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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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EMA’s CHMP Recommends Approval for BMS’s Opdivo/Yervoy Combo in mCRC
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Bristol-Myers Squibb’s (BMS, NYSE: BMY) anti-PD-1 drug Opdivo (nivolumab) in combination with the anti-CTLA-4 biologic Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch…
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Janssen-Cilag’s Lazcluze-Rybrevant Combo Receives Positive EMA Opinion for NSCLC Treatment
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Janssen-Cilag International NV, a subsidiary of the US pharmaceutical giant Johnson & Johnson (J&J; NYSE: JNJ), has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding the combination of Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). This combination therapy…
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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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Akeso Biopharma Initiates Phase III Clinical Trial for PD-1/VEGF Bispecific Antibody Combination
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first patient in a randomized, controlled, multicenter Phase III clinical study (AK117-302), assessing the combination of the innovative PD-1/VEGF bispecific antibody ivonescimab and its next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive…
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Merck and Moderna Launch Phase III Study for Individualized Neoantigen Therapy in Lung Cancer
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US pharmaceutical companies Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) and Moderna Inc. (NASDAQ: MRNA) have initiated the Phase III INTerpath-009 study to evaluate V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab). The study will focus on patients with resectable Stage…
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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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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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MediLink Therapeutics Partners with Amgen for Clinical Trial in Small Cell Lung Cancer
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Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the…
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Sanofi’s Sarclisa Secures FDA Approval for First-Line Multiple Myeloma Treatment
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Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib,…
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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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Adagene’s ADG126 Shows Promising Results in Phase Ib/II Study for MSS CRC at ESMO 2024
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Adagene Inc. (NASDAQ: ADAG), a biopharmaceutical company dedicated to the discovery and development of innovative antibody-based therapies, has announced updated results from the Phase Ib/II study of its anti-CTLA-4 SAFEbody, ADG126 (Muzastotug), in combination with pembrolizumab for the treatment of advanced/metastatic microsatellite stable colorectal cancer (MSS CRC) at the 2024…
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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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J&J’s Rybrevant-Lazclude Combo Approved by FDA, Challenging AstraZeneca’s Tagrisso in NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United States for the combined use of its bispecific antibody Rybrevant (amivantamab) and the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). Following a priority review, the US FDA approved this dual therapy for the first-line treatment of…
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Johnson & Johnson’s Rybrevant-Lazclude Combo Approved by FDA for First-Line NSCLC Treatment
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NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone with the US FDA’s approval of its bispecific antibody Rybrevant (amivantamab) in combination with the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). The priority review has led to a green light for the combined use of…
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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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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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Hengrui Medicine Advances in Breast Cancer Treatment with NMPA Clinical Trial Greenlight
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a pharmaceutical heavyweight based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical studies on its innovative drug candidates. The study will explore the synergistic effects of HRS-6209 in combination with HRS-1358, HRS-8080, or aromatase inhibitors, and…
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Chipscreen’s HDAC Inhibitor Chidamide to be Tested in Combination Therapy for CRC by NMPA
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Shenzhen Chipscreen Pharmaceutical Co., Ltd, a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical trial. The trial is designed to evaluate the efficacy and safety of Epidaza (chidamide) in combination with the PD-1 inhibitor sintilimab (Tyvyt) and…
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Abbisko Therapeutics Presents Positive Phase II Results for HCC Treatment at ESMO-GI
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotech company, has announced the presentation of Phase II study results for its irpagratinib in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) at the 2024 ESMO-GI annual meeting. Irpagratinib, a novel FGFR4 inhibitor discovered and developed by Abbisko,…
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Ascentage Pharma Presents Positive Clinical Results for Olverembatinib and Lisaftoclax at EHA Meeting
