELLECT study for its Category 1 drug iruplinalkib at the World Conference on Lung Cancer (WCLC). The study focuses on patients with cizotinib-resistant anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).…
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Betta Pharmaceuticals’ MCLA129 for Advanced Solid Tumors Accepted for Review by China’s NMPA
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical filing for MCLA129, a Category 1 biologic product intended for the treatment of advanced solid tumors. The potential indications for MCLA129 include, but…
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AstraZeneca and Daiichi Sankyo’s Dato-DXd Misses Overall Survival Endpoint but Shows Promise in NSCLC Subgroup
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AstraZeneca (NASDAQ: AZN) and its co-development partner, Japan’s Daiichi Sankyo, have released data from the TROPION-Lung01 Phase III study, which focuses on the TROP-2-targeted antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) as a second-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The molecule did not achieve…
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Akeso’s Ivonescimab Shows Promising Results in Phase III Clinical Trial for Hepatocellular Carcinoma
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced that its first-in-class bispecific antibody, ivonescimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE), has reached a significant milestone in its Phase III clinical trial for unresectable, non-metastatic hepatocellular carcinoma (HCC). The drug has demonstrated promising results…
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AstraZeneca Faces Investigation in China Over Data Privacy and Unapproved Drugs
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AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, is reportedly under the spotlight in Shenzhen, China, with an investigation involving five current and former employees, as per a report by Bloomberg. The probe is said to center on potential breaches of data privacy regulations and the unauthorized importation of drugs…
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Rigel Pharmaceuticals Strikes Deal with Kissei for Development and Commercialization of Rezlidhia in East Asia
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Rigel Pharmaceuticals Inc. (NASDAQ: RIGL), a biopharmaceutical company based in the U.S., has entered into a license and supply agreement with Japan’s Kissei Pharmaceutical Co., Ltd. The agreement grants Kissei the rights to develop and commercialize Rigel’s Rezlidhia (olutasidenib) across Japan, South Korea, and Taiwan. Rezlidhia is an oral isocitrate…
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True Health’s Advanced Microwave Ablation System Gains NMPA Nod for Liver Tumor Treatment
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True Health (Guangdong Hengqin) Medical Technology Co., Ltd has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative navigation positioning microwave ablation system. This advanced medical device utilizes CT images to devise a precise needle insertion plan prior to surgery and provides real-time guidance for the…
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European Commission Approves Merck’s Keytruda-Padcev Combo for First-Line Urothelial Carcinoma Treatment
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Merck & Co., Inc. (NYSE: MRK), a global healthcare leader based in the United States, has announced that the European Commission (EC) has granted approval for the use of Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma. This…
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Humanwell Healthcare’s Innovative Drug for Solid Tumors Gets Green Light from NMPA
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading pharmaceutical entity in China, has received a significant boost with the clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, HW071021. This novel drug, designed to combat advanced solid tumors, stands as a unique…
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EpimAb’s EMB-06 Secures $635 Million Licensing Agreement with Vignette for Multiple Myeloma Therapy
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EpimAb Biotherapeutics, a Shanghai-based biotech firm, has inked a licensing deal with Vignette for the development and commercialization of its T-cell engager (TCE) EMB-06 outside of Greater China. The agreement grants Vignette rights to EMB-06, a BCMA-targeting therapy, in regions excluding mainland China, Hong Kong, Macau, and Taiwan, with EpimAb…
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Henlius Biotech’s HLX17 Biosimilar to MSD’s Keytruda Wins NMPA Clinical Trial Approval
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SHANGHAI—Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its HLX17, a biosimilar version of MSD’s (Merck & Co., known as MSD outside the US) blockbuster drug Keytruda (pembrolizumab). The biosimilar targets all indications that the…
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Jiangsu Simcere Acquires Exclusive Rights to TargetRx’s TGRX-326 in Licensing Deal
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SHENZHEN—Shenzhen TargetRx, Inc., a leading developer of small-molecule kinase inhibitors, has entered into a licensing agreement with Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a fellow Chinese pharmaceutical company. The deal concerns TargetRx’s TGRX-326, an ALK/ROS1 dual receptor tyrosine kinase inhibitor currently at the clinical stage. According to the agreement,…
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China’s Sinovent and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
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BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Sinovent Inc.’s EZH2 inhibitor XNW5004 and GlaxoSmithKline’s (GSK) antibody drug conjugate (ADC) belantamab mafodotin are on track to receive breakthrough therapy designations (BTDs). Sinovent’s XNW5004 is targeting the recurrent or refractory peripheral T-cell lymphoma indication and has demonstrated potential…
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Zuellig Pharma Partners with Regeneron for Libtayo Launch in South Korea and Taiwan
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Singapore-headquartered Zuellig Pharma, a leading healthcare solutions provider, has entered into an agreement with US pharmaceutical giant Regeneron Pharmaceuticals Inc. to oversee the market launch and commercialization of Libtayo (cemiplimab), Regeneron’s proprietary programmed death-1 (PD-1) inhibitor, in South Korea and Taiwan. Financial details of the agreement were not disclosed. Libtayo…
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HutchMed Halts China Filing for Gastric Cancer Drug Fruquintinib Following Regulatory Feedback
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013), a China-based biopharmaceutical company, has announced the withdrawal of its New Drug Application (NDA) for fruquintinib, a VEGFR inhibitor, in combination with paclitaxel for the second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) in China. The decision to withdraw was made…
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Allist Pharmaceuticals Acquires Jacobio’s G12C Inhibitor and SHP2 Inhibitor Rights for Greater China Region
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SHANGHAI—Allist Pharmaceuticals Co., Ltd, a Shanghai-based biotech company, has entered into a licensing agreement with fellow Chinese firm Jacobio Pharma (HKG: 1167), securing rights to Jacobio’s KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 for research, development, manufacturing, regulatory filings, and commercialization in Greater China. The agreement encompasses mainland China,…
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CNGB Virogin’s VG161 On Track for Breakthrough Designation in China for Advanced Liver Cancer
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BEIJING—CNGB Virogin, a joint venture between Virogin Biotech and China National Biotec Group, is poised to secure a breakthrough therapy designation (BTD) from China’s National Medical Products Administration (NMPA) for its innovative drug VG161. The targeted indication for this recombinant human IL12/15-PDL1B herpes simplex type I oncolytic virus injection is…
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Sino Biopharmaceutical’s Anlotinib-Penpulimab Combo Meets Milestone in Phase III HCC Study
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HONG KONG—Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the successful completion of a pre-set interim analysis in its Phase III clinical study. The study combines anlotinib with penpulimab as a first-line treatment for advanced hepatocellular carcinoma (HCC), achieving the optimal efficacy thresholds for…
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JW Therapeutics’ CAR-T Therapy Carteyva Secures NMPA Approval for Mantle Cell Lymphoma Indication
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JW Therapeutics, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2126), has received additional indication approval from the National Medical Products Administration (NMPA) for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection). This approval extends to adult patients with…
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Legend Biotech’s Carvykti Receives NMPA Approval for Relapsed/Refractory Multiple Myeloma After Multi-Center Phase II Study
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Legend Biotech Corporation (NASDAQ: LEGN) has secured a significant milestone with the announcement of marketing approval from China’s National Medical Products Administration (NMPA) for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). This therapy is intended for patients with relapsed/refractory multiple myeloma (MM) who have undergone…
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Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy
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Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177), has received approval from the National Medical Products Administration (NMPA) to advance its antibody drug conjugate (ADC) BAT8006 into clinical trials in combination with bevacizumab. This trial will focus on maintenance therapy for…
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Regeneron Secures EU Approval for Ordspono, Its First Bispecific Antibody
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Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab) from the European Commission (EC). This marks a significant milestone as Ordspono becomes the company’s first bispecific antibody (BsAb) to receive approval, designated for the treatment of adult patients with relapsed or refractory (R/R) follicular…
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China’s Guilin Sanjin Pharmaceutical Advances BC011 with NMPA Approval for Phase I Clinical Trial
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Guilin Sanjin Pharmaceutical Co. Ltd, a Chinese pharmaceutical company listed on the Shenzhen Stock Exchange (SHE: 002275), has announced that its subsidiary, Dragon Boat Pharmaceutical (Shanghai) Co., Ltd, has obtained approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its drug candidate BC011,…
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BeiGene Advances R/R CLL/SLL Treatment with FDA Fast-Tracked BGB-16673 in Phase I/II Clinical Trial
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its novel compound BGB-16673. This investigational Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC), known as a proteolysis-targeting chimera (PROTAC) product, represents…
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China’s CDE Approves Multitude Therapeutics’ AMT-676 for Clinical Study in Solid Tumors
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The Center for Drug Evaluation (CDE) of China has granted clinical study approval for Multitude Therapeutics Inc.’s proprietary injectable drug candidate, AMT-676, as indicated on the CDE website. The drug is intended for the treatment of solid tumors. AMT-676 is an antibody-drug conjugate (ADC) that targets CDH17, a gene situated…
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Mabwell Bioscience Initiates Phase III Trial for 9MW2821 Combo in Urothelial Carcinoma Following NMPA Clearance
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has announced the commencement of patient enrollment for a pivotal Phase III clinical trial. The study will evaluate the efficacy and safety of 9MW2821 in combination with toripalimab for the first-line treatment of patients with locally advanced…
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Shouyao Holdings Receives Clinical Trial Approval for SY-7166 in Treating Multiple Myeloma
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Shouyao Holdings (Beijing) Co., Ltd, a biopharmaceutical company headquartered in Beijing and listed on the Shanghai Stock Exchange (SHA: 688197), has announced that it has obtained clinical trial approval for its drug candidate SY-7166 for the treatment of multiple myeloma (MM) as a monotherapy. SY-7166 is a highly potent and…
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Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments
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Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2696), has announced that its UK partner, Accord Healthcare Inc., has received marketing approval from Health Canada. This approval permits the use of Hanquyou (trastuzumab; HLX02), a biosimilar to Roche’s…
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Jiangsu Simcere Pharmaceutical Gets NMPA Green Light for SIM0508 Clinical Trial in Advanced Solid Tumors
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Jiangsu Simcere Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2096), has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate SIM0508. This molecule is a DNA polymerase theta (Pol theta) small molecule inhibitor, which is…
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Mabwell Bioscience Receives Approval for Phase III Trial of 9MW2821 in Cervical Cancer from China’s CDE
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Mabwell (Shanghai) Bioscience Co., Ltd, a biopharmaceutical company listed in China (SHA: 688062), has received approval from the Center for Drug Evaluation (CDE) in China to proceed with a Phase III clinical trial for its pipeline candidate, 9MW2821. The study is designed as a randomized, open, controlled, multi-center trial, comparing…
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ImmuneOnco Receives USD 10 Million Upfront Payment from Instil Bio Subsidiary for Licensing Deal
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has received a USD 10 million upfront payment from SynBioTx, the wholly owned subsidiary of US-based Instil Bio Inc (Nasdaq: TIL). This payment is in accordance with a licensing agreement finalized earlier this month. The agreement outlines the potential for an additional USD…
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Everest Medicines Launches Trial for Personalized mRNA Cancer Vaccine EVM16 in Solid Tumors
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Everest Medicines, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1952), has announced the commencement of an investigator-initiated trial (ITT) for its cutting-edge personalized mRNA cancer vaccine, EVM16. The trial, spearheaded by Beijing Cancer Hospital and Fudan University Shanghai Cancer Center, is a…
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Innovent Biologics’ Fulzerasib Receives NMPA Approval for Advanced NSCLC Treatment in China
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Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its drug fulzerasib. This approval grants the company the green light to market fulzerasib, under…
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Akeso Biopharma’s Ivonescimab Earns Category 1 Recommendation in China’s 2024 Lung Cancer Clinical Guideline
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Akeso Biopharma, a China-based pharmaceutical company listed on the Hong Kong Stock Exchange (HKG: 9926), has achieved a significant milestone with its bispecific antibody ivonescimab (AK112). This innovative drug, which targets both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), has been included in the “Clinical Practice Guideline for…
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Henlius Biotech Secures Exclusive Rights to Commercialize Convalife’s Generic Neratinib in China and Abroad
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. Henlius has secured the exclusive commercialization rights for Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional licensing…
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J&J’s Rybrevant-Lazclude Combo Approved by FDA, Challenging AstraZeneca’s Tagrisso in NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United States for the combined use of its bispecific antibody Rybrevant (amivantamab) and the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). Following a priority review, the US FDA approved this dual therapy for the first-line treatment of…
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Shanghai Henlius Biotech Secures Exclusive Rights to Convalife Pharmaceuticals’ Generic Neratinib in China
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SHANGHAI—Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. The deal grants Henlius the exclusive commercialization rights to Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional…
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Johnson & Johnson’s Rybrevant-Lazclude Combo Approved by FDA for First-Line NSCLC Treatment
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NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone with the US FDA’s approval of its bispecific antibody Rybrevant (amivantamab) in combination with the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). The priority review has led to a green light for the combined use of…
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Genmab CEO Signals Potential for China Partnership as BioNTech Exits acasunlimab Collaboration
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COPENHAGEN—In a strategic pivot following BioNTech (NASDAQ: BNTX)’s withdrawal from their co-development partnership on the PD-L1 x 4-1BB bispecific antibody acasunlimab, Denmark-based Genmab A/S (NASDAQ: GMAB) is reportedly seeking a commercial partner for its entry into the China market. This update was provided by CEO Jan Van de Winkel during…
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Sichuan Kelun Pharmaceutical’s H1 2024 Report Highlights MSD Collaboration Milestones
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CHENGDU—Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has released its financial report for the first half of 2024, detailing significant updates on its collaboration with US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK). The partnership, focused on the co-development of antibody drug conjugates (ADCs), has seen substantial progress…
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Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
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TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
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BioNTech’s BNT326/YL202 Clears FDA Hurdle, Advancing in Clinical Trials for Solid Tumor Treatment
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FRANKFURT—BioNTech SE (NASDAQ: BNTX), a leading German biotechnology company, has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase I clinical trial for BNT326/YL202, an anti-HER3 targeted antibody drug conjugate (ADC). This development paves the way for the resumption of trials…
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Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
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COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC) has granted market approval for its Tepkinly/Epkinly (epcoritamab), a CD3/CD20 bispecific T cell engager. The drug is indicated for third-line or later treatment of relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large…
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Sichuan Biokin Launches Phase III Trial for Bispecific ADC BL-B01D1 in Lung Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has commenced the first patient dosing in a Phase III clinical trial for its proprietary bispecific antibody drug conjugate (ADC), BL-B01D1. This innovative therapy is being evaluated for the treatment of recurrent small-cell lung cancer (SCLC) in patients who have previously not responded…
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Kelun Pharmaceutical’s Sacituzumab Tirumotecan Receives Priority Review for NSCLC Treatment
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Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870) has been granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for the drug’s application as a treatment for locally advanced or metastatic…
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Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
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Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2). According to a press release from the Medicines and Healthcare products Regulatory Agency (MHRA), the approval allows Vyloy to be used as a…
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Shandong Buchang Pharmaceuticals Partners with Lancet for BC001 Licensing in Eurasia
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Shandong Buchang Pharmaceuticals Co., Ltd. (SHA: 603858), based in China, has announced plans to enter a licensing agreement with Russia’s Lancet Pharmaceuticals, granting the latter regulatory filing, commercialization, and other rights for Buchang’s pipeline candidate BC001 across the Eurasian Economic Union, which includes Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan, and Uzbekistan.…
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Qilu Pharmaceutical Gains Approval for Generic Dasatinib, Expanding CML Treatment Options in China
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Qilu Pharmaceutical, based in China, has received marketing approval for its generic version of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) in China. This second-generation BCR-ABL tyrosine kinase inhibitor (TKI) is now available for the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant to or intolerant…
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Ascentage Pharma Secures NMPA Approval for Phase III Trial of Lisaftoclax in MDS
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Ascentage Pharma (HKG: 6855), based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a multi-center, randomized, double-blind Phase III study evaluating the efficacy of its novel drug, lisaftoclax (APG-2575), in combination with azacitidine (AZA) for the first-line treatment of newly diagnosed patients with higher-risk…
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Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and Daiichi Sankyo (TYO: 4568), has received conditional approval in China for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have undergone two or more…
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Wantai Biological’s HPV Vaccine Receives Priority Review from China’s CDE
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced that its nine-valent recombinant human papillomavirus (HPV) vaccine, co-developed with Xiamen University, has received priority review status from China’s Center for Drug Evaluation (CDE). This vaccine targets seven high-risk HPV types (HPV16, 18, 31, 33, 45, 52, and 58)…
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Junshi Biosciences Submits Twelfth Indication for PD-1 Inhibitor Loqtorzi in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced a new indication filing with Chinese regulators for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company is pursuing marketing approval for Loqtorzi as a first-line therapy for patients with unresectable or metastatic melanoma, marking the twelfth indication filing…
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Nanjing Sanhome’s Oritinib Ships Widely for EGFR-mutated NSCLC Treatment in China
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Nanjing Sanhome Pharmaceutical Co., Ltd, a notable player in the pharmaceutical sector, has announced the widespread distribution of its Category 1 chemical drug, oritinib, across key regions in China, including Jiangsu, Shanghai, Beijing, Henan, and Inner Mongolia. The drug has been made available to lung cancer specialists who are now…
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Boehringer Ingelheim’s Zongertinib Earns Breakthrough Designation in China for HER2-Mutated NSCLC
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Boehringer Ingelheim, a leading German pharmaceutical company, has received a significant endorsement from China’s Center for Drug Evaluation (CDE) with the breakthrough therapy designation (BTD) for its investigational HER2-targeted tyrosine kinase inhibitor (TKI), zongertinib (BI 1810631). This designation underscores the potential of zongertinib in treating adult patients with HER2-mutated advanced,…
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Chinese NMPA Approves Hengrui Med’s Generic Abraxane for Metastatic Pancreatic Cancer Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). The drug is now approved for use in combination with gemcitabine…
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Jiangsu Hengrui Medicine Gains NMPA Approval for Five Drug Candidates, Including IL-17A mAb for Psoriasis
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for a total of five drug candidates. This development marks a significant step in the company’s pipeline advancement. Vunakizumab, an…
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Harbour BioMed Reclaims Rights to HBM7008 as Cullinan Therapeutics Cancels Licensing Deal
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Harbour BioMed (HBM), a biopharmaceutical company with operations in the Netherlands, the United States, and Suzhou, China, has announced that its U.S. partner, Cullinan Therapeutics Inc., will be returning the rights to the pipeline molecule HBM7008. This move cancels the licensing agreement that was initially focused on the development and…
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WestGene Biopharma’s EB Virus-Targeting mRNA Vaccine WGc-043 Clears for Clinical Trials in China
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WestGene Biopharma Co., Ltd., a biotechnology company based in Chengdu, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with clinical trials for its candidate drug, WGc-043. This marks a significant milestone as WGc-043 is the world’s first mRNA therapeutic…
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Hansoh Pharmaceutical Secures Rights to Lupeng’s BTK Inhibitor LP-168 in Licensing Deal
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Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a leading pharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Lupeng Pharmaceutical Ltd for the next-generation Bruton’s tyrosine kinase (BTK) inhibitor, LP-168. According to the terms of the agreement, Hansoh will assume responsibility for research and…
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Zelgen Biopharmaceuticals’ ZG006 Earns Orphan Drug Designation from FDA for Small-Cell Lung Cancer
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, ZG006, which is under development for the treatment of small-cell lung cancer (SCLC). ZG006 is…
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Insilico Medicine’s ISM6331 Earns FDA Orphan Drug Designation for Mesothelioma Treatment
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Insilico Medicine, a China-based biotechnology company at the forefront of generative artificial intelligence (AI), has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate ISM6331. This potential best-in-class candidate drug is designed to treat mesothelioma, a rare and…
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Eisai and SEED Therapeutics Join Forces on Molecular Glue Degraders for Neurodegeneration and Cancer
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Eisai Co., Ltd (TYO: 4523), a Japanese pharmaceutical company, and SEED Therapeutics Inc., a U.S. biotech firm, have announced their intention to enter into a research collaboration aimed at developing novel molecular glue degraders for neurodegenerative diseases and oncology. Eisai will leverage SEED’s expertise in targeted protein degradation (TPD) to…
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Servier’s Voranigo Receives FDA Nod for IDH Inhibitor as Brain Tumor Treatment
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The U.S. Food and Drug Administration (FDA) has granted first-time approval for Voranigo (vorasidenib), a therapy developed by Servier Pharmaceutical plc. Voranigo, an inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2), has been approved for the treatment of adult and pediatric patients aged 12 years and older with Grade…
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Akeso Biopharma Initiates Phase III Clinical Trial for Cadonilimab in Hepatocellular Carcinoma
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced the first patient dosing in a Phase III clinical study for its drug candidate, cadonilimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE) for the treatment of unresectable, non-metastatic hepatocellular carcinoma (HCC). The study’s data for this…
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Antengene’s Xpovio Receives NDA Approval in Malaysia for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced the approval of its New Drug Application (NDA) for Xpovio (selinexor) in Malaysia. The drug is now approved for use in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (r/r…
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Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Clinical Trials in Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its pipeline drug candidate ZG005. The approvals will pave the way for trials to evaluate the efficacy and safety…
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Genor Biopharma Strikes Licensing Deal with TRC 2004 for Global Rights to GB261 Outside Greater China
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China-based Genor Biopharma Co., Ltd (HKG: 6998) has entered into a significant licensing and equity agreement with US-based TRC 2004, Inc., bestowing upon TRC 2004 the exclusive rights to develop, manufacture, and commercialize Genor’s innovative drug candidate, GB261, in all global territories excluding Greater China. This strategic partnership is set…
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Degen Biopharmaceutical’s DG01 PROTAC Drug Receives NMPA Clearance for Solid Tumor Studies
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Suzhou Degen Biopharmaceutical Co., Ltd, a leading specialist in PROteolysis TArgeting Chimeras (PROTAC) technology in China, has announced that its oral dual-targeted PROTAC drug, DG01, has been granted approval by the National Medical Products Administration (NMPA) to proceed with clinical studies for advanced or metastatic castration-resistant prostate cancer and liver…
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Lepu Biotechnology’s MRG003 Earns FDA Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its pipeline candidate, MRG003. This designation highlights the drug’s potential in treating recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), a significant…
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Huadong Medicine Secures Exclusive Rights to Immunochina’s CAR-T Therapy in China
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China-based pharmaceutical company Huadong Medicine Co., Ltd (SHE: 000963) has entered into a licensing agreement with Beijing-based gene therapy specialist Immunochina Pharmaceuticals. The agreement grants Huadong exclusive commercialization rights to Immunochina’s IM19, a promising CD19-targeted autologous chimeric antigen receptor (CAR) T cell therapy, within mainland China. Huadong will make an…
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Bristol-Myers Squibb Terminates Partnership with Agenus on TIGIT/CD96 Bispecific Antibody
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US pharmaceutical major Bristol-Myers Squibb (BMS; NYSE: BMY) has announced its decision to end its collaboration with Agenus Inc. (NASDAQ: AGEN) regarding the development of the TIGIT/CD96-targeted bispecific antibody BMS-986442 (AGEN1777). This move follows an initial decision to advance the antibody to Phase II trials earlier this year, which resulted…
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Yantai Dongcheng Pharmaceutical Secures NMPA Nod for PSMA-Targeted Radiotherapeutic Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug, 177LuLNC1011. This novel therapeutic is a prostate specific membrane antigen (PSMA)-targeted radioactive in vivo treatment…
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Lee’s Pharmaceutical Commences Phase I Clinical Trial for AI-Discovered HCC Drug AU409
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a leading biopharmaceutical company based in China, has announced the first dosing in a Phase I clinical study for AU409, an oral small molecule drug. The drug was discovered by Auransa Inc. using the AI platform SMarTR Engine and will be manufactured by Lee’s…
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ImmuneOnco Biopharmaceuticals Strikes Licensing Deal with Instil Bio for Global Rights to Dual-Targeted Antibodies
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has entered into a definitive licensing agreement with US-based Instil Bio Inc. (Nasdaq: TIL), granting InstilBio development and commercial rights outside China for ImmuneOnco’s proprietary PD-L1- and VEGF-targeted bispecific antibody, IMM2510, and its next-generation anti-CTLA-4 antibody, IMM27M. As per the agreement, a subsidiary…
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Sino Biopharmaceutical’s Benmelstobart Files for New Indication in China for Advanced RCC Treatment
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review a new indication filing for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb), benmelstobart (TQB2450). The filing seeks regulatory approval for the use…
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GSK’s Jemperli Receives EC Approval for Endometrial Cancer Treatment in Combination Therapy
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GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced that the European Commission (EC) has granted a new indication approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab). The approval allows for the use of Jemperli in combination with carboplatin-paclitaxel, a chemotherapy regimen, for the treatment of adult…
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NICE and AstraZeneca Fail to Reach Agreement on Enhertu Reimbursement for NHS
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The UK’s National Institute for Health and Care Excellence (NICE) has announced that negotiations with AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) for the reimbursement of the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) within the National Health Service (NHS) have concluded without an agreement. Enhertu is approved in the…
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BioNTech’s mRNA Cancer Immunotherapy BNT111 Achieves Primary Endpoint in Phase II Trial
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Germany-based BioNTech SE (NASDAQ: BNTX) has announced that its mRNA cancer immunotherapy BNT111, in combination with the programmed death-1 (PD-1) inhibitor Libtayo (cemiplimab), has achieved the primary endpoint in a Phase II clinical trial. The study, part of a collaboration with Regeneron, is assessing the combination and monotherapies in treating…
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FibroGen Inc. Enters Restructuring Mode After Late-Stage Trial Failures for Pamrevlumab
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US-based biotechnology company FibroGen Inc. (NASDAQ: FGEN), which maintains significant operations in China, is initiating damage control measures following the failure of two late-stage trials for its potential first-in-class anti-connective tissue growth factor (CTGF) fully human monoclonal antibody, pamrevlumab. In response to these setbacks, FibroGen has decided to terminate all…
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National Comprehensive Cancer Network Renews Partnership with Medlive for Oncology Guidelines Access in China
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The National Comprehensive Cancer Network (NCCN), a leading non-profit academic organization in the US, has renewed its strategic partnership with Medlive, a Beijing-based medical information service provider focused on clinicians. This collaboration aims to further promote the NCCN Clinical Practice Guidelines in Oncology within China, ensuring they are accessible through…
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Jiangsu Hengrui Medicine Receives NMPA Approval for SHR-A1921 Clinical Study in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its innovative antibody drug conjugate (ADC), SHR-A1921. The study will evaluate the efficacy and safety of SHR-A1921…
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3SBio’s Thrombopoietin Meets Primary Endpoint in Phase III Trial for Chronic Liver Disease Patients
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3SBio Inc. (HKG: 1530), a biopharmaceutical company based in China, has announced the successful conclusion of the Phase III TPO106 clinical trial for its thrombopoietin drug in patients with chronic liver disease associated thrombocytopenia who are scheduled for invasive surgery. The trial has met its pre-set primary endpoint, paving the…
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CStone Pharmaceuticals’ Sugemalimab Wins EU Nod as First-Line NSCLC Treatment
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has received marketing approval from the European Commission (EC) for its PD-L1 inhibitor, Cejemly (sugemalimab). The approval covers the drug’s use in combination with platinum-based chemotherapy as a first-line treatment for adults with metastatic non-small-cell lung cancer (NSCLC), excluding…
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Junshi Biosciences’ Toripalimab Recommended for EU Approval for Two Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for two new indications of its PD-1 inhibitor, Loqtorzi (toripalimab). The first is in combination with cisplatin and gemcitabine for first-line treatment of…
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Akeso Biopharma’s Ivonescimab NDA Accepted by NMPA, Strengthening NSCLC Treatment Options
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has received a significant boost with the acceptance of its New Drug Application (NDA) by the National Medical Products Administration (NMPA) for Yidafang (ivonescimab), a pioneering bispecific antibody targeting both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). This…
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Hengrui Medicine Advances in Breast Cancer Treatment with NMPA Clinical Trial Greenlight
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a pharmaceutical heavyweight based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical studies on its innovative drug candidates. The study will explore the synergistic effects of HRS-6209 in combination with HRS-1358, HRS-8080, or aromatase inhibitors, and…
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Zhejiang Haichang Biotech Secures EU Approval for Apexelsin: A New Hope in Cancer Treatment
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Zhejiang Haichang Biotech Co., Ltd, a partner of China-based Kexing Pharmaceutical (SHA: 688136), has secured marketing approval from the European Commission for its biosimilar, Apexelsin. This groundbreaking treatment, which mirrors the quality of BMS/Celgene’s Abraxane (paclitaxel, albumin-bound), is indicated for metastatic breast cancer, metastatic pancreatic cancer, non-small cell lung cancer,…
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Shanghai Escugen Partners with Innolake Biopharma to Develop Novel ADCs Using EZWi-Fit Platfo
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Shanghai Escugen, a Chinese biopharmaceutical company, has entered into a strategic partnership with fellow Chinese firm Innolake Biopharma to utilize Escugen’s innovative antibody-drug conjugate (ADC) platform, EZWi-Fit, in the development of ADC products targeting specific antigens selected by Innolake. Under the terms of the agreement, Innolake will employ EZWi-Fit to…
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Luye Pharma’s Subsidiary Gets NMPA Go-Ahead for First CD228-Targeted ADC BA1302
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a subsidiary of China-based Luye Pharma Group (HKG: 2186), has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical trial for its proprietary antibody-drug conjugate (ADC), BA1302. The trial, which is multi-center, open-label, and involves multiple dosages…
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Roche’s H1’24 Financials Show 5% Growth, Eye Care and Cancer Therapies Drive Sales
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Roche (SWX: ROG, OTCMKTS: RHHBY, SWX: RO), the Swiss pharmaceutical and diagnostics giant, has reported its financial results for the first half of 2024, with group sales remaining stable in Swiss franc terms. However, on a constant exchange rate basis, sales increased by 5% year-on-year to CHF 29.85 billion (USD…
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AstraZeneca’s Q2 2024 Results Highlight Strong Growth Across Therapies, Excluding Vaccines
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AstraZeneca (NASDAQ: AZN), a UK-based biopharmaceutical company, has reported its financial results for the second quarter and the first half of 2024, demonstrating robust growth. For the six-month period, total revenues increased by 18% year-on-year (YOY) to $25.617 billion, with product sales also experiencing an 18% rise to $24.629 billion.…
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Jiangsu Suzhong Pharma’s Sutetinib Earns Breakthrough Designation for NSCLC from China’s NMPA
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Jiangsu Suzhong Pharma Group Co., Ltd, a leading pharmaceutical company based in China, has received a breakthrough therapy designation from the National Medical Products Administration (NMPA) for its drug candidate sutetinib, which is under development for locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific non-resistant rare EGFR…
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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Cleared for Clinical Trial by NMPA
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate, PLAT001. This novel injectable drug is under evaluation for the treatment of general advanced or metastatic solid tumors.…
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Hinova Pharmaceuticals Receives NMPA Approval to Test Myelofibrosis Drug Candidate HP560
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biopharmaceutical company based in Chengdu, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 chemical drug candidate, HP560. The molecule is being evaluated as a potential treatment for myelofibrosis,…
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Novartis Partners with Dren Bio to Develop Next-Generation Cancer Therapies
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Novartis (NYSE: NVS), a leading Swiss pharmaceutical company, has entered into a strategic collaboration with California-based biotech firm Dren Bio Inc. to leverage Dren’s expertise in developing bispecific antibodies for cancer treatment. Under this agreement, Novartis is particularly interested in utilizing Dren’s proprietary Targeted Myeloid Engager and Phagocytosis Platform. As…
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ST Phi Therapeutics’ Universal Cell Therapy for Solid Tumors Gets Green Light for Clinical Trial in China
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ST Phi Therapeutics, a Hangzhou-based cell therapy specialist, has secured tacit approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial for its innovative cell therapy, CNK-UT002. This marks a significant milestone, as CNK-UT002 is the first universal cell therapy for solid tumors to be approved for…
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Bayer’s BAY 3375968 Receives NMPA Approval for Clinical Trial in Advanced Solid Tumors
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Bayer AG (ETR: BAYN), a multinational pharmaceutical giant based in Germany, has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 drug BAY 3375968. This novel Fc optimized anti-CCR8 antibody is currently the subject of a Phase I clinical study globally. BAY 3375968 has…
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Chipscreen’s HDAC Inhibitor Chidamide to be Tested in Combination Therapy for CRC by NMPA
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Shenzhen Chipscreen Pharmaceutical Co., Ltd, a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical trial. The trial is designed to evaluate the efficacy and safety of Epidaza (chidamide) in combination with the PD-1 inhibitor sintilimab (Tyvyt) and…
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China’s NMPA Considers Breakthrough Designations for Xiangxue and Innostellar’s Therapies
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Xiangxue Pharmaceutical Co., Ltd (SHE: 300147) and Innostellar Biotherapeutics Co., Ltd have both been noted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) as potential candidates for breakthrough therapy designations (BTDs). Xiangxue’s TAEST16001, a T-cell receptor TCR affinity-enhanced specific T-cell (TAEST) therapy, and Innostellar’s…
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Jiangsu Hengrui Receives NMPA Approval to Study CDK 4/6 Inhibitor Dalpiciclib in Combination with HRS-1358 for Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study combining its CDK 4/6 inhibitor, Dalpiciclib (SHR6390), with HRS-1358 for the treatment of breast cancer. This marks a significant step in expanding…
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Hansoh Pharmaceutical’s EGFR Inhibitor Ameile Files for Adjuvant Therapy Approval with NMPA
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading biopharmaceutical company based in China, has announced the submission of a market filing application for its epidermal growth factor receptor (EGFR) inhibitor, Ameile (almonertinib), to the National Medical Products Administration (NMPA). The application seeks approval for Ameile as an adjuvant therapy…
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Apeiron Therapeutics Sells Rights to CDK7 Inhibitor GTAEXS617 to Exscientia for USD 30 Million
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Apeiron Therapeutics, a Shanghai-based biopharmaceutical company, has reached an agreement to sell all rights to its oral CDK7 inhibitor GTAEXS617 to Exscientia plc (NASDAQ: EXAI), a US-based AI-driven pharmaceutical company. The total transaction value amounts to USD 30 million, comprising an upfront cash payment of USD 10 million and a…
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Anhui Anke Biotechnology Receives NMPA Clearance for Clinical Trial of mRNA Drug AFN0328 for HPV-Related Cancers
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Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its drug candidate AFN0328. The drug is intended for the treatment of malignant tumors associated with HPV16/18 infection, including cervical…
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Roche’s Genentech Terminates Relay Therapeutics Collaboration for SHP2 Inhibitor
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In a recent development, Roche Inc.’s subsidiary Genentech has given notice of termination for a license and collaboration agreement with Relay Therapeutics Inc., affecting the development of an oral small-molecule Src homology region 2 domain-containing phosphatase-2 (SHP2) inhibitor, RLY-1971, now known as migoprotafib or GDC-1971 . The termination, effective 180…
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Sino Biopharmaceutical’s Anlotinib Achieves Milestones in Phase III Trial for Soft-Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced positive interim data from a Phase III clinical study for its drug anlotinib. The study combines anlotinib with chemotherapy as a first-line treatment for advanced unresectable or metastatic soft-tissue sarcoma. The Independent Data Monitoring Committee (IDMC)…
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Full-Life Technologies Strikes USD 571.5 Million Licensing Deal with SK Biopharmaceuticals for Radiopharmaceutical Asset
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Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has entered into a lucrative licensing agreement with South Korea-based SK Biopharmaceuticals, granting the latter exclusive global rights to develop, manufacture, and commercialize the radiopharmaceutical FL-091. The deal is valued at USD 571.5 million…
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MGI Tech Partners with Predica Diagnostics to Advance RNA Sequencing in Cancer Detection
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MGI Tech Co., Ltd, a leading gene sequencing specialist based in China, has announced a strategic collaboration with Predica Diagnostics, a Netherlands-based company. Under this partnership, MGI will provide support to Predica in the development of targeted RNA sequencing tests utilizing MGI’s next-generation sequencing platforms. While the financial details of…
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BeiGene Receives NMPA Greenlight for BG-C9074 Clinical Trial in Advanced Solid Tumors
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Medical Products Administration (NMPA) in China has approved its clinical filing for the Category 1 pipeline candidate BG-C9074. The antibody drug conjugate (ADC) is set to be initially assessed for the treatment of general advanced solid tumors, marking…
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Celling Biotechnology’s CEL001 Earns Tacit Approval for Clinical Trials in China
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Celling Biotechnology Co., Ltd, a Guangzhou-based biopharmaceutical company, has announced that its pipeline candidate CEL001 has received tacit clinical trial approval in China. The drug candidate is an antibody fusion protein targeting PD-1, TIGIT, and IL-15, and is intended for the treatment of advanced solid tumors, with a particular focus…
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Shenzhen Tyercan Bio-Pharma’s TYE1001 Earns Tacit IND Approval from FDA for Advanced Solid Tumors
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Shenzhen Tyercan Bio-pharm Co., Ltd, a biopharmaceutical company based in China, has announced that it has received tacit Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its anti-tumor drug TYE1001. The drug is intended for the treatment of advanced solid tumors and lymphomas. TYE1001…
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Eisai’s Next-Gen SERD, Orserdu, Begins Real-World Study in Shanghai Ruijin Hospital’s Hainan Subsidiary
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Shanghai Ruijin Hospital’s Hainan subsidiary has initiated a real-world study for Orserdu (elacestrant), a next-generation selective estrogen receptor degrader (SERD) originally developed by Eisai (TYO: 4523). The drug was transferred to Radius Health for global development back in 2006. In a strategic move in July 2020, the Menarini Group, based…
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Oricell Therapeutics’ GPRC5D-Targeted CAR-T Therapy Earns FDA Fast Track for Multiple Myeloma
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Oricell Therapeutics Co., Ltd, a leading biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative therapy, OriCAR-017. This chimeric antigen receptor (CAR)-T cell therapy is targeted at GPRC5D, aiming to treat recurrent refractory multiple myeloma…
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Shanghai Escugen Initiates Phase III Clinical Trial for Breast Cancer Drug Candidate ESG401
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Shanghai Escugen, a biopharmaceutical company based in China, has announced the dosing of the first patient in a Phase III clinical study for its candidate drug ESG401. The study is assessing the efficacy of ESG401 in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-)…
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Ipsen Strikes Global Licensing Deal with Foreseen Biotechnology for First-in-Class ADC FS001
