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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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CStone Pharmaceuticals Partners with Pharmalink for Suemalimab Commercialization in MENA and South Africa
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a strategic commercial collaboration with Pharmalink Store – L.L.C – O.P.C (Pharmalink), a prominent pharmaceutical company based in the United Arab Emirates (UAE), concerning its anti-PD-L1 monoclonal antibody (mAb) sugemalimab. Commercial Rights and Deal TermsUnder the agreement, Pharmalink will acquire the commercial rights…
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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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Shanghai Junshi Biosciences’ Toripalimab Wins UK Approval for Nasopharyngeal and Oesophageal Cancers
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-1 inhibitor, toripalimab, marketed as Loqtorzi. This approval allows the use of toripalimab in…
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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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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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BeyondSpring Presents Positive Phase II Data for Plinabulin Combination Therapy in NSCLC at SITC
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BeyondSpring Inc. (NASDAQ: BYSI), a US-based biotech company, has announced the presentation of the latest results from the Phase II KeyPelms-004 study at the 39th Society for Immunotherapy of Cancer’s (SITC) Annual Meeting. The study evaluated the efficacy and safety of plinabulin combined with pembrolizumab plus docetaxel in 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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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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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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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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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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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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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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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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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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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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3D Medicines’ Envafolimab Earns NMPA Breakthrough Designation for TMB-H Solid Tumors
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3D Medicines (HKG: 1244), a biopharmaceutical company based in China, has announced that its envafolimab has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for an additional indication. The PD-L1 monoclonal antibody (mAb) is now indicated for the treatment of unresectable or metastatic solid tumors…
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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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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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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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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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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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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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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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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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Jiangsu Hengrui Medicine’s SHR-1701 Combo Therapy for Gastric Cancer Accepted for Review by China’s NMPA
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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 accepted for review its market filing for SHR-1701 in combination with fluorouracil and platinum for the first-line treatment of locally advanced unresectable, recurrent, or metastatic adenocarcinoma of…
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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 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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CStone Pharmaceuticals’ Sugemalimab Shows Promising Long-Term Survival Data at ESMO 202
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has presented long-term treatment and survival data for sugemalimab at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. The data comes from the GEMSTONE-302 study, which combines sugemalimab with platinum-based chemotherapy. The Phase III trial, a multicenter, randomized,…
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Merck’s Keytruda Gains Expanded Approval for First-Line Melanoma Treatment in China
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Merck & Co., Inc. (NYSE: MRK), a leading US pharmaceutical company, has announced that its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab), has received expanded approval in China. The updated approval allows the drug’s package insert to be revised to include “pembrolizumab is suitable for the treatment of unresectable or metastatic…
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iTeos Therapeutics and GSK’s Belrestotug/Dostarlimab Combo Shows Promising Results in NSCLC
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iTeos Therapeutics has announced the latest data from the Phase 2 platform study GALAXIES Lung-201, led by its development partner GSK. The study evaluates the efficacy of the combination therapy consisting of the anti-TIGIT monoclonal antibody belrestotug and the anti-PD-1 monoclonal antibody dostarlimab in patients with untreated, unresectable, locally advanced,…
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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 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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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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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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Innovent Biologics’ IBI363 Earns FDA Fast-Track Designation for Advanced Melanoma Treatment
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, IBI363. This PD-1/IL-2α bispecific antibody fusion protein is under development for the treatment of unresectable locally advanced or metastatic melanoma, excluding…
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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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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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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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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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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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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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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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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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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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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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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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Merck’s Q2 2024 Earnings Miss Estimates as China Market Downturn Surprises
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has reported its financial results for the second quarter of 2024, with global revenues reaching USD 16.1 billion, marking an 11% increase year-on-year when excluding currency impacts. Despite this growth, the company’s stock price declined by 9.81% as investors reacted to the…
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Bristol-Myers Squibb Q2 2024 Sales Boosted by Growth Portfolio, Offset by R&D Impairment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced its financial results for the second quarter of 2024, with global sales increasing by 11% year-on-year to $12.2 billion, based on constant exchange rates. The growth was driven in part by the company’s ‘growth portfolio,’ which includes a dozen newer drugs that saw…
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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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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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Junshi Biosciences’ Loqtorzi Inches Closer to Expanded Indication with NMPA Filing Acceptance
