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Jiangsu Hengrui’s Camrelizumab Earns Full Approval for Advanced Hepatocellular Carcinoma in China
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced the transition of its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab from conditional approval to full approval for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with sorafenib or chemotherapy. Camrelizumab’s Approval History and IndicationsCamrelizumab, which received first approval…
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Biocytogen Pharmaceuticals Receives CNIPA Patent for RenMab Human Antibody Mice Platform
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced receiving a prestigious patent award from the China National Intellectual Property Administration (CNIPA) for its in-house developed human antibody mice RenMab platform. This recognition underscores the company’s commitment to innovation in the field of antibody development. RenMab Technology Platform OverviewThe…
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BeiGene Initiates First-in-Human Trial for Next-Generation BCL-2 Inhibitor BGB-21447
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China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the first patient dosing in a first-in-human trial for its pipeline candidate, BGB-21447, a next-generation BCL-2 inhibitor. The trial, which is potentially superior to venetoclax based on preclinical activity, is being conducted at Shandong Hospital. Phase I Study Design and…
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Jiangsu Hengrui Pharmaceutials’ SHR-1209 for Hypercholesterolemia Accepted for NMPA Review
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China-based Jiangsu Hengrui Pharmaceutials (SHA: 600276) has announced that a market filing for its Category 1 biologic product, SHR-1209, has been accepted for review by the National Medical Products Administration (NMPA). The product is intended to treat hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood. Phase…
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Minghui Pharmaceutical Achieves First Dosing Milestone in Phase I Studies for ADC Candidates
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China-based biotech Minghui Pharmaceutical Inc. has reported that the first dosing has been completed in two Phase I studies assessing the company’s antibody drug conjugate (ADC) candidate drugs, MHB036C and MHB088C. Both candidates are developed on Minghui’s proprietary SuperTopoi platform, with MHB036C targeting TROP2 and MHB088C targeting B7-H3. SuperTopoi Platform…
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Xiamen ITG Group and Fosun Health Collaborate on Big Health Industry Fund and Medical Device Commercialization
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China-based Xiamen ITG Group Co., Ltd. (SHA: 600755) and Shanghai Fosun Health Technology (Group) Co., Ltd have announced a strategic partnership to establish a big health industry fund, collaborate on the commercialization of medical devices, and explore the development and application of health big data. While financial details of the…
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Australian Scleral Lens Epicon A Approved by China’s NMPA as 10th Novel Product
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Ruitai Bio’s Epicon A, a scleral lens product from Australia, has been approved by the National Medical Products Administration (NMPA) in China, marking it as the 10th novel product supported by Lecheng’s real-world data. This Category III medical device is set to make a significant impact on the correction of…
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CDE Considers Breakthrough Therapy Designation for Beijing Mabworks’ MIL162 and Amgen’s AMG 890
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The Center for Drug Evaluation (CDE) website indicates that China-based Beijing Mabworks Biotech Co., Ltd’s MIL162 and US firm Amgen’s AMG 890 are on track to receive breakthrough therapy designation (BTD) awards in China. MIL162 is under development as a treatment for primary membranous nephropathy (pMN), while AMG 890 targets…