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Ipsen (EPA: IPN; OTCMKTS: IPSEY), a French biopharmaceutical company, has announced a global licensing agreement with Chinese startup Foreseen Biotechnology for the latter’s lead pipeline candidate, FS001. This agreement grants Ipsen exclusive rights to develop, manufacture, and commercialize the antibody-drug conjugate (ADC) on a global scale. As per the terms…
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Sichuan Biokin Pharmaceutical Gets NMPA Approval for BL-M14D1 Clinical Trial in Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody-drug conjugate (ADC), BL-M14D1, intended for the treatment of advanced solid tumors. BL-M14D1 leverages the same…
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Beijing Sun-Novo Gets NMPA Green Light for STC008 Clinical Trial in Tumor Cachexia
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Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its investigational drug candidate STC008. This study will focus on the treatment of tumor cachexia…
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KeChow Pharma’s Keluping, First NRAS Mutant Melanoma Therapy, Hits the Market
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Shanghai-based KeChow Pharma has announced the official market launch of its groundbreaking drug, Keluping (tunlametinib), the world’s first targeted therapy designed specifically for NRAS mutant melanoma. Tunlametinib, a novel ATP noncompetitive MEK inhibitor that targets NRAS mutations, received marketing approval in China in March this year. The drug was granted…
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Allist Pharmaceuticals Faces Arbitration Over Promotion Agreement for Furmonertinib
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Allist Pharmaceuticals Co., Ltd, a Shanghai-based biopharmaceutical company, has announced that it has received a notice of the initiation of arbitration from the Shanghai International Economic and Trade Arbitration Commission. The applicant in this matter is Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA.600196; HKEX.02196), which is seeking the cancellation of…
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Amgen Halts Development of Claudin 6-Targeting BiTE Immune Therapy AMG 794
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company based in the U.S., has decided to halt the development of AMG 794, a half-life extended BiTE (bispecific T-cell engager) immune therapy that targets the oncofetal antigen Claudin 6 (CLDN6). This decision was disclosed on the clinicaltrials.gov website under the identifier NCT05317078,…
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Shanghai Junshi Biosciences’ HDAC Inhibitor JS125 Clinical Trial Application Accepted by NMPA
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for JS125 (WJ47156), a histone deacetylases (HDAC) inhibitor co-developed with Wigen Biomedicine Technology (Shanghai) Co., Ltd. This epigenetic regulator is intended for the treatment…
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GRIT Biotechnology and Quangang Pharmaceutical Co., Ltd Partner to Develop TIL and IL-2 Combination Therapy
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GRIT Biotechnology, a leading cell therapy specialist based in China, has entered into a strategic partnership with compatriot firm Quangang Pharmaceutical Co., Ltd. The collaboration aims to co-develop a combination therapy for solid tumors, leveraging tumor-infiltrating lymphocyte (TIL) therapy and recombination human interleukin-2 (IL-2). Interleukin-2 (IL-2) products, which are already…
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Shandong Buchang Pharmaceuticals Receives NMPA Approval for BC008-1A Biologic Product Clinical Trial
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product BC008-1A. This product is intended for the treatment of glioblastoma and advanced…
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Roche’s Alecensa Secures NMPA Approval as Adjuvant Therapy for Early-Stage NSCLC
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Roche (SWX: RO), the Swiss pharmaceutical giant, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its drug Alecensa (alectinib). This new indication is for use as a post-surgery adjuvant therapy in patients with stage 1B to stage IIIA non-small cell…
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Hinova Pharmaceuticals’ HP537 Receives FDA Approval for Phase I/II Clinical Trial in Hematologic Malignancies
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical study for its drug candidate HP537 in the treatment of hematologic malignancies. The Category 1 chemical had previously…
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Roche’s Tiragolumab Misses Primary Endpoints in NSCLC Trial, Study Halted
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Roche (SWX: ROG; SWX: RO; OTCMKTS: RHHBY), the Swiss pharmaceutical giant, has announced that a Phase II/III clinical trial for its TIGIT-targeted antibody tiragolumab, designed for non-small cell lung cancer (NSCLC), did not outperform Keytruda (pembrolizumab), a PD-1 inhibitor. The trial, known as SKYSCRAPER-06, was evaluating the efficacy of tiragolumab…
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Medigene AG Secures Chinese Patent for TCR-T Therapy Targeting NY-ESO-1 and LAGE 1a
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Medigene AG (ETR: MDG1), a biopharmaceutical company based in Germany, has announced that it has been granted patent protection in China for its T cell receptor (TCR) technology targeting NY-ESO-1 and LAGE 1a. This development pertains to the company’s lead pipeline candidate, MDG1015, which is a first-in-class, third-generation TCR-T therapy.…
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J&J’s Rybrevant Earns First-Line NSCLC Approval in Canada, a Milestone for EGFR Exon 20 Patients
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that Rybrevant (amivantamab) has received its first market approval in Canada. The drug is approved as a first-line treatment in combination with chemotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating epidermal growth factor receptor (EGFR) Exon…
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Ascentage Pharma Receives USD 100 Million Option Rights Payment from Takeda
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received a USD 100 million option rights payment from its Japanese partner Takeda (TYO: 4502), in accordance with an exclusive option agreement signed earlier last month. In June 2024, Takeda and Ascentage entered into an…
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HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
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HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for Tazverik (tazemetostat) for review. The company is seeking initial approval for Tazverik as a treatment for recurrent or refractory follicular lymphoma (FL), and the filing has been…
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CStone Pharmaceuticals Partners with Hengrui for Promotion of Ayvakit in China
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced a licensing agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), another Chinese pharmaceutical firm. The agreement grants Hengrui exclusive promotion rights to Ayvakit (avapritinib), CStone’s precision therapy, in mainland China. CStone maintains all rights to Ayvakit in…
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Astellas Pharma’s Xtandi Secures Third Market Approval in China for Prostate Cancer Treatment
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it has secured market approval in China for a new indication of its drug Xtandi (enzalutamide), marking its third such approval in the country. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer…
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Jiangsu Vcare Pharma Partners with Geneseeq Technology to Develop Companion Diagnostic for NTRK Inhibitor
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Jiangsu Vcare PharmaTech Co., Ltd, a biopharmaceutical company based in China, has entered into a partnership with Sino-Canadian firm Geneseeq Technology Inc. The collaboration aims to jointly develop and commercialize a companion diagnostic (CDx) reagent for Vcare’s NTRK inhibitor VC004. Financial details of the agreement were not disclosed. Preliminary clinical…
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Bristol-Myers Squibb Ends Collaboration with Eisai on Farletuzumab Eteribulin
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Bristol-Myers Squibb (BMS; NYSE: BMY), a prominent US pharmaceutical company, has decided to terminate its collaboration with Japanese pharmaceutical firm Eisai Co., Ltd, which was focused on the co-development of Eisai’s antibody drug conjugate (ADC) farletuzumab ecteribulin (FZEC; MORAb-202). According to a press release from Eisai, BMS’s decision is part…
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Tracon Pharmaceuticals Halts Development of Envafolimab After Clinical Trial Failure
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Tracon Pharmaceuticals (OTCMKTS: TCON), a US-based biopharmaceutical company, has decided to cease development of its programmed death-ligand 1 (PD-L1) inhibitor, envafolimab, following disappointing results from a clinical trial. The company had obtained the rights to develop this molecule for soft-tissue sarcomas in North America through a 2019 agreement with China’s…
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SCG Cell Therapy Receives FDA Approval for HPV-Targeted SCG142 Clinical Trial
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SCG Cell Therapy Pte. Ltd, a Singapore-headquartered biotechnology company with a presence in Shanghai, has announced that it has received clearance from the US Food and Drug Administration (FDA) to proceed with a Phase I/II clinical study for its investigational therapy, SCG142. This therapy is a human papillomavirus (HPV) specific…
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Moon Biotech Secures Exclusive State-Owned Fund Investment in Series C+ Round
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Moon (Guangzhou) Biotech Co., Ltd, a leading microbiome platform company based in China, has reportedly secured RMB 300 million (USD 41.3 million) in a Series C+ financing round. The funding was exclusively provided by SDIC JULI Investment, a state-owned investment fund. Established in 2015, Moon is recognized for possessing the…
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China’s Henlius Biotech Partners with Sermonix for Japan Development of Breast Cancer Drug
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Shanghai Henlius Biotech Inc. (HKG: 2696), a prominent biopharmaceutical company based in China, has announced an expansion of its licensing agreement with Sermonix Pharmaceuticals Inc., to include additional territories in Asia for the development and commercialization of HLX78 (oral lasofoxifene). This supplementary agreement facilitates a co-development partnership between Henlius and…
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Healthcare Firms Line Up for HKEX IPOs as Biotech Market Recovery Gains Momentum
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A number of healthcare companies are seeking to capitalize on the recovering market conditions by filing for initial public offerings (IPOs) on the Hong Kong Stock Exchange (HKEX), a venue that has been gaining traction among life sciences companies for their public listings. According to the HKEX website, recent IPO…
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Hinova Pharmaceuticals’ HP518 Earns FDA Fast-Track Designation for AR+ Triple Negative Breast Cancer
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Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate HP518 for the treatment of androgen receptor (AR)-positive triple negative breast cancer (TNBC). The Category 1 innovative drug candidate, HP518,…
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Gloria Bio’s Motixafortide Approved as Urgently Needed Import Drug by Hainan Medical Products Administration
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Guangzhou Gloria Biosciences Co., Ltd, a biopharmaceutical company based in China, has received approval from the Hainan Medical Products Administration for its CXCR4 antagonist motixafortide (BL-8040) as a special drug for import due to clinical urgency. The drug will be implemented and administered by Hainan Boao Lu Medical Hospital, a…
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BeiGene’s Tislelizumab Approved by China’s NMPA for First-Line Extensive Stage Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a biopharmaceutical company, has announced that its programmed-death (PD)-1 monoclonal antibody (mAb), tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China. The drug is now approved to be used in combination with chemotherapy for the treatment of patients with…
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Grand Pharmaceutical Group Ltd’s SIR-Spheres Set to Reach Wider Patient Base Through MediTrust Health Deal
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced a strategic partnership with MediTrust Health, an insurance, financing, and direct-to-patient pharmacy subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. This collaboration will focus on integrating Grand Pharma’s 90Y product into various commercial insurance schemes, aiming…
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IASO Biotherapeutics’ RD118 CAR-T Therapy Receives Clinical Trial Approval for Multiple Myeloma
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that it has received tacit clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy, RD118. RD118 is a fully human GPRC5D-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed/refractory multiple myeloma (r/r…
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CSPC Pharmaceutical’s Enronsubaimab Gets NMPA Nod for Recurrent Cervical Cancer
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) of China has approved its market approval filing for enronsubaimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb). The drug is indicated for the treatment of recurrent or metastatic…
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Genmab and AbbVie’s Epcoritamab Earns FDA Accelerated Approval for Follicular Lymphoma
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Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
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Novo Nordisk Moves to Acquire 2seventy bio’s Hemophilia A Program and Gene-Editing Technology
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Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a leading Danish biopharmaceutical company, is transitioning from a partnership to an acquisition deal with U.S. biotech firm 2seventy bio Inc. (NASDAQ: TSVT) for the development of a hemophilia A drug candidate. The companies have entered into an asset purchase agreement that will see…
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Abbisko Therapeutics Presents Positive Phase II Results for HCC Treatment at ESMO-GI
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotech company, has announced the presentation of Phase II study results for its irpagratinib in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) at the 2024 ESMO-GI annual meeting. Irpagratinib, a novel FGFR4 inhibitor discovered and developed by Abbisko,…
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Dizal Pharmaceutical’s Golidocitinib Breaks Record with Rapid Market Launch in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has seen its drug golidocitinib go from marketing approval to first prescriptions in a record time of just two days in China. This marks a significant milestone, as golidocitinib is the first and only approved Janus kinase 1…
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Amoy Diagnostics Partners with Servier to Develop Companion Diagnostic Reagent for IDH Mutations in China
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China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has entered into a partnership with French pharmaceutical company Servier to co-develop a companion diagnostic (CDx) reagent in China. This reagent is designed for detecting mutations in the isocitrate dehydrogenase (IDH) 1 and 2 genes. The product will complement Servier’s vorasidenib, which…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment…
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Antengene’s Xpovio Included in South Korea’s NHIS Reimbursement Drug List
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that South Korea’s National Health Insurance Service (NHIS) has included its drug Xpovio (selinexor) in the medical insurance reimbursement drug list, effective from July 1, 2024. The drug is indicated for the treatment of adult patients with…
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Novartis’s Scemblix STAMP Inhibitor for CML Accepted for Review by China’s NMPA
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its market filing for Scemblix (asciminib) accepted for review by China’s National Medical Products Administration (NMPA). Scemblix is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor, which is filed for the treatment of chronic myeloid leukemia (CML). As the world’s…
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Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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AstraZeneca’s Tagrisso Wins NMPA Approval for First-Line EGFR-mutated NSCLC Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI). The drug is now approved for use in combination with chemotherapy as a first-line treatment for…
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CSPC Pharmaceutical’s BCMA-Targeted CAR-T Therapy SYS6020 Receives NMPA Clinical Trial Approval
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for SYS6020, a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy. This marks a significant milestone for the company as SYS6020 is…
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Jiangsu Simcere Pharmaceutical Wins NMPA Nod for Biosimilar Version of Erbitux
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for CMAB009, a biosimilar of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab, which is marketed under the trade name Erbitux. The EGFR-targeted monoclonal antibody (mAb) was…
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J&J’s Tecvayli Earns NMPA Approval for Relapsed or Refractory Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S. healthcare company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Tecvayli (teclistamab) for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have received three or…
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Staidson Pharmaceutical Gets FDA Clearance for TNFR2-Targeted mAb SBT-1901
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its TNFR2-targeted monoclonal antibody (mAb), SBT-1901, for the treatment of locally advanced or metastatic solid tumors. Preclinical studies have demonstrated…
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Shanghai Haihe Pharmaceutical’s Glumetinib Earns Marketing Approval in Japan for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd, a Chinese pharmaceutical company, has announced that it has received marketing approval in Japan for its MET targeted tyrosine kinase inhibitor (TKI), glumetinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET 14 exon mutation. The approval is…
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Takeda’s Fruquintinib for Metastatic Colorectal Cancer Receives European Commission Marketing Approval
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its partner Takeda (TYO: 4502, NYSE: TAK) has received marketing approval from the European Commission for fruquintinib, a treatment for adult patients with metastatic colorectal cancer (CRC) who have previously been treated with chemotherapy regimens based on fluorouracil, oxaliplatin, and…
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Shanghai Pharmaceuticals’ Subsidiary Shaphar Med Collaborates with Magic Med to Enter Oncology
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Shanghai Pharmaceuticals Holding Co., Ltd (SPH, SHA: 601607; HKG: 2607), a leading pharmaceutical company in China, has announced that its subsidiary, Shaphar Medical Instruments (Shanghai) Co., Ltd, has entered into a partnership with Magic Med, a Chinese firm. This strategic collaboration signifies Shaphar Med’s inaugural venture into the oncology sector.…
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Sichuan Biokin Pharmaceutical Gets NMPA Go-Ahead for BL-M17D1 Solid Tumor Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bispecific antibody drug conjugate (ADC), BL-M17D1, which is designed for the treatment of advanced solid tumors.…
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Zhangzhou Pien Tze Huang’s PZH2113 Receives NMPA Clinical Trial Approval for Lymphoma Treatment
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Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436), a renowned traditional Chinese medicine (TCM) company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its PZH2113. This is an in-house developed Category 1 chemical drug intended for the treatment…
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Novartis Moves Toward Full Ownership of MorphoSys with Shareholder Squeeze-Out
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Novartis AG (NYSE: NVS), the Swiss pharmaceutical giant, is proceeding to fully acquire MorphoSys AG (OTCMKTS: MPSYF) by initiating a squeeze-out of its minority shareholders. Novartis had made a public takeover offer of EUR 68 per share, valuing the company at an aggregate EUR 2.7 billion (USD 2.9 billion), in…
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Keymed Biosciences’ CM313 Shows Promise in Treating Immune Thrombocytopenia, NEJM Study Says
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Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has published results from an exploratory clinical study on its Category 1 drug CM313 in the New England Journal of Medicine. CM313 is a CD38-targeted monoclonal antibody (mAb) being investigated for the treatment of primary immune thrombocytopenia (ITP). The…
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Xencor Reclaims Rights to Plamotamab After Janssen Halts Development
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Xencor Inc. (NASDAQ: XNCR), a U.S.-based biotechnology company, has announced that Johnson & Johnson (J&J, NYSE: JNJ)’s Janssen Biotech Inc. has opted not to proceed with the development of the bispecific T-cell engager plamotamab. As a result, Xencor regains exclusive global rights to the molecule, a CD20 x CD3 bispecific…
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Day One Biopharmaceuticals Expands Pipeline with MabCare Therapeutics Licensing Deal
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Day One Biopharmaceuticals (NASDAQ: DAWN), a California-based biotech company that recently celebrated its first drug approval, has announced an expansion of its pipeline through a licensing agreement with Shanghai-based MabCare Therapeutics. Day One will acquire exclusive development, manufacturing, and commercialization rights to MTX-13, an antibody-drug conjugate (ADC) targeting protein-tyrosine kinase…
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AstraZeneca’s AKT Inhibitor Truqap Misses Primary Endpoints in Phase III TNBC Trial
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AstraZeneca (NASDAQ: AZN), a leading UK-based pharmaceutical company, has encountered a setback in the Phase III clinical trial for its first-in-class adenosine triphosphate (ATP)-competitive AKT inhibitor, Truqap (capivasertib). The trial, known as CAPItelo-290, failed to meet its dual primary endpoints of improved overall survival (OS) in both the overall trial…
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Envonalkib, Chia Tai Tianqing’s Next-Gen ALK Inhibitor, Wins NMPA Approval for Untreated ALK+ NSCLC
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Chia Tai Tianqing’s next-generation ALK inhibitor, envonalkib, has received approval from the National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive for anaplastic lymphoma kinase (ALK) and have not been previously treated with ALK inhibitors. A…
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Ascentage Pharma Presents Positive Clinical Results for Olverembatinib and Lisaftoclax at EHA Meeting
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has presented the results of multiple clinical trials for two of its pipeline candidates at the 29th European Hematology Association (EHA) Annual Meeting. The candidates are olverembatinib, a Category 1 drug and approved BCR-ABL inhibitor, and the investigational BCL-2 inhibitor…
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Nanjing Sanhome’s Oritinib Wins NMPA Approval for EGFR T790M Positive NSCLC
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Nanjing Sanhome Pharmaceutical Co., Ltd has received approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug oritinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for EGFR T790M mutation in patients who have confirmed disease progression during or…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for Breast Cancer Drug Combo
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Jiangsu Hengrui Medicine (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate HRS7415 in combination with HRS-8080 for the treatment of breast cancer. HRS7415 is an anti-tumor agent that works by…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Phase II Trial in Pancreatic Cancer
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 innovative drug, chiauranib. The drug will be evaluated in combination with chemotherapy…
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Sichuan Kelun-Biotech Receives NMPA Clearance for SKB518 Clinical Trial in Solid Tumors
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received clearance from the National Medical Products Administration (NMPA) in China for a clinical trial filing of its pipeline candidate, SKB518. The novel antibody-drug conjugate (ADC) is slated for assessment in patients with general advanced solid tumors. Developed…
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BioNTech and MediLink’s HER3 ADC BNT326 Faces Partial Clinical Hold in the US
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BioNTech SE (NASDAQ: BNTX), a German biotechnology company, and its Chinese co-development partner MediLink Therapeutics (Suzhou) Co., Ltd, are facing a partial clinical hold in the U.S. for Phase I development of the HER3-targeted antibody drug conjugate (ADC) BNT326/YL202. The U.S. Food and Drug Administration (FDA) has decided to pause…
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Amgen’s Blincyto Secures New Indication Approval for B-ALL Consolidation Treatment in the US
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Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received a new indication approval from the U.S. Food and Drug Administration (FDA) for the U.S. market. The drug is now approved for the treatment of adult and pediatric patients aged one month or older with…
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MSD’s Keytruda Secures FDA Approval for Advanced or Recurrent Endometrial Carcinoma
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted an additional indication for its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab). The drug is now approved for use in combination with chemotherapy for adults with primary advanced or recurrent endometrial carcinoma,…
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FDA Approves Broadened Use of BMS’ Next-Gen TKI Augtyro for Advanced Solid Tumors
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an accelerated approval for its next-generation tyrosine kinase inhibitor (TKI), Augtyro (repotrectinib), for the treatment of locally advanced, metastatic, or unresectable NTRK fusion-positive solid tumors. This decision follows the drug’s progression after treatment or in…
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Innovent Biologics’ IBI363 Shows Promising Results in Phase Ia/Ib Trial for Advanced Solid Tumors
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced the results of a Phase Ia/Ib clinical trial for its investigational PD-1/IL-2 bispecific antibody fusion protein, IBI363. The study’s findings were presented at the European Society for Medical Oncology (ESMO) Annual Congress 2024, highlighting the molecule’s…
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Innovent Biologics’ CLDN18.2-Targeted ADC IBI343 Earns FDA Fast-Track Status
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the US Food and Drug Administration (FDA) has granted Fast-Track designation to its antibody-drug conjugate (ADC), IBI343. This CLDN18.2-targeted therapy has been previously cleared for clinical studies in patients with advanced unresectable or metastatic pancreatic…
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Haisco Pharmaceutical’s BRAF Inhibitor HSK42360 Gains NMPA Approval for Clinical Trials
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a leading pharmaceutical company based in China, has announced that it has secured another clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HSK42360. This BRAF V600 inhibitor is now poised to be evaluated in clinical trials for…
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Junshi Biosciences’ Toripalimab Scores New Indication for First-Line ES-SCLC Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced an expansion of indications for its immunotherapy drug Loqtorzi (toripalimab) following approval from China’s National Medical Products Administration (NMPA). The programmed death-1 (PD-1) inhibitor is now approved for use in combination with chemotherapy for the first-line treatment of patients…
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Junshi Biosciences’ Toripalimab-Bevacizumab Combo Meets Primary Endpoints in HCC Phase III Trial
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has declared a significant milestone with its multi-center, randomized Phase III HEPATORCH study. The trial evaluated the combination of Loqtorzi (toripalimab) with bevacizumab for first-line treatment of advanced hepatocellular carcinoma (HCC) and successfully met its primary endpoints, which included progression-free survival…
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Sino Biopharmaceutical’s KRAS Inhibitor Garsorasib Earns Breakthrough Designation in China
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Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has announced that its candidate garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd, has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation covers two indications: the treatment of…
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Bayer’s HER2 Targeting Drug BAY 2927088 Earns Breakthrough Designation in China
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The Center for Drug Evaluation (CDE) in China has granted Breakthrough Therapy Designation (BTD) to German pharmaceutical giant Bayer (ETR: BAYN)’s drug candidate BAY 2927088 for the treatment of HER2 mutant non-small cell lung cancer (NSCLC), as indicated on the CDE’s official website. This marks a significant regulatory milestone for…
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Novartis’s Tabrecta Earns NMPA Nod for MET-Positive Advanced NSCLC in China
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Swiss pharmaceutical titan Novartis has secured marketing approval from China’s National Medical Products Administration (NMPA) for its drug Tabrecta (capmatinib), intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a mesenchymal–epithelial transition (MET) exon 14 skipping mutation, who have not received…
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Shanghai Pharmaceuticals Halts Development of B001 and I022 for Selected Indications
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced the discontinuation of clinical studies and further development for its drug candidates B001, B001-A, I022, and I022-K. B001, a monoclonal antibody (mAb) intended for the treatment of CD20-positive B-cell non-Hodgkin’s lymphoma (B-NHL), has been suspended following the completion of Phase I,…
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MSD Makes Undisclosed Equity Investment in Cancer Diagnostics Firm DELFI Diagnostics
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an equity investment into DELFI Diagnostics, a U.S.-based developer of blood-based cancer tests, without disclosing the financial terms. The investment will enable DELFI to further develop its fragmentomics and artificial intelligence technologies, enhancing early cancer detection and treatment monitoring. DELFI’s proprietary…
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Qilu Pharmaceutical’s Generic Pomalidomide Wins NMPA Nod for Multiple Myeloma Treatment
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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its generic version of Celgene’s pomalidomide, expanding treatment options for multiple myeloma patients in China. This drug, a derivative of the immunomodulator thalidomide, is recognized for its anti-tumor efficacy. It…
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HutchMed Initiates Phase I Clinical Trial for HMPL-506 in Hematologic Malignancies
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HutchMed (HKG: 0013, NASDAQ: HCM) has announced the commencement of a Phase I clinical study for its investigational compound HMPL-506 in China, with the first patient having already been dosed. The molecule is being evaluated as a potential treatment for various hematologic malignancies. This multi-center, open-label Phase I study is…
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Sino Biopharmaceutical Presents FS222 Phase I Results at ASCO Annual Meeting
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Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has presented updates from a Phase I clinical trial for its tetravalent bispecific antibody (BsAb), FS222, at the American Society of Clinical Oncology (ASCO) annual meeting. The study focuses on the use of FS222 in treating advanced solid tumors…
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Jiangsu Hengrui’s HER2 Targeted ADC SHR-A1811 Poised to Earn Breakthrough Designation in China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2…
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Rightongene Bio Receives NMPA Approval for BCR-ABL P210 Fusion Gene Detection Kit
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Shanghai Rightongene Biotechnology Co., Ltd (SHA: 688217), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its BCR-ABL P210 fusion gene detection kit, which uses the fluorescence reverse transcription polymerase chain reaction (RT-PCR) method. The kit is…
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Bristol Myers Squibb’s Breyanzi Shows Promising Results in Three Lymphoma Trials
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced results from three distinct clinical trials assessing the efficacy of its CAR-T therapy Breyanzi (lisocabtagene maraleucel) in treating patients with relapsed or refractory large B-cell lymphoma (LBCL), mantle cell lymphoma (MCL), and relapsed or refractory follicular lymphoma (FL). In a placebo-controlled, late-stage…
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InnoCare’s Tafasitamab-Lenalidomide Combo on Track for Priority Review in China for DLBCL Treatment
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The Center for Drug Evaluation (CDE) website has indicated that InnoCare (HKG: 9969; SHA: 688428), a biopharmaceutical company based in China, is on track to receive priority review status for its drug candidate Minjuvi (tafasitamab) in combination with lenalidomide. This treatment is intended for adult patients with recurrent or refractory…
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Jiangsu Hengrui Receives NMPA Approval to Begin Clinical Trials for New Anticancer Biologic
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational SHR-4849 injection. The therapy is intended for the treatment of advanced malignant solid tumors. The biologic preparation,…
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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Cleared for Clinical Trials by China’s NMPA
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Huadong Medicine Co., Ltd (SHE: 000963), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for HDM2005, an antibody-drug conjugate (ADC) that targets the recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1). The molecule…
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Gilead and Arcus Biosciences Report Positive Combination Therapy Results in mCRC Trial
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Biopharmaceutical companies Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced safety and efficacy data from a Phase Ib/II clinical trial for a combination therapy in third-line metastatic colorectal cancer (mCRC). The trial evaluated the combination of adenosine receptor antagonist etrumadenant, anti-PD-1 drug zimberelimab, VEGF inhibitor bevacizumab, and chemotherapy…
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AstraZeneca’s Tagrisso Achieves Milestone Progression-Free Survival in Late-Stage Lung Cancer Study
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has announced preliminary results from a late-stage study for its EGFR inhibitor, Tagrisso (osimertinib), in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) characterized by exon 19 deletions or exon 21 mutations. The trial successfully met its…
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Varian Medical Gets China Approval for Fourth-Generation Halcyon Radiotherapy System
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Varian Medical Systems (NYSE: VAR), a US-based leader in cancer treatment technology, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its fourth-generation Halcyon radiotherapy platform. The Halcyon system is a circular rack radiotherapy platform designed to deliver efficient image-guided automated radiation therapy.-…
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CSPC Pharmaceutical Secures NMPA Nod for Generic Version of AstraZeneca’s Lynparza
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of AstraZeneca’s PARP inhibitor Lynparza (olaparib). This marks CSPC Pharmaceutical’s entry into the segment with the third generic…
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Akeso Biopharma’s Ivonescimab Outshines Keytruda in NSCLC Trial, Raises FDA Concerns
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FiercePharma.com has reported on the reactions of multinational corporation executives to the recent news that Akeso Biopharma (HKG: 9926) and partner Summit Therapeutics’ ivonescimab, a PD-1/VEGF bispecific antibody (BsAb), has become the first molecule to outperform Merck Sharp & Dohme’s (MSD) leading PD-1 therapy Keytruda (pembrolizumab) in a head-to-head trial…
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Eli Lilly’s KRAS Inhibitor Olomorasib Shows Promise in Phase I/II Trial for Advanced Solid Tumors
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Eli Lilly and Company (NYSE: LLY) has presented an update on a Phase I/II clinical trial for its KRAS inhibitor, olomorasib, in patients with KRAS G12C-mutant advanced solid tumors. The trial also explores the combination of olomorasib with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) top-selling checkpoint inhibitor, Keytruda (pembrolizumab),…
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Bristol Myers Squibb’s Krazati Meets Primary Endpoint in Late-Stage Lung Cancer Study
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage study for its KRAS inhibitor, Krazati (adagrasib), has successfully met its primary endpoint in patients with previously treated locally advanced or metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC). The study demonstrated that Krazati increased median progression-free survival (PFS) from…
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Pfizer’s Lorbrena Outperforms Xalkori in 5-Year ALK-Positive NSCLC Follow-Up
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Pfizer Inc. (NYSE: PFE) has announced the release of five-year follow-up data for its kinase inhibitor Lorbrena/Lorviqua (lorlatinib) in untreated ALK-positive advanced non-small cell lung cancer (NSCLC). The data revealed that Lorbrena demonstrated an 81% reduction in the rate of disease progression or death compared to Xalkori (crizotinib), and increased…
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Innovent Biologics Presents Clinical Data for Pipeline Candidates at ASCO 2024
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, presented updates on several pipeline candidates at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. IBI343 Phase I Study:The study of IBI343, a CLDN18.2 antibody-drug conjugate (ADC), for advanced pancreatic ductal adenocarcinoma or biliary tract cancer (BTC),…
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Gilead’s Trodelvy Misses Overall Survival Endpoint in Late-Stage Urothelial Cancer Study
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Gilead (NASDAQ: GILD) has announced that a late-stage study for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) did not meet the primary endpoint of overall survival (OS) in patients with previously treated locally advanced or metastatic urothelial cancer (mUC). This result casts uncertainty over the drug’s accelerated approval indication in…
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Chipscreen’s Chidamide in Sight of Breakthrough Therapy Designation in China for MSS/pMMR Colorectal Cancer
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Shenzhen Chipscreen Pharmaceutical Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that its drug Epidaza (chidamide) is on track to receive a breakthrough therapy designation (BTD) in China. The potential designation is for the use of chidamide in combination with PD-1 inhibitor sintilimab and bevacizumab for…
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CStone Pharmaceuticals’ Sugemalimab Receives Positive CHMP Opinion for NSCLC Treatment in Europe
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of sugemalimab in combination with chemotherapy as a first-line…
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FDA Extends Indication for BMS’ CAR-T Therapy Breyanzi to Include Relapsed MCL in Adults
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). The therapy is now approved as a treatment for relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two…
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Novartis Halts Development of KRAS Inhibitor Opnurasib Due to Competitive Market
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Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has reportedly halted the development of its Phase III KRAS inhibitor candidate, opnurasib, citing an increasingly competitive landscape in the sector. The drug was under development for the treatment of solid tumors, including non-small cell lung cancer (NSCLC). This decision comes in the…
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Burning Rock Expands Companion Diagnostics Partnership with Bayer for Precision Oncology in China
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Burning Rock Ltd (NASDAQ: BNR), a China-based medical technology company, has announced another partnership in the field of tumor companion diagnostics (CDx), this time with the German multinational corporation, Bayer. Previously Burning Rock had collaborated with Germany-based Merck KGaA in late 2021 for the development of CDx to support Merck’s…
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Laekna Therapeutics Initiates Phase III Trial for Breast Cancer Candidate LAE002 in Combination with Fulvestrant
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its pipeline candidate LAE002 (afuresertib) in combination with fulvestrant. This new treatment regimen targets HR+/HER2- locally advanced or metastatic breast cancer. The multi-center, randomized,…
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Gilead Partners with Cartography Biosciences to Develop Therapies for Triple-Negative Breast Cancer
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Gilead Sciences (NASDAQ: GILD) has entered into a collaboration agreement with Cartography Biosciences, a US-based biotechnology company, to discover and develop novel therapies for triple-negative breast cancer (TNBC) and adenocarcinoma. Cartography will leverage its computational and genomics platform to identify and validate target antigens and pairs of antigens in cancer,…
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Alphamab Oncology’s KN046 Misses Primary Endpoint in Phase III Pancreatic Cancer Study
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced disappointing results from the Phase III KN046-303 study for its bispecific antibody (BsAb) KN046. The drug, which targets both programmed cell death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), failed to meet its primary endpoint when used in…
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Yantai Dongcheng Pharmaceutical Receives NMPA Approval for SSTR2 Targeted Radioactive Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate, 177LuLNC1010. This investigational therapy is a somatostatin receptor 2 (SSTR2) targeted radioactive drug designed for the…
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Jiangsu Hengrui’s SHR-A1921 Anticipated to Gain NMPA Breakthrough Designation for Ovarian Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its drug candidate SHR-A1921 is on track to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. SHR-A1921 is an antibody…
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Bio-Thera Solutions Receives NMPA Approval for BAT6005 and BAT1308 Combination Therapy Trial
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidates BAT6005 in combination with BAT1308 for the treatment of locally advanced or metastatic solid tumors. BAT6005…
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Shanghai Fosun Pharma’s FCN-159 File for Dendritic and Histiocytic Tumors Accepted by China’s NMPA
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for the novel small-molecule drug FCN-159 for review. The drug is being considered for the treatment of dendritic and histiocytic tumors, indications that have previously…
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CStone Pharmaceuticals Expands European Reach with Ewopharma Partnership for Sugemalimab
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced a strategic partnership with Ewopharma, granting the European firm commercialization rights to its programmed death-ligand 1 (PD-L1) inhibitor sugemalimab across Switzerland and 18 Central and Eastern European Countries (CEECs). The CEECs include EU member states such as Bulgaria,…
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Chinese Pharma Companies Set to Showcase Cancer Treatments at ASCO 2024
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The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 to June 4 in Chicago, will feature updates from Chinese pharmaceutical companies Ascentage Pharma (HKG: 6855), Lepu Biotechnology Co., Ltd (HKG: 2157), Transcenta Holding Ltd, and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) on their…
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Bristol Myers Squibb Invests in UK Immuno-Oncology Firm NeoPhore’s Series B Extension Round
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Bristol Myers Squibb (BMS; NYSE: BMY) has participated in an oversubscribed Series B extension round for NeoPhore, a UK-based immuno-oncology company. The funds will be utilized by NeoPhore to advance its pre-clinical studies, with the goal of delivering a small-molecule candidate by 2025. The specific amount invested by BMS was…
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Sandoz Receives European Commission Approval for Biosimilars Wyost and Jubbonti
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The European Commission (EC) has granted registration approval to Sandoz, a Switzerland-headquartered pharmaceutical company (SWX: SDZ), for its biosimilars Wyost and Jubbonti. These products are reference treatments for Amgen’s (NASDAQ: AMGN) bone treatments Xgeva (denosumab) and Prolia (denosumab), respectively. Sandoz anticipates launching the biosimilars in November 2025. Wyost is indicated…
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RemeGen’s Disitamab Vedotin on Track for Breakthrough Designation in Muscle Invasive Bladder Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression,…
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Sino Biopharmaceutical’s Benmelstobart Shows Positive Results in RCC Combination Therapy Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced positive interim analysis results from a Phase III clinical study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) in combination with anlotinib for the treatment of advanced unresectable or metastatic renal cell carcinoma…
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Eli Lilly Partners with Aktis Oncology to Advance Cancer Radiopharmaceuticals
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Eli Lilly and Company (NYSE: LLY) has announced a strategic partnership with Aktis Oncology, a US-based developer of anticancer radiopharmaceuticals, to co-develop first-in-class treatments for solid tumors and diagnostic products. Under the terms of the agreement, Aktis is set to receive an upfront payment of USD 60 million, a significant…
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MSD Partners with Dragonfly Therapeutics to Combine Keytruda with NK Cell Engager in Cancer Treatment
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Merck, Sharp & Dohme (MSD; NYSE: MRK), the producer of the leading checkpoint inhibitor Keytruda (pembrolizumab), has entered into a collaborative agreement with Dragonfly Therapeutics for the combination therapy of Keytruda and Dragonfly’s tri-specific natural killer (NK) cell engager, DF9001. The partnership aims to explore treatment options for advanced solid…
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Alvotech and Dr. Reddy’s Partner to Challenge Amgen’s Denosumab with Biosimilar AVT03
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Amgen’s (NASDAQ: AMGN) dominance in the bone treatment market with its blockbuster drugs Xgeva and Prolia (denosumab) may face a new challenge as Alvotech (NASDAQ: ALVO), an Iceland-based biopharmaceutical company, has licensed its biosimilar candidate AVT03 to India’s Dr. Reddy’s Laboratories (NYSE: RDY) for the European and US markets. This…
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NK CellTech’s NK-Cell Therapy Gets Green Light from China’s NMPA for Solid Tumor Treatment
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NK CellTech, a Shanghai-based developer of natural killer (NK) cell therapies, has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its proprietary genetically modified NK-cell therapy. This marks a significant milestone as the company’s molecule is set to be assessed as a treatment…
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Laekna Therapeutics’ mCRPC Drug Combo Advances to Phase III with FDA Approval
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its drug combination LAE001 and LAE002 (afuresertib) in patients with metastatic castration-resistant prostate cancer (mCRPC) who…
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Amoy Diagnostics Teams Up with Boehringer Ingelheim for CDx Developmen
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in China’s tumor precision medicine space, has entered into a strategic collaboration with Germany’s Boehringer Ingelheim to advance the development of companion diagnostics (CDx). The partnership is aimed at identifying non-small cell lung cancer (NSCLC) patients who are most likely…
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Jiangsu Hengrui’s Fluzoparib Gains NMPA Approval as Maintenance Therapy for Ovarian Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has approved a new indication for its PARP inhibitor, fluzoparib. The drug is now approved for use as a maintenance therapy in patients with advanced epithelial ovarian cancer,…
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Sichuan Biokin’s BL-B01D1 Advances to Phase III for HR+/HER2- Breast Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its investigational bispecific antibody-drug conjugate (ADC), BL-B01D1. This in-house developed molecule is designed to target locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. The…
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Alphamab Oncology’s JSKN016 Begins Phase I Clinical Trial for Solid Tumor Treatment
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical study for JSKN016, its innovative antibody-drug conjugate (ADC) targeting both HER3 and TROP2 in patients with solid tumors. The open-label, multi-center Phase I study is designed to conduct a…