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has taken a significant step forward with the submission of another indication filing for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company has announced that the National Medical Products Administration (NMPA) in China has accepted the filing for review. This…
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Shanghai Fosun Pharmaceutical Gets NMPA Green Light for FH-2001 and Serplulimab Combo Clinical Trial
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Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), 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 its co-developed FH-2001 in combination with HanSiZhuang (serplulimab, HLX10) for the treatment of advanced…
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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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Shanghai Henlius Biotech Advances Serplulimab Phase III Trial for First-Line Metastatic Colorectal Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan to conduct a global, multi-center Phase III study. The study will evaluate the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10) in…
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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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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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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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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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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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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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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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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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Gilead and Arcus Biosciences Report Positive Interim Phase II Data for Domvanalimab Combo in GI Cancers
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Gilead (NASDAQ: GILD) and Arcus Biosciences (NYSE: RCUS) have announced interim Phase II data for their anti-TIGIT biologic domvanalimab in combination with the anti-PD-1 drug zimberelimab. The treatment is being investigated for locally advanced unresectable or metastatic upper gastrointestinal cancers. The study, which has a median time on treatment of…
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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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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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Akeso Inc.’s Ivonescimab Shows Positive Interim Analysis in Phase III NSCLC Study
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Akeso Inc. (HKG: 9926), a biopharmaceutical company based in China, has announced positive interim analysis results from the regulatory Phase III HARMONi-2 (AK112-303) study. The study assessed ivonescimab as a monotherapy against pembrolizumab in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically targeting patients with…
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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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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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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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Akeso Biopharma’s Ivonescimab Approved for NSCLC Treatment in China
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced that its bispecific antibody (BsAb) ivonescimab (AK112), which targets programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), has been approved for use in combination with chemotherapy to treat locally advanced or metastatic non-squamous non-small cell lung cancer…
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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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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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Biotherus Inc. Advances PM8002 Bispecific Antibody to Phase III for Triple Negative Breast Cancer
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China’s Biotheus Inc. has announced the initiation of a Phase III clinical study for its investigational bispecific antibody, PM8002, which targets both PD-L1 and VEGF. The study will evaluate the safety and efficacy of PM8002 in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic…
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Jiangsu Hengrui’s Camrelizumab/Apatinib Combo Denied FDA Approval Over Manufacturing Issues
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The US Food and Drug Administration (FDA) has issued a complete response letter to Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, regarding its application for camrelizumab, a programmed death-1 (PD-1) monoclonal antibody (mAb), in combination with small-molecule targeted cancer therapy apatinib. The treatment was being considered…
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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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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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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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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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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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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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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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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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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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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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Shanghai Junshi Biosciences’ PD-1 Inhibitor Toripalimab Files for Two Indications in Hong Kong
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Hong Kong Drug Office (DO) has accepted two indication approval filings for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The filings seek approval for the drug in combination with chemotherapy as a first-line treatment for metastatic or…
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Henlius Biotech Ships First International Batch of HanSiZhuang for Cancer Treatment to Indonesia
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biotech company from China, has announced the first international shipment of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab), from Shanghai Pudong Airport to Indonesia. HanSiZhuang, the inaugural innovative monoclonal antibody (mAb) developed by Henlius, has gained approval from the National Medical Products…
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Innovent Biologics Partners with Xuanzhu Biopharma for Clinical Trial of Sintilimab and KM-501 in Advanced Tumors
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Innovent Biologics, Inc. (HKG: 1801), based in China, has entered into a clinical trial collaboration and supply agreement with Xuanzhu Biopharma to explore the combination therapy of Tyvyt (sintilimab) with KM-501, a novel HER-2 bispecific antibody drug conjugate (ADC). This partnership aims to develop potential treatment options for advanced solid…
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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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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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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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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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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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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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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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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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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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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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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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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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Sinocelltech’s PD-1 Inhibitor SCT-I10A for HNSCC Accepted for NMPA Review
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Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that its market approval filing for the investigational product SCT-I10A, a programmed-death 1 (PD-1) monoclonal antibody (mAb), has been accepted for review by the National Medical Products Administration (NMPA). The filed indication is for the treatment of head and…