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has presented the results of multiple clinical trials for two of its pipeline candidates at the 29th European Hematology Association (EHA) Annual Meeting. The candidates are olverembatinib, a Category 1 drug and approved BCR-ABL inhibitor, and the investigational BCL-2 inhibitor…
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Jiangsu Hengrui Medicine Gets NMPA Green Light for Breast Cancer Drug Combo
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Jiangsu Hengrui Medicine (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate HRS7415 in combination with HRS-8080 for the treatment of breast cancer. HRS7415 is an anti-tumor agent that works by…
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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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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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Jacobio Pharma’s KRAS G12C Inhibitor Combo Shows Promising Results in NSCLC at ASCO 2024
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, presented updated data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting for its KRAS G12C inhibitor glecirasib (JAB-21822) in combination with an SHP2 inhibitor (JAB-3312) as a frontline treatment for non-small cell lung cancer (NSCLC) patients with…
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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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RemeGen’s Disitamab Vedotin on Track for Breakthrough Designation in Muscle Invasive Bladder Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression,…
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Sino Biopharmaceutical’s Benmelstobart Shows Positive Results in RCC Combination Therapy Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced positive interim analysis results from a Phase III clinical study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) in combination with anlotinib for the treatment of advanced unresectable or metastatic renal cell carcinoma…
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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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Laekna Therapeutics’ mCRPC Drug Combo Advances to Phase III with FDA Approval
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its drug combination LAE001 and LAE002 (afuresertib) in patients with metastatic castration-resistant prostate cancer (mCRPC) who…
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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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Jacobio Pharma’s KRAS G12C Inhibitor Gains NMPA Approval for Phase III CRC Study
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a regulatory Phase III clinical study. The study will evaluate the combination of the company’s KRAS G12C inhibitor, glecirasib, with Erbitux (cetuximab) for…
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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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Sichuan Biokin’s EGFR/HER3 ADC Expands Phase II Clinical Program with NMPA Approval
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct seven Phase II clinical studies for its antibody-drug conjugate (ADC), BL-B01D1, in combination with a PD-1 inhibitor, with or without chemotherapy. The combo therapy, previously approved for…
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Henlius’ HER2 Dual-Targeted Therapy Gets Green Light for Global Phase III Trial by FDA
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a global multi-center Phase III clinical study. The study will evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line…
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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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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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Shanghai Henlius Biotech Advances TIGIT-Targeting HLX53 to Phase II Clinical Trial for Hepatocellular Carcinoma
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Shanghai Henlius Biotech Inc., (HKG: 2696), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase II clinical study. The study will evaluate the tolerability, safety, and efficacy of HLX53, an Fc fusion protein targeting T cell immunoglobulin and ITIM…
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Hengrui Medicine Gets NMPA Approval for Clinical Study of CDK 4/6 Inhibitor Combo in Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for the combination of dalpiciclib (SHR6390) and HRS8807 in the treatment of breast cancer. Dalpiciclib, the first domestically-developed…
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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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GSK’s ViiV Healthcare Expands Dovato Indication to Include Adolescents with HIV-1 Infection
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GlaxoSmithKline’s (GSK; NYSE: GSK) ViiV Healthcare has received an indication extension from the US Food and Drug Administration (FDA) for its antiretroviral treatment Dovato (dolutegravir + lamivudine). The drug is now approved for use in virologically suppressed or treatment-naive adolescents aged 12 years and older with HIV-1 infection, a demographic…
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Jiangsu Hengrui Medicine Secures IND Approvals for Two Drug Candidates from China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received Investigational New Drug (IND) approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, marking a significant step in the company’s pharmaceutical development pipeline. The approvals clear the way for a Phase Ib/II study combining adebrelimab (SHR-1316)…
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Hinova Pharmaceuticals Receives NMPA Greenlight for HP501 Clinical Trial in Gout Patients
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Shanghai-based Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its investigational drug HP501 in combination with febuxostat for the treatment of primary gout with hyperuricemia. This marks a significant step forward in addressing…