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Jacobio Pharma’s Gecirasib Gets Priority Review for NSCLC Treatment by China’s NMPA
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Jacobio Pharma (HKG: 1167), a leading biopharmaceutical company based in China, has announced that its New Drug Application (NDA) for glecirasib has been accepted by China’s National Medical Products Administration (NMPA) with priority review status. The KRAS G12C inhibitor is being reviewed for its potential as a treatment for second-line…
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Shanghai Fosun Pharma’s FCN-159 Receives Priority Review for Pediatric Neurofibromatosis Treatment
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has achieved a significant milestone with its novel small-molecule chemical drug FCN-159, as indicated on the Center for Drug Evaluation’s (CDE) website. The drug has been granted priority review status for the treatment of plexiform neurofibroma (PN) in children aged…
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Jiayue Pharmaceutical’s JYP0015 Secures $365 Million Licensing Agreement with Erasca
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Guangzhou Jiayue Pharmaceutical Technology Co., Ltd, a Chinese pharmaceutical company, has entered into a licensing agreement with Erasca (NASDAQ: ERAS), a US-based biopharmaceutical company. Under the terms of this agreement, Erasca has been granted exclusive rights to research, develop, and commercialize Jiayue Pharma’s pan-RAS (ON) inhibitor, JYP0015, excluding China mainland,…
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FDA Gives Accelerated Nod to Amgen’s Imdelltra in Small Cell Lung Cancer
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The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN) for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has proven unresponsive to chemotherapy. This accelerated approval is based on early Phase II data highlighting…
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Shanghai UniCAR-Therapy’s Innovative CAR-T Therapy Targets Breakthrough Designation with IL-6 Silencing
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Shanghai UniCAR-Therapy Bio-Medicine Technology Co., Ltd, a leading biopharmaceutical company based in China, is on track to secure breakthrough therapy designation (BTD) for its innovative autologous CD19 targeted chimeric antigen receptor (CAR) T-cell therapy. This therapy features a unique function of silencing interleukin-6 (IL-6) expression and is intended for the…
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Bayer’s 225Ac-PSMA-Trillium Therapy Begins Early-Stage Clinical Trial for mCRPC
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Bayer AG (ETR: BAYN), a multinational pharmaceutical company based in Germany, has this week commenced an early-stage trial for its targeted radionuclide therapy, 225Ac-PSMA-Trillium. The trial is focused on treating advanced metastatic castration-resistant prostate cancer (mCRPC). This innovative therapeutic candidate incorporates a PSMA-targeting small molecule designed to deliver an alpha…
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Merck KGaA Subsidiary Teams Up with Aulos Bioscience to Test PD-L1 and Anti-IL-2 Combination
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Germany’s Merck KGaA (ETR: MRK) has announced that its Switzerland-based subsidiary, Ares Trading, has entered into a partnership with US-based Aulos Bioscience. This collaboration aims to advance the clinical development of Merck’s anti-PD-L1 drug Bavencio (avelumab) in combination with Aulos’s anti-IL-2 antibody candidate, AU-007. The financial details of the agreement…
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Insilico Medicine’s ISM8207 Enters Phase I Clinical Trial for Lymphoma and Solid Tumors
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China’s generative artificial intelligence (AI)-driven biotech firm, Insilico Medicine, has announced the first patient dosing in a Phase I clinical study for ISM8207, a potential first-in-class drug candidate co-developed with Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196). The open-label, multi-center Phase I study aims to evaluate the…
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Fosun Pharmaceutical Advances Lasofocine Clinical Trials for Breast Cancer after NMPA Nod
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct two clinical studies for lasofociene. The first trial is a Phase I study in healthy subjects, while the second is a global multi-center Phase…
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Roche and Genprex Initiate Phase I Trial Combining Tecentriq and Reqorsa for ES-SCLC
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Switzerland-based Roche (SWX: ROG) is advancing the evaluation of its anti-PD-L1 drug, Tecentriq (atezolizumab), in combination with Genprex’s (NASDAQ: GNPX) gene therapy, Reqorsa (quaratusugene ozeplasmid), for the treatment of extensive-stage small cell lung cancer (ES-SCLC). Genprex has initiated the dose escalation phase of a Phase I clinical trial, with the…
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BeiGene’s Brukinsa Secures Conditional Approval in China for R/R Follicular Lymphoma
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company based in China, has received conditional approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The approval is for the use of Brukinsa in combination with the CD20-targeted obinutuzumab for…
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MSD Discontinues Vibostolimab and Keytruda Combo Trial in High-Risk Melanoma
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced its decision to cease development of the anti-TIGIT antibody vibostolimab in combination with its anti-PD-1 drug Keytruda (pembrolizumab) as an adjuvant treatment for resected high-risk melanoma. This strategic move follows an interim analysis that failed to meet the primary endpoint of…
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HutchMed’s HMPL-306 Advances to Phase III Trial in R/R AML Patients
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the commencement of the RAPHAEL study, a pivotal multi-center, randomized, open-label, regulatory Phase III trial. The study aims to evaluate the efficacy and safety of HMPL-306 in patients with recurrent/refractory (R/R) acute myeloid leukemia (AML) featuring isocitrate dehydrogenase (IDH) 1 or…
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Zai Lab’s ROS1 Inhibitor Augtyro Earns NMPA Nod for Advanced NSCLC Treatment
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Augtyro (repotrectinib). This treatment is intended for adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).…
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NMPA Accepts Jiangsu Yahong Meditech’s Application for Cervical HSIL Treatment Cevira
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for Cevira (APL-1702) for the treatment of high-grade squamous intraepithelial lesions (HSIL) of the cervix, excluding in…
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Huadong Medicine’s EGFR Inhibitor Mefatinib for NSCLC Accepted by NMPA for Review
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Huadong Medicine Co., Ltd (SHE: 000963), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its filing for market approval of mefatinib. The drug is proposed as a first-line treatment for locally advanced or metastatic non-small cell lung cancer…
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Novartis Inks Deal to Acquire Mariana Oncology, Bolstering Radioligand Therapy Portfolio
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Swiss pharmaceutical giant Novartis (NYSE: NVS) is poised to expand its oncology portfolio by acquiring Mariana Oncology, a US-based specialist in radioligand therapy (RLT). The agreement is subject to customary closing conditions and includes a substantial upfront payment of USD 1 billion, plus potential milestone payments of up to USD…
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BMS’s Opdivo/Yervoy Combo Misses PFS Endpoint in Unresectable Stage III NSCLC Trial
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that a late-stage trial for its checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with unresectable stage III non-small cell lung cancer (NSCLC) did not achieve its primary endpoint of progression-free survival (PFS). The study compared the efficacy and safety of Opdivo…
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FDA Reviews BMS’ Opdivo Subcutaneous Formulation for Broad Indications
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The US Food and Drug Administration (FDA) has agreed to review a submission from Bristol-Myers Squibb (BMS; NYSE: BMY) for a subcutaneous formulation of its anti-PD-1 therapy Opdivo (nivolumab). The new formulation utilizes Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) and aims to cover all previously approved indications for the…
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Yunnan Baiyao’s Radiopharmaceutical INR101 Advances to Clinical Trial Stage with NMPA Approval
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Yunnan Baiyao Group Co., Ltd (SHE: 000538), a traditional Chinese medicine (TCM) company based in Kunming, has received approval from the National Medical Products Administration (NMPA) in China to conduct a clinical study for its Category 1 chemical drug, INR101. The study will initially assess the drug in healthy volunteers…
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Jacobio Pharma’s KRAS G12C Inhibitor Gains NMPA Approval for Phase III CRC Study
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a regulatory Phase III clinical study. The study will evaluate the combination of the company’s KRAS G12C inhibitor, glecirasib, with Erbitux (cetuximab) for…
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Qilu Pharmaceutical Achieves First Approval for Generic Bendamustine in China
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The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic bendamustine, marking it as the first of its kind in China for the treatment of malignant tumors. Bendamustine, a bifunctional nitrogen mustard derivative, is recognized for its ability to induce cell death through multiple mechanisms, thereby…
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MSD’s Keytruda Adjuvant Treatment for High-Risk Endometrial Cancer Fails to Meet Primary Endpoint
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its blockbuster drug Keytruda (pembrolizumab) as an adjuvant treatment in newly diagnosed, high-risk endometrial cancer failed to meet the primary endpoint of disease-free survival (DFS). Although the analysis of the co-primary endpoint of overall survival (OS)…
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WestGene Biopharma’s Groundbreaking mRNA Vaccine for EB Virus Tumors Gets FDA Green Light
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WestGene Biopharma Co., Ltd., a biopharmaceutical company based in Chengdu, has announced that its drug candidate WGc-043 has been approved for clinical trials by the US Food and Drug Administration (FDA). WGc-043 is recognized as the world’s first clinically approved mRNA therapeutic vaccine targeting Epstein-Barr (EB) virus-related tumors. The vaccine…
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Chia Tai Tianqing’s PD-L1 Antibody Benmelstobart Wins NMPA Nod for ES-SCLC
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China-based Chia Tai Tianqing has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The drug is approved as a first-line treatment for extensive stage small cell lung cancer (ES-SCLC) in combination with anlotinib…
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Sichuan Biokin Pharmaceutical Advances BL-B16D1 to Clinical Trial for Advanced Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its in-house developed bispecific antibody drug conjugate (ADC), BL-B16D1, in patients with advanced solid tumors. Biokin Pharma,…
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Bio-Thera Solutions’ PD-1 and ADC Combo Gets NMPA Approval for Clinical Trial in Solid Tumors
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Bio-Thera Solutions, Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy of BAT1308 and BAT8006 in patients with advanced solid tumors. BAT1308 is an in-house developed programmed death-1 (PD-1) monoclonal…
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Abbisko and Allist Pharmaceuticals Initiate Phase II Trial for NSCLC Drug Combination
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Abbisko Therapeutics Co., Ltd (HKG: 2256) and Allist Pharmaceuticals Co., Ltd have announced the upcoming start of a multi-center, open Phase II clinical study to evaluate the combination of Abbisko’s ABSK043 and Allist’s furmonertinib in patients with advanced non-small cell lung cancer (NSCLC). The study aims to establish the optimal…
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J&J’s Erleada Plus ADT Shows 0% Biochemical Recurrence Rate in High-Risk Prostate Cancer Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Phase II clinical trial for the androgen receptor inhibitor Erleada (apalutamide), in combination with androgen deprivation therapy (ADT), successfully met its primary endpoint of biochemical recurrence (BCR) in patients with high-risk localized prostate cancer (HRLPC) following radical prostatectomy (RP). The…
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Mabwell Bioscience’s 9MW2821 Earns Orphan Drug Status from FDA for Esophageal Cancer
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its pipeline candidate, the antibody-drug conjugate (ADC) 9MW2821. This designation is for the drug’s potential in treating esophageal…
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Innovent Biologics’ CLDN18.2 ADC IBI343 Receives Breakthrough Designation in China
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC), IBI343, targeting CLDN18.2, has been granted breakthrough therapy designation (BTD) status in China. This designation highlights the potential of IBI343 as a third-line treatment option for patients with advanced gastric or…
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Yantai Dongcheng Pharmaceutical’s Radiopharmaceutical 18F-LNC1007 Cleared for Australian Phase I Trial
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that its radioactive diagnostic drug, 18F-LNC1007 injection, has successfully passed a safety review conducted by the US Food and Drug Administration (FDA). This clearance paves the way for the drug to commence a Phase I clinical…
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Sichuan Biokin’s EGFR/HER3 ADC Expands Phase II Clinical Program with NMPA Approval
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct seven Phase II clinical studies for its antibody-drug conjugate (ADC), BL-B01D1, in combination with a PD-1 inhibitor, with or without chemotherapy. The combo therapy, previously approved for…
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Merus’s Zenocutuzumab Receives Priority Review Status from FDA for Lung and Pancreatic Cancer Indications
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Dutch biotechnology company Merus (NASDAQ: MRUS) has announced that the US Food and Drug Administration (FDA) has accepted for review its market approval filing for zenocutuzumab, a first-in-class HER2/HER3 bispecific antibody (BsAb), for the treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer. The application has been granted…
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Betta Pharmaceuticals Files for Market Approval of CDK4/6 Inhibitor BPI-16350 in China
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has filed for market approval in China for its drug candidate BPI-16350. The cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor is being developed in combination with fulvestrant for the treatment of locally advanced or recurrent hormone…
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Henlius’ HER2 Dual-Targeted Therapy Gets Green Light for Global Phase III Trial by FDA
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a global multi-center Phase III clinical study. The study will evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line…
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Jacobio Pharma Applies for Approval of KRAS G12C Inhibitor Gecirasib in China
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Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced the submission of a New Drug Application (NDA) to China’s Center for Drug Evaluation (CDE) for its investigational drug glecirasib. The KRAS G12C inhibitor is being sought after for approval as a treatment for second-line and above advanced or metastatic…
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Biocytogen and BioCopy AG Collaborate on TCR-Mimic Antibody Development for Cancer Therapies
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a China-based biopharmaceutical company, has announced an evaluation and potential licensing agreement with BioCopy AG, a research-driven biotechnology firm based in Basel, Switzerland. This agreement grants BioCopy access to a fully human library of TCR-mimic antibodies that target intracellular antigens. These antibodies are…
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EyePoint Pharmaceuticals’ Durvayu Fails to Meet Primary Endpoint in NPDR Trial
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EyePoint Pharmaceuticals Inc., (NASDAQ: EYPT) has announced that its drug candidate Durvayu (vorolanib intravitreal insert; EYP-1901) did not meet its primary endpoints in the Phase II PAVIA clinical trial for non-proliferative diabetic retinopathy (NPDR). Although the trial data showed some treatment effect, including a reduction in NPDR progression rates at…
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Kelun-Biotech’s RET Inhibitor A400 Advances to Phase II Trial with FDA Approval
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, has announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its RET inhibitor A400/EP0031…
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Jacobio Pharma’s Glecirasib Shows Promise in Phase II Study for NSCLC Presented at ASCO
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has announced the presentation of results from a Phase II regulatory study for its KRAS G12C inhibitor, glecirasib, at the 2024 American Society of Clinical Oncology (ASCO) Plenary Series. In terms of efficacy, the study reported a confirmed objective response…
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BeiGene’s Anti-PD-1 Therapy Tislelizumab Expands Indication for Gastric Cancer in China
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that its anti-PD-1 therapy, tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China for the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ) in combination with fluorouracil and platinum-based…
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China’s NMPA Approves Shenzhen Chipscreen’s Chidamide for DLBCL Indication
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Shenzhen Chipscreen Pharmaceutical Co., Ltd, a biopharmaceutical company based in China, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Epidaza (chidamide). The drug is indicated for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2…
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Zhejiang Huahai Pharmaceutical Wins IND Approval for Antibody-Drug Conjugate from China’s NMPA
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its innovative injectable drug candidate, HB0052. The drug is initially intended for evaluation in patients with general advanced solid tumors.…
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EOC Pharma’s Entinostat Secures Chinese Approval for Breast Cancer Treatment
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US-China biotech firm EOC Pharma has received market approval from China’s National Medical Products Administration (NMPA) for its entinostat, an oral histone deacetylase (HDAC) inhibitor, for the treatment of locally advanced or metastatic breast cancer in patients with hormone receptor (HR) positive and human epidermal growth factor receptor-2 (HER2) negative…
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Kexing Pharmaceutical Secures Global Rights for Qingfeng’s Generic Olaparib
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China’s Kexing Pharmaceutical (SHA: 688136) has secured a global commercialization licensing agreement with Qingfeng Pharmaceutical Group for the latter’s generic version of olaparib. Under this deal, Kexing will obtain commercial rights for the product across an initial batch of 10 international markets. Meanwhile, Qingfeng’s generic formulation is currently awaiting regulatory…
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HutchMed’s Partner Takeda Gets CHMP Nod for Fruquintinib as CRC Treatment in Europe
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its collaborator Takeda (TYO: 4502, NYSE: TAK) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of fruquintinib for the treatment of adult patients with…
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AbelZeta Pharma’s CAR-T Therapy C-CAR031 Receives Implicit Approval for Clinical Study in China
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Sino-US biotechnology company AbelZeta Pharma Inc., operating in Rockville, Maryland, and Shanghai, China, has received implicit approval for its autologous armored GPC3-targeted chimeric antigen receptor (CAR) T cell therapy, C-CAR031, developed by its subsidiary, Shanghai Cellular Biopharmaceutical Group Ltd. The therapy is intended for the treatment of GPC3+ advanced or…
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Wuhan Bio-Raid Biotechnology Secures NMPA Approval for First-in-Class CD99-Targeted CAR-T Therapy
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Wuhan Bio-Raid Biotechnology Co., Ltd, a leading developer of chimeric antigen receptor (CAR)-T cell therapies in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its proprietary BRD-03. This autologous CD99-targeted CAR-T therapy is classified as a Category 1 biologic therapeutic…
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MSD Reports USD 15.8 Billion in Q1 2024 Sales, Marked by 11% YOY Growth Excluding Forex Impact
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has released its financial report for the first quarter of 2024, announcing sales of USD 15.8 billion, an increase of 11% year-on-year (YOY) excluding the impact of foreign exchange rates. The pharmaceutical division contributed USD 14.0 billion to the top line, with a…
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US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
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Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food and Drug Administration’s (FDA) approval for marketing Hanquyou (trastuzumab; HLX02), a biosimilar to Roche (SWX: ROG)’s cancer treatment Herceptin (trastuzumab). The biosimilar will be available in the US under the trade name Hercessi. Originally approved…
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Bristol Myers Squibb Reports 6% YOY Revenue Growth in Q1 2024, Driven by Eliquis and Reblozyl
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Pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY) has reported a 6% year-on-year (YOY) increase in revenues for the first quarter of 2024, excluding the impact of foreign exchange, reaching USD 11.9 billion, according to the company’s latest financial report. The U.S. market contributed USD 8.5 billion, marking a 7%…
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Roche’s Q1 2024 Turnover Rises 2% YOY, Driven by New Medicines and Diagnostics
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Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has reported a 2% year-on-year (YOY) increase in turnover at constant exchange rates (CER) for the first quarter of 2024, reaching CHF 14.4 billion (USD 15.7 billion). The growth was modest but steady, driven by newer medicines and diagnostics, which compensated for…
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Insilico Medicine Partners with invoX Pharma to Boost AI-Driven Drug Discovery
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China’s generative artificial intelligence (AI)-driven biotech firm Insilico Medicine has entered into a partnership with compatriot firm invoX Pharma, a subsidiary of Sino Biopharmaceutical Ltd (HKG: 1177). The collaboration aims to combine Insilico’s AI and computer-aided drug discovery expertise, including its proprietary PandaOmics target discovery engine, with invoX’s innovative drug…
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Betta Pharmaceuticals’ BPI-16350 Combo Therapy Shows Improved PFS in Breast Cancer Trial
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an update on its Phase III clinical study for BPI-16350, a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, used in combination with fulvestrant for the treatment of locally advanced or recurrent hormone receptor positive (HR+) HER2-negative metastatic breast cancer in patients…
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Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
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The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS) for its radioligand therapy (RLT) Lutathera (lutetium Lu 177 dotatate) for the treatment of SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients aged 12 and older. This expansion of the drug’s original indication for adult patients…
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Abbisko Therapeutics’ Irpagratinib Earns Orphan Drug Designation from US FDA for Hepatocellular Carcinoma
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its novel small-molecule FGFR4 inhibitor, irpagratinib. The designation is in recognition of the drug’s potential in treating hepatocellular carcinoma (HCC). Irpagratinib, an FGFR4 inhibitor originally discovered…
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MSD Partners with Hanmi Pharmaceutical to Develop Combination Therapy for Solid Tumors
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with South Korea’s Hanmi Pharmaceutical (KRX: 128940) to develop a combination therapy using MSD’s top-selling anti-PD-1 therapy Keytruda (pembrolizumab) and Hanmi’s bispecific antibody (BsAb) BH3120 for the treatment of progressive or metastatic solid tumors. The financial details of the…
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Novartis Reports 11% YOY Sales Growth in Q1 2024, Led by Entresto and Cosentyx
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has reported an 11% year-on-year (YOY) increase in constant currency terms during the first quarter of 2024, reaching USD 11.8 billion in sales. The growth was driven by strong performances across all key brands and geographies. The top-selling and growth-driving drugs included hypertension therapy…
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BeiGene’s Tislelizumab Secures EC Approval for Three NSCLC Indications
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the European Committee (EC) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, for three distinct non-small cell lung cancer (NSCLC) indications. The approvals allow for the use of tislelizumab in the following scenarios: The approvals were supported by…
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Akeso Biopharma Submits sNDA for Cadonilimab in Cervical Cancer to China’s CDE
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China-based Akeso Biopharma (HKG: 9926) has announced the submission of a supplementary New Drug Application (sNDA) for its innovative bispecific antibody, cadonilimab (AK104), which targets both programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The sNDA filing seeks to expand the use of cadonilimab in combination with chemotherapy and…
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Jiangsu Hengrui Medicine Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, controlled Phase II/III clinical study. The study will assess the efficacy and safety of its programmed death-1 (PD-1)…
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CANbridge Pharmaceuticals’ CAN008 Fails to Meet Phase II Endpoints in Glioblastoma Multiforme
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CANbridge Pharmaceuticals (HKG: 1228) has announced that its Phase II clinical study for CAN008 (asunercept) in newly diagnosed glioblastoma multiforme (GBM) did not achieve progression-free survival (PFS) or overall survival (OS) benefits. As a result, the Sino-US biopharma company has decided to discontinue the development of CAN008 for GBM. The…
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GenScript’s Subsidiary Legend Biotech Expands EU Approval for CAR-T Therapy Carvykti
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has secured an expanded indication approval from the European Union for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy is now approved as a…
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MSD Strikes Deal with GV20 Therapeutics to Test Anti-PD-1 Combo in Solid Tumor Therapies
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a global healthcare leader, has entered into a strategic collaboration with GV20 Therapeutics, a biopharmaceutical company specializing in antibody therapeutics with operations in both China and the U.S. The partnership aims to combine GV20’s groundbreaking IGSF8-targeted biologic, GV20-0251, with MSD’s best-selling anti-PD-1 therapy,…
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Jiangsu Hengrui’s SHR-A2102 Earns FDA Fast Track Status for Urothelial Carcinoma Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, SHR-A2102. This designation is in recognition of the drug’s potential to treat advanced urothelial carcinoma,…
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Hengrui Medicine Gets Green Light from NMPA for Two Anti-Cancer Drugs
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR-3276 and HRS2398. SHR-3276 is slated for study in patients with general advanced solid…
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Roche’s Alecensa approved by FDA as First ALK Inhibitor for Adjuvant Treatment of NSCLC
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Roche Holding AG (SWX: ROG; OTCMKTS: RHHBY), a Swiss multinational healthcare company, announced last week that the US Food and Drug Administration (FDA) has granted regulatory approval for Alecensa (alectinib) as an adjuvant treatment for patients with ALK-positive non-small cell lung cancer (NSCLC). This marks the first approval of an…
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Impact Therapeutics Boosts War Chest with $55.2 Million Series D+ Round for Cancer Drugs
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Impact Therapeutics, a biopharmaceutical company based in China, has reportedly secured RMB 400 million (USD 55.2 million) in a Series D+ financing round. The round was co-led by GTJA Investment and KingRay Capital, a state-owned investor focused on small and micro enterprises. Additional participants in the financing round included Guojin…
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Sichuan Biokin Gets NMPA Green Light for BL-B01D1 ADC in NSCLC Clinical Trial
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative antibody-drug conjugate (ADC), BL-B01D1. The approval allows for the combination of BL-B01D1 with a PD-1 inhibitor, with…
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Innovent Biologics’ Pemazyre Wins Macau Approval for Cholangiocarcinoma Treatment
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has received marketing approval from Macau for its cancer therapy Pemazyre (pemigatinib). The drug is indicated for patients with advanced, metastatic, or unresectable cholangiocarcinoma, who have been previously treated with at least one systemic therapy and have confirmed FGFR2…
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Chia Tai Tianqing’s Rovadicitinib Meets Main Goal in Myelofibrosis Trial, Eyes Market Filing
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Chia Tai Tianqing, a renowned pharmaceutical company based in China, has declared that it has successfully met the primary endpoint in a pivotal study for its Category 1 drug, rovadicitinib, for the treatment of medium-to-high-risk myelofibrosis (MF). The company is advancing towards filing for market approval in China, following consultations…
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Shanghai Escugen and Anke Bio Partner to Develop ADC Products with EZWi-Fit Platform
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Shanghai Escugen, a biopharmaceutical company based in China, has entered into a licensing and cooperation agreement with Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009). Under the terms of the agreement, Escugen will grant Anke Bio the rights to its antibody-drug conjugate (ADC) technology platform, EZWi-Fit, for the development of…
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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of CD47 Inhibitor TIMDARPACEPT
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). This drug is the first SIRPαFc fusion protein targeting CD47 to be designed in China.…
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Shanghai Henlius Biotech Advances TIGIT-Targeting HLX53 to Phase II Clinical Trial for Hepatocellular Carcinoma
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Shanghai Henlius Biotech Inc., (HKG: 2696), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase II clinical study. The study will evaluate the tolerability, safety, and efficacy of HLX53, an Fc fusion protein targeting T cell immunoglobulin and ITIM…
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Sichuan Biokin’s BL-B01D1 Earns Breakthrough Designation for Nasopharyngeal Carcinoma Treatment
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration for its antibody-drug conjugate (ADC), BL-B01D1. This designation is for the treatment of patients with late-stage locally advanced or metastatic nasopharyngeal…
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Innovent Biologics’ IBI133 Receives Tacit Approval for Clinical Trial from China’s CDE
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The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. (HKG: 1801) for its antibody drug conjugate (ADC) IBI133. The molecule is slated for assessment as a treatment for irresectable locally advanced or metastatic solid tumors. Previously, in December 2023, IBI133 had…
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Boehringer Ingelheim Surpasses Bayer in Pharma Sales with EUR 20.8 Billion in 2023
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Boehringer Ingelheim, a major German pharmaceutical company, has released its financial report for 2023, announcing human pharma sales of EUR 20.8 billion (USD 22.1 billion), marking a 10.3% year-on-year (YOY) increase, excluding currency effects. Additionally, animal health sales rose by 6.9% YOY to EUR 4.7 billion (USD 4.9 billion), leading…
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Carvykti CAR-T Therapy Sales Reach $157 Million in Q1 2024, Reports GenScript Subsidiary Legend Biotech
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GenScript Biotech Corporation (HKG: 1548), a leading Contract Research Organization (CRO) based in China, has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), achieved sales of USD 157 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in the first quarter of 2024, which…
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AstraZeneca’s Imfinzi Shows Sustained Survival Benefit in Advanced Biliary Tract Cancer Trial
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has this week announced 3-year results from a Phase III clinical trial of its anti-PD-L1 therapy Imfinzi (durvalumab) in combination with chemotherapy for the treatment of advanced biliary tract cancer (BTC). The trial, after a median follow-up of 41.3 months,…
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Sanofi Advances Phase I/II Trial of Trifunctional NK Cell Engager in Blood Cancers
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Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, has administered the first dose to a patient in the second part of a Phase I/II clinical trial for the trifunctional NK cell engager SAR443579, targeting blood cancers. The announcement was made by fellow French biotechnology company Innate Pharma (NASDAQ: IPHA) this…
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Roche’s Columvi Meets Overall Survival Endpoint in Diffuse Large B-Cell Lymphoma Trial
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Roche (SWX: RO), a leading Swiss pharmaceutical company, has announced that a late-stage clinical trial for its bispecific antibody Columvi (glofitamab) has successfully met its primary endpoint of overall survival (OS) in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The trial involved patients who had received…
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Keymed Biosciences Achieves First Dosing in Global Phase III Trial for Claudin 18.2 Targeting ADC
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Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced the completion of the first dosing in a global multi-center Phase III study for its Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) CMG901 (AZD0901). The ADC is being evaluated as a treatment for advanced solid tumors in the…
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Hengrui Medicine Gets NMPA Approval for Clinical Study of CDK 4/6 Inhibitor Combo in Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for the combination of dalpiciclib (SHR6390) and HRS8807 in the treatment of breast cancer. Dalpiciclib, the first domestically-developed…
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Bayer Partners with Hologic to Develop Contrast-Enhanced Mammography Solution for Breast Cancer Diagnosis
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Bayer (ETR: BAYN), a multinational pharmaceutical and life sciences company headquartered in Germany, has announced a strategic partnership with Hologic (NASDAQ: HOLX), a leading women’s health specialist. The collaboration aims to develop a contrast-enhanced mammography (CEM) solution that serves as a cost-effective adjunct to traditional mammography for breast cancer diagnosis.…
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Sanofi Explores Sale of Amunix Pharmaceuticals as It Shifts Focus to Immunology
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Sanofi (NASDAQ: SNY), the France-based pharmaceutical giant, is reportedly in talks with potential buyers for Amunix Pharmaceuticals, an immuno-oncology company it acquired in 2021, according to Endpoints News. This move aligns with Sanofi’s 2023 earnings report, which outlined plans to shift resources away from oncology to bolster its immunology pipeline,…
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Enhertu Shows 58.3% Response Rate in Phase II Lung Cancer Study, AstraZeneca and Daiichi Sankyo Report
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The Phase II DESTINY-Lung05 study results for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568, OTCMKTS: DSNKY), were unveiled at the American Association for Cancer Research (AACR) 2024 annual meeting. The study reported an objective response rate (ORR) of 58.3% (95% CI:…
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Sino Biopharmaceutical to Present Phase II Data for Garsorasib at AACR 2024
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Sino Biopharmaceutical Ltd. (HKG: 1177) announced that it will present the results of a Phase II study for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd., at the American Association for Cancer Research (AACR) 2024 annual meeting. The study focuses on non-small cell lung cancer (NSCLC)…
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Roche Secures CE Mark for Ventana HER2 Test, Enhancing Access to AstraZeneca’s Enhertu
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Roche (SWX: ROG), based in Switzerland, has received CE marking from the European Commission (EC) for a new indication of its antibody-based test, Ventana HER2 (4B5). This test serves as a companion diagnostic to identify breast cancer patients eligible for AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo’s (TYO: 4568) antibody-drug…
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Jiangsu Hengrui Secures NMPA Approval for Clinical Study of SHR-A2102 and SHR-8068 in Advanced Tumors
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-A2102 in combination with SHR-8068 in patients with advanced solid tumors. SHR-A2102 is an internally developed antibody-drug conjugate (ADC) that targets Nectin-4, a protein whose high…
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Merck Sharp & Dohme Acquires Abceutics for Next-Generation ADC Technology
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Global healthcare leader Merck, Sharp & Dohme (MSD) (NYSE: MRK) has secured a strategic acquisition of Abceutics, a preclinical biopharmaceutical startup focused on optimizing antibody-drug conjugates (ADCs). The financial details of the transaction remain undisclosed. Abceutics has developed a series of payload-binding selectivity enhancers (PBSEs) designed to increase the safety…
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Simcere Pharmaceutical’s SIM0500 Earns FDA Fast-Track Designation for Multiple Myeloma
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Simcere Pharmaceutical Group (HKG: 2096), a leading China-based pharmaceutical company, has announced that its trispecific antibody SIM0500 has received fast-track designation from the US Food and Drug Administration (FDA) for the treatment of multiple myeloma (MM). The drug targets GPRC5D, BCMA, and CD3, and is intended for patients who have…
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Roche’s Inavolisib Earns Priority Review Status in China for PIK3CA-Mutated Breast Cancer
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Swiss pharmaceutical giant Roche (SWX: ROG) has received priority review status from China’s Center for Drug Evaluation (CDE) for its investigational drug inavolisib (GDC-0077), a phosphatidylinositol-3 kinase α (PI3Kα) inhibitor. The drug is being evaluated for the treatment of PIK3CA-mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2…
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Sichuan Biokin Pharmaceuticals Initiates Phase III Trial for BL-M05D1 in Esophageal Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced the commencement of patient enrollment in a Phase III clinical trial for its antibody-drug conjugate (ADC), BL-M05D1, in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This milestone marks a significant advancement in the development of BL-M05D1, which targets…
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Jiangsu Hengrui Medicine Gains NMPA Approval for HRS-4642 Clinical Trial in KRAS G12D Mutated Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its drug candidate HRS-4642 in patients with advanced solid tumors harboring the KRAS G12D mutation. This marks a significant step in the company’s endeavor to address the…
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Alphamab Oncology’s JSKN003 Demonstrates Promising Results in Phase I HER2-Targeted Solid Tumor Study
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Alphamab Oncology (HKG: 9966) presented compelling data from a Phase I clinical trial of its HER2-targeted antibody-drug conjugate (ADC), JSKN003, at the AACR 2024 annual meeting. Conducted in Australia, the study focused on advanced solid tumors with HER2 expression. JSKN003, which utilizes a click reaction for conjugation, showcased superior serum…
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Beijing Aosaikang Pharmaceuticals Achieves Clinical Milestone for c-MET Inhibitor ASKC202
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced the presentation of promising data from a Phase I dosage escalation study (ASKC202-001) for its investigational small-molecule c-MET inhibitor, ASKC202, in advanced solid tumors at the American Association for Cancer Research (AACR) 2024 annual meeting. This development underscores the company’s commitment…
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Transcenta Holdings Ltd Collaborates with Agilent Technologies on Companion Diagnostic for Osemitamab
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China-based biotech company Transcenta Holdings Ltd (HKG: 6628) has announced a strategic agreement with Agilent Technologies to co-develop Claudin18.2 companion diagnostic reagents, marking a significant step in the global development of osemitamab combined with nivolumab plus chemotherapy for first-line treatment of locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ)…
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CStone Pharmaceuticals Submits New Drug Application for Gavreto in China, Eyes Local Manufacturing
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has submitted a market approval filing to the National Medical Products Administration (NMPA) for Gavreto (pralsetinib), an oral, once-daily, highly selective RET inhibitor. The company plans to manufacture the drug locally, marking a strategic shift from overseas supply. Gavreto…
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Jiangsu Hengrui Medicine Secures IND Approvals for Two Drug Candidates from China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316)…
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Adicon Launches GuardantOMNI Test to Advance Tumor Therapy Development in China
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Adicon Holdings Ltd (HKG: 9860), a China-based independent clinic laboratory service provider, has announced the launch of its GuardantOMNI test, a 500-gene panel based on blood sample detection, alongside its previously introduced liquid biopsy product, Guardant360. This initiative aims to enhance the development of tumor-targeted drugs and immunotherapies in clinical…
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Merck Collaborates with Caris Life Sciences to Develop First-in-Class Antibody-Drug Conjugates
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German pharmaceutical giant Merck (ETR: MRK) has entered into a strategic collaboration with Caris Life Sciences’ research unit, Caris Discovery, to uncover novel oncology targets and develop first-in-class antibody-drug conjugates (ADCs). The partnership aims to harness Caris’ precision medicine expertise and Merck’s ADC technology to accelerate the discovery and development…
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AstraZeneca’s Imfinzi Achieves Positive Results in Late-Stage Trial for Small Cell Lung Cancer
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that a late-stage trial for its anti-PD-L1 drug Imfinzi (durvalumab) has successfully met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC). The trial’s success marks a significant milestone…
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AstraZeneca and Daiichi Sankyo’s Enhertu Secures FDA Approval for HER2-Positive Solid Tumors
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Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional indication by the US Food and Drug Administration (FDA) for their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). The new indication authorizes the use of Enhertu as a treatment for unresectable or metastatic HER2-positive solid…
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Bristol Myers Squibb’s Abecma Receives FDA Approval for Wider Use in Multiple Myeloma Treatment
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The US Food and Drug Administration (FDA) has granted an indication extension for Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T therapy Abecma (idecabtagene vicleucel), approving it for use in adult patients with triple-class exposed relapsed or refractory multiple myeloma (r/rMM) who have received two or more prior lines of therapy.…
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Dizal Pharmaceutical’s Sunvozertinib Earns FDA Breakthrough Therapy Designation for NSCLC
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a leading Chinese pharmaceutical company, has announced that its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). This designation is in recognition of sunvozertinib’s potential as a first-line treatment for…
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Sino Biopharmaceutical Partners with Boehringer Ingelheim to Bring Innovative Cancer Therapies to China
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a strategic partnership with Germany’s Boehringer Ingelheim (BI) to introduce BI’s innovative cancer therapies to the mainland China market. Under the terms of the agreement, Sino Bio will provide support for the co-development and co-commercialization of several clinical-stage drugs, including brigimadlin, zongertinib, and…
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Sichuan Kelun-Biotech Presents Positive Results for Sacituzumab Tirumotecan at AACR 2024
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced the presentation of favorable results from two clinical studies on sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC), at the American Association for Cancer Research (AACR) 2024 annual meeting. The drug is under global co-development with Merck, Sharp &…
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Huadong Medicine Gets NMPA Approval for Clinical Trial of FRα-Targeting ADC Elahere
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for Elahere (mirvetuximab soravtansine), the company’s antibody drug conjugate (ADC) that targets folate receptor α (FRα). The study will evaluate Elahere as a…
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Junshi Biosciences’ Toripalimab Approved for First-Line RCC Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has received a new indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 therapy, Loqtorzi (toripalimab). The drug is now approved for use in combination with axitinib to treat first-line moderate- to high-risk unresectable or metastatic renal cell…
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Ipsen Secures NMPA Approval for Somatuline in Advanced Neuroendocrine Tumors
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Ipsen (EPA: IPN; OTCMKTS: IPSEY), a France-based biopharmaceutical company, has received new indication approval from the National Medical Products Administration (NMPA) for its Somatuline (lanreotide) sustained-release injection. This approval allows for the treatment of unresectable, highly differentiated or moderately differentiated, locally advanced, or metastatic gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs), aimed…
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Legend Biotech’s Carvykti Secures FDA Approval for Expanded Use in Multiple Myeloma
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy has now received an expanded indication for the treatment of relapsed/refractory multiple myeloma (r/r…
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Genmab Acquires Profound Bio for $1.8 Billion, Targeting Expanding ADC Pipeline
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Denmark-based biotech Genmab A/S (NASDAQ: GMAB) has announced a significant all-cash acquisition of Sino-US biotech Profound Bio, targeting its antibody drug conjugate (ADC) pipeline in a deal valued at $1.8 billion, set to close in the first half of 2024. The agreement has received approval from the boards of both…
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European Commission Approves Reblozyl for First-Line Treatment of MDS-Related Anemia
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The European Commission (EC) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension for its erythropoietic agent Reblozyl (luspatercept) as a first-line treatment for transfusion-dependent anemia associated with lower-risk myelodysplastic syndromes (MDS) in adult patients. Originally indicated for anemia related to beta-thalassemia, Reblozyl is now positioned to address…
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AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO: 4568) have submitted a filing to the U.S. Food and Drug Administration (FDA) for their antibody-drug conjugate (ADC) datopotamab deruxtecan, aimed at treating unresectable or metastatic HR-positive, HER2-negative breast cancer in adults who have previously…
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Jiangsu Hengrui’s Fluzoparib Receives Breakthrough Therapy Designation for HER2-Negative Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its indication approval filing for fluzoparib—a poly (ADP-ribose) polymerase (PARP) inhibitor—has been awarded breakthrough therapy designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation applies to fluzoparib, both as a monotherapy and in combination…
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Zai Lab Announces Positive Phase III Data for Krazati in KRASG12C-mutated NSCLC, Plans NDA Filing in China