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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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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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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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BeiGene Ltd Reports Q3 2023 Financial Results with 102% YOY Revenue Increase
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has released its financial results for the third quarter of 2023. The biotechnology company reported total revenues of USD 781 million, with global product sales reaching USD 595 million, marking year-on-year (YOY) increases of 102% and 70%, respectively. Net profits for the…
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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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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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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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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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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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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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Coherus’s Loqtorzi Gains FDA Approval for Nasopharyngeal Carcinoma Treatment
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Coherus Biosciences (NASDAQ: CHRS) executives held an investor conference call on October 30, 2023, to discuss the recent US FDA approval for Loqtorzi (toripalimab) as both a first- and second-line treatment for nasopharyngeal carcinoma (NPC). This approval, co-developed with Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), marks a…
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Boan Biotech Enrolls First Patient in Phase III Study for Opdivo Biosimilar BA1104 in China
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate BA1104. This marks a significant milestone as BA1104 becomes the first biosimilar to Opdivo (nivolumab) to reach the Phase III stage in…
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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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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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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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BMS Revenue Slips Due to Revlimid Erosion: Q3 2023 Insights
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Bristol Myers Squibb (BMS; NYSE: BMY) reported a 3% year-on-year (YOY) revenue decline, excluding foreign exchange impact, to USD 11.0 billion for Q3 2023, as detailed in the company’s recently released financial report. The downturn was primarily attributed to a significant 41% YOY drop in sales of the multiple myeloma…
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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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Alphamab Oncology Presents Promising Data for KN046 and KN026 at ESMO 2023
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China-based Alphamab Oncology (HKG: 9966) has released data snapshots from clinical studies for two of its pipeline candidates, KN046 and KN026, at the European Society for Medical Oncology (ESMO) Congress 2023. These bispecific antibodies (BsAbs) are being evaluated for their efficacy and safety in treating various types of cancers, with…
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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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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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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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Abbisko Therapeutics to Unveil Phase I Data for ABSK011 and ABSK043 at ESMO 2023
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Shanghai-based biotech powerhouse Abbisko Therapeutics Co., Ltd (HKG: 2256) is preparing to present the results of Phase I clinical studies for two of its pipeline candidates at the 2023 European Society for Medical Oncology (ESMO) Congress. The spotlight will be on ABSK011, a small-molecule FGFR4 inhibitor, and ABSK043, an in-house…
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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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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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Henlius Pharmaceutical Secures GMP Compliance for PD-1 Inhibitor Serplulimab in Indonesia
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Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced that its partner, PT Kalbe Genexine Biologics (KGbio), through its subsidiary PT Kalbio Global Medika, has received a GMP inspection completion letter from the Badan Pengawas Obat dan Makanan (BPOM), a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in Indonesia.…
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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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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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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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Coherus Biosciences Awaits FDA Decision on Toripalimab with Year-End Approval Forecast
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Coherus Biosciences Inc., (NASDAQ: CHRS), a US-based biotechnology company, has provided an update on the progress of its programmed death-1 (PD-1) inhibitor, toripalimab, at the US Food and Drug Administration (FDA). Toripalimab is under license from China’s Junshi Biosciences (HKG: 1877; SHA: 688180). The FDA has completed its clinical study…
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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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Shanghai Junshi’s Tuoyi Meets Primary Efficacy Endpoint in Phase III Melanoma Study
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that the Phase III MELATORCH study (NCT03430297) for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) has successfully reached the progression-free survival (PFS) primary efficacy endpoint. This study evaluates Tuoyi as a first-line…
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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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Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Solid Tumor Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline drug candidate, ZG005. The trial will evaluate the efficacy of ZG005 in combination with the Category 1 anti-cancer drug donafenib…
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BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal
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China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS) to terminate their licensing deal from January 2021, under which Novartis held co-development and commercial rights to the programmed death-1 (PD-1) inhibitor, tislelizumab, in North America, Japan, the EU, and six other European countries. BeiGene…
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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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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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Asieris Pharmaceuticals’ APL-1202 Shows Positive Interim Analysis in MIBC Trial with BeiGene’s Tislelizumab
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has revealed positive results from a Phase II interim analysis of its drug candidate APL-1202, combined with BeiGene Ltd’s (NASDAQ: BGNE; HKG: 6160) programmed death-1 (PD-1) inhibitor tislelizumab, as neoadjuvant chemotherapy (NAC) in muscular invasive bladder cancer (MIBC). The trial has demonstrated…
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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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ImmuneOnco’s IMM2510 and IMM27M Achieve Milestones in Phase I Clinical Trials
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the completion of patient enrollment for Phase I dosage escalation studies for both IMM2510 and IMM27M, with the recommended Phase II dosage (RP2D) determined for each. IMM2510: A PD-L1/VEGF Bispecific Antibody for Solid TumorsIMM2510, a PD-L1/VEGF bispecific antibody (BsAb) based on…
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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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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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Shanghai Junshi Biosciences’ JS207 Bispecific Antibody Receives NMPA Clinical Trial Approval
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) in China has approved a clinical trial filing for its bispecific antibody (BsAb) JS207. The drug is under development to target PD-1 and VEGF for the treatment of advanced malignant tumors. Pre-Clinical…
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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)…
