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Henlius’ HER2 Dual-Targeted Therapy Gets Green Light for Global Phase III Trial by FDA
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a global multi-center Phase III clinical study. The study will evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line…
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Jacobio Pharma Applies for Approval of KRAS G12C Inhibitor Gecirasib in China
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Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced the submission of a New Drug Application (NDA) to China’s Center for Drug Evaluation (CDE) for its investigational drug glecirasib. The KRAS G12C inhibitor is being sought after for approval as a treatment for second-line and above advanced or metastatic…
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Biocytogen and BioCopy AG Collaborate on TCR-Mimic Antibody Development for Cancer Therapies
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a China-based biopharmaceutical company, has announced an evaluation and potential licensing agreement with BioCopy AG, a research-driven biotechnology firm based in Basel, Switzerland. This agreement grants BioCopy access to a fully human library of TCR-mimic antibodies that target intracellular antigens. These antibodies are…
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EyePoint Pharmaceuticals’ Durvayu Fails to Meet Primary Endpoint in NPDR Trial
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EyePoint Pharmaceuticals Inc., (NASDAQ: EYPT) has announced that its drug candidate Durvayu (vorolanib intravitreal insert; EYP-1901) did not meet its primary endpoints in the Phase II PAVIA clinical trial for non-proliferative diabetic retinopathy (NPDR). Although the trial data showed some treatment effect, including a reduction in NPDR progression rates at…
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Kelun-Biotech’s RET Inhibitor A400 Advances to Phase II Trial with FDA Approval
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, has announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its RET inhibitor A400/EP0031…
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Jacobio Pharma’s Glecirasib Shows Promise in Phase II Study for NSCLC Presented at ASCO
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Jacobio Pharma (HKG: 1167), a biopharmaceutical company based in China, has announced the presentation of results from a Phase II regulatory study for its KRAS G12C inhibitor, glecirasib, at the 2024 American Society of Clinical Oncology (ASCO) Plenary Series. In terms of efficacy, the study reported a confirmed objective response…
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BeiGene’s Anti-PD-1 Therapy Tislelizumab Expands Indication for Gastric Cancer in China
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that its anti-PD-1 therapy, tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China for the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ) in combination with fluorouracil and platinum-based…
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China’s NMPA Approves Shenzhen Chipscreen’s Chidamide for DLBCL Indication
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Shenzhen Chipscreen Biosciences Co., Ltd, a biopharmaceutical company based in China, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Epidaza (chidamide). The drug is indicated for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2…
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Zhejiang Huahai Pharmaceutical Wins IND Approval for Antibody-Drug Conjugate from China’s NMPA
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its innovative injectable drug candidate, HB0052. The drug is initially intended for evaluation in patients with general advanced solid tumors.…
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EOC Pharma’s Entinostat Secures Chinese Approval for Breast Cancer Treatment
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US-China biotech firm EOC Pharma has received market approval from China’s National Medical Products Administration (NMPA) for its entinostat, an oral histone deacetylase (HDAC) inhibitor, for the treatment of locally advanced or metastatic breast cancer in patients with hormone receptor (HR) positive and human epidermal growth factor receptor-2 (HER2) negative…
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Kexing Pharmaceutical Secures Global Rights for Qingfeng’s Generic Olaparib
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China’s Kexing Pharmaceutical (SHA: 688136) has secured a global commercialization licensing agreement with Qingfeng Pharmaceutical Group for the latter’s generic version of olaparib. Under this deal, Kexing will obtain commercial rights for the product across an initial batch of 10 international markets. Meanwhile, Qingfeng’s generic formulation is currently awaiting regulatory…
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HutchMed’s Partner Takeda Gets CHMP Nod for Fruquintinib as CRC Treatment in Europe
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its collaborator Takeda (TYO: 4502, NYSE: TAK) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of fruquintinib for the treatment of adult patients with…
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AbelZeta Pharma’s CAR-T Therapy C-CAR031 Receives Implicit Approval for Clinical Study in China
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Sino-US biotechnology company AbelZeta Pharma Inc., operating in Rockville, Maryland, and Shanghai, China, has received implicit approval for its autologous armored GPC3-targeted chimeric antigen receptor (CAR) T cell therapy, C-CAR031, developed by its subsidiary, Shanghai Cellular Biopharmaceutical Group Ltd. The therapy is intended for the treatment of GPC3+ advanced or…
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Wuhan Bio-Raid Biotechnology Secures NMPA Approval for First-in-Class CD99-Targeted CAR-T Therapy
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Wuhan Bio-Raid Biotechnology Co., Ltd, a leading developer of chimeric antigen receptor (CAR)-T cell therapies in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its proprietary BRD-03. This autologous CD99-targeted CAR-T therapy is classified as a Category 1 biologic therapeutic…
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MSD Reports USD 15.8 Billion in Q1 2024 Sales, Marked by 11% YOY Growth Excluding Forex Impact
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has released its financial report for the first quarter of 2024, announcing sales of USD 15.8 billion, an increase of 11% year-on-year (YOY) excluding the impact of foreign exchange rates. The pharmaceutical division contributed USD 14.0 billion to the top line, with a…
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US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
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Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food and Drug Administration’s (FDA) approval for marketing Hanquyou (trastuzumab; HLX02), a biosimilar to Roche (SWX: ROG)’s cancer treatment Herceptin (trastuzumab). The biosimilar will be available in the US under the trade name Hercessi. Originally approved…
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Bristol Myers Squibb Reports 6% YOY Revenue Growth in Q1 2024, Driven by Eliquis and Reblozyl
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Pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY) has reported a 6% year-on-year (YOY) increase in revenues for the first quarter of 2024, excluding the impact of foreign exchange, reaching USD 11.9 billion, according to the company’s latest financial report. The U.S. market contributed USD 8.5 billion, marking a 7%…
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Roche’s Q1 2024 Turnover Rises 2% YOY, Driven by New Medicines and Diagnostics
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Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has reported a 2% year-on-year (YOY) increase in turnover at constant exchange rates (CER) for the first quarter of 2024, reaching CHF 14.4 billion (USD 15.7 billion). The growth was modest but steady, driven by newer medicines and diagnostics, which compensated for…
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Insilico Medicine Partners with invoX Pharma to Boost AI-Driven Drug Discovery
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China’s generative artificial intelligence (AI)-driven biotech firm Insilico Medicine has entered into a partnership with compatriot firm invoX Pharma, a subsidiary of Sino Biopharmaceutical Ltd (HKG: 1177). The collaboration aims to combine Insilico’s AI and computer-aided drug discovery expertise, including its proprietary PandaOmics target discovery engine, with invoX’s innovative drug…
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Betta Pharmaceuticals’ BPI-16350 Combo Therapy Shows Improved PFS in Breast Cancer Trial
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an update on its Phase III clinical study for BPI-16350, a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, used in combination with fulvestrant for the treatment of locally advanced or recurrent hormone receptor positive (HR+) HER2-negative metastatic breast cancer in patients…