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Zai Lab (NASDAQ: ZLAB; HKG: 9688), a China-based biotech company, has announced positive Phase III results for Krazati (adagrasib) in the treatment of KRASG12C-mutated non-small cell lung cancer (NSCLC) as a second-line therapy. The company is now preparing to submit a New Drug Application (NDA) to China’s National Medical Products…
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Huihe Healthcare’s Vispearl Microsphere Earns Marketing Approval in China for Innovative Cancer Treatment
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Shanghai-based Huihe Healthcare, a developer of interventional medical devices for structural heart diseases, has secured marketing approval in China for its innovative Vispearl drug-loaded microsphere product. This product is designed for use in the embolization treatment of malignant tumors within vascular-rich parenchymal organs and is recognized as the first of…
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Junshi Biosciences Gets Green Light for Global Phase III Study of Tifcemalimab Combination Therapy in LS-SCLC
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877), a leading biotech company based in China, has received approval from the Pharmaceuticals and Medical Devices Agency of Japan to initiate a global multi-center Phase III study. The study will be a randomized, double-blind, placebo-controlled trial investigating the combination of tifcemalimab (TAB004/JS004) and…
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Bristol Myers Squibb’s Krazati Trial Yields Positive Phase III Results in NSCLC
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Last week, Bristol Myers Squibb (BMS; NYSE: BMY) unveiled preliminary results from a Phase III confirmatory trial for its KRAS inhibitor Krazati (adagrasib) in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying a KRASG12C mutation. This encouraging data reinforces BMS’s strategic 2023 acquisition of original…
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AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health, Labour, and Welfare (MHLW) its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with endocrine therapy Faslodex (fulvestrant). This combination therapy is intended for the treatment of unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive, HER2-negative…
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Gilead Strikes Deal with Xilio Therapeutics for Tumor-Activated IL-12 Candidate
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Gilead Sciences (NASDAQ: GILD) has announced an in-licensing agreement with fellow US biotechnology company Xilio Therapeutics (NASDAQ: XLO) to acquire an early-stage tumor-activated interleukin 12 (IL-12) for the treatment of solid tumors. Gilead will pay an initial sum of USD 43.5 million for the exclusive development and global commercialization rights…
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Jiangsu Hengrui’s SHR-A1921 Earns FDA Fast-Track Status for Platinum-Resistant Ovarian Cancer Therapies
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a distinguished pharmaceutical entity, has announced that it has been granted Fast-Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), SHR-A1921. This designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube…
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IASO Biotherapeutics Gets NMPA Go-Ahead for BCMA-Targeted CAR-T Therapy Clinical Trial
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IASO Biotherapeutics, a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidate CT103A, known as equecabtagene autoleucel. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy designed for patients…
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BeiGene and GenFleet Join Forces for DLBCL Trial Combining Brukinsa and GFH009
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a China-based biotechnology company, has entered into a clinical research and drug supply cooperation agreement with fellow Chinese firm GenFleet Therapeutics. The partnership will kick off a Phase Ib/II clinical trial to evaluate the safety and efficacy of a combination regimen featuring…
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HutchMed’s Orpathys Files for Expanded Indication in NSCLC Treatment in China
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that the National Medical Products Administration (NMPA) in China is currently reviewing a new market approval filing for Orpathys (savolitinib), a MET inhibitor co-developed with AstraZeneca. The company is seeking a new indication for the drug as a first-line treatment for…
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Astellas Pharma’s Padcev Combo Therapy Accepted for Review in China for Urothelial Carcinoma
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that China’s Center for Drug Evaluation (CDE) has accepted for review a supplementary Biologic License Application (sBLA) for its drug Padcev (enfortumab vedotin). The application seeks to expand the use of Padcev in combination with pembrolizumab for the…
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Zai Lab and Novocure Report Positive Phase III Results for TTFields in NSCLC Brain Metastases
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, and Novocure (Nasdaq: NVCR), a UK-based oncology innovator, have announced positive results from the Phase III METIS trial. The trial evaluated the efficacy of the Tumor Treating Fields (TTFields) therapeutic device in combination with supportive care for…
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Jiangsu Hengrui Receives NMPA Approval for SHR-7631 ADC Clinical Study in Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 antibody drug conjugate (ADC), SHR-7631, in patients with advanced solid tumors. While the…
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Wuhan YZY Biopharma Initiates Phase II Study for M701 in Malignant Pleural Effusion Treatment
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its investigational drug M701. M701 is a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, currently under assessment as…
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Innovent Biologics Initiates Phase III Neoshot Study for MSI-H/dMMR Colon Cancer Treatment
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the first subject dosing in the randomized, multi-center Phase III Neoshot study for its anti-CTLA-4 monoclonal antibody IBI310. The study combines IBI310 with the PD-1 inhibitor sintilimab as a neoadjuvant treatment for patients with resectable MSI-H/dMMR…
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Nuvation Bio to Acquire AnHeart Therapeutics in All-Stock Deal Amid Biotech Pressures
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U.S.-based biotech Nuvation Bio Inc. (NYSE: NUVB) has announced a definitive agreement to acquire China-based AnHeart Therapeutics Inc. in an all-stock transaction, which has received approval from the boards of both companies. The deal is contingent upon approval from AnHeart’s shareholders and is anticipated to close in the second quarter…
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FDA Grants Full Approval to AbbVie’s Elahere for Advanced Ovarian Cancer Treatment
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This week, the U.S. Food and Drug Administration (FDA) granted full approval to AbbVie’s (NYSE: ABBV) antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer following up to three prior therapies. This approval marks an upgrade from the 2022…
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Zylox-Tonbridge Secures NMPA Approval for Advanced Flow Diverter Targeting Intracranial Aneurysms
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Zylox-Tonbridge Medical Technology (HKG: 2190), a China-based developer of nerve and peripheral vascular interventional devices, has secured marketing approval from the National Medical Products Administration (NMPA) for its flow diverter (FD). This device represents a significant advancement in the treatment of intracranial aneurysms, particularly large and giant aneurysms. Notably, this…
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MSD’s Phase III Trial of Keytruda Plus Lynparza Misses Primary Endpoints in NSCLC
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an unfavorable outcome for a Phase III trial combining Keytruda (pembrolizumab) and Lynparza (olaparib) in the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). The study, which aimed to evaluate the efficacy of this combination therapy, was halted after…
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Shanghai Institute’s Biosimilar Rituximab Approved by NMPA for Lymphoma Treatments
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Shanghai Institute of Biological Products Co., Ltd has announced that its biosimilar version of Roche/Genentech’s Mabthera (rituximab) has received approval from the National Medical Products Administration (NMPA) for the treatment of Non-Hodgkin’s lymphoma, including follicular non-Hodgkin’s lymphoma and CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma, as well as chronic lymphoblastic…
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Roche Invests EUR 90 Million in New Gene Therapy Center in Germany
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Swiss pharmaceutical giant Roche (SWX: RO) has inaugurated a new gene therapy development center in Germany, following an investment of EUR 90 million (USD 97.4 million). The expansive 2,500 square meter facility is designed to specialize in the production of gene vectors for clinical trials across various therapeutic areas, including…
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Grand Pharma Receives NMPA Approval for Global Phase III Study of RDC ITM-11 in GEP-NETs
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the COMPOSE study. This is a prospective, randomized, controlled, open-label, global multi-center Phase III study designed to assess the efficacy, safety,…
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NeuExcell Therapeutics Doses First Patient in Groundbreaking Clinical Trial for NeuroD1 Gene Therapy
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NeuExcell Therapeutics, a Shanghai-based developer of in vivo neural regenerative therapies, has announced the first patient dosing in a clinical trial for its first-in-class (FIC) NeuroD1 gene therapy product, NXL-004, targeting malignant glioma. This marks NXL-004 as the world’s first gene therapy of its kind to enter the clinical setting.…
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FDA Grants Accelerated Approval for Takeda’s Iclusig in Newly Diagnosed Ph+ ALL
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The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan’s Takeda Pharmaceutical Company (TYO: 4502) for its tyrosine kinase inhibitor (TKI) Iclusig (ponatinib) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This follows the drug’s previous…
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Bayer and Thermo Fisher Partner to Develop Rapid Companion Diagnostics for Precision Oncology
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Germany’s Bayer (NYSE: BAYE) has entered into a strategic partnership with U.S. life sciences leader Thermo Fisher Scientific (NYSE: TMO) to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx) aimed at enhancing precision cancer therapies. Financial terms of the collaboration remain undisclosed. According to the press release, the diagnostic tests…
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BMS Reports Positive Phase III Results for Opdivo and Yervoy in Advanced HCC
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Bristol Myers Squibb (BMS; NYSE: BMY) announced this week that its Phase III study evaluating the combination of anti-PD-1 drug Opdivo (nivolumab) and anti-CTLA-4 biologic Yervoy (ipilimumab) as a first-line treatment for advanced hepatocellular carcinoma (HCC) has yielded promising top-line results. According to data from a pre-specified interim analysis, the…
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Antengene’s ATG-022 Advances to Dose Expansion Phase in Phase II CLINCH Study for Solid Tumors
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Antengene Corporation Ltd (HKG: 6996), a leading biopharmaceutical company based in China, has announced that ATG-022, an antibody drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), has progressed into the dosage expansion phase of the Phase II CLINCH study. This trial is evaluating ATG-022 as a monotherapy for advanced or metastatic…
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CSPC Pharmaceutical Secures NMPA Approval for Clinical Study of SYS6023 in Advanced Solid Tumors
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody drug conjugate (ADC) SYS6023 in patients with advanced solid tumors. SYS6023 is designed to target specific receptors on tumor surfaces, allowing…
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Jiangsu Hengrui Receives NMPA Approval for Phase Ib/II Study of HRS2398 in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II study. The study will assess the drug candidate HRS2398 in combination with HRS-1167 or adebrelimab…
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CSPC Pharmaceutical Gets NMPA Greenlight for SYH2039 Clinical Study in Advanced Malignant Tumors
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 chemical drug candidate, SYH2039, which targets advanced malignant tumors. SYH2039 is a potent inhibitor of methionine adenosine…
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AstraZeneca to Acquire Fusion Pharmaceuticals in a Deal Valued at USD 2.4 Billion
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AstraZeneca (AZ; NASDAQ: AZN), the UK-based pharmaceutical giant, has announced its intention to acquire Fusion Pharmaceuticals (NASDAQ: FUSN), a Canada-based developer of radioconjugate (RC) therapies, in a deal valued at up to USD 2.4 billion, including upfront and potential contingent value payments. The acquisition is expected to be finalized in…
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Dr. Reddy’s Launches Biosimilar Versavo in UK to Challenge Roche’s Cancer Therapy Avastin
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Dr. Reddy’s Laboratories (NYSE: RDY), a prominent Indian pharmaceutical company, has launched its biosimilar Versavo (bevacizumab) in the UK market, presenting a challenge to Roche’s established cancer therapy Avastin. Versavo, a biosimilar to Avastin, has been approved for the treatment of various metastatic cancers, including colorectal cancer, non-squamous non-small cell…
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AstraZeneca’s Lynparza-Imfinzi Combo Shows Promising Results in Endometrial Cancer Study
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical giant, has presented interim results from a late-stage study combining the PARP inhibitor Lynparza (olaparib) with the anti-PD-L1 Imfinzi (durvalumab) for the treatment of newly diagnosed advanced or recurrent endometrial cancer. The study has shown promising outcomes, with the combination therapy extending the…
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Teruisi Pharma’s TRS005 Receives Support for Breakthrough Designation in China for CD20-Positive Lymphoma
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The Center for Drug Evaluation (CDE) in China has signaled that Teruisi Pharma’s antibody drug conjugate (ADC), TRS005, which targets CD20, is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory CD20-positive diffuse large B-cell lymphoma (DLBCL). The drug is being developed specifically for…
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Pfizer’s Elrexfio Anticipated for Priority Review in China for Relapsed/Refractory Multiple Myeloma
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The Center for Drug Evaluation (CDE) in China has indicated that Pfizer (NYSE: PFE)’s Elrexfio (elranatamab), a bispecific antibody targeting BCMA and CD3, is on track for priority review as a potential treatment for triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/r MM). This development signifies a significant step…
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GSK’s Jemperli Shows Survival Benefits in Phase III Endometrial Cancer Study
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GlaxoSmithKline (GSK; NYSE: GSK), a leading UK pharmaceutical company, has presented early results from a Phase III study for its PD-1-blocking antibody Jemperli (dostarlimab) in the treatment of primary advanced or recurrent endometrial cancer. The placebo-controlled trial aims to expand the current indication for frontline mismatch repair deficient (dMMR)/microsatellite instability-high…
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BeiGene’s Tislelizumab Receives FDA Approval for Esophageal Squamous Cell Carcinoma
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BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). The approval is for patients who have been previously treated…
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Hansoh Pharmaceutical Secures Global Rights to Biotheus’ BsAb HS-20117/PM1080
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading pharmaceutical company based in China, has announced a licensing agreement with domestic firm Biotheus. Under the terms of the agreement, Hansoh will secure exclusive global rights to develop, manufacture, and commercialize Biotheus’s bispecific antibody (BsAb) HS-20117/PM1080, along with sub-license rights. The…
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Simcere Pharmaceutical’s Suvemcitug Files for Approval in China for Recurrent Ovarian Cancer
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that an approval filing for its drug candidate suvemcitug (also known as sevacizumab; APX-003; BD-0801) has been submitted in China and accepted for review by the National Medical Products Administration (NMPA). The filing seeks the first indication…
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Bristol Myers Squibb’s Breyanzi Receives FDA Accelerated Approval for CLL/SLL Treatment
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The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have undergone at least two prior lines…
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Mabwell’s Nectin-4 Targeting ADC 9MW2821 Shows Promise in Cervical Cancer Clinical Study
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced positive results from a clinical study of its pipeline candidate, the antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data, highlighting the potential of 9MW2821 in treating cervical cancer, is set to be presented…
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FDA Advisory Committee Backs Wider Use of Abecma in Relapsed or Refractory Multiple Myeloma
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An advisory committee to the US Food and Drug Administration (FDA) has recommended the use of Abecma (idecabtagene vicleucel), a CAR-T therapy developed by Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy bio (NASDAQ: TSVT), for the treatment of triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/rMM). This recommendation…
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Shanghai Henlius Initiates Phase I Trial for HLX42, an Innovative ADC Targeting EGFR
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first subject dosing in a Phase I clinical trial for HLX42, an antibody-drug conjugate (ADC) co-developed with Suzhou-based Medilink Therapeutics. The study will initially evaluate HLX42 in patients with advanced or metastatic solid tumors in China. HLX42 is an innovative ADC…
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KeChow Pharma Secures Conditional Approval for HL-085, a First-of-Its-Kind MEK Inhibitor for Advanced Melanoma
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Shanghai-based KeChow Pharma has received conditional marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug HL-085, aimed at treating advanced melanoma with NRAS mutations in patients who have experienced failure with anti-PD-1/PD-L1 therapies. HL-085 is a groundbreaking ATP non-competitive MEK inhibitor that specifically targets NRAS…
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Boehringer Ingelheim, J&J, and Novo Holdings Invest in Asgard Therapeutics for Cancer Immunotherapy
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Germany’s Boehringer Ingelheim (BI), US-based Johnson & Johnson (J&J; NYSE: JNJ), and Denmark’s major Novo Nordisk’s controlling shareholder, Novo Holdings, have participated in a EUR 30 million (USD 32.6 million) Series A financing round for Sweden-based Asgard Therapeutics. Asgard Therapeutics specializes in in in vivo cell reprogramming for cancer immunotherapy,…
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Pfizer’s Sugemalimab Secures NMPA Approval for Gastric and Gastroesophageal Junction Adenocarcinoma
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Pfizer (NYSE: PFE), a leading pharmaceutical company in the US, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor, for the first-line treatment of inoperable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma (G/GEJ) expressing…
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Allist Pharmaceuticals Secures NMPA Approval for Phase I Study of AST2169 Liposome in KRAS G12D Tumors
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd. (SHA: 688578) has received clearance from the National Medical Products Administration (NMPA) in China to commence a Phase I clinical study of its AST2169 liposome. This study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AST2169 in patients with advanced solid tumors…
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Genor Biopharma Secures NMPA Review for Lerociclib in Advanced Breast Cancer Indication
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Genor Biopharma Co., Ltd. (HKG: 6998) has announced that the National Medical Products Administration (NMPA) has accepted its filing for another indication approval of lerociclib (GB491), a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor. The new indication seeks to utilize lerociclib in combination with letrozole for patients with hormone receptor-positive…
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Pfizer’s Adcetris Combo Shows Improved Survival in Relapsed/Refractory DLBCL Late-Stage Trial
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Pfizer (NYSE: PFE) has announced positive results from a late-stage clinical trial for its antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study successfully met its primary endpoint, demonstrating an improvement in overall survival (OS)…
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MSD Strikes Deal with Pearl Bio to Tap into Synthetic Biology for Oncology Targets
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into a strategic agreement with Pearl Bio, a synthetic biology company, to leverage Pearl’s genomically recoded organisms (GROs) platform. This platform is designed for the discovery and development of biologic molecules that incorporate non-standard amino acids, enabling the targeting of previously…
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MSD Partners with IDEAYA Biosciences to Develop Combination Therapy for Endometrial Cancer
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with IDEAYA Biosciences (NASDAQ: IDYA), a US-based biotechnology company, to clinically develop the combination of MSD’s top-selling anti-PD-1 therapy Keytruda (pembrolizumab) with IDEAYA’s potential first-in-class poly (ADP-ribose) glycohydrolase (PARG) inhibitor IDE161. The collaboration focuses on treating microsatellite instability-high (MSI-high)…
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Bio-Thera Solutions Gets Green Light for Phase Ib/II Study of ADC BAT8008 in Advanced Solid Tumors
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received approval from the National Medical Products Administration to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) BAT8008 in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an innovative ADC that consists of…
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Betta Pharmaceuticals’ Ensartinib Accepted for FDA Review for First-Line ALK+ NSCLC Treatment
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Betta Pharmaceuticals (SHE: 300558), a pharmaceutical company based in China, has announced that the market filing for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery, has been accepted for review by the US Food and Drug Administration (FDA). The drug is intended for the first-line…
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InnoCare Pharma Receives IND Approval in China for BCL2 Inhibitor Combo Therapy
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InnoCare Pharma (HKG: 9969; SHA: 688428), a Beijing-based biotech company, has announced that it has received approval for an Investigational New Drug (IND) clinical trial filing in China. The company is set to initiate a clinical trial for its pipeline B-cell lymphoma-2 (BCL2) inhibitor, ICP-248, in combination with its Bruton’s…
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Simcere Pharmaceutical Gets NMPA Approval for Clinical Study of Trispecific Antibody SIM0500
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SIM0500, a trispecific antibody targeting GPRC5D, BCMA, and CD3. This molecule is intended for the treatment of recurrent or…
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Kexing Pharmaceutical Secures Rights for Chia Tai Tianqing’s Generic Ibrance in 11 Countries
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Kexing Pharmaceutical (SHA: 688136), based in China, has entered into an international collaboration agreement with fellow Chinese firm Chia Tai Tianqing, securing commercialization rights for Chia Tai’s generic version of Pfizer’s Ibrance (palbociclib). This agreement encompasses an initial batch of 11 countries. Palbociclib, recognized as the world’s first CDK4/6 inhibitor,…
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Kelun-Biotech’s A400 Receives Fast-Track Status from FDA for RET Fusion-Positive NSCLC
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its investigational RET inhibitor, A400/EP0031. This drug is being developed for the treatment of RET fusion-positive…
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Sinocelltech Gains NMPA Approval for Clinical Study of SCTB35 in B-Cell Non-Hodgkin’s Lymphoma
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Sinocelltech Group Ltd (SHA: 688520), based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational bispecific antibody (BsAb), SCTB35. This novel molecule targets both CD20 and CD3 and is being evaluated as a treatment for…
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Innovent and HutchMed’s Combination Therapy Set for Priority Review in China for Advanced Endometrial Cancer
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China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics Inc.’s (HKG: 1801) PD-1 inhibitor Tyvyt (sintilimab injection) and HutchMed’s (HKG: 0013, NASDAQ: HCM) Elunate (fruquintinib) is on track to receive priority review status in China. This designation pertains to the treatment of advanced mismatch…
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Simcere Secures FDA Approval for Clinical Study of Trispecific Antibody SIM0500 in Multiple Myeloma
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Simcere Pharmaceutical Group (HKG: 2096), based in China, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its trispecific antibody, SIM0500, which targets GPRC5D, BCMA, and CD3. This innovative molecule is being evaluated as a treatment for recurrent or refractory multiple myeloma…
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Lepu Biotechnology’s MRG004A ADC Gains Fast Track Designation for Pancreatic Cancer
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Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed antibody-drug conjugate (ADC) MRG004A has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This indication previously secured the ADC an orphan drug designation (ODD)…
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Merck’s 2023 Annual Report: A Mixed Bag Amid Global Challenges
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Merck KGaA (ETR: MRK), a leading German chemical, reported a 5.6% decline in its global net sales for the fiscal year 2023, amounting to €21.0 billion ($23.0 billion). This contraction was partially attributed to the adverse impact of foreign exchange rates. The company’s Healthcare division, however, posted a 2.7% increase…
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BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its anti-PD-1 drug Opdivo (nivolumab). The drug is now approved in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma (UC) in adults. The…
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Shanghai Fosun Pharma Gets NMPA Green Light for Universal NK Cell Therapy GCK-01 Clinical Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its universal NK cell therapy, GCK-01. This Category 1 innovative therapeutic…
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Shanghai Fosun Pharma Gets NMPA Green Light for XS-02 Solid Tumor Clinical Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate XS-02 in patients with advanced solid tumors. XS-02 is a…
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Luye Pharma Launches Small-Cell Lung Cancer Treatment Zepzelca in Hong Kong and Macau
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the official market launch of Zepzelca (lurbinectedin), a novel drug for the treatment of small-cell lung cancer (SCLC), in Hong Kong and Macau. Lurbinectedin, discovered and developed by Spain-based Pharma Mar, S.A. (MCE: PHM), is a selective inhibitor of…
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Proviva Therapeutics Secures $18 Million in Series A Financing to Advance PTX-912
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Proviva Therapeutics, a Shanghai-based clinical-stage biotechnology company, has reportedly secured USD 18 million in a Series A financing round led by Lapam Capital, Ennovation Ventures, and Sangel Capital. The funds raised will be directed towards the clinical advancement of the company’s core product, PTX-912. Specializing in the development of next-generation…
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CARsgen Launches BCMA-Targeted CAR-T Therapy in China with High Price Point
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China-based CAR-T cell therapy specialist CARsgen Therapeutics Holdings Ltd. (HKG: 2171) has launched its BCMA-targeted CAR-T cell therapy, CT053 (zevorcabtagene autoleucel; zevor-cel), with a price tag of RMB 1.15 million (USD 160,000), as reported by The Paper, a local media outlet. The company anticipates that the drug’s annual end sales…
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EMA Reviews J&J’s Darzalex Subcutaneous Formulation for Newly Diagnosed Multiple Myeloma
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The European Medicines Agency (EMA) has this week received an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for a subcutaneous formulation of its anti-CD38 drug Darzalex (daratumumab). The filing seeks approval for the combination therapy with bortezomib, lenalidomide, and dexamethasone as a treatment for newly diagnosed multiple…
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Gilead and Merus Form Strategic Oncology Alliance to Develop Trispecific T-Cell Engagers
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Gilead Sciences Inc., (NASDAQ: GILD), has entered into a strategic partnership with Netherlands-based Merus N.V. (NASDAQ: MRUS) to discover two to three trispecific T-cell engagers in the field of oncology. Merus is set to receive an upfront payment of $56 million, an equity investment worth $25 million, and is eligible…
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Duality Biologics’ DB-1303 on Track for Breakthrough Designation for HER2+ Endometrial Cancer
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The Center for Drug Evaluation (CDE) website has indicated that DB-1303, a HER2 targeted antibody drug conjugate (ADC) developed by Duality Biologics, a biotech company with operations in both the United States and China, is poised to receive breakthrough therapy designation (BTD). The proposed use for the treatment is for…
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Bayer Posts 1.2% YOY Sales Decline in 2023 with Pharmaceuticals and Consumer Health Segment Updates
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Germany’s Bayer (ETR: BAYN) has released its financial results for 2023, marking a year of declining sales that culminated in a 1.2% year-on-year (YOY) drop in constant currency and portfolio-adjusted terms, reaching €47.6 billion (USD 51.7 billion). The Pharmaceuticals segment generated €18.1 billion (USD 19.6 billion) with a 0.4% decline…
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Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
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The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical company, registration approvals for its biosimilars Wyost (denosumab) and Jubbonti (denosumab). These biosimilars reference and share the same indications as Amgen’s (NASDAQ: AMGN) bone treatments Xgeva and Prolia, respectively. With this approval, Sandoz’s drugs become…
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Bio-Thera Solutions Receives NMPA Approval for Three Cancer Treatments Including a Novel ADC
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for three of its drug candidates. These include BAT8010 in combination with BAT1006 for the treatment of locally advanced or metastatic solid tumors, as well as BAT7205 as…
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EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
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The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug conjugate (ADC) datopotamab deruxtecan, developed jointly by UK-based AstraZeneca (AZ; NASDAQ: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). The indications submitted for review are for the treatment of locally advanced or metastatic nonsquamous non-small cell…
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Luye Pharma Initiates Phase III Clinical Trial for Irinotecan Liposome Injection in Small-Cell Lung Cancer
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its irinotecan liposome injection, LY01610. The Phase III study, which is multi-center, randomized, open-label, and parallel-designed, aims to evaluate the efficacy and safety of LY01610 in…
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Hengrui Medicine Gets NMPA Green Light for KRAS G12C Inhibitor Clinical Trial in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for HRS-7058, an innovative and selective drug candidate, in patients with advanced solid tumors harboring the KRAS G12C mutation. This development marks a significant step for Hengrui Medicine…
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Innovent Biologics’ Taletrectinib Receives Second NDA Acceptance in China for ROS1 Positive NSCLC
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted a second New Drug Application (NDA) for its investigational drug taletrectinib. This next-generation tyrosine kinase inhibitor (TKI) targets ROS1 and NTRK fusion mutations and is currently…
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BeiGene’s Brukinsa Outperforms Acalabrutinib in MAIC for Relapsed/Refractory CLL, Says BeiGene
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the results of a matching-adjusted indirect comparison (MAIC) between its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), and acalabrutinib in terms of efficacy. The comparison is based on data from the Phase III ALPINE and Phase III ASCEND studies, which…
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BMS’s Yervoy-Opdivo Combo on Track for Breakthrough Therapy Designation in China for CRC
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The China Center for Drug Evaluation (CDE) website has indicated that the market approval filing for Bristol-Myers Squibb’s (BMS, NYSE: BMY) combination regimen of Yervoy (ipilimumab) and Opdivo (nivolumab) for first-line unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) is on track to receive…
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Shanghai Fosun Pharma’s GCK-01 CAR-NK Cell Therapy Gets Tacit Clinical Approval from China’s CDE
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The China Center for Drug Evaluation (CDE) website has indicated that Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), has received tacit approval for a Category 1 biologic preparation, GCK-01, to proceed with clinical trials. The therapeutic candidate is intended for the treatment of recurrent or refractory follicular…
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J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
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The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ) full approval for the use of Rybrevant (amivantamab) in combination with chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This bispecific antibody (BsAb)…
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Haihe Pharmaceuticals Licenses Glumetinib to Taiho for Exclusive Development in Japan and Asia
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Shanghai Haihe Pharmaceutical Co., Ltd has entered into a licensing agreement with Taiho Pharmaceutical Co., Ltd, granting the Japanese company exclusive rights to develop, manufacture, and commercialize glumetinib, a MET-targeted tyrosine kinase inhibitor (TKI), in Japan and other Asian countries (excluding China) and Oceania. Haihe has already submitted a market…
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Fosun Pharmaceutical Secures NMPA Approval for Phase II Study of FCN-338 and FCN-647 in Chronic Lymphocytic Leukemia
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its Bcl-2 inhibitor FCN-338 in combination with the BTK inhibitor FCN-647, targeting chronic lymphocytic leukemia/small lymphocytic lymphoma. FCN-338…
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Jiangsu Hengrui Receives NMPA Approval for HRS-1167 Clinical Trials in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276) has secured clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy HRS-1167, which will be evaluated in combination with SHR-A1921, bevacizumab, or abiraterone plus prednisone/prednisolone for the treatment of advanced solid tumors. HRS-1167 is a second-generation PARP inhibitor…
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CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
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The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs). Adrenaline is gaining priority status due to new…
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CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product CT053 (zevorcabtagene autoleucel; zevor-cel). This B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy is now…
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FDA Withdraws Approval for Multiple Myeloma Drug Pepaxto Over Safety and Efficacy Concerns
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The US Food and Drug Administration (FDA) has announced its final decision to withdraw approval for Pepaxto (melphalan flufenamide), a drug initially approved for use in combination with dexamethasone to treat certain patients with multiple myeloma (MM). The decision stems from two key factors: (1) a confirmatory study, conducted as…
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Chia Tai Tianqing’s Anlotinib-Benmelstobart Combo Therapy Receives CDE Review for Endometrial Cancer
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Chia Tai Tianqing, a renowned biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted for review a new indication filing for its anlotinib (trade name: FOCUS V) in combination with the anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The proposed indication…
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AstraZeneca’s AZD0486 Receives NMPA Greenlight for Clinical Study in B-Cell Leukemia
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AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its drug candidate AZD0486 (TNB-486) in patients with recurrent or refractory B-cell acute lymphoblastic leukemia. AZD0486 is a bispecific antibody (BsAb) that targets both…
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BMS’s Azacitidine, First Oral AML Therapy, Reaches GBA Patients via Special Policy
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Bristol-Myers Squibb (BMS, NYSE: BMY), a leading US pharmaceutical company, has announced the clinical application of its drug azacitidine in Shenzhen, within the Guangdong Hong Kong Macao Greater Bay Area (GBA). This marks the use of the world’s first and only oral maintenance therapy for acute myeloid leukemia (AML) in…
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Abbisko Therapeutics Reports Positive Phase I Results for ABSK061 in Solid Tumors at ESMO TAT 2024
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Shanghai-based Abbisko Therapeutics Co., Ltd. (HKG: 2256) has revealed promising outcomes from a global, multi-center Phase I trial evaluating the safety, tolerability, pharmacokinetics (PK), and anti-tumor efficacy of its oral FGFR2/3 inhibitor, ABSK061, in treating solid tumors. These findings were presented at the European Society for Medical Oncology (ESMO) TAT…
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Shandong Buchang Pharmaceuticals Gets NMPA Greenlight for Phase I Study of BC001 in Solid Tumors
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I study for its investigational biologic product BC001. The study will assess the safety, tolerability, efficacy, and pharmacokinetics of BC001, a…
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Bayer’s BAY 2927088 Receives FDA Breakthrough Therapy Designation for HER2-Mutated NSCLC
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The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough therapy designation for its tyrosine kinase inhibitor (TKI) BAY 2927088. The drug is under review as a potential treatment for unresectable or metastatic non-small cell lung cancer (NSCLC) with activating HER2 (ERBB2) mutations that have…
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Haisco Pharmaceutical Gets NMPA Greenlight for HSK39775 Solid Tumor Drug Candidate
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate HSK39775, intended for the treatment of advanced solid tumors. Preclinical study results have demonstrated HSK39775’s potential efficacy across…
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Harbour BioMed Partners with Boostimmune to Develop Novel ADC Therapies
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Harbour BioMed (HKG: 2142), a biotechnology company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced an antibody drug conjugate (ADC) discovery cooperation agreement with South Korea-based ADC specialist Boostimmune, Inc. The financial details of the agreement have not been disclosed. As per the terms…
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BeiGene’s Tislelizumab Receives CHMP Recommendation for Three NSCLC Indications in Europe
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BeiGene (NASDAQ: BGNE) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended its programmed death-1 (PD-1) inhibitor tislelizumab for a marketing license for three non-small cell lung cancer (NSCLC) indications. The CHMP’s positive opinion is for: Patients with EGFR or ALK mutation-positive…
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Novo Nordisk Partners with Neomorph to Target Undruggable Diseases with Molecular Glue Degraders
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Danish pharmaceutical giant Novo Nordisk (CPH: NOVO-B) has entered into a partnership with US-based Neomorph to discover, develop, and commercialize molecular glue degraders targeting specific indications in cardiometabolic and rare diseases. Neomorph will be responsible for the discovery and pre-clinical development of the candidates, for which it will receive up…
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AstraZeneca Expands Global Footprint with Shanghai Strategic Center
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AstraZeneca (AZ, NASDAQ: AZN) has declared that Shanghai is now its fifth global strategic center, joining the ranks of Cambridge in the UK, Boston and Gethersburg in the United States, and Gothenburg in Sweden. This move is complemented by AstraZeneca’s plan to collaborate with innovative pharmaceutical companies in Shanghai for…
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Kexing Pharmaceutical Partners with Yabao to Distribute Generic Nexavar in Ten Countries
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China-based Kexing Pharmaceutical (SHA: 688136) has entered into an overseas cooperation agreement with fellow domestic firm Yabao Pharmaceutical Group Co., Ltd. (SHA: 600351) to distribute a generic version of Bayer (ETR: BAYN)’s Nexavar (sorafenib). Under this agreement, Kexing will serve as the exclusive agent for the tyrosine kinase inhibitor (TKI)…
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GenScript’s Subsidiary Legend Biotech Gets CHMP Nod for Carvykti Label Expansion in Multiple Myeloma
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GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the label expansion of its (BCMA)-directed chimeric antigen receptor T…
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Mabwell Bioscience Cancels Licensing Agreements with Yangtze River Pharma for Two Drug Candidates
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced the cancellation of licensing agreements with Yangtze River Pharmaceutical Group for two of its drug candidates: 8MW0511, a recombinant (yeast secreted) human serum albumin human granulocyte colony-stimulating factor (I) fusion protein for injection, and 9MW1111,…
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Mabwell Bioscience’s Nectin-4 Targeting ADC Earns FDA Fast-Track Designation for Esophageal Cancer
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) 9MW2821. This candidate targets Nectin-4 and is under investigation for the treatment of advanced, recurrent,…
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Boehringer-Ingelheim Partners with CBmed to Accelerate First-in-Class Cancer Medicines Development
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Boehringer-Ingelheim, a German pharmaceutical giant, has entered into a long-term strategic partnership with Austria-based CBmed GmbH Center for Biomarker Research in Medicine (CBmed). The collaboration aims to leverage translational medicine approaches to expedite the development of first-in-class oncology drugs, with the ultimate goal of transforming the lives of cancer patients…
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Jiangsu Hengrui Receives NMPA Approval for Adjuvant Therapy Clinical Study of Adebrelimab in NSCLC
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its PD-L1 monoclonal antibody (mAb) adebrelimab (SHR-1316) in combination with chemotherapy as adjuvant therapy for patients with resectable stage II or III…
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Hinova Pharmaceuticals’ HP537 Receives CDE Approval for Clinical Study in Hematologic Malignancies
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its Category 1 chemical drug HP537, targeting hematologic malignancies. This development marks a significant step for Hinova Pharmaceuticals as…
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Jiangsu Hengrui’s CD79b Targeting ADC SHR-A1912 Earns FDA Fast-Track Designation for R/R DLBCL
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) SHR-A1912, targeting CD79b, in the treatment of recurrent/refractory diffuse large B-cell lymphoma (R/R DLBCL) in…
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AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial for Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI), has successfully met its primary endpoint of progression-free survival (PFS) in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). The trial evaluated a once-daily…
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Immune-Onc Therapeutics’ IO-202 Earns Orphan Drug Designation for CMML from US FDA
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Immune-Onc Therapeutics, the Hangzhou-based subsidiary of US company Immune-Onc Therapeutics Inc., has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate IO-202, which is being developed to treat chronic myelomonocytic leukemia (CMML). This potential first-in-class LILRB4 antagonist was…
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Innovent Biologics’ Tyvyt Receives Marketing Approval for Multiple Indications in Macau
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced that it has received marketing approval for Tyvyt (sintilimab injection), a PD-1 inhibitor co-developed with US pharmaceutical giant Eli Lilly, for multiple indications in Macau. The drug has been approved to treat classic Hodgkin’s lymphoma (cHL),…
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MSD’s Belzutifan and Sperogenix’s Vamorolone Targeted for Priority Review by China’s CDE
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The Center for Drug Evaluation (CDE) website has indicated that Merck, Sharp & Dohme’s (MSD; NYSE: MRK) belzutifan and Sperogenix Therapeutics Ltd’s vamorolone are on track to receive priority review statuses in China. Belzutifan, which targets von Hippel Lindau (VHL) disease-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma,…
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AstraZeneca Secures Shareholder Approval for $1 Billion Acquisition of Gracell Biotechnologies
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The proposed acquisition of China-based Gracell Biotechnologies Inc. (Nasdaq: GRCL) by UK pharmaceuticals giant AstraZeneca (AZ, NASDAQ: AZN) has received approval from Gracell’s shareholders during an extraordinary general meeting held on February 19, 2024. An overwhelming 99.9% of shareholders voted in favor of AstraZeneca’s $1 billion acquisition, with potential total…
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BMS Seeks FDA Priority Review for Krazati in Advanced Colorectal Cancer
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Bristol Myers Squibb (BMS; NYSE: BMY) has submitted a priority review application to the U.S. Food and Drug Administration (FDA) for an additional indication of its KRASG12C inhibitor, Krazati (adagrasib), in combination with cetuximab (Merck’s Erbitux) for pre-treated patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA…
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WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
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WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG: 2359) based in China, has announced the U.S. FDA’s approval of its Philadelphia facility to commence analytical testing and manufacturing of Amtagvi (lifileucel) for Iovance. This novel therapy received accelerated approval for its Biologics License…
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HitGen’s Vernalis Partners with Hox Therapeutics to Develop Novel Cancer Inhibitors
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HitGen Inc. (SHA: 688222), based in China, announced that its wholly owned subsidiary Vernalis (R&D) Ltd will collaborate with Hox Therapeutics Ltd, a private biotech firm dedicated to developing highly targeted cancer therapies, to create inhibitors aimed at undisclosed targets. Vernalis will leverage its advanced protein science capabilities and Hit…
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Merck’s Keytruda Under Priority Review for New Indication in Endometrial Carcinoma
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This week, the U.S. FDA granted priority review status to an indication extension filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab), seeking approval as a treatment for primary advanced or recurrent endometrial carcinoma, the most prevalent gynecological cancer. The FDA anticipates reaching a…
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Immune-Onc Therapeutics Partners with Roche for Phase Ib/II Study of IO-108 in Liver Cancer
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Immune-Onc Therapeutics Inc., based in the U.S., is entering into a collaboration with Roche (SWX: ROG) to conduct a Phase Ib/II clinical study evaluating its LILRB2 (ILT4) monoclonal antibody (mAb) IO-108 in combination with Roche’s PD-L1 mAb atezolizumab and VEGF mAb bevacizumab. This study aims to target first-line localized advanced,…
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Innovent Biologics Partners with ImmVirX to Launch Clinical Study Combining Tyvyt and IVX037
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Innovent Biologics Inc. (HKG: 1801), based in China, has announced the signing of a clinical study and supply cooperation agreement with ImmVirX Pty Ltd. This strategic partnership will facilitate a clinical study that combines Innovent’s Tyvyt (sintilimab), a programmed death-1 (PD-1) inhibitor already approved in China for seven different indications,…