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Sichuan Biokin Secures NMPA Approval for Phase II Study of BL-M07D1 in Advanced Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506), based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) BL-M07D1 in patients with advanced solid tumors. The trial will evaluate BL-M07D1 in combination…
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Jiangsu Hengrui’s Fluzoparib Receives Breakthrough Therapy Designation for HER2-Negative Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its indication approval filing for fluzoparib—a poly (ADP-ribose) polymerase (PARP) inhibitor—has been awarded breakthrough therapy designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation applies to fluzoparib, both as a monotherapy and in combination…
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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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AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health, Labour, and Welfare (MHLW) its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with endocrine therapy Faslodex (fulvestrant). This combination therapy is intended for the treatment of unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive, HER2-negative…
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BeiGene and GenFleet Join Forces for DLBCL Trial Combining Brukinsa and GFH009
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a China-based biotechnology company, has entered into a clinical research and drug supply cooperation agreement with fellow Chinese firm GenFleet Therapeutics. The partnership will kick off a Phase Ib/II clinical trial to evaluate the safety and efficacy of a combination regimen featuring…
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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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MSD’s Phase III Trial of Keytruda Plus Lynparza Misses Primary Endpoints in NSCLC
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an unfavorable outcome for a Phase III trial combining Keytruda (pembrolizumab) and Lynparza (olaparib) in the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). The study, which aimed to evaluate the efficacy of this combination therapy, was halted after…
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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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Jiangsu Hengrui Receives NMPA Approval for Phase Ib/II Study of HRS2398 in Advanced Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II study. The study will assess the drug candidate HRS2398 in combination with HRS-1167 or adebrelimab…
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Pfizer’s Adcetris Combo Shows Improved Survival in Relapsed/Refractory DLBCL Late-Stage Trial
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Pfizer (NYSE: PFE) has announced positive results from a late-stage clinical trial for its antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study successfully met its primary endpoint, demonstrating an improvement in overall survival (OS)…
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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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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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Fosun Pharmaceutical Secures NMPA Approval for Phase II Study of FCN-338 and FCN-647 in Chronic Lymphocytic Leukemia
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its Bcl-2 inhibitor FCN-338 in combination with the BTK inhibitor FCN-647, targeting chronic lymphocytic leukemia/small lymphocytic lymphoma. FCN-338…
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Jiangsu Hengrui Receives NMPA Approval for HRS-1167 Clinical Trials in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276) has secured clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy HRS-1167, which will be evaluated in combination with SHR-A1921, bevacizumab, or abiraterone plus prednisone/prednisolone for the treatment of advanced solid tumors. HRS-1167 is a second-generation PARP inhibitor…
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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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BMS Seeks FDA Priority Review for Krazati in Advanced Colorectal Cancer
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Bristol Myers Squibb (BMS; NYSE: BMY) has submitted a priority review application to the U.S. Food and Drug Administration (FDA) for an additional indication of its KRASG12C inhibitor, Krazati (adagrasib), in combination with cetuximab (Merck’s Erbitux) for pre-treated patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA…
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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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Jacobio Pharma Gets CDE Green Light for Phase III Study Combining Gleevec Inhibitors in NSCLC
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Jacobio Pharma (HKG: 1167), a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to initiate a regulatory Phase III clinical study. The study will assess the combination of its KRAS G12C inhibitor glecirasib with pipeline SHP2 inhibitor JAB-3312 for…
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Laekna Therapeutics Reports Phase II Data for Afuresertib in Platinum-Resistant Ovarian Cancer
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Laekna Therapeutics Shanghai Co., Ltd, a China-based pharmaceutical company, has announced topline data from the global multi-center Phase II PROFECTA-II study for its afuresertib combined with paclitaxel in the treatment of platinum-resistant ovarian cancer (PROC). The Sino-US study aimed to assess the efficacy and safety of the combination therapy in…