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Mabwell Bioscience Receives FDA Green Light for B7-H3 Targeting ADC 7MW3711
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) 7MW3711, which targets B7-H3. The molecule is intended to be assessed…
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BMS and Sichuan Biokin Commence Joint Development of EGFR/HER3-Targeted ADC
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese pharmaceutical company, has announced that a licensing and cooperation agreement with US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) has officially come into effect as of February 8, 2024, following the expiration of the waiting period for the deal. The agreement…
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Jacobio Pharma Gets CDE Green Light for Phase III Study Combining Gleevec Inhibitors in NSCLC
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Jacobio Pharma (HKG: 1167), a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to initiate a regulatory Phase III clinical study. The study will assess the combination of its KRAS G12C inhibitor glecirasib with pipeline SHP2 inhibitor JAB-3312 for…
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Phanes Therapeutics’ PT886 Receives CDE Approval for Clinical Trials in Advanced Solid Tumors
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Sino-US biotechnology company Phanes Therapeutics Inc. has announced that it has received clinical trial approval from China’s Center for Drug Evaluation (CDE) for its first-in-class claudin 18.2/CD47 bispecific antibody (BsAb) PT886, intended for the treatment of advanced solid tumors including gastric cancer, gastroesophageal junction cancer, and pancreatic cancer. PT886, a…
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ImmunoTech Biopharm Gets NMPA Green Light for Clinical Study of aT19 Injection for B-ALL
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ImmunoTech Biopharm Ltd (HKG: 6978), a specialist in chimeric antigen receptor T-cell (CAR-T) therapies based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its aT19 injection. The treatment is designed as a sequential therapy for patients…
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GSK’s Avodart Receives NMPA Approval to Resume Sales in China from September
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The National Medical Products Administration (NMPA) has released a notification announcing that GlaxoSmithKline’s (GSK) Avodart (dutasteride) has been given the green light to resume import, sales, and use in China, effective from September 1, 2023. This follows a previous suspension due to an unsuccessful overseas site inspection by the NMPA…
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AstraZeneca Reports 6% Revenue Growth in 2023, Driven by Oncology and Diabetes Drug Sales
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AstraZeneca (AZ; NASDAQ: AZN), the UK-based multinational, reported its financial results for 2023 this week, revealing a 6% year-on-year increase in annual global revenues, reaching USD 45.8 billion at constant exchange rates. Oncology revenue surged by 21%, while cardiovascular, renal, and metabolism (CVRM) sales rose 18%. Respiratory and immunology (R&I)…
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AbbVie Expands Licensing Agreement for Innovative sCAR-T Platform with Scripps Research
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AbbVie (NYSE: ABBV) has expanded its collaboration with Scripps Research’s Calibr-Skaggs Institute, securing licensing rights to the institute’s investigational switchable CAR-T (sCAR-T) platform, which has shown promising early-stage results. The agreement entails an upfront payment, along with potential milestone payments and royalties, allowing AbbVie to access the program for up…
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CMS Secures NMPA Approval for Clinical Trials of TYK2 Inhibitor CMS-D001 and GnRH Antagonist CMS-D002
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for two of its drug candidates: CMS-D001 and CMS-D002. CMS-D001 is a highly selective TYK2 (tyrosine kinase 2) inhibitor aimed at treating immune inflammatory diseases, including…
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Yantai Dongcheng Acquires Full Rights to Alfatide II, Targeting Diagnostic and Therapeutic Applications
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Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) has announced its acquisition of all rights to alfatide II across all diagnostic and therapeutic fields and indications. Alfatide II, initially developed by Dr. Chen Xiaoyuan and previously licensed to Jiangsu Xinrui Pharmaceutical Co., Ltd. for further development, is currently in the…
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Gilead’s 2023 Flat Sales Reflect Stagnation and COVID-19 Demand Decline
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Gilead Sciences Inc. (NASDAQ: GILD) has reported a stagnant performance for the year 2023, with total product sales remaining unchanged at USD 26.9 billion. Amid a broad decline in demand for COVID-19 treatments, the company’s antiviral Veklury (remdesivir) sales could not offset the downturn, although HIV sales increased by 6%…
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Gilead’s 2023 Stagnation Foresees Flat 2024 Sales as Veklury Revenues Dwindle
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Gilead Sciences (NASDAQ: GILD) has reported a stagnant performance for 2023, with product sales remaining flat at USD 26.9 billion. The company’s financials were affected by a widespread downturn in demand for COVID-19 treatments, as its antiviral Veklury (remdesivir) sales offset growth in other areas. HIV sales reached USD 18.2…
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Amgen’s Q4 2023 Results Showcase 9% YOY Growth, 18 Drugs Hit Record Sales
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Biopharmaceutical giant Amgen (NASDAQ: AMGN) has reported its financial results for Q4 2023, announcing annual sales of USD 26.9 billion, reflecting a substantial 9% year-on-year (YOY) increase, primarily driven by volume growth. In an earnings call, CEO Robert Bradway highlighted that a remarkable 18 of the company’s medicines achieved record…
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Eli Lilly’s 2023 Revenue Soars on Metabolism Drugs, Anticipates Further Growth in 2024
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Eli Lilly and Company (NYSE: LLY) reported a robust 2023 financial performance with a 20% year-on-year (YOY) increase in revenue, reaching USD 34.1 billion, as detailed in their Q4 2023 report released this week. This growth was substantially driven by the company’s metabolism drugs, indicating a recovery from the COVID-19…
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Innovent Biologics Posts 65% YOY Growth in Q4 2023 with Over RMB 1.6 Billion in Sales
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Chinese biopharmaceutical company Innovent Biologics Inc., (HKG: 1801) has reported impressive quarterly sales figures, announcing over RMB 1.6 billion (USD 219 million) in product sales for Q4 2023, marking a 65% year-on-year (YOY) increase. In the final quarter of the year, Innovent’s PD-1 inhibitor, Tyvyt (sintilimab injection), maintained strong market…
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Shanghai Procurement Platform Offers Price Cut Leeway to Escape ‘High-Priced Drugs’ Tag
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Shanghai’s Sunshine Medical Procurement All-in-One (SMPA) platform has announced a significant policy shift regarding non-winning bids in the 9th round of volume-based procurement (VBP). The notification suggests that drugs which did not secure a winning bid and are eligible for online procurement in Shanghai may be exempted from the “high-priced…
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BioNTech and Duality’s DB-1305 Earns Fast-Track Status for Platinum-Resistant Cancers
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German biotechnology company BioNTech SE (NASDAQ: BNTC) and its partner Duality Biologics (Suzhou) Co., Ltd have received fast-track designation from the U.S. Food and Drug Administration for their jointly developed drug candidate DB-1305/BNT325. This designation is in recognition of the drug’s potential to treat platinum-resistant epithelial ovarian cancer, fallopian tube…
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Novartis to Acquire MorphoSys for €2.7 Billion in Strategic Oncology Expansion
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Switzerland-based Novartis (NYSE: NVS) has announced a voluntary public takeover offer to acquire Germany-based biopharmaceutical firm MorphoSys (FSE: MOR; NASDAQ: MOR) for €2.7 billion. The transaction is anticipated to finalize in the first half of 2024, pending the fulfillment of customary conditions. By acquiring MorphoSys, Novartis aims to incorporate two…
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Zhejiang Anglikang Enters R&D Cooperation Agreement with Affinity Biopharmaceutical
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China-based Zhejiang Anglikang Pharmaceutical Co., Ltd. (SHE: 002940) has entered into a research and development (R&D) collaboration and licensing agreement with fellow domestic entity Affinity Biopharmaceutical Co., Ltd. Under the terms of the agreement, Affinity grants Anglikang exclusive rights for R&D, manufacturing, and commercialization of QHL-1618, a fully water-soluble small-molecule…
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MSD’s Keytruda Secures 13th Indication Approval in China for Biliary Carcinoma Treatment
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that its drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced or metastatic biliary…
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Healthstar Medical Commences Phase III Clinical Trial for KC1036 in Esophageal Cancer
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Healthstar Medical Development Co., Ltd (SHA: 603590), a Beijing-based pharmaceutical company, has announced the first patient dosing in a Phase III clinical study for its drug candidate KC1036, which is aimed at treating patients with advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This marks a significant milestone in…
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Abbisko Therapeutics Secures $70 Million Upfront Payment in Licensing Deal with Merck KGaA
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Shanghai-based biotechnology firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has declared the successful conclusion of the initial phase of a licensing agreement with Merck KGaA, concerning its proprietary colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021). As part of this agreement, Abbisko has received an upfront payment of USD 70…
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Johnson & Johnson’s Talquetamab and Daiichi Sankyo’s Enhertu Eye Priority Review in China
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s Talvey (talquetamab) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) are on track to receive priority review statuses. Talquetamab, a bispecific GPRC5D-directed CD3 T-cell engager, is in development for the treatment of adult patients with recurrent/refractory…
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AbbVie Reports $54.3 Billion in 2023 Revenues Amid Humira Erosion and Segment Variability
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AbbVie (NYSE: ABBV) reported revenues of $54.3 billion for 2023, reflecting a 5.9% year-on-year decline at constant currency rates, as the company grapples with the erosion of its flagship immunosuppressant, Humira (adalimumab). While the neuroscience and aesthetics segments showed resilience with revenue increases of 18.5% and 0.9%, generating $7.7 billion…
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Biotech Pharmaceutical Secures Approval for Nimotuzumab in Head and Neck Cancer Treatment
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Sino-Cuban joint venture Biotech Pharmaceutical Limited (BPL) has secured another indication approval in China for its biologic drug nimotuzumab, now authorized for the treatment of locally advanced head and neck squamous cell carcinoma (HNCC). Nimotuzumab, an EGFR monoclonal antibody (mAb), previously received marketing approvals in China for nasopharyngeal carcinoma (NPC)…
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China Reports Over 4.8 Million New Cancer Cases in 2022 Amid Rising Incidence and Mortality Rates
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China’s National Cancer Center (NCC) has released the latest national cancer statistics, approved by the National Health Commission (NHC). The data, calculated in collaboration with the International Agency for Research on Cancer (IARC), aligns with the GLOBOCAN 2022 report. In 2022, China reported 4,824,700 new cancer cases, with a standard…
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Sichuan’s Ancocare Gets FDA Green Light for Phase I/III Study of Oncolytic Virus in Neuroblastoma
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Sichuan-based Flavivirus technology platform developer Ancocare has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I/III clinical study for its double spear type I oncolytic virus DS1-H2-1 in neuroblastoma. The product, which leverages the Flavivirus technology platform, is a positive…
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Roche Posts Modest 2023 Growth Amid Shifts in Demand for COVID-Related Products
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Swiss pharmaceutical giant Roche (SWX: ROG) has published its 2023 financial results, showing a modest 1% year-on-year (YOY) increase in global sales at constant exchange rates (CER) to CHF 58.7 billion (USD 68.5 billion). This growth was primarily due to a 6% YOY expansion in the pharmaceutical business to CHF…
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Merck KGaA’s Tepmetko Launches in China, Expanding Access to MET Inhibitor for Lung Cancer Patients
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Merck KGaA (NYSE: MRK), a leading German science and technology company, has announced the commercial launch of its targeted lung cancer therapy, Tepmetko (tepotinib), in China. This marks a significant milestone as multiple hospitals across the country have begun writing the first prescriptions for this MET inhibitor. Tepmetko, which has…
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Chia Tai Tianqing and Fudan University Shanghai Cancer Center Join Forces for Innovative Drug Development
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Chia Tai Tianqing, a China-based pharmaceutical company, has entered into a strategic partnership with Fudan University Shanghai Cancer Center to intensify their collaboration on clinical trials for innovative drugs. The agreement leverages Chia Tai Tianqing’s comprehensive industrial chain strength in scientific and technological innovation and the Shanghai Cancer Center’s leading…
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Shanghai Junshi Biosciences’ Toripalimab Aims for Singapore Approval in Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has submitted market approval applications in Singapore for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug is proposed for use as a first-line treatment for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC)…
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Takeda Reports Flat 9-Month Revenue Growth Amid Pipeline Optimization Efforts
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Takeda (TYO: 4502), a leading Japanese pharmaceutical company, has released its financial results for the 9-month period ended December 31, 2023, reporting a revenue of JPY 3.2 trillion (USD 21.9 billion) with a 0.0% growth at constant exchange rates (CER). The company’s performance was impacted by declines in oncology, neuroscience,…
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Novartis Sees Robust Growth in Innovative Medicines with 2023 Financials Reflecting a Shift Toward R&D Focus
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, reported a substantial leap in its global sales for the last financial year, amassing USD 45.4 billion—a 10% year-on-year (YOY) increase in constant currency terms, as per the 2023 financials released this week. This achievement marks Novartis’s inaugural annual report following the strategic…
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Manhattan BioSolutions Strikes Agreement with Biocytogen for Access to Novel Tumor Antigens
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Manhattan BioSolutions Inc., a U.S.-based biotechnology company, has entered into an assessment and potential licensing agreement with Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a Chinese biopharmaceutical firm. Through this agreement, Manhattan BioSolutions is poised to gain access to a range of antibodies targeting a novel tumor antigen that is…
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Pfizer Reports USD 58.5 Billion in Revenues Amid Post-Pandemic Sales Shifts and Oncology Pipeline Expansion
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Pfizer Inc. (NYSE: PFE) has reported a significant downturn in global revenues for the week, amounting to USD 58.5 billion, following a 41% year-on-year (YOY) decrease in operational terms. This substantial drop reflects the diminishing sales of the SARS-CoV-2 vaccine Comirnaty and the antiviral treatment Paxlovid. The reported figures align…
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Astellas Forges Partnership with Mass General Brigham to Boost Oncology and Rare Disease Research
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced a strategic partnership with Mass General Brigham, a prominent academic institution in the United States. This collaboration aims to drive scientific and clinical advancements in critical areas, including oncology, rare diseases, and cell and gene therapy. Astellas will…
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Mabwell Bioscience Extends Research Partnership with Fudan University Cancer Center
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Mabwell (Shanghai) Bioscience Co., Ltd., (SHA: 688062) has announced the renewal of its strategic research partnership with Fudan University Shanghai Cancer Center. The collaboration, initiated in July 2021, focuses on advancing research cooperation, nurturing talent, enhancing hospital management, and constructing robust platforms for scientific exchange. The partnership has seen significant…
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Hengrui Medicine Scores First-Mover Status with FDA Approval for Generic Astagraf XL
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its sustained-released generic version of Astagraf XL (tacrolimus), originally developed by Japan-based Astellas. With this…
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Gilead Increases Stake in Arcus Biosciences and Invests in Anti-TIGIT Program
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Gilead (NASDAQ: GILD) has strengthened its 2020 collaboration agreement with US-based Arcus Biosciences (NYSE: RCUS) by amending it to accelerate their joint program on the anti-TIGIT monoclonal antibody (mAb) domvanalimab. The amendment includes an additional investment of USD 320 million, which increases Gilead’s ownership stake in Arcus to 33% and…
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AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for Enhertu (trastuzumab deruxtecan), submitted in partnership with Japan’s Daiichi Sankyo (TYO: 4568) to the US Food and Drug Administration (FDA), has been granted priority review. The treatment is now under consideration for unresectable or metastatic…
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Bristol Myers Squibb’s Subcutaneous Opdivo Shows Noninferiority in Phase III ccRCC Trial
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Bristol Myers Squibb (BMS; NYSE: BMY) this week announced preliminary Phase III data demonstrating that its subcutaneous formulation of Opdivo (nivolumab), developed in partnership with Halozyme Therapeutics (NASDAQ: HALO), is noninferior to the intravenous version for patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The equivalence trial…
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Johnson & Johnson’s Rybrevant and Lazertinib Filings Accepted for Review by CDE
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The Center for Drug Evaluation (CDE) has confirmed that Johnson & Johnson’s (J&J, NYSE: JNJ) market filings for Rybrevant (amivantamab) and lazertinib, designated as JXSS2400004 and JXHS2400009 respectively, have been accepted for review. Amivantamab-vmjw, a bispecific antibody targeting EGFR and MET, received its initial approval in May 2021 for the…
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Laekna Therapeutics Reports Phase II Data for Afuresertib in Platinum-Resistant Ovarian Cancer
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Laekna Therapeutics Shanghai Co., Ltd, a China-based pharmaceutical company, has announced topline data from the global multi-center Phase II PROFECTA-II study for its afuresertib combined with paclitaxel in the treatment of platinum-resistant ovarian cancer (PROC). The Sino-US study aimed to assess the efficacy and safety of the combination therapy in…
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Yantai Dongcheng’s Radiopharmaceutical 68GaLNC1007 Gets FDA Nod for Diagnostic Use in Solid Tumors
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) for its radiopharmaceutical 68GaLNC1007. This diagnostic agent targets fibroblast activating protein (FAP) and integrin αvβ3 and is under development to support the treatment…
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Roche Commences Phase II Trial of Repare Therapeutics’ ATR Inhibitor, Camonsertib, in Solid Tumors
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Swiss pharmaceutical giant Roche (SWX: ROG) has reached a significant milestone this week with the dosing of the first patient in an open-label Phase II trial using its Canadian partner Repare Therapeutics’ (NASDAQ: RPTX) ATR inhibitor, camonsertib. The trial aims to evaluate the safety and efficacy of various targeted therapies…
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Roche’s Tecentriq in Combination with Exelixis’s Cabometyx Meets Primary Endpoint in mCRPC Phase III Study
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced positive results from a Phase III study showcasing the efficacy of its anti-PD-L1 drug Tecentriq (atezolizumab) in combination with Exelixis’s (NASDAQ: EXEL) tyrosine kinase inhibitor (TKI) Cabometyx (cabozantinib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The study focused on…
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Biosion’s SIRPα-Targeting Monoclonal Antibody BSI-082 Clears US FDA Clinical Trial Hurdle
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Biosion, a global clinical-stage biotechnology company dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its pipeline candidate BSI-082. This monoclonal antibody (mAb) targets SIRPα and is under development for the…
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MSD’s Keytruda Combines with PharmAbcine’s PMC-309 in Phase Ia/b Solid Tumor Trial
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its blockbuster anti-PD-1 drug Keytruda (pembrolizumab) has entered a Phase Ia/b trial in combination with South Korea-based PharmAbcine’s (KOSDAQ: 208340) VISTA-inhibiting biologic PMC-309 for the treatment of advanced or metastatic solid tumors. The study aims to determine the recommended dose,…
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China Grand Pharmaceutical Gets NMPA Green Light for mRNA Cancer Vaccine ARC01 Phase I Study
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, dosage escalation Phase I study for its therapeutic cancer vaccine ARC01 (A002). The study will assess the safety, tolerability, immunogenicity, pharmacokinetics, and…
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China Anti-Cancer Association Forms Consortium for Standardizing Cancer Research Ethics Reviews
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The medical ethics professional committee of the China Anti-Cancer Association (CACA) has announced the formation of the China Cancer Clinical Research Medical Ethics Review Mutual Recognition Consortium. This consortium aims to streamline and standardize the ethical review process for clinical research in cancer treatment across China. The founding members of…
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Boan Biotech Secures FDA Orphan Drug Designations for Two Claudin18.2 Targeting Candidates
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Boan Biotech (HKG: 6955), a Chinese biotechnology company, has announced that it has received orphan drug designation (ODD) awards from the US Food and Drug Administration (FDA) for two of its pipeline candidates. The ODDs were granted to the antibody BA1105 and the antibody-drug conjugate (ADC) BA1301, both of which…
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Alphamab and 3D Medicines License Envafolimab Rights to Glenmark for Multiple Regions
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Alphamab Oncology (HKG: 9966) and 3D Medicines (HKG: 1244), two Chinese pharmaceutical companies, have announced a licensing agreement with Glenmark Pharmaceuticals Ltd (NSE: GLENMARK). The agreement grants the Indian company exclusive development and commercialization rights to the co-developed drug envafolimab (KN035) in India, Asia Pacific (excluding Singapore, Thailand, Malaysia), Middle…
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Phanes Therapeutics’ First-in-Class BsAb PT217 Accepted for Review by China’s CDE
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Sino-US biotechnology company Phanes Therapeutics Inc. has announced that the Investigational New Drug (IND) filing for its potential first-in-class in-house bispecific antibody (BsAb) PT217 has been accepted for review by China’s Center for Drug Evaluation (CDE). PT217 is designed to directly kill tumor cells through the antibody-dependent cellular phagocytosis (ADCP)…
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Harbour BioMed Gets FDA Green Light for Phase I Study of BsAb Targeting PD-L1 and CD40
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Harbour BioMed (HKG: 2142), a biotechnology company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and anti-tumor…
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BMS’s Opdivo-Yervoy Combo Cuts Cancer Progression Risk by 79% in Phase III Study
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Bristol Myers Squibb (BMS; NYSE: BMY) has published late-stage and long-term data for its anti-PD-1 drug Opdivo (nivolumab) across various cancer indications. Early results from a Phase III trial in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) indicate that the combination of Opdivo with anti-CTLA-4…
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Tcelltech’s B7-H3 Targeting CAR-T Therapy TX103 Gets Tacit Clinical Approval for Glioblastoma
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The Center for Drug Evaluation (CDE) website in China has indicated that Tcelltech’s TX103, a chimeric antigen receptor (CAR) T cell therapy targeting B7-H3, has received tacit approval to proceed with clinical trials for the treatment of malignant glioblastoma. Suzhou Porton Biologics Ltd, Tcelltech’s Contract Development and Manufacturing Organization (CDMO)…
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Merck’s Bavencio Shows Promising Survival Data in Real-World Urothelial Carcinoma Studies
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German pharmaceutical company Merck (NYSE: MRK) has released data from real-world studies for its anti-PD-L1 biologic Bavencio (avelumab), used as a maintenance therapy in eligible patients with locally advanced or metastatic urothelial carcinoma (UC). Preliminary results indicate that the median overall survival (OS) in patients without progression after first-line chemotherapy…
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BriSTAR Immunotech’s LILRB4-Targeted Cell Therapy YTS104 Gets Tacit Approval for Clinical Trial in China
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BriSTAR Immunotech, a clinical-stage cell therapy company based in Beijing, has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) in China for its YTS104, a specific LILRB4-targeted cell therapy based on its STAR-T platform. The targeted indications for YTS104 include recurrent/refractory acute myeloid leukemia (AML), chronic…
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Legend Biotech’s Carvykti Files for European Approval as Second-Line MM Treatment
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GenScipt Biotech Corp. (HKG: 1548), a China-based Contract Development and Manufacturing Organization (CDMO), through its subsidiary Legend Biotech Corporation (NASDAQ: LEGN), has announced a market approval filing in Europe for its chimeric antigen receptor (CAR)-T therapy Carvykti (ciltacabtagene autoleucel). The therapy is proposed as a second-line treatment for recurrent/refractory (R/R)…
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Gilead’s Trodelvy Misses Primary Endpoint in Late-Stage NSCLC Trial
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Gilead Sciences (NASDAQ: GILD) has announced that a late-stage trial for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in metastatic or advanced non-small cell lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS) in patients who had previously received treatment for metastatic NSCLC. Despite this setback,…
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Novartis Lutathera Combo Therapy Shows Significant Progress in GEP-NETs
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced preliminary results from a Phase III study that evaluated the efficacy of radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) in combination with the symptom-control drug octreotide as a first-line therapy for SSTR+ well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The clinical…
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AstraZeneca’s Imfinzi Meets Primary Endpoint in Hepatocellular Carcinoma Trial
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced the successful completion of the primary endpoint in a Phase III trial for its anti-PD-L1 drug Imfinzi (durvalumab). The trial investigated the combination of Imfinzi with bevacizumab, originally developed by Roche (SWX: ROG) as Avastin, and transarterial chemoembolization (TACE) for embolization-eligible hepatocellular…
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J&J’s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) into a full registration. Balversa is indicated for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 mutations in patients who…
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Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China,…
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InnoCare Makes Minjuvi Combo Treatment Available to Patients in China’s GBA
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InnoCare (HKG: 9969; SHA: 688428), a China-based biopharmaceutical company, has announced that the combination treatment of Minjuvi (tafasitamab) plus lenalidomide is now accessible to patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA).…
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BeiGene Submits Additional Application for Tislelizumab in NSCLC in China
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BeiGene (NASDAQ: BGNE) has announced the submission of a supplementary Biologic License Application in China for its programmed death-1 (PD-1) inhibitor, tislelizumab. The company is seeking regulatory approval for a new indication in the perioperative (neoadjuvant + adjuvant) treatment of patients with resectable non-small cell lung cancer (NSCLC). The Center…
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Sinocelltech Granted NMPA Approval for Phase I Clinical Trial in Hematological Malignancies
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Sinocelltech Group Ltd (SHA: 688520), a biopharmaceutical company based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its monoclonal antibody SCTC21C, targeting CD38+ hematological malignant tumors. This development marks a significant step forward in…
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CARsgen Therapeutics’ CT041 Shows Promising Results in Advanced Solid Tumors at ASCO GI 2024
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China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the presentation of interim results from the Phase Ib ELIMYN18.2 study’s dosage escalation phase for its pipeline asset, CT041. The data will be showcased at the esteemed 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI 2024). The study is…
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Beijing Aosaikang Initiates Phase III Trial for Advanced Gastric Cancer Treatment
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has registered a Phase III clinical study with Clinicaltrials.gov for its Claudin18.2-targeted antibody ASKB589. The trial will investigate the use of ASKB589 in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. The study aims…
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Eisai and Medivir’s Combo Therapy Advances in Liver Cancer with Positive Trial Results
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Japanese pharmaceutical company Eisai’s (TYO: 4523) kinase inhibitor Lenvima (Lenvatinib), combined with Swedish partner Medivir’s (STO: MVIR) chemotherapy fostroxacitabine bralpamide (fostrox), has demonstrated positive outcomes in an open-label Phase Ib/IIa trial for advanced hepatocellular carcinoma (HCC), Medivir announced. Following last year’s encouraging early data, these results are expected to pave…
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Luye Pharma’s Biosimilar Bevacizumab Gets GMP Certification in Brazil
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA) for its biosimilar version of Roche’s blockbuster drug Avastin (bevacizumab). This certification marks a significant step forward in Luye’s efforts…
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Qilu Pharmaceutical’s Iruplinalkib Gains Additional Indication Approval in China for ALK-Positive NSCLC
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The National Medical Products Administration (NMPA) website has indicated that Qilu Pharmaceutical’s Category 1 drug, Iruplinalkib, has received additional indication approval in China. The new indication is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Previously approved in China…
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Hengrui Medicine Receives NMPA Approval for Phase II Cervical Cancer Study
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will investigate the combination of its PD-L1 monoclonal antibody adebrelimab (SHR-1316) with concurrent chemotherapy for the treatment of locally…
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Roche’s Tecentriq SC Receives European Nod as First Subcutaneous PD-(L)1 Therapy
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Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization to Roche (SWX: ROG) for its anti-PD-L1 drug Tecentriq SC (atezolizumab). This subcutaneous formulation utilizes Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) and is now approved for the same indications as the original intravenous version of Roche’s…
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RemeGen’s MSLN-Targeted ADC RC88 Clears to Begin Phase I/IIa Study in China
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RemeGen Co., Ltd (HKG: 9995; SHA: 688331), a leading Chinese biotech firm, has announced that it has received approval from China’s Center for Drug Evaluation (CDE) to initiate a Phase I/IIa clinical study for RC88, a mesothelin (MSLN)-targeted antibody drug conjugate (ADC). The trial will assess the safety and efficacy…
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Chipscreen NewWay Biosciences Initiates Phase I Trial for PD-1/CD40 Bispecific Antibody Candidate NWY001
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China-based Chengdu Chipscreen NewWay Biosciences Co., Ltd has announced that the first patient has been dosed in a Phase I clinical trial for its investigational PD-1/CD40 bispecific antibody (BsAb) candidate, NWY001. The multi-center, non-random, open-label trial is conducted under the leadership of Sun Yat-Sen University Cancer Center, with objectives to…
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3D Medicines Secures Registration for Envafolimab in Macau for Advanced Solid Tumors
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3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the registration of its PD-L1 monoclonal antibody (mAb) envafolimab in Macau. The approval designates envafolimab for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. Envafolimab is notable for being the world’s first…
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Neuboron Medtech Secures Clinical Trial Approval for First BNCT Drug in China
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Neuboron Medtech Ltd., based in China, has received clinical trial approval for its borofalan (10b) injection, as indicated on the website of China’s Center for Drug Evaluation (CDE). This marks the first boron neutron capture therapy (BNCT) to enter regulatory studies in China and the second globally, targeting recurrent malignant…
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SciClone’s Partner Menarini Files for Elacestrant Approval in Macau for Advanced Breast Cancer
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SciClone Pharmaceuticals Inc. (HKG: 6600) has announced that its Italian partner, Menarini Group, has submitted a pre-licensing application for the import of Orserdu (elacestrant) in Macau, seeking approval for its use in treating advanced or metastatic breast cancer. Elacestrant, a next-generation selective estrogen receptor degrader (SERD) developed by Eisai (TYO:…
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RemeGen Secures Fast-Track Designation for RC88 in Platinum-Resistant Ovarian Cancer
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China-based biotech RemeGen Co., Ltd (HKG: 9995; SHA: 688331) has received fast-track designation (FTD) from the US FDA for its pipeline candidate RC88, a mesothelin (MSLN)-targeted antibody-drug conjugate (ADC). This designation recognizes RC88’s potential as a treatment for platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers. Developed in-house,…
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CSPC Pharmaceutical Secures FDA Approval for Clinical Study of JMT106 in GPC3-Positive Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received approval from the US FDA to commence a clinical study for its bispecific fusion protein, JMT106, targeting GPC3-positive solid tumors. JMT106 is designed to target both GPC3 and interferon receptors, aiming to elicit antibody-dependent cellular cytotoxicity (ADCC) while activating the immune…
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BioNTech Acquires Pre-Clinical Asset and ADC Technology from Portuguese Biotech CellmAbs
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Germany’s BioNTech (NASDAQ: BNTX) has licensed a pre-clinical antibody candidate and additional antibody-drug conjugate (ADC) technology from Portugal-based biotechnology company CellmAbs. The agreement marks Portugal’s first billion-dollar transaction in the life sciences sector. Under the terms, CellmAbs will receive undisclosed upfront and near-term payments, potential milestone payments reaching several hundred…
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MSD’s Keytruda Gains FDA Approval for Advanced Cervical Cancer Treatment
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has received regulatory approval from the US Food and Drug Administration (FDA) for the use of its anti-PD-1 drug Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 stage III-IVA cervical cancer. This marks…
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CARsgen Therapeutics Gets NMPA Approval for CAR-T Therapy CT011 in Hepatocellular Carcinoma
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its chimeric antigen receptor (CAR)-T therapy, CT011. The study will focus on patients with GPC3 positive stage IIIa hepatocellular carcinoma (HCC) who are…
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Simcere Pharmaceutical Group Gets NMPA Green Light for USP1 Inhibitor SIM0501
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Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its cancer drug candidate SIM0501, intended for the treatment of advanced solid tumors. SIM0501 is a small-molecule inhibitor of ubiquitin specific peptidase 1 (USP1), a protein that is…
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Fosun Kite and Medi Cover Launch First Value-Based Payment Plan for Lymphoma Treatment
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Fosun Kite and Medi Cover, a health management and patient service platform under Sinopharm (HKG: 1099), have jointly introduced the first value-based payment (VBP) plan for lymphoma associated with Fosun Kite’s chimeric antigen receptor (CAR) T cell therapy, Yescarta (axicabtagene ciloleucel). Under this innovative plan, eligible patients who do not…
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Bio-Thera Solutions Receives NMPA Approval for Combined Phase Ib/II Study of BAT7104 and BAT4706
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Bio-Thera Solutions Ltd (SHA: 688177), a Chinese biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a combined Phase Ib/II clinical study for its pipeline drugs BAT7104 and BAT4706 in patients with advanced malignant tumors. BAT7104 is a bispecific antibody (BsAb)…
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C4 Therapeutics Outlines 2024 Focus Amid 30% Workforce Reduction, Prioritizes Key Oncology Trials
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C4 Therapeutics (NASDAQ: CCCC), a leader in protein degradation, announced this week its strategic focus for 2024, which includes a significant reduction of 30% in its workforce. The U.S.-based company will prioritize ongoing Phase I/II trials for CFT7455 and CFT1946, targeting relapsed/refractory multiple myeloma (r/rMM) and BRAF V600X-mutant solid tumors,…
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Henlius Biotech Secures Exclusive Rights to Sermonix’s Lasofoxifene for Breast Cancer Treatment in China
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Shanghai Henlius Biotech Inc. (HKG: 2696) has entered into a partnership and licensing agreement with U.S.-based Sermonix Pharmaceuticals Inc. for exclusive development, manufacturing, and commercialization rights in China for the investigational drug lasofoxifene. This ESR1 antagonist is being developed as a treatment for breast cancer. Under the terms of the…
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GenFleet’s SLS009 Receives Fast-Track and Orphan Drug Designations from U.S. FDA for Lymphoma and Leukemia
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Shanghai-based biotech GenFleet Therapeutics announced that its CDK9 inhibitor, SLS009 (GFH009), has received fast-track and orphan drug designation (ODD) statuses from the U.S. FDA. These designations highlight the drug’s potential as a treatment for recurrent or refractory peripheral T-cell lymphoma (PTCL) and recurrent or refractory acute myeloid leukemia (AML). In…
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Pfizer and Genmab’s Tivdak Earns Priority Review from FDA for Full Registration
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The US Food and Drug Administration (FDA) has accepted for priority review a filing from Pfizer (NYSE: PFE) and Genmab (NASDAQ: GMAB) for the full registration of their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). Tivdak currently holds an accelerated approval from 2021 for the treatment of recurrent or metastatic cervical…
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International Society for Cell & Gene Therapy Comments on FDA’s CAR-T Investigation
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The International Society for Cell & Gene Therapy (ISCT) has published a statement addressing the US Food & Drug Administration’s (FDA) investigation into a potential link between T-cell malignancies and CAR-T cell therapies. The FDA launched the inquiry in November following 20 reported cases of patients developing these malignancies after…
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OBI Pharma Gets US FDA Green Light for TROP2 Targeting ADC Cancer Therapy Clinical Study
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OBI Pharma (4174.TWO), partner to Biosion Inc., has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I/II study for its novel antibody drug conjugate (ADC) cancer therapy, OBI-992, which targets TROP2. The antibody molecules utilized in the development of…
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Johnson & Johnson to Acquire Ambrx Biopharma in a Deal Valued at USD 2 Billion
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare conglomerate, has announced its intention to acquire Ambrx Biopharma (NASDAQ: AMAM), a U.S.-based developer of antibody drug conjugates (ADCs). The deal is valued at approximately USD 2 billion in equity and carries a net cash requirement of USD 1.9 billion, with…
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MSD to Acquire Harpoon Therapeutics for USD 680 Million, Expanding Its Oncology Pipeline
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has announced its intention to acquire Harpoon Therapeutics (NASDAQ: HARP) for approximately USD 680 million. The acquisition is expected to be completed in the first half of 2024, subject to approval by Harpoon’s stockholders and the fulfillment of…
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ShuWen Biotech’s MammaTyper Diagnostic Kit Receives NMPA Approval for Breast Cancer Molecular Classification
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ShuWen Biotech Co., Ltd, a biopharmaceutical company based in Zhejiang, has announced that its MammaTyper diagnostic kit has received market approval from the National Medical Products Administration (NMPA). The kit is intended for use in cases where immunohistochemistry (IHC) results are indeterminate or unsatisfactory, or when the IHC outcome significantly…
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Allist Pharmaceuticals’ Furmonertinib and AstraZeneca’s Enhertu Earn Breakthrough Designations in China for NSCLC Treatments
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The Center for Drug Evaluation (CDE) in China has indicated on its website that Allist Pharmaceuticals Co., Ltd, a Shanghai-based biotech firm, has received breakthrough therapy designations (BTDs) for its epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) furmonertinib and for Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC)…
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CSBIO’s Multi-Kinase Inhibitor CSCJC3456 Gets Green Light for Clinical Trials in Advanced Solid Tumors
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its small-molecule multi-kinase inhibitor, CSCJC3456. This molecule is now set to be evaluated in the context of general advanced malignant…
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Hengrui Medicine Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921. This investigational treatment is to be used in combination with adebrelimab (SHR-1316) and SHR-8068…
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MSD Advances Four Oncology Candidates to Late-Stage Trials, Including Partnerships with Kelun-Biotech and Orion
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced significant progress in its oncology pipeline with the advancement of four candidates to late-stage trials that are currently enrolling participants. The first molecule is the LSD1 inhibitor bomedemstat, which is being developed for the treatment of essential thrombocythemia (ET). Nemtabrutinib, a…
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AbbVie Partners with Umoja Biopharma to Develop Next-Generation CAR-T Therapies
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AbbVie (NYSE: ABBV) has entered into a collaboration agreement with Umoja Biopharma, a US-based company specializing in next-generation in-situ CAR-T cell therapies. Under the partnership, the two companies will develop up to four programs targeting selected cancer therapies chosen by AbbVie. AbbVie has also secured an exclusive option to license…
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BMS’s Abraxane Approved in China for First-Line Metastatic Pancreatic Cancer Treatment
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Bristol Myers Squibb (BMS, NYSE: BMY), a leading U.S. pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Abraxane (paclitaxel, albumin). This approval is for the first-line treatment of metastatic pancreatic cancer in combination with gemcitabine. Since June 2008,…
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Lion TCR Partners with MaxCyte to Develop mRNA-Based TCR-T Therapies for Solid Tumors and Viral Diseases
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Lion TCR, a Singapore-based clinical-stage biotechnology company with backing from Chinese investors, has entered into a partnership with U.S. firm MaxCyte Inc. to harness mRNA technology for the development of TCR-T therapies. These therapies are aimed at treating solid tumors and virus-related diseases. The collaboration will enable Lion to utilize…
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Akeso Biopharma Submits New Indication Application for Cadonilimab in Gastric Cancer Treatment
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Akeso Biopharma (HKG: 9926), a leading biopharmaceutical company based in China, has announced the submission of a new indication supplementary approval filing for its bispecific antibody (BsAb) drug candidate, cadonilimab (AK104). The company is seeking to expand the use of cadonilimab in combination with chemotherapy as a first-line treatment for…
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JW Therapeutics Secures NMPA Review for CAR-T Therapy in Mantle Cell Lymphoma
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JW Therapeutics (HKG: 2126), a Chinese biopharmaceutical company, has announced that it has submitted an additional indication application for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), targeting recurrent or refractory mantle cell lymphoma (r/r MCL). The National Medical Products Administration (NMPA) has accepted the filing…
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Jiangsu Hengrui Medicine Advances Novel Cancer Therapies with NMPA Clinical Trial Approval
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, multi-center Phase Ib/II clinical study. The study will assess the efficacy of three of the company’s novel pipeline candidates in combination regimens against general solid tumors. The drugs in…
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Allorion Therapeutics and Avenzo Seal Deal for Global Rights to CDK2 Inhibitor
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China-based Allorion Therapeutics has entered into a licensing agreement with Avenzo Therapeutics Inc., granting the US firm global development and commercialization rights (excluding Greater China) to Allorion’s cyclin-dependent-kinases 2 (CDK2) inhibitor. The agreement also includes an exclusive option for a pre-clinical program anticipated for IND filing in 2025. As part…
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Jiangsu Hengrui Medicine Secures NMPA Approval for Abiraterone in Prostate Cancer Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 2.2 drug abiraterone, a modified androgen synthesis inhibitor. The drug is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and newly diagnosed high-risk…
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ImmunoTech Biopharm Commences Patient Enrollment in Phase II Study for CAR-T-19 Injection
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ImmunoTech Biopharm Ltd, a China-based specialist in chimeric antigen receptor T-cell (CAR-T) therapies (HKG: 6978), has announced the enrollment of the first patient in a Phase II clinical study for its CAR-T-19 injection. The treatment is under development for children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL).…
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Kexing Pharmaceutical Enters Global Licensing Agreement with Xiling Lab for Eribulin Generic
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China-based Kexing Pharmaceutical (SHA: 688136) has entered into a global licensing and supply agreement with fellow domestic firm Xiling Lab for the commercialization of its generic version of the breast cancer treatment eribulin, originally marketed as Halaven by Eisai. The agreement grants Xiling commercial and supply rights in 36 countries,…
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Bio-Thera Solutions Grants Macter International Exclusive Rights to Avzivi in Pakistan and Afghanistan
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Bio-Thera Solutions (SHA: 688177), a Guangzhou-based biopharmaceutical company, has announced a licensing and commercialization agreement with Macter International Ltd., a company based in Pakistan. Under the terms of the agreement, Bio-Thera will transfer Avzivi (bevacizumab), a biosimilar version of Roche’s Avastin, to Macter. Macter will gain exclusive distribution and marketing…
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InventisBio’s KRAS G12C Inhibitor Garsorasib NDA Accepted for Review by China’s NMPA
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InventisBio (Shanghai) Co., Ltd (SHA: 688382), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) for its candidate garsorasib (D-1553) has been accepted for review by China’s National Medical Products Administration (NMPA). The KRAS G12C inhibitor is intended for the treatment of locally advanced or metastatic non-small…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Approval for NSCLC Perioperative Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced an additional indication approval for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), from China’s National Medical Products Administration (NMPA). The drug is now approved for use as perioperative treatment in combination with…
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Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
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The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from Swiss pharmaceutical giant Roche (SWX: ROG). The first approval is for Phesgo (trastuzumab, pertuzumab), indicated for the treatment of HER2-positive early and metastatic breast cancer. The second approval is for faricimab, which targets neovascular age-related…
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BeiGene’s Tislelizumab Secures 12th Indication Approval in China for HCC First-Line Treatment
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received approval in China for the first-line treatment of irresectable or metastatic hepatocellular carcinoma (HCC), marking the drug’s 12th indication approval in the country. The approval is supported by the RATIONALE 301 study, a randomized, open-label, global…
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BMS’ Augtyro Receives EMA Review for Advanced Lung Cancer and Solid Tumors Treatments
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The European Medicines Agency (EMA) has accepted for review a filing submitted by Bristol Myers Squibb (BMS; NYSE: BMY) for its orphan drug, Augtyro (repotrectinib), which targets ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and NTRK-positive locally advanced or metastatic solid tumors. The next-generation tyrosine kinase inhibitor…
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Allorion Therapeutics Strikes Deal with AstraZeneca for EGFR L858R Inhibitor Development and Commercialization
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Allorion Therapeutics, a China-based biopharmaceutical company, has announced an exclusive option and global licensing agreement with AstraZeneca (AZ, NASDAQ: AZN) to develop and commercialize a novel allosteric inhibitor targeting the L858R mutation of the epidermal growth factor receptor (EGFR). The drug is intended for the treatment of advanced EGFR mutant…
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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Gets US FDA Approval for Clinical Trials
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its novel injectable PLAT001, intended for the treatment of advanced or metastatic solid tumors, including pancreatic cancer. PLAT001, a groundbreaking nanomedicine,…
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Medilink Therapeutics Secures Multi-Billion Dollar Deal with Roche for c-MET Targeting ADC
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Medilink Therapeutics, a Suzhou-based biopharmaceutical company, has entered into a global collaboration and licensing agreement with Swiss pharmaceutical giant Roche concerning YL211, an antibody drug conjugate (ADC) targeting c-Mesenchymal-epithelial transition factor (c-MET) for the development of a treatment for solid tumors. This agreement marks Medilink’s fifth out-license deal for ADC…
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Beijing Avistone Pharmaceuticals Raises RMB 1 Billion in Series B Funding to Accelerate Drug Development
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Beijing Avistone Pharmaceuticals Biotechnology Co., Ltd, based in China, has successfully closed its Series B funding round, raising RMB 1 billion (approximately USD 140 million). The round was jointly led by CS Capital and IDG Capital, with additional contributions from YanChuang Group, Cathay Capital, and existing investor Bain Capital. The…
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Boan Biotech Secures FDA Orphan Drug Designations for Pancreatic Cancer Treatments
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China-based Boan Biotech (HKG: 6955) has announced that its novel antibody BA1105 and antibody-drug conjugate (ADC) BA1301 have received orphan drug designations (ODDs) from the U.S. Food and Drug Administration (FDA). Both therapies target Claudin18.2 (CLDN18.2) for the treatment of pancreatic cancer. BA1105 is being developed for Claudin18.2 positive advanced…
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Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
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Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and Drug Administration (FDA) to update the label of Yescarta (axicabtagene ciloleucel) to include overall survival (OS) data for its use as a second-line treatment for relapsed or refractory large B-cell lymphoma (r/r LBCL). This new…
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Shanghai Henlius Secures Indonesian Approval for HanSiZhuang in Small-Cell Lung Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) for its anti-PD-1 monoclonal antibody, HanSiZhuang (serplulimab). This approval allows the drug to be used in the treatment of extensive-stage small-cell lung cancer (ES-SCLC). Henlius is collaborating with…
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Eli Lilly Completes Acquisition of Point Biopharma, Expanding Radiopharmaceutical Portfolio
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Eli Lilly (NYSE: LLY) has finalized its acquisition of radiopharmaceutical company Point Biopharma (NASDAQ: PNT) this week, following the clearance of the last regulatory requirement last month. As part of the acquisition, Lilly gains access to Point’s PNT2002, a PSMA-targeting radiopharmaceutical currently in Phase III trials for metastatic castration-resistant prostate…
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Fosun’s HLX42 Receives Fast-Track Designation from FDA for NSCLC Treatment
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Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196; SHA: 600196) has announced that its antibody-drug conjugate (ADC) HLX42 has received fast-track designation from the U.S. Food and Drug Administration (FDA). The drug is being co-developed with its subsidiary Shanghai Henlius Biotech Inc. (HKG: 2696) and Suzhou-based Medilink Therapeutics, specifically targeting advanced…
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Simcere Secures Approval for Local Manufacturing of Cosela, Boosting Patient Access
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China-based Simcere Pharmaceutical Group (HKG: 2096) has received supplementary filing approval for its drug Cosela (trilaciclib), enabling the transfer of its manufacturing technology from G1 Therapeutics to Simcere’s facility in Hainan. This transition paves the way for localized production of the CDK4/6 inhibitor, enhancing patient accessibility across the region. Trilaciclib,…
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Elpiscience Partners with Astellas for Bi-Specific Macrophage Engager Research
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China-based Elpiscience Biopharmaceuticals has announced a research collaboration and licensing agreement with Japan’s Astellas Pharma Inc. (TYO: 4503), focusing on Elpiscience’s innovative bi-specific macrophage engager, ES019, along with another program. The partnership will involve joint early-stage research on these two initiatives, with Elpiscience granting Astellas the option to include up…
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J&J’s Janssen Secures Exclusive Global Rights to Develop LCB84 ADC from LegoChem Biosciences
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Johnson & Johnson’s (J&J; NYSE: JNJ) pharmaceutical subsidiary, Janssen, has entered into an exclusive global agreement with South Korean-based LegoChem Biosciences (LCB; KOSDAQ: 141080) to develop and commercialize the antibody drug conjugate (ADC) LCB84. Under the terms of the agreement, LCB is set to receive $100 million in upfront payments…
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BMS Expands Oncology Portfolio with $4.1 Billion RayzeBio Acquisition
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced the acquisition of RayzeBio (NASDAQ: RYZB), a clinical-stage developer of actinium-based radiopharmaceutical therapeutics (RPT), bolstering its oncology portfolio. BMS will purchase all outstanding shares of RayzeBio for an estimated $4.1 billion, with the transaction anticipated to close in the first half of…
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Amgen’s Lumakras Faces Full Approval Delay as FDA Requests New Study
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The US Food and Drug Administration (FDA) has declined to grant full approval for Amgen’s (NASDAQ: AMGN) Lumakras (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). The regulator has requested an additional confirmatory study, which Amgen intends to…
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Healthstar Medical Receives NMPA Go-Ahead for KC1036 Esophageal Cancer Study
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Beijing-based Healthstar Medical Development Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for KC1036 in combination with a programmed-death 1 (PD-1) inhibitor as first-line maintenance therapy for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). KC1036,…
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Simcere Affiliate Xianbo Biotech Gets China Nod for CAR-T Therapy SNC109
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Shanghai Xianbo Biotech Co., Ltd, known as Simnova outside of China and an affiliate of Simcere Investment Group, has received tacit clinical trial approval from Chinese authorities for its SNC109, an in-house developed treatment for recurrent glioblastoma. SNC109 is a dual chimeric antigen receptor (CAR)-T cell therapy designed on Xianbo…
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Biocytogen and Lepu Biotechnology Develop WT1-Targeted Trispecific Antibody for Cancer Treatment
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd, (HKG: 2315) and Lepu Biotechnology Co., Ltd (HKG: 2157) have announced significant progress in the co-development of their trispecific T cell connector, having identified a WT1/HLA-A02 targeted T-cell connector, WT1×CD3×4-1BB trispecific antibody, as part of their collaboration initiated last year. Pre-clinical data for this product…
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Aidea Pharmaceutical Co. Terminates ACC006 Technology Transfer Deal with Lixin Bio
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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has resolved to terminate its technology transfer agreement with Guangzhou Lixin Biological Technology Co., Ltd. concerning the drug candidate ACC006. Initially inked in December 2021, the agreement saw Aidea Pharma bestow upon Lixin Bio the rights to its cancer drug candidate ACC006 for…
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AstraZeneca to Acquire China’s Gracell Biotechnologies in $1.2 Billion Deal
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Pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced its intention to fully acquire Gracell Biotechnologies Inc., (NASDAQ: GRCL), a China-based developer of chimeric antigen receptor (CAR) T cell therapies. This marks the first major merger and acquisition (M&A) deal by a foreign company targeting one of China’s newest generation biotechs.…
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FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
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The US Food and Drug Administration (FDA) has accepted under priority review a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) and Daiichi Sankyo (TYO: 4568) for their jointly developed antibody-drug conjugate (ADC) patritumab deruxtecan. The treatment is intended for patients with locally advanced or metastatic EGFR-mutated non-small cell…
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J&J’s Rybrevant-Lazertinib Combo Accepted for FDA Review in NSCLC
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The US Food and Drug Administration (FDA) has accepted for review Johnson & Johnson’s (J&J; NYSE: JNJ) application for Rybrevant (amivantamab), a bispecific antibody, in combination with lazertinib, a tyrosine kinase inhibitor (TKI), for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon…
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Shouyao Holdings Receives Ethical Approval for Phase III Study of ALK Inhibitor SY-3505
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Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received ethical approval to conduct a pivotal Phase III clinical study for its third-generation anaplastic lymphoma kinase (ALK) inhibitor, SY-3505. The study is a randomized, controlled, multi-center trial designed to assess the efficacy and safety of SY-3505…
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Hengrui Medicine-Backed Nanjing Tianyinshan Hospital Opens as Class 3A Oncology Specialist Center
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Nanjing Tianyinshan Hospital, a private Class 3A oncology specialist hospital invested in by Hengrui Medicine (SHA: 600276), commenced operations on December 22. The hospital is headed by Professor Qin Shukui, a prominent figure in the field of oncology. Situated in the Nanjing Jiangning High Tech Zone, the hospital spans a…
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Jiangxi Jemincare Group Secures Clinical Trial Approvals for Six Drugs in China and the US
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China-based Jiangxi Jemincare Group (SHA: 603222) has announced receiving clinical trial approvals for six of its Category 1 chemical drugs in China and the United States, with indications spanning cancer, kidney diseases, and infectious diseases. JMKX003801, approved for study in China for severe infections caused by Gram-negative bacteria, has demonstrated…
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CStone Pharmaceuticals Regains Exclusive Rights to Tibsovo in Greater China and Singapore
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced an agreement with French pharmaceutical company Servier that returns exclusive development, manufacturing, and commercialization rights to Tibsovo (ivosidenib) in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan, as well as Singapore. Originally developed by US-based Agios Pharmaceuticals,…
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Sanofi Halts Development of Tusamitamab Ravtansine After Missed Trial Endpoints
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Sanofi (NASDAQ: SNY) has announced the discontinuation of its antibody-drug conjugate (ADC) tusamitamab ravtansine following disappointing results from a Phase III trial in metastatic non-squamous (NSq) non-small cell lung cancer (NSCLC) patients with high CEACAM5 expression. The trial did not meet its dual primary endpoints, as indicated by an interim…
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CStone Pharmaceuticals Disbands Sales Team for Gavreto After NRDL Setback
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CStone Pharmaceuticals (HKG: 2616) has confirmed media reports regarding the dismissal of its sales team for Gavreto (pralsetinib), marking a significant shift in the Chinese company’s commercial strategy for its first product to reach the market. Gavreto, which was licensed to Allist Pharmaceuticals Co., Ltd in November 2023, did not…
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Sino Biopharmaceutical Completes Enrollment for Phase III Trial of Anlotinib in Soft Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a China-based pharmaceutical giant, has announced the completion of patient enrollment for a Phase III clinical trial of anlotinib, marketed under the trade name FOCUS V, in conjunction with chemotherapy for first-line treatment of advanced soft tissue sarcoma. The trial, conducted by Jiangsu Chia Tai…
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Legend Biotech’s Carvykti Therapy to Include Myeloid Neoplasms Warning in Label Update
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GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), will update the warning label for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), to account for the potential risk of myeloid neoplasms in patients…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
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Lee’s Pharmaceutical’s Socazolimab Becomes China’s First PD-L1 mAb for Cervical Cancer
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured in-licensed rights for socazolimab, a treatment for recurrent-metastatic cervical cancer, according to the National Medical Products Administration (NMPA) website. This drug marks the first programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb) for cervical cancer in China. Socazolimab, originally developed by US-based Sorrento…
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Jiangsu Hengrui Medicine Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
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Gilead Acquires Pre-Clinical IL-18BP Targeting Antibody Candidate from Compugen in $848 Million Deal
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Gilead (NASDAQ: GILD) has licensed a potential first-in-class IL-18 binding protein (IL-18BP) targeting antibody candidate from cancer immunotherapy developer Compugen (NASDAQ: CGEN), which is currently in the pre-clinical stage. Gilead will assume development responsibilities from Phase II onwards and will pay USD 60 million upfront, with up to USD 788…
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MSD Partners with Owkin to Develop MSI-H Biomarker Screening for Cancers
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US pharmaceutical company Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into a partnership with French firm Owkin to develop and commercialize a pre-screening procedure for identifying the microsatellite instability- (MSI) H biomarker in various cancers. The initiative aims to test for MSI-H in endometrial, gastric, small intestinal, and…
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Sanofi Expands Oncology Portfolio with NK Cell Engager In-License from Innate Pharma
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Sanofi (NASDAQ: SNY) has in-licensed a natural killer (NK) cell engager candidate for solid tumors from France-based Innate Pharma (NASDAQ: IPHA), as per an agreement reached in 2022. Sanofi will pay an initial fee of EUR 15 million (USD 16.4 million) and is committed to potential milestone payments of up…
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Healthstar Medical Gets NMPA Approval for KC1036 Clinical Study in Juventus sarcoma
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Beijing-based Healthstar Medical Development Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate KC1036 in advanced Juventus sarcoma for adolescents aged 12 and above. KC1036, a tyrosine kinase inhibitor (TKI) that targets AXL, VEGFR2, and FLT3,…
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China Grand Pharmaceuticals Secures Distribution of Sirtex’s SIR-Spheres for Liver Cancer
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) announced that its subsidiaries, Beijing Purevalley Biotechnology Co., Ltd and Chengdu Purevalley Biotechnology Co., Ltd, have entered into a distribution agreement with Australian firm Sirtex Medical Ltd. This agreement centers on the distribution of Sirtex’s SIR-Spheres (Y-90 microsphere) injection, a…
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European Commission Expands Keytruda Indications for Advanced Cancer Treatments
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The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications for its leading anti-PD-1 therapy, Keytruda (pembrolizumab), approving its use as a first-line treatment in combination with chemotherapy for locally advanced unresectable or metastatic biliary tract carcinoma (BTC) and HER2-negative gastric or gastroesophageal junction (GEJ)…
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HighField Biopharmaceutical Doses First Patient in HFK1 Clinical Trial Targeting Solid Tumors
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Hangzhou-based HighField Biopharmaceutical, a leader in immuno-oncology focused on innovative lipid-based therapies, has announced the initiation of dosing for the first patient in a clinical trial of its candidate HFK1. This investigational drug is an immunoliposome encapsulating doxorubicin, aimed at targeting various solid tumors. The trial is being conducted concurrently…
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BGI Genomics Receives NMPA Approval for Innovative Colorectal Cancer Detection Kit
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BGI Genomics Co., Ltd. (SHE: 300676), a leading genomics firm based in China, has announced the approval of its medical device license from the National Medical Products Administration (NMPA) for a novel gene methylation detection kit. The kit employs fluorescence PCR technology to assess the combined methylation status of the…
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InventisBio’s KRAS G12C Inhibitor D-1553 Advances Toward Priority Review in China
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According to the China Center for Drug Evaluation (CDE), Shanghai-based InventisBio Co., Ltd. (SHA: 688382) is on track to secure priority review status for its KRAS G12C inhibitor, D-1553, aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed KRAS G12C mutation, particularly in patients…
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Keytruda Gains 12th Indication Approval in China for HER2-Negative Gastric Cancer
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US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its immunotherapy drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced unresectable or metastatic HER2-negative…
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FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer
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Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la/mUC). The FDA’s decision is…
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Bio-Thera Solutions Gets NMPA Green Light for PD-1 Inhibitor BAT1308 in Endometrial Cancer
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its programmed death-1 (PD-1) inhibitor, BAT1308, in the treatment of endometrial cancer. BAT1308 is an internally developed…
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MSD’s Welireg Gains FDA Approval for Advanced Renal Cell Carcinoma
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The US Food and Drug Administration (FDA) has granted an indication extension approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan), expanding its use as a therapy for advanced renal cell carcinoma (RCC) in adults who have previously received a PD-1/L1 inhibitor and a VEGF tyrosine…
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Bayer Partners with ClearNote Health to Explore Prostate Cancer Treatment Response
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German multinational pharmaceutical company Bayer (ETR: BAYN) has partnered with U.S. diagnostics firm ClearNote Health to delve into the study of treatment response and resistance in metastatic hormone-sensitive prostate cancer. The collaborative project will leverage ClearNote’s epigenomic platform, which employs machine learning algorithms to analyze patient blood samples, monitor DNA-based…
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3D Medicines Initiates Phase III Trial for Envafolimab in NSCLC Patient
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3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the enrollment of the first patient in a Phase III clinical study for its PD-L1 monoclonal antibody (mAb), envafolimab. The randomized, controlled, double-blinded, multi-center trial will evaluate envafolimab in combination with chemotherapy as a neoadjuvant/adjuvant therapy for patients with resectable…
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Lepu Biotechnology’s Pancreatic Cancer Drug Earns Orphan Drug Status from FDA
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Lepu Biotechnology Co., Ltd (HKG: 2157), a Chinese pharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), MRG004A, which is being developed to treat pancreatic cancer. MRG004A is an innovative ADC that targets…
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AbelZeta Pharma Expands Janssen Partnership to Include Commercial Rights in China
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AbelZeta Pharma Inc., a Sino-US biotechnology company with operations in Rockville, Maryland, and Shanghai, China, has announced an updated global collaboration and licensing agreement with Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ). According to the revised agreement, Janssen will now secure commercialization rights to CAR-T therapies C-CAR039…
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AbbVie and Genmab’s Epcoritamab Shows Promising Results in Follicular Lymphoma Study
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AbbVie (NYSE: ABBV) and Genmab (NASDAQ: GMAB) have presented Phase I/II clinical data for their T-cell engager, Tepkinly/Epkinly (epcoritamab), in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of therapy. Interim results, with a median follow-up of 17.4 months, showed that the…
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Amgen’s Tarlatamab Receives FDA Priority Review for Advanced Small Cell Lung Cancer Treatment
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The US Food and Drug Administration (FDA) has granted priority review status to Amgen (NASDAQ: AMGN) for its potential first-in-class bispecific T-cell engager (BiTE) tarlatamab as a second-line treatment for advanced small cell lung cancer (SCLC). The action date for the review is set for June 12, 2024. This decision…
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Abbisko Therapeutics’ Pimicotinib Earns FDA Fast-Track Status for TGCT Treatment
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology firm, has announced that its colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021), has received fast-track designation from the US Food and Drug Administration (FDA). The drug is under development for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Pimicotinib,…
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BMS Presents Promising Golcadomide Trial Results for Non-Hodgkin Lymphomas
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Bristol Myers Squibb (BMS; NYSE: BMY) has presented results from Phase I and Phase I/II trials for combination therapies with golcadomide, a potential first-in-class drug from the company’s CELMoD line of protein degraders, in the treatment of non-Hodgkin lymphomas. The Phase I study indicated that previously untreated patients with aggressive…
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J&J’s Carvykti Demonstrates Extended Time to Symptom Worsening in Multiple Myeloma Patients
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Johnson & Johnson (J&J; NYSE: JNJ) has released data from a Phase III study showing that its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel), extended the median time until symptom worsening to 23.7 months in patients with relapsed and lenalidomide-refractory multiple myeloma (MM) after one to three prior lines of therapy,…
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Shanghai Henlius Biotech Submits Another Application for Serplulimab in China
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new market filing for its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), seeking approval for use in combination with chemotherapy for first-line non-squamous non-small cell lung cancer (nsqNSCLC). The filing, accepted for review by the National Medical Products Administration (NMPA), marks the…
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HutchMed’s Elunate-Tyvyt Combination Study for Renal Cell Carcinoma Completes Enrollment
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China-based HutchMed (NASDAQ: HCM) has announced the completion of patient enrollment in its Phase II/III clinical study for Elunate (fruquintinib) in combination with Tyvyt (sintilimab) for the treatment of second-line locally advanced or metastatic renal cell carcinoma (RCC). The randomized, open-label controlled study aims to compare the efficacy and safety…
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Luye Pharma’s Lurbinectedin Receives Market Approval in Hong Kong for SCLC Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board has approved a market approval filing for the company’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients with tumor progression during or after platinum-based chemotherapy. The approval, facilitated by the…
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BMS Advances TIGITxCD96 Bispecific Antibody into Phase II Dose Expansion
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Bristol Myers Squibb (BMS; NYSE: BMY) has advanced its development program for the TIGITxCD96 bispecific antibody (BsAb) BMS-986442 into a Phase II dose expansion trial. The candidate was licensed from Agenus (NASDAQ: AGEN) in 2021, and as part of the agreement, Agenus will receive a USD 25 million cash payment,…
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Sichuan Biokin and Bristol Myers Squibb Ink USD 8.4 Billion Licensing Deal for ADC Candidate
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese pharmaceutical company, has announced a landmark licensing and cooperation agreement with US pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY). The agreement focuses on Biokin’s antibody-drug conjugate (ADC) candidate, BL-B01D1, which targets EGFR and HER3. The deal was conducted specifically between…
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Kelun-Biotech’s SKB264 NDA Accepted by NMPA for mTNBC, Poised to Be China’s First TROP2-targeted ADC
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Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has had its New Drug Application (NDA) for SKB264 accepted for review by China’s National Medical Products Administration (NMPA). This application is based on results from the OptiTROP-Breast01 study,…
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Chinese Biotech Precision Biotechnology Gets NMPA Green Light for Advanced Cancer Therapies
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Chongqing Precision Biotechnology Co., Ltd, a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for C-13-60 cell preparations as a local treatment in the abdominal cavity for CEA+ advanced malignant tumors, including a range of cancers such as colorectal, esophageal, gastric,…
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MSD Halts Phase III Trial of Keytruda Combo in NSCLC After Missing Primary Endpoints
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of a Phase III trial for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with AstraZeneca’s (AZ; NASDAQ: AZN) co-developed PARP inhibitor Lynparza (olaparib) for metastatic squamous non-small cell lung cancer (NSCLC). The decision follows the trial’s failure to meet…
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Novartis Reports Kisqali Success in Reducing Recurrence Risk in Early Breast Cancer
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Novartis (NYSE: NVS) has announced an update on the late-stage trial for its CDK4/6 inhibitor Kisqali (ribociclib) in early breast cancer. Data from 78.3% of patients who completed treatment showed a significant reduction in the risk of recurrence, with 30% and 24.5% decreases for stage II and stage III tumors,…
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Pfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC
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Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National Medical Products Administration (NMPA) for sugemalimab, a treatment for first-line irresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluorouracil and platinum. This approval marks sugemalimab as the first programmed…
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Mabwell Secures NMPA Approval for Phase III Study of ADC 9MW2821 in Urothelial Carcinoma
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Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical study for its antibody-drug conjugate (ADC), 9MW2821, which targets Nectin-4. The randomized, open-label, controlled, multi-center Phase III trial aims to evaluate the efficacy…
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Eli Lilly Seeks Approval for Pirtobrutinib in China for Relapsed Mantle Cell Lymphoma
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Eli Lilly (NYSE: LLY) has submitted a marketing approval application for pirtobrutinib, an oral, non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, according to the China Center for Drug Evaluation (CDE) website. The application targets adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously undergone BTK inhibitor…
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Shenzhen TargetRx’s TGRX-678 Set to Receive Breakthrough Therapy Designation for CML-AP
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Shenzhen TargetRx, Inc., a China-based developer of small-molecule kinase inhibitors, is poised to receive breakthrough therapy designation (BTD) for its Bcr-Abl inhibitor, TGRX-678, according to the China Center for Drug Evaluation (CDE) website. This designation recognizes the molecule’s promising potential for treating accelerated chronic myeloid leukemia (CML-AP) in patients who…
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Shanghai Pharmaceuticals Gains NMPA Approval for WST04 Clinical Trials in Oncology
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607), a leading pharmaceutical distribution company in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its oral probiotic preparation, WST04, aimed at treating advanced malignant solid tumors. Preclinical studies indicate that WST04 significantly enhances the anti-tumor efficacy of…
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Jiangsu Hengrui Seeks NMPA Approval for Camrelizumab-Famitinib Combo in Cervical Cancer
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), based in China, has announced that its market approval filing for the programmed death-1 (PD-1) monoclonal antibody camrelizumab, in combination with multi-kinase inhibitor famitinib for recurrent or metastatic cervical cancer, has been accepted for review by the National Medical Products Administration (NMPA). This…
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Antengene Secures NDA Approval for Xpovio in Macau for Advanced Multiple Myeloma
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Antengene Corp., Ltd. (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval from the regulatory authority in Macau for its product Xpovio (selinexor). This approval is specifically for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R…
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AbbVie Partners with BigHat Biosciences to Develop Next-Gen Antibodies for Oncology and Neuroscience
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AbbVie (NYSE: ABBV) has enlisted the expertise of BigHat Biosciences, a US-based company specializing in machine learning and wet lab platforms, to discover and develop next-generation antibodies for multiple therapeutic targets in oncology and neuroscience. BigHat will receive an upfront payment of USD 30 million, with the potential for up…
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J&J Forecasts 5-7% CAGR Through 2030, Driven by Innovative Medicine and Device Growth
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Johnson & Johnson (J&J; NYSE: JNJ) has presented an update on its business strategy, pipeline, and financial outlook amidst the loss of exclusivity for its blockbuster immunosuppressant Stelara (ustekinumab) in the US. The company anticipates operational sales growth of 5% to 6% in 2024 and 3% or more in 2025,…
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China’s Betta Pharmaceuticals Advances CFT8919 for EGFR-Mutated NSCLC After NMPA Approval
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for CFT8919, a metamorphic BiDA degradation agent licensed from U.S. firm C4 Therapeutics, Inc. (NASDAQ: CCCC). The study will focus on…
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Luye Pharma’s Lurbinectedin for Metastatic SCLC Wins Macau Regulatory Nod
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that Macau’s medical products administration bureau has approved a market approval filing for the firm’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients experiencing tumor progression during or after platinum-based chemotherapy. The approval is…
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Yantai Dongcheng Pharmaceutical Gets NMPA Green Light for FAP-Targeting Radiotherapeutic Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to proceed with a clinical study for its radiotherapeutic drug, 177Lu-LNC1004, which targets advanced solid tumors. The drug is designed to treat fibroblast activation protein (FAP)-positive…
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Simcere Pharmaceutical’s SIM0501 Receives FDA Approval for Advanced Solid Tumor Clinical Trial
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Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its cancer drug candidate SIM0501, which targets advanced solid tumors. The company’s clinical filing was previously accepted for review by China’s National Medical Products Administration (NMPA) in…
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Eli Lilly’s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia
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The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory…
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AbbVie to Acquire ImmunoGen for USD 10.1 Billion, Expanding Oncology Portfolio
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AbbVie (NYSE: ABBV) has reached an agreement to acquire fellow U.S. biotech ImmunoGen (NASDAQ: IMGN) for an equity value of approximately USD 10.1 billion. The transaction is anticipated to close in mid-2025, pending the fulfillment of customary regulatory conditions. This acquisition will enhance AbbVie’s portfolio with Elahere (mirvetuximab soravtansine), an…
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Akeso Biopharma Files New Indication for Penpulimab in First-Line NPC Treatment
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Akeso Biopharma (HKG: 9926) has announced a new indication filing for its programmed death-1 (PD-1) inhibitor, penpulimab (AK105), seeking approval for its use in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with chemotherapy. The application is currently under review by China’s Center for Drug Evaluation (CDE).…
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Shanghai Junshi’s Loqtorzi Enters Australian Market Approval Process for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Therapeutic Goods Administration (TGA) in Australia has accepted its market approval filing for Loqtorzi (toripalimab), a programmed death-1 (PD-1) inhibitor. The application seeks approval for two indications: as a first-line treatment in combination with cisplatin and gemcitabine…
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CARsgen Therapeutics Secures U.S. FDA Approval for CT071 Clinical Trials in Multiple Myeloma
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), based in China, has announced that it has received clinical trial approval from the U.S. FDA for its chimeric antigen receptor (CAR)-T cell product, CT071, aimed at treating recurrent/refractory multiple myeloma (R/R MM) and primary plasma cell leukemia (PCL). CT071 is developed using the…
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Lepu Biotechnology’s MRG003 Gains Fast-Track Status from U.S. FDA for Nasopharyngeal Carcinoma
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Lepu Biotechnology Co., Ltd (HKG: 2157), based in China, has announced that its flagship product MRG003 has received fast-track status from the U.S. FDA for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The antibody-drug conjugate (ADC), which targets the epidermal growth factor receptor (EGFR), was previously granted orphan drug…
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Sichuan Kelun-Biotech to Present Promising Phase II Results for SKB264 in mTNBC at SABCS 2023
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Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), is poised to present updated results from a Phase II study expansion cohort for its antibody-drug conjugate, SKB264, targeting previously treated metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio…
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TG ImmunoPharma Secures U.S. FDA IND Approval for Promising mAb TGI-5 Targeting Multiple Cancers
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TG ImmunoPharma Co., Ltd, based in China, has announced that it has received Investigational New Drug (IND) approval from the U.S. FDA for its proprietary monoclonal antibody (mAb), TGI-5. While the specific target of this molecule remains undisclosed, the company claims it could be a potential global first-in-class treatment. TGI-5…
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AbbVie’s Telisotuzumab-Vedotin Shows Promising Results in NSCLC Phase 2 Trial
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AbbVie (NYSE: ABBV) has unveiled data from a Phase 2 trial of its potential first-in-class antibody-drug conjugate (ADC) telisotuzumab-vedotin, which targets c-Met protein-overexpressing, EGFR-wild-type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The trial results showed an overall response rate (ORR) of 35% in patients with high c-Met levels and 23%…
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Boehringer Ingelheim Partners with Phenomic AI to Target Stroma-Rich Cancers
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Boehringer Ingelheim (BI), a German pharmaceutical company, has entered into a partnership with Canada’s Phenomic AI to leverage the latter’s single-cell transcriptomics platform for the discovery of drug targets in stroma-rich cancers, including colorectal and pancreatic tumors. In return for the option to license the identified targets and secure development…
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Jiangsu Hengrui Receives NMPA Approval for Esophageal Cancer and Breast Cancer Clinical Trials
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for adebrelimab (SHR-1316) in combination with neoadjuvant chemotherapy for locally advanced surgically resectable esophageal squamous cell carcinoma (ESCC) in the perioperative setting. Additionally, the Chinese pharmaceutical company…
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Asieris Pharmaceuticals’ Hexvix for Bladder Cancer Accepted for Review by China’s NMPA
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Asieris Pharmaceuticals (SHA: 688176), a specialist in urogenital cancer based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its Hexvix (APL-1706) for the diagnosis and management of bladder cancer. Hexvix stands as the only globally approved agent…
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Jiangxi Jemincare’s KRAS Inhibitor Earns Breakthrough Designation from China’s CDE for NSCLC
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The China Center for Drug Evaluation (CDE) website has indicated that Jiangxi Jemincare Group’s proprietary small-molecule KRAS inhibitor, JMKX001899, has been granted breakthrough therapy designation (BTD) status for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation in patients who have previously received…
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CAR T-Cell Therapy Stocks Plunge as FDA Investigates Cancer Reports Linked to Treatments
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Shares of Chimeric Antigen Receptor (CAR) T cell therapy companies plummeted on November 28, 2023, following an announcement from the U.S. FDA regarding an investigation into reports of patients developing cancer as a potential side effect of their treatments. The FDA’s notice highlighted that both clinical trials and post-market surveillance…
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JW Therapeutics Secures Priority Review for Carteyva in Relapsed/Refractory Mantle Cell Lymphoma
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JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva (relmacabtagene autoleucel injection), has received priority review status for the treatment of relapsed or refractory mantle cell lymphoma (r/r MCL). This designation recognizes the drug’s status as a breakthrough therapy. Relmacabtagene autoleucel is an autologous…
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Healthstar Medical Launches Phase III Study for KC1036 in Advanced Esophageal Cancer
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Healthstar Medical Development Co., Ltd (SHA: 603590), based in Beijing, has received approval from China’s Center for Drug Evaluation (CDE) to commence a Phase III clinical study for its investigational drug candidate, KC1036. This randomized, controlled, open-label, multi-center Phase III trial aims to evaluate the efficacy and safety of KC1036…
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AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
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AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the European Medicines Agency (EMA) and granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (r/r) follicular lymphoma (FL). These regulatory decisions are backed by…
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Henlius Biotech Gets FDA Clearance for Clinical Study of PD-L1 Targeting ADC HLX43
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Shanghai Henlius Biotech Inc. (HKG: 2696), a Chinese biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) HLX43, which is co-developed with Suzhou-based Medilink Therapeutics. The molecule is set to be evaluated in patients with…
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CSPC Pharmaceutical Gets NMPA Green Light for SYH2038 Solid Tumor Study
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 chemical drug, SYH2038, in advanced solid tumors. SYH2038 is a highly selective SOS1 inhibitor, with no similar…
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Abbisko Therapeutics Launches Phase II Trial for Pimocitinib in Advanced Pancreatic Cancer
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced the initiation of a Phase II clinical study for its Category 1 innovative drug ABSK021 (pimicotinib) in advanced pancreatic cancer in China, with the first patient now dosed. The multi-center, open-label Phase II study (ABSK021-202) is being conducted…
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Xiamen Inno Medical Partners with Olympus to Advance AI in Digestive Endoscopy
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Xiamen Inno Medical Technology Co., Ltd., a China-based specialist in artificial intelligence (AI) powered digestive endoscopy, has entered into a partnership with Olympus Corporation, a major player in the digestive endoscopy field. The collaboration aims to explore innovative applications and development of AI technology within the digestive endoscopy sector. Financial…
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Coherus Biosciences Sets Price for PD-1 Inhibitor Loqtorzi at $8,892.03, Offering 20% Discount Compared to Keytruda
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Coherus Biosciences Inc. (NASDAQ: CHRS) announced yesterday in an SEC filing the wholesale price for its newly launched PD-1 inhibitor, Loqtorzi (toripalimab), in the U.S. market. The drug, co-developed under license from Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877; SHA: 688180), will retail at $8,892.03 per single-use vial. Loqtorzi received…
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DxVx Secures License for OVM-200 Anti-Cancer Vaccine from Oxford Vacmedix
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South Korea-based DxVx is poised to license OVM-200 from Oxford Vacmedix (OVM), with plans to further develop the anti-cancer vaccine. OVM is anticipated to initiate a Phase Ib study for the vaccine in the UK in the near future, while DxVx will launch a study in Asia, encompassing South Korea…
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KingWise Partners with Truking Technology for Gynecological Tumor Gene Therapy Facilities
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KingWise, a Wuhan-based specialist in gynecological tumor diagnostics, has entered into a partnership with local firm Truking Technology Ltd (SHE: 300358) concerning KingWise’s facilities for gynecological tumor gene therapy products. Truking will offer KingWise a comprehensive end-to-end (EPC) solution for biopharmaceutical front-end processes, including factory design, purification engineering, water distribution…
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Sichuan Kelun Pharmaceutical’s RET Inhibitor A400 Earns FDA Orphan Drug Designation
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its RET inhibitor A400/EP0031 in the treatment…
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Jiangxi Jemincare Group Secures NMPA Approval for Generic Ibrance Capsules
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Jiangxi Jemincare Group, a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Pfizer’s (NYSE: PFE) Ibrance (palbociclib). This follows the company’s earlier approval for its active pharmaceutical ingredients (APIs) of palbociclib in China. Palbociclib, initially…
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Jiangsu Hengrui Medicine Receives NMPA Approval for Phase Ib/II Study of Dalpiciclib and HRS-8080
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China-based Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has announced that it received approval from the National Medical Products Administration (NMPA) to initiate a Phase Ib/II clinical study. This trial will evaluate the combination of dalpiciclib (SHR6390) and HRS-8080 in patients with ER+/HER2- irresectable or metastatic breast cancer. HRS-8080: A…
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Pyrotech Biotechnology’s PTT-936 Gets US FDA Clinical Trial Approval
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Pyrotech (Beijing) Biotechnology Co., Ltd, a China-based biotech firm, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed innate immune agonist, PTT-936. The specific targeted indication for this trial remains undisclosed. Mechanism of Action and Preclinical Success PTT-936…
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SCG Cell Therapy’s SCG101 Receives Tacit Approval for Cholangiocarcinoma Clinical Trial in China
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China’s Center for Drug Evaluation (CDE) website has indicated that SCG Cell Therapy Pte. Ltd’s SCG101 autologous T cell therapy has obtained tacit clinical trial approval in China. This marks a world-first clinical indication for the treatment of cholangiocarcinoma. SCG101’s Expanding Clinical IndicationsSCG101, a TCR-T cell therapy, targets specific hepatitis…
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Akeso Biopharma’s Cadonilimab Meets Primary Endpoint in Phase III Cervical Cancer Study
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China-based Akeso Biopharma (HKG: 9926) has announced that its Phase III AK104-303 study for cadonilimab (AK104), an innovative bispecific antibody targeting programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), has achieved its primary endpoint. The study combines the antibody with chemotherapy and optional bevacizumab for the first-line treatment of…