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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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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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Beijing Aosaikang Initiates Phase III Trial for Advanced Gastric Cancer Treatment
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has registered a Phase III clinical study with Clinicaltrials.gov for its Claudin18.2-targeted antibody ASKB589. The trial will investigate the use of ASKB589 in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. The study aims…
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Eisai and Medivir’s Combo Therapy Advances in Liver Cancer with Positive Trial Results
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Japanese pharmaceutical company Eisai’s (TYO: 4523) kinase inhibitor Lenvima (Lenvatinib), combined with Swedish partner Medivir’s (STO: MVIR) chemotherapy fostroxacitabine bralpamide (fostrox), has demonstrated positive outcomes in an open-label Phase Ib/IIa trial for advanced hepatocellular carcinoma (HCC), Medivir announced. Following last year’s encouraging early data, these results are expected to pave…
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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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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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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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Healthstar Medical Receives NMPA Go-Ahead for KC1036 Esophageal Cancer Study
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Beijing-based Healthstar Medical Development Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for KC1036 in combination with a programmed-death 1 (PD-1) inhibitor as first-line maintenance therapy for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). KC1036,…
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J&J’s Rybrevant-Lazertinib Combo Accepted for FDA Review in NSCLC
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The US Food and Drug Administration (FDA) has accepted for review Johnson & Johnson’s (J&J; NYSE: JNJ) application for Rybrevant (amivantamab), a bispecific antibody, in combination with lazertinib, a tyrosine kinase inhibitor (TKI), for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon…
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FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer
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Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la/mUC). The FDA’s decision is…
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Bio-Thera Solutions Gets NMPA Green Light for PD-1 Inhibitor BAT1308 in Endometrial Cancer
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its programmed death-1 (PD-1) inhibitor, BAT1308, in the treatment of endometrial cancer. BAT1308 is an internally developed…
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BMS Presents Promising Golcadomide Trial Results for Non-Hodgkin Lymphomas
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Bristol Myers Squibb (BMS; NYSE: BMY) has presented results from Phase I and Phase I/II trials for combination therapies with golcadomide, a potential first-in-class drug from the company’s CELMoD line of protein degraders, in the treatment of non-Hodgkin lymphomas. The Phase I study indicated that previously untreated patients with aggressive…
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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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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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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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Takeda’s Takecab Receives NMPA Approval for Helicobacter pylori Eradication in China
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Takeda (TYO: 4502), a Japan-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Takecab (vonoprazan) to eradicate Helicobacter pylori (HP) when combined with appropriate antibiotics. The vonoprazan-based quadruple regimen, which includes bismuth, is the first of its…
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Jiangsu Hengrui Medicine Receives NMPA Approval for Phase Ib/II Study of Dalpiciclib and HRS-8080
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China-based Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276) has announced that it received approval from the National Medical Products Administration (NMPA) to initiate a Phase Ib/II clinical study. This trial will evaluate the combination of dalpiciclib (SHR6390) and HRS-8080 in patients with ER+/HER2- irresectable or metastatic breast cancer. HRS-8080: A…
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MicuRx Pharmaceuticals Secures NMPA Approval for MRX-4 and Contezolid Combination Therapy
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative anti-microbial agent MRX-4, in combination with contezolid (MRX-I). This novel treatment targets infections caused by drug-resistant Gram-positive bacteria, marking a significant advancement in antibiotic therapy. Overview…
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BeiGene’s Brukinsa Secures Additional EU Approval for Follicular Lymphoma Treatment
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for the Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The European Commission has approved Brukinsa in combination with obinutuzumab (Roche’s CD20-targeted Gazyva) as a third-line treatment for relapsed or refractory (R/R) follicular lymphoma (FL). This marks…
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Beijing Aosaikang’s Combo Therapy for NSCLC Accepted for Clinical Trial by NMPA
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the China National Medical Products Administration (NMPA) has accepted a clinical trial application for the combination of two pipeline candidates, ASKC202 tablets and ASK120067 tablets. The company is seeking to evaluate this combination therapy in adults…