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Boehringer Ingelheim Acquires T3 Pharmaceuticals to Boost Immuno-Oncology Portfolio
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Germany’s Boehringer Ingelheim has announced the purchase of Switzerland-based biotechnology firm T3 Pharmaceuticals this week, in a strategic move to expand its immuno-oncology pipeline. The transaction is valued at up to CHF 450 million (USD 510 million), highlighting Boehringer Ingelheim’s commitment to advancing cancer treatments. T3 Pharmaceuticals’ Innovative Approach to…
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AnHeart Therapeutics and Innovent Biologics File Taletrectinib for Marketing Approval in China
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China’s Center for Drug Evaluation (CDE) has indicated on its website that taletrectinib, an ROS1/NTRK inhibitor co-developed by AnHeart Therapeutics and Innovent Biologics Inc. (HKG: 1801), has been filed for marketing approval. The drug is intended to treat ROS1 fusion positive non-small cell lung cancer (NSCLC) in patients who have…
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Janssen Submits Indication Extension Application to FDA for Rybrevant in NSCLC Treatment
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has filed an indication extension application with the US Food and Drug Administration (FDA) for its bispecific antibody Rybrevant (amivantamab) in combination with chemotherapy. The treatment is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)…
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BeiGene Ltd Strikes Exclusive Global License Deal with Ensem Therapeutics for CDK2 Inhibitor
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China-based biopharmaceutical company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced a licensing agreement with Ensem Therapeutics Inc., a biopharma company incubated by CBC Group and operating in Massachusetts, US, and Shanghai, China. According to the agreement, BeiGene will obtain an exclusive global license to Ensem’s oral cyclin-dependent…
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Fosun Pharmaceutical’s FCN-437c filing Accepted for Review by China’s NMPA
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Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for FCN-437c. The small molecule drug candidate is under development for the treatment of hormone receptor (HR) positive and human epidermal growth factor…
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CSPC Pharmaceutical’s Glumetinib Earns Breakthrough Therapy Designation in China
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Glumetinib, a MET targeted tyrosine kinase inhibitor (TKI) co-developed by CSPC Pharmaceutical Group Ltd (HKG: 1093) and Shanghai Haihe Pharmaceutical Co., Ltd, has been granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) in China. The drug is indicated for locally advanced or metastatic non-small cell lung…
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Medilink Therapeutics’ YL201 Earns Orphan Drug Designation for Esophageal Cancer
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Suzhou-based Medilink Therapeutics has announced that it has obtained orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its antibody-drug conjugate (ADC) YL201, which is being developed to treat esophageal cancer (EC). YL201, a B7H3-targeted ADC product, is based on Medilink’s Tumor Microenviroment Activable LINker (TMALIN)…
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BeiGene’s Brukinsa Secures Additional EU Approval for Follicular Lymphoma Treatment
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for the Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The European Commission has approved Brukinsa in combination with obinutuzumab (Roche’s CD20-targeted Gazyva) as a third-line treatment for relapsed or refractory (R/R) follicular lymphoma (FL). This marks…
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Usynova Pharmaceuticals Inks Licensing Deal with AstraZeneca for KRASG12D Inhibitor UA022
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Shanghai-based Usynova Pharmaceuticals Ltd has announced a licensing agreement with UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) concerning its pipeline candidate, UA022. UA022 is a small-molecule drug targeting the KRASG12D mutation, currently in the pre-clinical stages of development. Terms of the Agreement and FinancialsUnder the agreement, AstraZeneca (AZ) will secure…
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Ascentage Pharma Secures Additional Indication Approval for Olverembatinib from NMPA
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China-based Ascentage Pharma (HKG: 6855) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Category 1 drug, olverembatinib. This second market-approved indication is for the treatment of adult patients with chronic myeloid leukemia (CML) in the chronic phase (CP) who are resistant and/or intolerant…
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Apollomics’ Partner Avistone Wins Conditional Approval for c-Met Inhibitor in China
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US-based biotech Apollomics Inc., (NASDAQ: APLM) has announced that its Chinese partner, Avistone Biotechnology Co., Ltd, has received conditional market approval for the c-Met inhibitor vebreltinib from the National Medical Products Administration (NMPA). The approval is for the treatment of patients with MET exon 14 skipping non-small cell lung cancer…
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Fosun Pharmaceutical Secures Clinical Trial Approvals for VT-101 in China and the US
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced receiving clinical trial approvals for its VT-101 from both the National Medical Products Administration (NMPA) in China and the US Food and Drug Administration (FDA). VT-101 is a next-generation recombinant oncolytic adenovirus product that features a triple-targeted tumor regulation mechanism,…
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Baheal Pharmaceutical Group Enters Commercialization Partnership with Guangdong Ruidio Technology
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China-based health services and distribution giant Baheal Pharmaceutical Group has struck a commercialization partnership with Guangdong Ruidio Technology Co., Ltd. Under the terms of the agreement, Baheal acquires commercialization rights to Ruidio’s series of radioactive drugs, including 99mTc-3PRGD2, 99mTc-HP-Ark2, and 99mTc-POFAP, as well as imaging equipment products such as SPECT.…
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Pfizer and Astellas Pharma Secure FDA Approval for Xtandi in High-Risk Non-Metastatic Prostate Cancer
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Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval from the US Food and Drug Administration (FDA) for their androgen receptor signaling inhibitor Xtandi (enzalutamide). The drug is now approved as a treatment for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high…
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AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with fulvestrant. This treatment is indicated for HR-positive, HER2-negative locally advanced or metastatic recurrent or refractory breast…
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Alphamab Oncology’s JSKN003 ADC: Promising Preliminary Data in Advanced Solid Tumors
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Alphamab Oncology (HKG: 9966) has released preliminary data from a Phase I clinical study on its JSKN003-KN026 antibody drug conjugate (ADC) in Australia, focusing on advanced solid tumors. This open-label, multi-center, dosage escalation study is designed to evaluate the safety, tolerability, and preliminary efficacy of the molecule in treating these…
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BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY) registration approval for its next-generation tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. This decision follows a priority review of Phase…
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Astellas Pharma Acquires Propella Therapeutics for $175 Million to Boost Prostate Cancer Treatment
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Japan’s Astellas Pharma (TYO: 4503) has announced the negotiation of a purchase agreement for US biopharmaceutical company Propella Therapeutics this week, with a transaction value of USD 175 million. The deal is anticipated to be finalized by March 2024, subject to the fulfillment of customary conditions. With this acquisition, Astellas…
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Eli Lilly Clears Final Regulatory Hurdle with NRC Approval for Point Biopharma Acquisition
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The Nuclear Regulatory Commission (NRC) of the US has given its approval for the transfer of a radioactive materials license from Point Biopharma (NASDAQ: PNT) to Eli Lilly (NYSE: LLY). This decision marks the final regulatory clearance necessary for Eli Lilly’s acquisition of Point Biopharma, which was announced last month.…
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Merck KGaA Outlines Expansion Plans for US Healthcare Market with Anticipated 2025 Drug Launches
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Germany’s Merck KGaA (ETR: MRK), a leading player in the global pharmaceutical industry, has this week unveiled its strategic plans for the US healthcare market. The company, which currently commercializes two cancer treatments in the US, is gearing up to launch two additional drugs by 2025. Furthermore, Merck anticipates continuing…
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EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
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Novartis Pharma AG Partners with Legend Biotech Corp. for CAR-T Therapies in $1.1 Billion Deal
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China-based Legend Biotech Corp., (NASDAQ: LEGN) has secured a second multinational partnership for its chimeric antigen receptor (CAR) T cell therapies with Novartis Pharma AG (NYSE: NVS) in a landmark USD 1.1 billion deal. The Swiss pharmaceutical giant has acquired exclusive global development, manufacturing, and commercialization rights to certain assets…
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BMS Secures ORM-6151 for Acute Myeloid Leukemia Treatment with Orum Therapeutics Deal
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Bristol Myers Squibb (BMS; NYSE: BMY) has made a significant move in the field of oncology by purchasing ORM-6151, a potential first-in-class antibody-drug conjugate (ADC) from US-based Orum Therapeutics. The acquisition includes approval from the local regulator for ORM-6151 to enter a Phase I study for acute myeloid leukemia (AML)…
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Bayer Withdraws Aliqopa FDA Filing Following Missed Phase III Endpoint
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Germany-based pharmaceutical major Bayer (ETR: BAYN) has announced its decision to withdraw the filing for the kinase inhibitor Aliqopa (copanlisib) with the US Food and Drug Administration (FDA). Aliqopa, which received accelerated approval in 2017 for the treatment of relapsed follicular lymphoma (FL), failed to meet the primary endpoint of…
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AnchorDx Medical Partners with DiaCarta for Global Molecular Diagnostics Development
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AnchorDx Medical Co., Ltd, a specialist in methylation high-throughput sequencing based in China, has entered into a partnership with DiaCarta, Ltd, a US-based precision molecular diagnostics company. The collaboration aims to focus on the development and commercialization of cancer screening products, leveraging their proprietary technologies in DNA methylation and mutation…
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Beijing-Based Immupeutics Medicine Secures Tens of Millions in Pre-Series A+ Financing
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Immupeutics Medicine, a Beijing-based developer in the field of tumor immunotherapy, has reportedly secured tens of millions of renminbi in a pre-Series A+ financing round. The funding round was led by Beijing state-owned Capital Operation and Management Center, with additional investments from Junshi Bio, Alwin Capital, and the company’s founder.…
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Servier’s Tibsovo Receives FDA Approval for IDH1-Mutated R/R MDS, Expanding Indications
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France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has granted market approval for its drug Tibsovo (ivosidenib) for the treatment of recurrent or refractory (R/R) myelodysplastic syndrome (MDS) with IDH1 mutation. This marks the fifth indication for the drug in the IDH1 mutant cancer…
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AstraZeneca’s Imfinzi Gains NMPA Approval for First-Line Cholangiocarcinoma Treatment
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The National Medical Products Administration (NMPA) of China has indicated on its website that it has approved AstraZeneca’s (AZ, NASDAQ: AZN) programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab), for use in combination with chemotherapy for the treatment of first-line locally advanced or metastatic cholangiocarcinoma (BTC). This marks a significant expansion…
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Bayer Shifts Focus of Recursion Pharmaceuticals Collaboration to Precision Oncology
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Germany-headquartered Bayer (ETR: BAYN) has announced a significant modification to its 2020 drug discovery collaboration with US biotechnology firm Recursion Pharmaceuticals (NASDAQ: RXRX). The partnership, which was initially focused on fibrosis, will now shift its attention to precision oncology. This strategic move will see the initiation of up to seven…
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Beijing Aosaikang’s Combo Therapy for NSCLC Accepted for Clinical Trial by NMPA
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the China National Medical Products Administration (NMPA) has accepted a clinical trial application for the combination of two pipeline candidates, ASKC202 tablets and ASK120067 tablets. The company is seeking to evaluate this combination therapy in adults…
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China’s NMPA Grants Conditional Approval for Juventas’ CAR-T Therapy Inaticabtagene Autoleucel
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The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Chinese firm Juventas Cell Therapy Ltd. The drug is indicated for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. Inaticabtagene Autoleucel’s…
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Danaher Corporation Partners with CHEA to Boost Oncology Centers in Chinese Counties
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US-based science and technology services giant Danaher Corporation (NYSE: DHR) has entered into a partnership with the hospital management unit of the China Health Economics Association (CHEA). The collaboration aims to promote the development of oncology prevention and control centers at the county hospital level in China, with no financial…
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Yantai Dongcheng Pharmaceutical Gets Singapore HSA Nod for Phase I Study of 177Lu-LNC1003
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the Health Sciences Authority (HSA) in Singapore to conduct a Phase I clinical study for its investigational drug, 177Lu-LNC1003. 177Lu-LNC1003: A Radiopharmaceutical for Advanced Prostate Cancer177Lu-LNC1003 is a radioactive in vivo therapeutic drug that targets prostate…
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ImmVira’s MVR-T3011 IV Achieves Positive Outcomes in US Phase I Clinical Study
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Shenzhen-based biotechnology company ImmVira has announced the successful completion of Phase I clinical studies in the United States for its intravenous oncolytic virus product, MVR-T3011 IV. The trial, which focuses on late stage patients with various tumor types, yielded “exceptional” safety results and demonstrated initial efficacy for certain indicationsThe study…
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CStone Pharmaceuticals Enters Licensing Agreement with Allist Pharmaceuticals for Gavreto in China
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a licensing agreement with Allist Pharmaceuticals Co., Ltd, granting the Shanghai-based biotech exclusive commercial promotion rights to Gavreto (pralsetinib) in mainland China. CStone retains development, regulatory filing, and other rights excluding promotion in mainland China. Under the agreement, CStone will receive an undisclosed…
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Roche’s Lymphoma Therapy Columvi Receives NMPA Approval for Adult Patients with Relapsed DLBCL
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its novel lymphoma therapy, Columvi (glofitamab). The drug is now approved to treat adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who have…
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ImmuneOnco Biopharmaceuticals’ Timdarpacept (IMM01) Earns Orphan Drug Designation for CMML
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug timdarpacept (IMM01). This marks a significant milestone for the company’s first SIRPαFc fusion protein targeting CD47, which was designed in China.…
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Abbisko Therapeutics’ CD73 Inhibitor ABSK051 Clears for Phase I Clinical Trial in China
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its next-generation CD73 inhibitor, ABSK051, in China. This first-in-human (FIH), multi-center, open-label study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD),…
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US FDA Approves HutchMed and Takeda’s Fruzaqla for Metastatic Colorectal Cancer Treatment
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The US Food and Drug Administration (FDA) has granted approval to HutchMed (NASDAQ: HCM) and its partner Takeda (NYSE: TAK, TYO: 4502) for their oral tyrosine kinase inhibitor Fruzaqla (fruquintinib), marking the second approval this year for a China-developed innovative drug. The drug is indicated for adult patients with previously…
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Zymeworks and BeiGene Terminate Licensing Agreement for ZW49 ADC
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Zymeworks Inc. (NASDAQ: ZYME), a Canada-based biotech company, has announced in its Q3 financial report that the licensing agreement with China’s BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) for the antibody drug conjugate (ADC) zanidatamab zovodotin (ZW49) has been cancelled. This development affects the HER2-targeted ADC that BeiGene had…
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Senti Biosciences and Celest Therapeutics Partner on CAR-NK Cell Therapy Clinical Trial in China
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Senti Biosciences Inc., (NASDAQ: SNTI), a San Francisco-based biotech company, has announced a strategic collaboration and license agreement with Shanghai-based Celest Therapeutics Co., Ltd. The partnership will see Celest manage a pilot clinical trial in mainland China for Senti’s SENTI-301A, an off-the-shelf CAR-NK cell therapy targeting GPC3-expressing tumors. Senti will…
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Abbisko Therapeutics Receives FDA Approval for Phase I Study of FGFR4 Inhibitor ABSK012
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received clearance from the US Food and Drug Administration (FDA) to commence a Phase I clinical study of its next-generation FGFR4 mutant inhibitor, ABSK012, for the treatment of advanced solid tumors. Objectives of the Phase I…
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FibroGen Inc. Reports 155% YOY Sales Increase in Q3 2023 Financial Results
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US-based biotechnology company FibroGen Inc., (NASDAQ: FGEN) has reported its financial results for the third quarter of 2023, showcasing a significant year-on-year (YOY) increase in global sales. The company’s revenues rose by 155% to USD 40.1 million, reflecting the success of its anti-anemia drug for chronic kidney disease (CKD), Evrenzo…
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Gilead Sciences and Arcus Biosciences Announce Positive Phase II Data for Domvanalimab Combination Therapy
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Gilead Sciences (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have this week released preliminary data from a Phase II study combining Gilead’s anti-TIGIT biologic domvanalimab with Arcus’ anti-PD-1 drug zimberelimab plus chemotherapy for the treatment of locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The study marks…
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SciClone Pharmaceuticals Secures Exclusive Rights to Menarini Group’s Orserdu in China
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China’s SciClone Pharmaceuticals Inc., (HKG: 6600) has entered into a licensing and cooperation agreement with the Italy-headquartered Menarini Group. This agreement grants SciClone exclusive development and commercialization rights to Menarini’s Orserdu (elacestrant) in China. SciClone will be responsible for conducting clinical trials, regulatory filings, and marketing and distribution of Orserdu…
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RinuaGene Receives US FDA IND Approval for HPV-Associated Tumor mRNA Vaccine RG002
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RinuaGene, a leading mRNA specialist headquartered in Suzhou, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its human papillomavirus (HPV) associated tumor therapeutic mRNA vaccine, RG002. This marks a significant step forward in the development of the vaccine,…
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Enhertu Receives Priority Review Status for HER2-Positive Gastric Cancer Treatment in China
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The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), is set for priority review status in China. This priority review is specifically for the ADC’s potential use as a…
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BioNTech Secures Exclusive Rights to Biotheus Inc.’s BsAb PM8002 in Landmark Deal
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Germany’s BioNTech (NASDAQ: BNTX) has entered into an exclusive license and collaboration agreement with China-based Biotheus Inc., focusing on the development and commercialization of the bispecific antibody (BsAb) PM8002. The deal grants BioNTech development, manufacturing, and commercial rights to PM8002 in all markets outside of Greater China, marking a significant…
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Seagen’s Adcetris Combo with Keytruda Shows Promising Results in Phase II Study
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), has released the results of a Phase II study combining its antibody drug conjugate (ADC) Adcetris (brentuximab vedotin) with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy Keytruda (pembrolizumab). The study focused on patients with…
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Zhejiang Huahai Pharmaceutical’s HB0052 Receives US FDA IND Approval for Solid Tumors
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IntroductionZhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its injectable drug candidate, HB0052. The drug will initially be assessed in general advanced solid tumors, marking a significant…
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BeiGene’s ZW25 on Track for Priority Review for Cholangiocarcinoma Treatment by CDE
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The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab) is set to receive priority review status for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in patients with high HER2 expression who have previously received systemic treatment. This priority review status is a…
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CSPC Pharmaceutical Group Gets NMPA Approval for SYS6011 Biologic Drug Clinical Study
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a China-based pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 biologic drug candidate, SYS6011. The study will be focused on general solid tumors, marking a significant step…
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Bayer Extends Collaboration with Broad Institute to 2028 for Oncology Drug Targets and Therapies
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Germany’s Bayer (NYSE: ETR) has announced the extension of its 2013 collaboration agreement with the US-based research center, the Broad Institute, until 2028. The partnership focuses on identifying new drug targets in oncology and developing innovative cancer therapies. The financial details of the extended agreement have not been disclosed. Combining…
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Gaush Meditech Ltd Receives NMPA Approval for Rigid Corneal Contact Lens
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Gaush Meditech Ltd (HKG: 2407), a company based in Suzhou, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its rigid corneal contact lens. This development marks a significant step forward for the company, as it now offers a highly rigid gas permeable…
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Amoy Diagnostics Receives NMPA Approval for MSI Detection Kit as Companion Diagnostic for Immunotherapy
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in the Chinese diagnostics industry, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its human microsatellite instability (MSI) detection kit. This kit, which utilizes fluorescent PCR capillary electrophoresis,…
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Wuhan Hiteck Biological Pharma Receives NMPA Approval for Aponermin in Multiple Myeloma Treatment
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Wuhan Hiteck Biological Pharma Co., Ltd (SHE: 300683), a Chinese biopharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aponermin. This approval is for the treatment of adult patients with recurrent or refractory multiple myeloma who have previously undergone…
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Abbisko Therapeutics to Present CSF-1R Inhibitor ABSK021 Data at CTOS Annual Meeting
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it will present data from two clinical studies on its next-generation CSF-1R inhibitor, ABSK021 (pimicotinib), at the Connective Tissue Oncology Society (CTOS) annual meeting. The presentations will highlight significant findings from the Phase Ib clinical study and the ongoing…
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Ascentage Pharma’s Olverembatinib Showcases Promising Results at ASH Annual Meeting
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Suzhou-based Ascentage Pharma (HKG: 6855) has presented the latest results of multiple studies regarding its innovative drug candidate olverembatinib at the 65th American Society of Hematology (ASH) annual meeting. The data highlights the potential of olverembatinib in treating various hematological malignancies, including chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic…
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I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA
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China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for their CD38 monoclonal antibody (mAb), felzartamab. This designation highlights the drug’s potential as a treatment for primary membranous nephropathy (PMN), a rare…
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Eli Lilly & Co. Reports 36% YOY Sales Growth in Q3 2023 with Key Drug Performances
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Eli Lilly & Co., (NYSE: LLY) has announced its financial results for the third quarter of 2023, showing a 36% year-on-year (YOY) increase in sales to USD 9.5 billion in constant currency terms. This figure includes a USD 1.42 billion one-off payment from the sale of the Zyprexa (olanzapine) portfolio…
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Pfizer Inc. Reports Q3 2023 Revenue Contraction and Launches Cost Realignment Program
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US pharmaceutical giant Pfizer Inc., (NYSE: PFE) has released its financial results for the third quarter of 2023, reporting a contraction of -41% year-on-year (YOY) in operational terms to USD 13.2 billion, excluding foreign currency fluctuations. The quarter was marked by a net loss of USD 2.38 billion, the company’s…
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AstraZeneca Partners with Cellectis for Next-Generation Cell and Gene Therapies
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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has announced a strategic partnership with Cellectis (EPA: ALCLS; NASDAQ: CLLS) to develop next-generation therapeutics, focusing on areas of high unmet need such as oncology, immunology, and rare diseases. This collaboration aims to leverage Cellectis’s gene editing technologies and manufacturing capabilities to advance…
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Daiichi Sankyo Reports 19.5% YOY Revenue Growth in First Half of Fiscal 2023
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Japan’s Daiichi Sankyo (TYO: 4568) reported a robust 19.5% year-on-year (YOY) increase in revenue for the six months ended September 30, 2023, reaching JPY 726.3 billion (USD 4.8 billion), according to the company’s financial report published this week. This growth was driven by a combination of factors, including the depreciation…
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Chongqing Precision Biotechnology’s PCAR-19B Receives CDE Nod for Breakthrough Therapy Designation
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The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co., Ltd’s PCAR-19B cell autologous reinfusion preparation is on track to receive breakthrough therapy designation (BTD). This designation recognizes the potential of PCAR-19B as a treatment for patients aged 3 to 21 years old with CD19-positive…
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Sichuan Kelun-Biotech’s SKB264 Receives Priority Review Status for TNBC Treatment in China
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The China’s Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd’s (HKG: 6990) drug candidate, SKB264, is on track to obtain priority review status for the treatment of unresectable, locally advanced, or metastatic triple negative breast cancer (TNBC) in China. This development is particularly significant…
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Hinova Pharmaceuticals’ HP518 Receives NMPA Approval for mCRPC Clinical Trial
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China-based biopharmaceutical company Hinova Pharmaceuticals (SHA: 688302) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) in China for its drug candidate HP518, which is being developed to treat metastatic castration-resistant prostate cancer (mCRPC). The androgen receptor (AR)-targeted PROteolysis TArgeting Chimera (PROTAC) drug…
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3SBio Inc. and CStone Pharmaceuticals Enter Strategic Partnership for Nofazinlimab
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China-based 3SBio Inc., (HKG: 1530) has announced a strategic partnership and exclusive licensing agreement with compatriot firm CStone Pharmaceuticals (HKG: 2616), focusing on CStone’s anti-programmed death-1 (PD-1) antibody, nofazinlimab. This partnership signifies a significant expansion in the immuno-oncology space for both companies. Financial Terms and Agreement DetailsUnder the terms of…
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Shanghai Henlius Biotech’s HanSiZhuang Shows Positive Results in Phase III ASTRUM-002 Study
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company in China, has unveiled positive data from the Phase III ASTRUM-002 study. The study assessed the efficacy of its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), in combination with chemotherapy for first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC). The…
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AnHeart Therapeutics Signs Exclusive License Deal with Nippon Kayaku for Taletrectinib
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China-based AnHeart Therapeutics has announced the signing of an exclusive license deal with Japan-based biopharma Nippon Kayaku Co., Ltd. This strategic partnership grants Nippon Kayaku marketing and distribution rights for AnHeart’s leading pipeline candidate, taletrectinib, a next-generation ROS1 inhibitor. Taletrectinib: A Promising Treatment for ROS1-Positive NSCLCTaletrectinib is an oral, potent,…
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BioLineRx Licenses Multiple Myeloma Drug Motixafortide to Guangzhou Gloria Biosciences
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Israel’s BioLineRx has entered into a licensing agreement with Guangzhou Gloria Biosciences Co., Ltd., based in China, focusing on the development of BioLineRx’s multiple myeloma drug, motixafortide. This strategic partnership grants Gloria exclusive rights to develop motixafortide across all indications throughout Asia. As part of the agreement, Gloria is making…
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Allist Pharmaceuticals’ Furmonertinib Receives FDA Breakthrough Therapy Designation for NSCLC
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd (SHA: 688578) has announced that it has received breakthrough therapy designation (BTD) from the US FDA for its drug candidate furmonertinib. This designation underscores the drug’s potential as a treatment for previously untreated, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with epidermal…
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CDE Grants Priority Review to LaNova’s LM-302, Roche’s Alectinib, and Alphamab’s KN026
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China’s Center for Drug Evaluation (CDE) has indicated that LaNova Medicines’ LM-302, Roche’s (SWX: ROG) alectinib, and Alphamab Oncology’s HER2-targeted bispecific antibody (BsAb) KN026 (anbenitamab) are set for priority reviews. This designation is a significant step that could expedite the availability of these drugs to patients in need. LM-302: A…
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GenFleet Therapeutics’ SLS009 Receives FDA Fast-Track Status for PTCL Treatment
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Shanghai-based biotech GenFleet Therapeutics has announced that its investigational drug SLS009 (GFH009) has received fast-track status from the US FDA for the treatment of recurrent/refractory adult peripheral T-cell lymphoma (PTCL) patients. This CDK9 inhibitor was previously awarded an orphan drug designation (ODD) by the FDA in mid-October, highlighting its potential…
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CStone Pharmaceuticals Receives NMPA Approval for Sugemalimab in R/R ENKTL
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor. The drug is now approved for the treatment of recurrent or refractory extranodal NK/T cell lymphoma (R/R…
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Simcere Pharmaceutical Group Secures Full Approval for Cosela in China
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Simcere Pharmaceutical Group (HKG: 2096), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has converted the first conditional approval in China for Cosela (trilaciclib) to full approval. Originally discovered by US biotech G1 Therapeutics Inc, trilaciclib was in-licensed by Simcere in August…
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BMS and Karyopharm Partner to Evaluate Mezigdomide and Xpovio in Relapsed/Refractory Multiple Myeloma
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Bristol Myers Squibb (BMS; NYSE: BMY) has entered into a collaboration and supply agreement with Karyopharm Therapeutics (NASDAQ: KPTI) to evaluate the combination of BMS’s cereblon E3 ligase modulator (CELMoD) candidate, mezigdomide, with Karyopharm’s first-in-class Exportin 1 (XPO1) inhibitor, Xpovio (selinexor), plus dexamethasone. This combination is targeted at relapsed/refractory multiple…
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AbbVie’s Q3 2023 Report Shows 6.0% YOY Decline in Net Revenues
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AbbVie (NYSE: ABBV) released its Q3 2023 financial report last week, revealing a 6.0% year-on-year (YOY) decline in net revenues for the first nine months of the year, amounting to USD 40.0 billion. The decrease was attributed to underperformance across most business areas, with the exception of neuroscience, which reported…
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Alphamab Oncology and 3D Medicines Gain FDA Approval for Envafolimab Phase III Trial
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Partners Alphamab Oncology (HKG: 9966) and 3D Medicines (HKG: 1244) have announced that they have received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for envafolimab (KN035) in proficient mismatch repair (fMMR) advanced or recurrent endometrial cancer combined with lenvatinib. This approval…
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Fosun Pharma Gains NMPA Approval for Clinical Trials of HLX42 and HLX43 ADCs
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced that it has received approval from the National Medical Products Administration (NMPA) in China to conduct separate clinical studies for HLX42 and HLX43. These two pipeline candidates are antibody drug conjugates (ADCs) co-developed by subsidiary Shanghai Henlius Biotech Inc., (HKG:…
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Junshi Biosciences’ PD-1 Inhibitor Loqtorzi Approved by FDA for Nasopharyngeal Carcinoma
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the US FDA has approved its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), for the treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). The approval marks a significant milestone as Loqtorzi becomes the first…
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TG ImmunoPharma’s Bispecific Antibody TGI-6 Approved for Phase I Clinical Study by NMPA
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China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its bispecific antibody (BsAb) TGI-6 in China. This approval marks a significant milestone in the development of innovative cancer treatments within the country.…
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Wyze Biotech’s RJMty19 Injection Accepted for CDE Review for r/r B-Cell NHL
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Wyze Biotech Co., Ltd, a Guangdong-based developer of off-the-shelf universal DNT cell therapies, has announced that an investigational new drug (IND) filing for its immune cell product RJMty19 injection has been accepted for review by China’s Center for Drug Evaluation (CDE). The therapy is intended for assessment as a treatment…
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Shanghai Henlius Biotech and Intas Pharmaceuticals Ink New Licensing Deal for PD-1 mAb
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China’s Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new licensing agreement with India-based Intas Pharmaceuticals Ltd, granting Intas exclusive development and commercialization rights to its anti-programmed death-1 (PD-1) monoclonal antibody (mAb) HanSiZhuang (serplulimab) in Europe and India. This strategic partnership further expands the global reach of Henlius’s innovative…
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Takeda’s Global Revenues Grow: Strong Performance in Plasma Therapies and Gastroenterology
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Japan-based pharmaceutical giant Takeda (TYO: 4502) has released its financial results for the 6-month period ending September 30, 2023, with global revenues hitting JPY 2.1 trillion (USD 14.0 billion). This represents a 6.4% year-on-year (YOY) increase in reported terms, or a more modest 1.4% growth at constant exchange rates (CER).…
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Abbisko Therapeutics Gets NMPA Approval for Phase I Study of ABSK112 in NSCLC
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Shanghai-based biotechnology firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, ABSK112. This next-generation EGFR inhibitor, which targets the Exon20ins mutation, is set to be evaluated as…
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Sinotau Pharmaceutical Group Secures Rights to Blue Earth Diagnostics’ Flotufolastat in China
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Sinotau Pharmaceutical Group, a Beijing-based nuclear medicine enterprise, has entered into a licensing agreement with UK molecular imaging company Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A. Through this deal, Sinotau will gain development, manufacturing, and commercialization rights to Blue Earth’s PSMA targeted PET imaging agent, Flotufolastat (18F).…
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Huadong Medicine’s Elahere Accepted for NMPA Review in China for Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted the market filing for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine), targeting folate receptor α (FRα). This marks a significant step towards making the treatment available for patients in China. Acquisition…
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Novartis’ Pluvicto Demonstrates Positive Phase III Results in mCRPC Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has released encouraging data from a Phase III study for its radioligand therapy (RLT) Pluvicto (177Lu vipivotide tetraxetan). The study focused on patients with prostate-specific membrane antigen (PSMA)-positive progressive metastatic castration-resistant prostate cancer (mCRPC), a challenging form of the disease. Primary Endpoint and Risk…
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Innovent Biologics’ GFH925 on Track for Priority Review Status for NSCLC Treatment
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The Center for Drug Evaluation (CDE) has indicated that Innovent Biologics’s (HKG: 1801) Category 1 chemical drug, GFH925, is set to receive priority review status for the treatment of advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients who have received at least one systemic treatment. This…
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Zhejiang Jianfeng Receives FDA Approval for JFAN-1001 Clinical Trial in NSCLC
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Zhejiang Jianfeng Group Co., Ltd (SHA: 600668), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, JFAN-1001. The drug is indicated for the treatment of locally advanced or metastatic…
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CSPC Pharmaceutical Gains NMPA Approval for Clinical Study of Bispecific Antibody NBL-028
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its investigational bispecific antibody (BsAb) NBL-028. The drug targets CLDN6 and CD137, focusing initially on advanced tumors with CLDN6 expression, such as testicular…
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Shanghai Henlius Initiates Global Phase III Study for HanSiZhuang in LS-SCLC
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China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the milestone of the first patient dosing in the global multi-center Phase III clinical study for its anti-PD-1 monoclonal antibody (mAb) HanSiZhuang (serplulimab). The study is evaluating the drug in combination with chemotherapy and concurrent radiotherapy for patients with limited-stage small…
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EC Approves AstraZeneca and Daiichi Sankyo’s Enhertu for Advanced HER2+ NSCLC
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The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) to AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568). This approval is for the treatment of advanced HER2-positive non-small cell lung cancer (NSCLC) in adults who require systemic therapy following chemotherapy. The…
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Dizal’s Sunvozertinib Shows Promising Efficacy in Advanced NSCLC at ESMO 2023
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented compelling efficacy and safety data for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, at the European Society for Medical Oncology (ESMO) Congress 2023. The drug is being evaluated for first-line treatment in advanced non-small cell lung cancer (NSCLC) with EGFR…
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Novartis Q3 Earnings Reflect Strong Growth Post-Sandoz Spinoff
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Novartis (NYSE: NVS) has released its Q3 2023 financial results, marking the first report since the company sharpened its focus on innovative medicines following the spinoff of Sandoz (SWX: SDZ) earlier this month. The financials reveal a robust performance with net sales reaching USD 34.0 billion for the first nine…
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Fosun Pharma Gains NMPA Approval for Phase I Trial of XS-03 in Advanced Solid Tumors
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a leading healthcare conglomerate in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, XS-03. This study will focus on evaluating the drug’s efficacy in…
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Shandong Luoxin’s LX-039 Demonstrates Promise in Phase I Oncology Study at ESMO
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Shandong Luoxin Pharmaceutical Group Stock Co., Ltd (SHE: 002793), a China-based pharmaceutical innovator, has published data from a Phase I clinical study for its novel anti-tumor drug, LX-039. This oral selective estrogen receptor modulator (SERD) was in the spotlight at the European Society for Medical Oncology (ESMO) Congress 2023, where…
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Kintor’s Proxalutamide Shows Promise in Metastatic Breast Cancer Study at ESMO
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has published the latest data from a Phase Ic clinical study evaluating its proxalutamide in combination with endocrine therapies (ETs) for metastatic breast cancer. The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2023, shedding light on the drug’s potential…
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Ascentage Pharma’s Pelcitoclax Shows Promise in ESMO Study for NSCLC
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Suzhou-based pharmaceutical company Ascentage Pharma (HKG: 6855) has published the latest results from a Phase Ib study of its pelcitoclax (APG-1252), a dual inhibitor of BCL-2 and BCL-xL proteins, in combination with AstraZeneca’s Tagrisso (osimertinib) for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). The findings were presented at…
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Yiling Pharmaceutical Gains NMPA Approval for XY0206 in AML Trial
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, XY0206. The drug is intended for use in treating acute myeloid leukemia (AML) with FLT3-ITD mutation (FMS-like tyrosine kinase 3 internal…
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Janssen’s TAR-200 Shows High Complete Response Rate in Bladder Cancer Study
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has published data from a Phase IIb study demonstrating the efficacy of its intravesical gemcitabine delivery system, TAR-200, in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) carcinoma in situ-positive. The study results are a significant step forward in the…
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Novartis’ Kisqali Plus Endocrine Therapy Shows Improved Survival in Early Breast Cancer Study
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Switzerland-based pharmaceutical company Novartis (NYSE: NVS) has announced additional results from an ongoing Phase III study evaluating the CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy for stage II and III HR+/HER2- early breast cancer (EBC). The findings confirm that the combination therapy significantly improves invasive disease-free survival (iDFS)…
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Shanghai Henlius Receives GMP Certification from ANVISA for Biosimilar Manufacturing
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) subsidiary Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the receipt of two Good Manufacturing Practice (GMP) certificates from Brazil’s National Health Surveillance Agency (ANVISA). This certification confirms that Henlius’ biologics manufacturing plant located in the Xuhui district of…
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Jacobio Pharma’s Glecirasib Combo Shows Promising Results in ESMO Congress 2023 Presentation
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China-based Jacobio Pharma (HKG: 1167) has presented clinical data for its KRAS G12C inhibitor glecirasib in combination with its pipeline SHP2 inhibitor JAB-3312 at the European Society for Medical Oncology (ESMO) Congress 2023. The data comes from a Phase I/II study that enrolled 144 patients with KRAS G12C mutated cancers,…
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InxMed Presents Positive Data for FAK Inhibitor Ifebemtinib at ESMO 2023
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China-based firm InxMed (Nanjing) Co., Ltd has updated two clinical studies for its first-in-class small-molecule FAK inhibitor ifebemtinib (IN10018) at the European Society for Medical Oncology (ESMO) Congress 2023. The studies evaluated the drug’s efficacy and safety in treating platinum-resistant recurrent ovarian cancer and advanced triple negative breast cancer. Phase…
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CDE Grants Priority Review to Pearl Biotech’s Breatinib for Glioblastoma Treatment
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China’s Center for Drug Evaluation (CDE) has indicated that Beijing Pearl Biotechnology Co., Ltd’s breatinib has obtained priority review status for the treatment of WHO grade 4 astrocytoma with isocitrate dehydrogenase (IDH) mutation and PTPRZ1-MET (ZM) fusion gene, or adult glioblastoma (GBM) patients who have relapsed after, or become intolerant…
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Roche’s Q3 2023 Report Shows 1% Global Growth Amid Lower COVID-19 Product Demand
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Swiss pharmaceutical giant Roche (SWX: ROG) released its Q3 2023 report, indicating that a reduced demand for COVID-19 products impacted global growth, resulting in a 1% year-on-year (YOY) increase at constant exchange rates over the first nine months, with total sales amounting to CHF 44.1 billion (USD 49.4 billion). Excluding…
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BMS’s Subcutaneous Opdivo Meets Phase III Study Endpoints in ccRCC
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced positive results from a Phase III comparative study of its anti-PD-1 drug Opdivo (nivolumab) formulated as a subcutaneous injection. The study, conducted in pre-treated advanced or metastatic clear cell renal cell carcinoma (ccRCC) patients, utilized Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) for…
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MSD Collaborates with Daiichi Sankyo on Development of Innovative ADC Candidates
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic collaboration agreement with Japan-based Daiichi Sankyo (TYO: 4568) focused on the development and commercialization of three potential first-in-class deruxtecan-based antibody-drug conjugate (ADC) candidates. This partnership aims to advance innovative treatments for various types of cancer. ADC Candidates and Development…
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Roche’s Alecensa Shows Unprecedented 76% Improvement in Disease-Free Survival in NSCLC Trial
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Roche (SWX: ROG) subsidiary Genentech has revealed preliminary but promising results from a Phase III trial for Alecensa (alectinib) in patients with early-stage resected ALK-positive non-small cell lung cancer (NSCLC). The trial demonstrated that the ALK inhibitor significantly improved disease-free survival (DFS) by an unprecedented 76% compared to chemotherapy, meeting…
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BeiGene’s Tislelizumab Shows Promising Results in ESMO Presentations for GC/GEJC and NSCLC
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China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced two late-breaking presentations of Phase III data for its programmed death-1 (PD-1) inhibitor tislelizumab at the European Society for Medical Oncology (ESMO) Congress 2023. The presentations include an oral presentation for tislelizumab in combination with chemotherapy for advanced…
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BeiGene Submits Supplementary BLA for Tislelizumab in Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE) has announced that its supplementary Biologic License Application (sBLA) for the programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the Center for Drug Evaluation (CDE) in China. The application seeks approval for the drug to be used in combination with etoposide and chemotherapy as…
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Mabwell to Present Promising Clinical Data at 2023 ESMO Congress
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it will present the latest clinical data for its investigational drugs 9MW2821 and 8MW0511 at the upcoming 2023 European Society for Medical Oncology (ESMO) Congress. This presentation underscores the company’s commitment to advancing innovative therapies in oncology. 9MW2821: Promising…
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Ascentage Pharma and AstraZeneca Expand Collaboration on CLL/SLL Treatment
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China’s Ascentage Pharma (HKG: 6855) and UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) have entered into a second clinical collaboration agreement to further study the combination of Ascentage’s Bcl-2 inhibitor lisaftoclax with AZ’s BTK inhibitor acalabrutinib (Calquence). This partnership is specifically aimed at conducting a registrational Phase III trial to…
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MSD Partners with Phanes Therapeutics for Innovative Cancer Combo Therapy
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Global pharmaceutical leader Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a strategic partnership with US-based biotechnology firm Phanes Therapeutics to develop a novel combination therapy. The collaboration will see MSD’s anti-PD-1 blockbuster Keytruda (pembrolizumab) paired with Phanes’s first-in-class CD47×claudin 18.2 drug PT886, targeting claudin 18.2-positive gastric or gastroesophageal…
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Jiangsu Hengrui Licenses Camrelizumab-Apatinib Combo to Elevar Therapeutics
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China-based pharmaceutical giant Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has signed a significant licensing agreement with US-headquartered Elevar Therapeutics. The deal grants Elevar global exclusive development and commercialization rights to Hengrui’s programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab in combination with apatinib for the treatment of hepatocellular carcinoma (HCC),…
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Kelun-Biotech to Present SKB264 Study Results for Metastatic Breast Cancer at ESMO
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China-based pharmaceutical innovator Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) and its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) are preparing to present the results of a Phase I/II basket study for their drug SKB264 (MK-2870) at the 2023 European Society for Medical Oncology (ESMO) Congress. The study focuses…
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Hainan Poly Pharm’s PL002 Accepted for FDA Review for Liver Cancer Surgery
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China-based pharmaceutical company Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that the Investigational New Drug (IND) filing for its novel injectable PL002 has been accepted for review by the US Food and Drug Administration (FDA). The drug is indicated for preoperative diagnosis and intraoperative navigation in patients with…
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FDA Approves Pfizer’s Braftovi + Mektovi Combo for BRAF V600E Metastatic NSCLC
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for the combination therapy of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This decision is supported by interim results from an ongoing Phase…
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Sichuan Huiyu Pharmaceutical’s HYP2090PTSA Gains NMPA Approval for KRAS G12C Solid Tumors
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HYP2090PTSA. This small molecule KRAS G12C/PI3K inhibitor is intended for the treatment of advanced solid tumors with KRAS G12C…
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J&J’s Cetrelimab and TAR-200 Gain Tacit Approvals for Bladder Cancer Trials
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J; NYSE: JNJ) has received two tacit clinical trial approvals for its Category 1 drug cetrelimab combined with TAR-200. The approvals are for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) patients not receiving BCG treatment, and…
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RemeGen Secures NMPA Approval for Phase II Study of Disitamab Vedotin in Breast Cancer
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China-based biopharma RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with breast cancer. First Home-Grown ADC with Conditional Approvals Disitamab vedotin stands…
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Ascentage Pharma Initiates Phase III Study for APG-2575 and Calquence in CLL/SLL
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced the approval to commence a global multi-center, randomized, open-label pivotal Phase III clinical trial evaluating the efficacy and safety of APG-2575 combined with Calquence (acalabrutinib) in untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. Earlier this year, the drug received clearance for a…
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Betta Pharmaceuticals Secures NMPA Approval for Befotertinib in NSCLC Treatment
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China-based Betta Pharmaceuticals Co., Ltd. (SHE: 300558) has officially announced its receipt of market approval from the National Medical Products Administration (NMPA) for befotertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This critical approval allows befotertinib to be used as a first-line treatment for locally advanced or…
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MSD’s Keytruda Achieves Primary Endpoint in Late-Stage NSCLC Trial
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that a late-stage trial for its anti-PD-1 drug Keytruda (pembrolizumab) has successfully met the primary endpoint of statistically significant and clinically meaningful improvement in overall survival (OS) in patients with resectable non-small cell lung cancer (NSCLC). The trial evaluated Keytruda as…
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Medilink Therapeutics Enters Global Licensing Agreement with BioNTech for HER3-Targeted Antibody Drug Conjugates
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Suzhou-based Medilink Therapeutics has announced a strategic cooperation and global licensing agreement with Germany-headquartered BioNTech SE (NASDAQ: BNTX). Under this partnership, the two companies will collaborate to develop next-generation antibody drug conjugates (ADCs) targeting the human epidermal growth factor receptor 3 (HER3). Leveraging TMALIN Technology for Enhanced Efficacy The ADC…
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GenFleet Therapeutics’ CDK9 Inhibitor SLS009 Earns Orphan Drug Status for AML
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Shanghai-based biotechnology company GenFleet Therapeutics has announced that its CDK9 inhibitor, SLS009 (GFH009), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation is a significant milestone, recognizing the drug’s potential to address a rare and…
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Roche’s Forimtamig Receives Tacit Approval for Multiple Myeloma Clinical Trials
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The Center for Drug Evaluation (CDE) has indicated that Swiss pharmaceutical giant Roche (SWX: ROG) has secured tacit clinical trial approval for its Category 1 biologic product, forimtamig (RG6234), in the treatment of multiple myeloma (MM). Promising Efficacy in Phase I Trials Forimtamig is a bispecific antibody (BsAb) designed to…
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AstraZeneca Seeks Approval for Capivasertib in Combination with Faslodex for Breast Cancer Treatment
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AstraZeneca (AZ, NASDAQ: AZN) has submitted a market approval filing for its Category 1 drug candidate, capivasertib, in combination with Faslodex (fulvestrant), according to the China Center for Drug Evaluation (CDE) website. The filing has been accepted for review, marking a significant step forward in the treatment of hormone receptor…
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Jiangsu Hengrui Medicine Gets NMPA Approval for Anti-Tumor Drug Candidate SHR-2022
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug candidate, SHR-2022 injection. This marks a significant step forward in the development of a new approach…
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BioCity Biopharma Partners with AstraZeneca for Phase Ib/II Study in Hepatocellular Carcinoma
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China-based biotech firm BioCity Biopharma has entered into a clinical study partnership with UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN). The collaboration aims to conduct a Phase Ib/II study assessing the safety and efficacy of BioCity’s BC3402 in combination with AstraZeneca’s Imfinzi (durvalumab) for the treatment of advanced hepatocellular cell…
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Shanghai Shende Wuchuang Secures $28 Million in Series D Financing for Medical Device Innovation
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Shanghai Shende Wuchuang Times Medical Technology Co., Ltd has reportedly secured nearly RMB 200 million (USD 28 million) in a Series D financing round, bringing the company’s total funding to RMB 400 million (USD 56 million). The investors in this round include Zhuji Huiri Yingtian Equity Investment and Hefei Industrial…
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GluBio Pharmaceutical’s GLB-002 Receives NMPA Approval for Clinical Trials in Hematological Tumors
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GluBio Pharmaceutical Co., Ltd, a specialist in molecular glue targeted protein degradation (TPD) based in Zhejiang, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its molecular glue degrading agent, GLB-002. The drug is indicated for the treatment of non-Hodgkin’s lymphoma (NHL)…
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BMS to Acquire Mirati Therapeutics in a $4.8 Billion Deal
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Bristol-Myers Squibb (BMS; NYSE: BMY) has entered into a definitive merger agreement with US-based oncology specialist Mirati Therapeutics (NASDAQ: MRTX) in a transaction valued at USD 4.8 billion, with an additional potential contingent value right (CVR) payment of up to USD 1.0 billion to Mirati stockholders. The companies anticipate completing…
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Eli Lilly Launches Three New Oncology Programs Targeting KRAS and Nectin-4
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Eli Lilly (NYSE: LLY) has announced the initiation of three innovative oncology programs focusing on KRAS and Nectin-4, all of which are currently in the pre-clinical stage. This strategic move highlights Lilly’s commitment to advancing cancer therapies that target specific oncogenic pathways. Details of the New Oncology Programs The new…
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Beijing Launches Comprehensive Plan to Eliminate Cervical Cancer by 2030
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The Beijing Municipal Health Commission, in collaboration with the Beijing Municipal Medical Insurance Bureau and seven other governmental bodies, has unveiled an “Implementation Plan for Accelerating the Elimination of Cervical Cancer in Beijing (2023-2030).” This ambitious campaign aims to significantly reduce cervical cancer incidence through a series of targeted preventive…
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Mabwell Bioscience Enters Licensing Agreement with Laboratorios Legrand for Biosimilars in Colombia and Ecuador
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced a strategic licensing agreement with Colombia-headquartered Laboratorios Legrand S.A. Under this agreement, Laboratorios Legrand will manage the regulatory filing and commercialization of Mabwell’s biosimilars, MAILISHU and 9MW0321, which are both biosimilars of denosumab. This deal specifically covers the territories of…
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HutchMed and Takeda Submit Fruquintinib NDA for Metastatic CRC in Japan
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that its partner Takeda (TYO: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the approval of fruquintinib as a treatment for adult patients with previously treated metastatic colorectal cancer (CRC).…
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Sichuan Biokin’s IZalontamab Gets US FDA Greenlight for NSCLC Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its innovative biologic drug, izalontamab (SI-B001). The trial will focus on assessing the efficacy of izalontamab in combination…
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Innovent Biologics Withdraws Parsaclisib Filing in China, Halts Development
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Innovent Biologics Inc., a leading China-based biotech company (HKG: 1801), has announced the voluntary withdrawal of its market approval filing for the drug candidate parsaclisib in China. Furthermore, the company has decided to halt all further development of the molecule, as stated in their press release. Background on Parsaclisib and…
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Jiangsu Hengrui Licenses Pyrotinib to Dr. Reddy’s for Indian Market
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has entered into a licensing agreement with India-headquartered Dr. Reddy’s Laboratories, granting the latter exclusive development and commercialization rights for its HER1/HER2/HER4 inhibitor, pyrotinib, in India. Financial Terms of the Agreement Under the terms of the agreement, Hengrui will receive an upfront…
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Eli Lilly Acquires Point Biopharma to Enhance Oncology Portfolio
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Eli Lilly (NYSE: LLY) announced last week its agreement to acquire radiopharmaceutical company Point Biopharma (NASDAQ: PNT) in a strategic move to bolster its oncology portfolio with several pre-clinical and clinical radioligand candidates. The acquisition, valued at USD 1.4 billion, will involve Lilly purchasing all outstanding shares of Point through…
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Takeda Initiates Global Withdrawal of Exkivity Following Phase III Trial Results
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Japan-based Takeda (TYO: 4502) has announced the voluntary global withdrawal of its tyrosine kinase inhibitor (TKI) Exkivity (mobocertinib) from the U.S. market. This decision comes after a Phase III confirmatory trial failed to meet its primary efficacy endpoint. Exkivity, a first-in-class therapy, had previously received conditional approvals worldwide as a…
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PharmaEssentia Announces Licensing Agreement with WuXi Biologics for Antibody Development
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Taiwan-based PharmaEssentia Corporation (TPE: 6446, FRA: 8Z1) has entered into a licensing agreement with China’s WuXi Biologics (HKG: 2269), a leading Contract Research, Development, and Manufacturing Organization (CRDMO). This agreement grants PharmaEssentia exclusive rights for research and development, manufacturing, and marketing of specific antibody sequences targeting the myeloid immune checkpoint,…
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Vela Diagnostics Partners with SRL Inc. to Expand Molecular Diagnostics in Japan
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Singapore-based Vela Diagnostics, a global leader in integrated molecular solutions for diagnosing infectious diseases and cancer, has announced a strategic research collaboration with SRL Inc., a premier Japanese healthcare service provider. This partnership is designed to enhance the distribution of Vela Diagnostics’ advanced molecular diagnostic solutions within Japan, although financial…
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Transcenta Secures FDA Approval for Phase III Trial of Osemitamab
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China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate the global Phase III pivotal TranStar study for its pipeline candidate, osemitamab (TST001). This clinical trial will evaluate the efficacy of osemitamab in combination with nivolumab and…
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CStone Pharmaceuticals’ PDGFRA Mutation Detection Kit Receives NMPA Approval
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its “Human PDGFRA Gene D842V Mutation Detection Kit”. This companion diagnostic (CDx) kit, co-developed with Beijing-based Genetron Holdings Ltd (Nasdaq: GTH), is used for the detection…
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RemeGen and Akeso Biopharma Initiate Phase II Study for Gastric Cancer Combo Therapy
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China-based RemeGen Ltd (HKG: 9995) is poised to conduct a Phase II clinical study in collaboration with fellow Chinese firm Akeso Biopharma (HKG: 9926). The study will assess the combination of RemeGen’s antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), with Akeso’s bispecific antibody, cadonilimab (AK104), for the treatment of gastric…
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Healthstar Medical’s KC1036 Pediatric Indication Accepted for NMPA Review
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Beijing-based Healthstar Medical Development Co., Ltd (SHA: 603590) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 chemical drug, KC1036, for a pediatric indication. This development signifies a significant step forward in the exploration of new treatment options for pediatric…
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Elpiscience Biopharmaceuticals Initiates Phase I Trial for Anti-LILRB2 Antibody ES009
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Elpiscience Biopharmaceuticals, a China-based biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical trial in Australia for its pipeline candidate, ES009. This investigational drug is an anti-LILRB2 (ILT4) monoclonal antibody developed to target cancers, marking a significant step in the company’s oncology research…
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Mabwell Bioscience Initiates Phase Ib/II Study for Nectin-4 Targeting ADC 9MW2821
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced the first patient dosing in a Phase Ib/II clinical study for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The study is designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of 9MW2821 in combination with…
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BioTroy Therapeutics Receives US FDA IND Approval for Anti-Tumor Drug BT02
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BioTroy Therapeutics, a Shanghai-based developer of cancer immunotherapies, has announced the receipt of Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its innovative anti-tumor drug, BT02. This monoclonal antibody (mAb) targets solid tumors with a novel mechanism, representing a significant step forward in cancer…
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Sichuan Kelun-Biotech’s KL-A167 and SKB264 Gain Tacit Clinical Trial Approval in China
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The Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has received tacit clinical trial approval for its KL-A167 injection and SKB264 injection. These drugs are set to be assessed as a combination treatment for unresectable locally advanced, recurrent, or metastatic HR+/HER2 breast…
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EC Approves AbbVie’s Tepkinly for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its bispecific antibody (BsAb) Tepkinly (epcoritamab), a treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults who have undergone two or more lines of systemic therapy. This decision comes on the heels of…
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Jiangsu Hengrui Medicine Secures NMPA Approvals for Two Cancer Drug Candidates
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its investigational drug candidates, SHR-A1912 and SHR-1826. These drugs will be assessed for their efficacy in…
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Novartis’ Lutathera Meets Primary Endpoint in Phase III Trial for GEP-NETs
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that a Phase III trial for its radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) combined with the symptom-control drug octreotide has successfully met its primary endpoint of progression-free survival (PFS) in patients with SSTR-positive, aggressive, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement…
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Abbisko Therapeutics Gets NMPA Approval for Irpagratinib Combination Study in HCC
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline candidate irpagratinib (ABSK121) in combination with lenvatinib for the treatment of advanced or irresectable hepatocellular carcinoma (HCC). This development marks a…
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Abbisko Therapeutics’ Irpagratinib Receives FDA Clearance for Phase I Study in HCC
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its pipeline candidate, irpagratinib (ABSK121), a fibroblast growth…
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Fosun Pharma’s Serplulimab Approved for Esophageal Squamous Cell Carcinoma and Grafalon for GvHD Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses of two of its key products. The company’s Programmed-death 1 (PD-1) inhibitor, HaiSiZhuang (serplulimab), has been approved for a new indication in the treatment of first-line PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous…
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MSD’s Keytruda Meets Endpoints in Urothelial Carcinoma Trial but Misses in NSCLC Study
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading global pharmaceutical company, last week released clinical data from separate late-stage studies for its anti-PD-1 biologic, Keytruda (pembrolizumab), in combination with other oncology therapies from different partners. The results presented a mixed picture of success and challenges in the field of…
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Betta Pharmaceuticals’ CFT8919 Accepted for Review by China’s NMPA for EGFR L858R Solid Tumors
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted a clinical trial filing for its Category 1 drug candidate, CFT8919. This development marks a significant step forward in the drug’s journey towards clinical evaluation and potential…
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I-Mab Regains Global Rights to CD47 Antibody Lemzoparlimab Following AbbVie Deal Termination
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China-based biopharmaceutical company I-Mab (NASDAQ: IMAB) has received a notice from US-based AbbVie Global Enterprises Ltd, announcing the termination of their license and collaboration agreement concerning CD47 antibody compounds and products. The agreement, initially signed on September 3, 2020, and amended on August 15, 2022, will officially end on November…
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Amgen Launches Global Collaboration Network to Advance Oncology Research
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Amgen (NASDAQ: AMGN) has announced the launch of a new collaboration network that connects its oncology team with eight prominent research centers across Australia, Canada, France, Germany, South Korea, Spain, and the United States. This initiative is designed to accelerate the development of new cancer treatments for conditions with unmet…
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Roche’s Genentech Partners with Orionis Biosciences for Molecular Glue Therapies
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Genentech, a subsidiary of Swiss pharmaceutical giant Roche (SWX: ROG), has announced a partnership with Belgium-based Orionis Biosciences to discover molecular glue-class small-molecule treatments in oncology and neurodegeneration. This strategic collaboration aims to leverage Orionis’s proprietary platform for high-throughput discovery, rational design, and optimization of candidates that modulate intermolecular interactions,…
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Abbott Expands Biosimilars Portfolio with mAbxience In-License Agreement
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Abbott (NYSE: ABT) has announced the in-licensing of several biosimilar drugs from Spain-based biotechnology firm mAbxience for select markets in Latin America, Southeast Asia, the Middle East, and Africa. mAbxience, which had its majority stake acquired by German group Fresenius (ETR: FRE) from Argentina-based Insud Pharma last year, specializes in…
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Merck Forges Partnerships with BenevolentAI and Exscientia for Precision Drug Discovery
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German pharmaceutical company Merck (NYSE: MRK) has announced two separate strategic collaborations with UK-based artificial intelligence-driven precision drug design companies BenevolentAI (AMS: BAI) and Exscientia (NASDAQ: EXAI). These partnerships aim to discover potential first-in-class and best-in-class small-molecule therapies in the fields of oncology, neurology, and immunology. Terms of Collaboration and…
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China’s NHC Expands Rare Disease List, Includes 21 Cancer Types
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The National Health Commission (NHC) of China has released an updated national list of rare diseases, doubling the number of conditions to 86, including 21 cancer types. This marks the first update to China’s orphan disease schedule since the initial list of 121 conditions was introduced in 2018. Market Access…
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Jiangsu Yahong’s Cevira Meets Primary Endpoint in Phase III Cervical HSIL Study
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, has announced that its Phase III clinical study for Cevira (APL-1702) in high-grade squamous intraepithelial lesions (HSIL) of the cervix has successfully reached its primary endpoint. Study Design and ResultsThe global, multi-center Phase III study was…
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GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
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The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical company, for its JAK1/JAK2/ACVR1 inhibitor Ojjaara (momelotinib). The drug is indicated for anemic adults with intermediate or high-risk myelofibrosis, a blood cancer affecting approximately 25,000 people in the United States. This…
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Eli Lilly Partners with Boundless Bio to Develop CHK1 Inhibitor for Solid Tumors
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Eli Lilly (NYSE: LLY) has announced a partnership with precision oncology specialist Boundless Bio to clinically develop Boundless’s CHK1-targeting small-molecule inhibitor (SMI) BBI-355 in combination with Lilly’s CDK4/6 inhibitor Verzenio (abemaciclib). This collaboration aims to target locally advanced or metastatic solid tumors with oncogene amplifications, with Boundless highlighting its candidate…
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FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
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The US Food and Drug Administration (FDA) has granted priority review status to an indication extension application filed by Merck, Sharp & Dohme (MSD; NYSE: MRK) for its oral HIF-2α inhibitor Welireg (belzutifan). The application seeks approval for the treatment of advanced renal cell carcinoma (RCC) in adults who have…
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Astellas Pharma’s Xtandi NDA for mHSPC Treatment Accepted by China’s CDE
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE) has accepted for review the New Drug Application (NDA) for its medication Xtandi (enzalutamide), which is intended for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). NDA Basis and Study ResultsThe NDA is…
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Zhejiang Medicine Gets NMPA Approval for NCB003 Clinical Study for Advanced Solid Tumors
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Zhejiang Medicine Co., Ltd (SHA: 600216), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational injectable drug, NCB003. This next-generation targeted coupling long-acting human interleukin-2 (IL-2) drug is being developed to treat patients…
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Zelgen Biopharmaceuticals’ rhTSH Achieves Primary Endpoint in Phase III Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that its Phase III clinical study for the drug candidate, recombinant human thyroid stimulating hormone for injection (rhTSH), has successfully reached its pre-set primary endpoint. Following this achievement, the company will proceed with a pre-BLA (Biologics License…
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Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
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Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE: NVS) next month, has received a positive review from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar. The biosimilar is intended for use in treating HER2-positive…
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Gilead’s Kite CAR-T Therapy Yescarta Achieves 71% CMR in Phase II Trial for R/R LBCL Patients
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Gilead’s (NASDAQ: GILD) subsidiary Kite has announced early results from a Phase II trial of its CAR-T therapy, Yescarta (axicabtagene ciloleucel), for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT). The study achieved a primary endpoint…
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EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), in the treatment of advanced non-small cell lung…
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BMS Expands Partnership with Samsung Biologics for Oncology Drug Manufacturing
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Global pharmaceutical company Bristol-Myers Squibb (BMS; NYSE: BMY) has announced an expansion of its existing partnership with Samsung Biologics (KRX: 207940) for the production of an unnamed oncology antibody drug. This new agreement signifies a further step in the collaboration between the two companies, focusing on enhancing the manufacturing capabilities…
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EMA’s CHMP Recommends Approval of Keytruda as Adjuvant NSCLC Treatment
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy, Keytruda (pembrolizumab), as an adjuvant treatment for non-small cell lung cancer (NSCLC) in adults who are at a high risk of…
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Novartis’s Kisqali Reduces Cancer Recurrence Risk in HR+/HER2- Early Breast Cancer: Phase III Results
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has published results from a Phase III study of its CDK4/6 inhibitor Kisqali (ribociclib) in combination with endocrine therapy (ET) as an adjuvant treatment for HR+/HER2- early breast cancer (EBC). The data, recorded for up to three years, indicated that Kisqali reduced the risk…
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Akeso Biopharma’s AK132 Receives Green Light for Clinical Trial in Advanced Solid Tumors
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Akeso Biopharma’s (HKG: 9926) AK132, a bispecific antibody (BsAb) targeting Claudin18.2 and CD47, has received approval from China’s Center for Drug Evaluation to proceed with a clinical study in patients with advanced malignant solid tumors. This marks the sixth in-house developed BsAb from the Chinese firm to enter clinical development.…
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Tuodao Medical’s Percutaneous Puncture Surgery Robot NP100 Approved in China
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China-based surgical robot developer Tuodao Medical Technology Co., Ltd has received marketing approval for its percutaneous puncture surgery robot, known as the puncture surgery navigation and positioning system NP100. This approval marks a significant advancement in the field of surgical robotics within the country. Puncture Surgery and Its ChallengesPuncture surgery…
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Japan’s MHLW Reviews GSK’s Momelotinib for Myelofibrosis Treatment
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has accepted for review a filing by UK-based GlaxoSmithKline (GSK; NYSE: GSK) for its first-in-class candidate, momelotinib, as a potential treatment for the blood cancer myelofibrosis. The submission is supported by Phase III clinical trial results that show significant improvements…
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AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib study for the antibody-drug conjugate (ADC) datopotamab deruxtecan in combination with checkpoint inhibitor Imfinzi (durvalumab). The study, conducted in partnership with Daiichi Sankyo (TYO: 4568), focused on first-line advanced or metastatic non-small cell lung cancer…
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Sichuan Kelun Pharmaceutical Secures Exclusive Rights to TBM-001 for Bone Metastasis Diagnosis
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has entered into an exclusive licensing agreement with the Affiliated Hospital of Southwest Medical University. The agreement pertains to TBM-001, a radionuclide drug conjugate (RDC) designed for early diagnosis and…
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Chongqing Lummy Pharmaceutical’s Subsidiary Receives NMPA Approval for CUD002 mRNA Vaccine
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Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006), through its subsidiary Sichuan Cunde Therapeutics Co., Ltd, has received clinical trial approval from the National Medical Products Administration (NMPA) for the CUD002 injection. This mRNA-edited DC (dendritic cell) tumor therapeutic vaccine product is based on patient tumor neoantigens, marking a significant step…
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Dizal Pharmaceutical’s Golidocitinib NDA Accepted for Review by NMPA
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for golidocitinib, a first-in-class JAK1 inhibitor. The drug candidate is filed for the initial indication of treating recurrent refractory peripheral T-cell lymphoma (r/r PTCL). Supporting…
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EMA Approves Astellas’ Xtandi for Non-Metastatic Hormone-Sensitive Prostate Cancer
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The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval for its androgen receptor inhibitor Xtandi (enzalutamide). This approval expands the use of Xtandi as a treatment for non-metastatic hormone-sensitive prostate cancer (nmHSPC) in patients with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.…
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Boehringer Ingelheim Gets NMPA Approval for Brigimadlin Safety and Efficacy Study in China
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Germany-based Boehringer Ingelheim (BI) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the Brightline-2 study in China. The study will assess the safety and efficacy of the company’s MDM2-p53 antagonist, brigimadlin (BI 907828), in patients with locally advanced/metastatic, MDM2 amplification, TP53 wild-type…
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AstraZeneca’s Tagrisso Combination Therapy Shows Improved Efficacy in EGFR-mutated NSCLC
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UK-headquartered AstraZeneca (AZ; NASDAQ: AZN) has announced interim Phase III data demonstrating that the addition of pemetrexed plus cisplatin/carboplatin chemotherapy to tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) improves therapeutic effects in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The combination therapy reduced the risk of…
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Janssen Reports Positive Results from Phase Ib/II Study of Rybrevant Combo in EGFR-mutated NSCLC
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has provided an update on an ongoing Phase Ib/II study cohort assessing the safety and pharmacokinetics of the bispecific antibody (BsAb) Rybrevant (amivantamab) in combination with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy for the treatment of relapsed/refractory EGFR-mutated non-small cell lung…
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AstraZeneca’s Enhertu Shows Promising Results in Phase II HER2-mutant NSCLC Trial
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AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-mutant unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The trial assessed the efficacy and safety of different dosages of Enhertu, revealing that while a…
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JW Therapeutics and 2seventy Bio Expand Partnership for Cell Therapy Development
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China-based cell therapy firm JW Therapeutics (HKG: 2126) and US biotech 2seventy Bio Inc., (NASDAQ: TSVT) have announced plans to build on their 2022 collaboration agreement. The latest deal grants JW Therapeutics the option to develop up to two additional candidate drugs from 2seventy Bio’s product portfolio, including a T…
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Exelixis Secures Global Rights to Develop Insilico Medicine’s USP1 Inhibitor ISM3091
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China-based generative artificial intelligence (AI)-driven biotech Insilico Medicine has entered into an exclusive license agreement with US firm Exelixis Inc., (NASDAQ: EXEL), granting Exelixis global rights to develop and commercialize ISM3091, a potentially best-in-class small molecule inhibitor of USP1. USP1 has been identified as a synthetic lethal target in the…
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HutchMed Advances Tazverik Phase II Trial for Follicular Lymphoma in China
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in a bridging study for Tazverik (tazemetostat) in China. Tazverik, originated by US firm Epizyme Inc., was licensed to HutchMed for development in Greater China in an agreement reached in August 2021. Tazverik’s Background and Previous ApprovalsThe…
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Amgen’s Lumakras Combo Shows Promising Results in KRAS-mutated NSCLC Early-Stage Trial
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Amgen (NASDAQ: AMGN) has announced positive early-stage data for its KRASG12C inhibitor Lumakras (sotorasib) when combined with carboplatin and pemetrexed in the treatment of KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) in adults. The confirmed objective response rate (ORR) and disease control rate (DCR) in treatment-naive patients were 65%…
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Gilead’s Trodelvy Combo with MSD’s Keytruda Shows Promise in NSCLC Phase II Trial
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Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
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Shanghai Junshi Biosciences to Acquire Stake in Anlingke Biopharmaceutical for Cancer Therapy Programs
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced its intention to acquire a 9.45% stake in start-up biopharma company Shanghai Anlingke Biopharmaceutical Co., Ltd for a consideration of RMB 30.6 million. This strategic acquisition is set to be completed through the transfer of two cancer therapy…
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Oriomics Secures Series B+ Funding to Advance Liver and Digestive Cancer Screening
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Hangzhou-based Oriomics, a specialist in cancer screening based on circulating tumor DNA (ctDNA) methylation detection, has reportedly raised close to RMB 100 million (USD 13.7 million) in a Series B+ financing round. The round was led by Fortune Capital, with additional investments from Tao Capital, Hotgen Biotech, and the company’s…
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Abbisko Therapeutics Receives EMA Approval for Phase III Study of Pimicotinib for TGCT
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the European Medicines Agency (EMA) to conduct a Phase III clinical study for its Category 1 innovative drug ABSK021 (pimicotinib), which is being assessed as a treatment for tendon sheath giant cell tumor (TGCT).…
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Allist Pharmaceuticals and ArriVent Biopharma Release Promising Interim Data on Furmonertinib for NSCLC
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd and its US partner ArriVent Biopharma Inc. have jointly released interim data from a Phase Ib trial at the 2023 World Conference on Lung Cancer (WCLC) meeting. The trial assessed the efficacy of furmonertinib as a treatment for non-small cell lung cancer (NSCLC), specifically…
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EMA Reviews Janssen’s Balversa for Advanced Urothelial Carcinoma with FGFR3 Alterations
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The European Medicines Agency (EMA) has accepted for review a filing made by the Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) for the tyrosine kinase inhibitor (TKI) Balversa (erdafitinib) as a treatment for locally advanced unresectable or metastatic urothelial carcinoma (UC) in adults with susceptible fibroblast growth factor…
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Jiangsu Hengrui Medicine Gets NMPA Approval for Phase Ib/III Study of Dalpiciclib in mHSPC
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind Phase Ib/III clinical study. The study will assess the combination of dalpiciclib (SHR6390) with abiraterone plus prednisone in patients with metastatic hormone…
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Merck’s Keytruda Approved in China for MSI-H/dMMR Advanced Solid Tumors: A Biomarker-Driven Milestone
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US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed drug Keytruda (pembrolizumab) has been approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene deficient (dMMR) advanced solid tumors. This includes colorectal cancer patients who have…
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Immunofoco’s IMC008 Earns Orphan Drug Designation for Pancreatic Cancer from FDA
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Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration for its next-generation autologous CAR-T therapy, IMC008, for the treatment of pancreatic cancer. This follows the company’s first ODD status granted for gastric cancer in the country less…
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Shanghai Haihe Pharmaceutical’s Glumetinib Filed for Marketing in Japan for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for its Category 1 product, glumetinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET 14 exon mutation. Glumetinib’s Development and EfficacyCo-developed by Haihe Pharma and the Chinese Academy…
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LIQUIK Study Interim Results to Showcase Lucence’s Liquid Biopsy Advancements at WCLC 2023
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Precision medicine specialist Lucence, with a presence in Suzhou, Hong Kong, and Palo Alto, California, has announced that the interim results of the LIQUIK study, a prospective international multicenter liquid biopsy study for lung cancer, will be reported at the IASLC 2023 World Conference on Lung Cancer (WCLC) held on…
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Luye Pharma’s Botawei Receives NMPA Approval for Breast Cancer Treatment
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Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, trade-named Botawei, for the treatment of breast cancer in premenopausal and perimenopausal women eligible for hormone therapy. Botawei: A Pioneering Treatment for…
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Janssen’s Rybrevant Combo Meets Primary Endpoint in Advanced NSCLC Study
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Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ), has released an update on a late-stage study for its bispecific antibody (BsAb) Rybrevant (amivantamab). The study investigated the combination of Rybrevant with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy in treating advanced or metastatic non-small cell lung cancer (NSCLC)…
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CSPC Pharmaceutical’s Narlumosbart Approved by NMPA for Bone Giant Cell Tumors
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CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for narlumosbart (JMT103), an anti-RANKL monoclonal antibody (mAb), to treat giant cell tumors of bone that are inoperable or may lead to severe…
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Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2 positive advanced colorectal cancer, marking…
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Harbin Gloria Pharmaceuticals’ Zimberelimab Receives NMPA Approval for Cervical Cancer Treatment
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China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its programmed cell death-1 (PD-1) monoclonal antibody (mAb) zimberelimab. The drug is indicated for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1…
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Seagen and Genmab Announce Positive Phase III Results for Tivdak in Cervical Cancer
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Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), and its partner Genmab (NASDAQ: GMAB), have announced the achievement of the primary endpoint in a Phase III trial for their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). The trial focuses on patients with recurrent or metastatic…
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Sihuan Pharmaceutical’s Birociclib NDA Accepted for Review by China’s NMPA
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for birociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, for review. The drug is intended for the treatment of HR+/HER2- advanced breast cancer in patients who have…
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Bayer Subsidiary’s Parkinson’s Treatment Bemdaneprocel Shows Promise in Phase I
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Germany-based Bayer (ETR: BAYN) has announced that its subsidiary BlueRock Therapeutics’ open-label Phase I study for cell therapy bemdaneprocel in Parkinson’s disease has successfully met the safety and tolerability primary endpoint. After one year, no bemdaneprocel-related serious adverse events (SAEs) were reported. Additionally, dose-dependent improvement in motor symptoms and evidence…
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AstraZeneca’s Calquence Approved by NMPA for Chronic Lymphocytic Leukemia Treatment
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic…
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Roche’s Alecensa Achieves Milestone in Adjuvant Therapy Trial for Early-Stage NSCLC
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Switzerland-based pharmaceutical giant Roche (SWX: ROG) has released an update from an interim analysis of a late-stage trial for its ALK inhibitor Alecensa (alectinib) as adjuvant therapy in the early setting for resected non-small cell lung cancer (NSCLC) with ALK mutations. These mutations are present in approximately 5% of NSCLC…
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Eli Lilly’s Verzenios Receives NMPA Approval for Extended Indication in Early-Stage Breast Cancer
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US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has announced that the National Medical Products Administration (NMPA) has approved an indication extension for its Verzenios (abemaciclib). The drug is now indicated as adjuvant therapy for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and lymph…
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XtalPi Partners with Parthenon Therapeutics to Harness AI for Solid Tumor Antibody Development
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has entered into a strategic partnership with US cancer therapy developer Parthenon Therapeutics Inc. to develop antibodies targeting solid tumors. This collaboration aims to leverage the power of AI to advance oncology treatments. Access to XtalPi’s XupremAb Platform and “Experiment+AI” SolutionsUnder the terms…
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Zai Lab’s Margenza (Margetuximab) Approved by China’s NMPA for HER2-Positive Breast Cancer
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The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB, HKG: 9688) Margenza (margetuximab), an Fc-engineered monoclonal antibody (mAb) targeting HER2 and developed by MacroGenics Inc., has been approved for the China market. The drug is indicated for the treatment of metastatic HER2-positive breast cancer…
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Servier Group’s Pancreatic Cancer Therapy Onivyde Launches in Major Chinese Cities
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France-based Servier has announced the first prescriptions for its pancreatic cancer therapy, Onivyde (irinotecan), in 10 hospitals across major cities in China, including Tianjin, Beijing, Shanghai, Nanjing, Fuzhou, and Guangzhou. The drug is used to treat metastatic pancreatic cancer after gemcitabine treatment, in combination with 5-fluorouracil (5-FU) plus leucovorin (LV).…
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Takeda Secures Exclusive Rights to ImmunoGen’s Elahere in Japan Through New Agreement
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Japanese pharmaceutical company Takeda (TYO: 4502) has entered into an exclusive collaboration and license agreement with ImmunoGen (NASDAQ: IMGN) to develop and commercialize ImmunoGen’s antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) in Japan. Elahere has received accelerated approval in the United States for the treatment of FRα-positive platinum-resistant epithelial ovarian, fallopian…
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Bayer Initiates US Recall of TRK Inhibitor Vitrakvi Due to Mold Contamination
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Germany-based Bayer (ETR: BAYN) has announced a voluntary recall of a specific lot of its tropomyosin receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib) in the US market following the detection of contamination by the Penicillium brevicompactum mold in the oral solution. While no adverse events have been reported, Bayer has advised…
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Genscript’s CAR-T Therapy JNJ-4528 Demonstrates 100% Effective Rate in Long-Term Myeloma Study
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Genscript Biotech Corporation (1548.HK), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the publication of long-term follow-up data from the Phase 1b/2 study, CARTITUDE-1. The study, conducted in partnership with Janssen Pharmaceutical, focuses on the chimeric antigen receptor (CAR)-cell therapy JNJ-4528 for the treatment of recurrent or…
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Innovent Biologics and Eli Lilly & Co.’s Tyvyt Achieves Primary Endpoints in Phase II ESCC Clinical Study
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Innovent Biologics (HKEX: 01801), a prominent biotech firm headquartered in Suzhou, China, and Eli Lilly & Co. (Nasdaq: LLY), a titan of the US pharmaceutical industry, have jointly declared a significant milestone in the Phase II clinical study known as ORIENT-2. The study focuses on the co-developed anti-programmed death-1 (PD-1)…
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Zai Lab’s Optune Approved by China’s NMPA, Offering New Hope for Glioblastoma Patients
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Zai Lab Ltd (Nasdaq: ZLAB), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its innovative therapeutic device, Optune. This tumor treating fields (TTFields) product is now cleared for use in newly diagnosed glioblastoma in combination with temozolomide, and as a monotherapy…