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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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BMS and Karyopharm Partner to Evaluate Mezigdomide and Xpovio in Relapsed/Refractory Multiple Myeloma
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Bristol Myers Squibb (BMS; NYSE: BMY) has entered into a collaboration and supply agreement with Karyopharm Therapeutics (NASDAQ: KPTI) to evaluate the combination of BMS’s cereblon E3 ligase modulator (CELMoD) candidate, mezigdomide, with Karyopharm’s first-in-class Exportin 1 (XPO1) inhibitor, Xpovio (selinexor), plus dexamethasone. This combination is targeted at relapsed/refractory multiple…
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GSK’s ViiV Healthcare Secures NMPA Approval for Vocabria in HIV-1 Treatment
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UK pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has announced that its HIV joint venture, ViiV Healthcare, has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir injection). The drug is approved for use in combination with Johnson & Johnson/Janssen Pharmaceutical’s (J&J, NYSE: JNJ) Rekambys (rilpivirine long-acting injection)…
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Jacobio Pharma’s Glecirasib Combo Shows Promising Results in ESMO Congress 2023 Presentation
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China-based Jacobio Pharma (HKG: 1167) has presented clinical data for its KRAS G12C inhibitor glecirasib in combination with its pipeline SHP2 inhibitor JAB-3312 at the European Society for Medical Oncology (ESMO) Congress 2023. The data comes from a Phase I/II study that enrolled 144 patients with KRAS G12C mutated cancers,…
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InxMed Presents Positive Data for FAK Inhibitor Ifebemtinib at ESMO 2023
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China-based firm InxMed (Nanjing) Co., Ltd has updated two clinical studies for its first-in-class small-molecule FAK inhibitor ifebemtinib (IN10018) at the European Society for Medical Oncology (ESMO) Congress 2023. The studies evaluated the drug’s efficacy and safety in treating platinum-resistant recurrent ovarian cancer and advanced triple negative breast cancer. Phase…
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Ascentage Pharma and AstraZeneca Expand Collaboration on CLL/SLL Treatment
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China’s Ascentage Pharma (HKG: 6855) and UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) have entered into a second clinical collaboration agreement to further study the combination of Ascentage’s Bcl-2 inhibitor lisaftoclax with AZ’s BTK inhibitor acalabrutinib (Calquence). This partnership is specifically aimed at conducting a registrational Phase III trial to…
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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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FDA Approves Pfizer’s Braftovi + Mektovi Combo for BRAF V600E Metastatic NSCLC
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for the combination therapy of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This decision is supported by interim results from an ongoing Phase…
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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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Ascentage Pharma Initiates Phase III Study for APG-2575 and Calquence in CLL/SLL
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced the approval to commence a global multi-center, randomized, open-label pivotal Phase III clinical trial evaluating the efficacy and safety of APG-2575 combined with Calquence (acalabrutinib) in untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. Earlier this year, the drug received clearance for a…
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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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Novartis’ Lutathera Meets Primary Endpoint in Phase III Trial for GEP-NETs
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that a Phase III trial for its radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) combined with the symptom-control drug octreotide has successfully met its primary endpoint of progression-free survival (PFS) in patients with SSTR-positive, aggressive, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement…
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Abbisko Therapeutics Gets NMPA Approval for Irpagratinib Combination Study in HCC
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline candidate irpagratinib (ABSK121) in combination with lenvatinib for the treatment of advanced or irresectable hepatocellular carcinoma (HCC). This development marks a…
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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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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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InnoCare Pharma and ArriVent Biopharma Partner on Clinical Study for Advanced NSCLC Treatment
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced that it has received the green light to conduct a clinical study in China for its drug candidate ICP-189, in combination with ArriVent Biopharma Inc.’s furmonertinib, for the treatment of advanced non-small cell lung cancer (NSCLC). The collaboration between InnoCare and…
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Janssen Reports Positive Results from Phase Ib/II Study of Rybrevant Combo in EGFR-mutated NSCLC
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has provided an update on an ongoing Phase Ib/II study cohort assessing the safety and pharmacokinetics of the bispecific antibody (BsAb) Rybrevant (amivantamab) in combination with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy for the treatment of relapsed/refractory EGFR-mutated non-small cell lung…
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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…
