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Hansoh Pharmaceutical Gets NMPA Approval for HS-20117 Bispecific Antibody Clinical Study
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for HS-20117, a bispecific antibody (BsAb) targeting both EGFR and cMet in advanced solid tumors. Strategic Licensing Deal with BiotheusIn a significant move to expand its…
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Chinese Pharma Companies Update Pipelines at ASCO 2023 Annual Meeting
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A number of Chinese pharmaceutical companies have shared updates on their pipeline developments at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. Among them are CSPC Pharmaceutical Group Ltd (HKG: 1093), Alphamab Oncology (HKG: 9966), and Innovent Biologics Inc. (HKG: 1801). CSPC’s CLDN18.2 ADC Demonstrates Promise in Phase…
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Sinovac Biotech Partners with Bogota to Establish BogotáBio for Vaccine Production
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China-based Sinovac Biotech Ltd (NASDAQ: SVA) has announced a strategic partnership with Bogota, the capital of Colombia, to establish a joint venture named BogotáBio. The collaboration aims to strengthen local manufacturing capabilities for multiple vaccines and enhance novel vaccine research and development within the country. Colombia was one of the…
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Longreach Group Puts Quasar Medical on the Block, Attracting Major Bidders
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Private equity firm Longreach Group, which specializes in the Asian market, is in the process of auctioning off its medical equipment unit, Quasar Medical. According to Reuters, bidders include Boyu Capital, Hillhouse Capital, and BPEA EQT. Quasar Medical is valued at USD 600 million and reported sales of USD 30…
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Gracell Biotechnologies’ GC012F Showcases Positive Data at ASCO Annual Meeting
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Suzhou-based biotech firm Gracell Biotechnologies Inc., (Nasdaq: GRCL) has announced positive data for its pipeline candidate GC012F at the American Society of Clinical Oncology (ASCO) Annual Meeting. GC012F is a FasTCAR-T therapy targeting both B-cell maturation antigen (BCMA) and CD19, under development for the treatment of relapsed/refractory multiple myeloma (r/r…
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Biosyngen’s BRG01 Earns Orphan Drug Designation from US FDA for Nasopharyngeal Carcinoma
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Biosyngen, a leading cell therapy developer based in Guangzhou, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its first-in-class nasopharyngeal carcinoma (NPC) cell therapy, BRG01. BRG01: A Pioneering Cell Therapy for NPCBRG01 is a genetically modified T cell product…
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NMPA Clears Medtronic’s Corindus for Marketing of Advanced Coronary Surgery Systems
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The National Medical Products Administration (NMPA) has granted marketing approval for the “coronary artery interventional surgery control system” and “disposable coronary artery interventional surgery control system attachment,” both developed by Medtronic Inc.’s subsidiary Corindus Inc., based in the US. Enhancing Surgical Precision and SafetyThis approval highlights a significant step forward…
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NMPA Grants Market Approval for Lanzhou Kejin Taiji’s Carbon Ion Therapy System
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The National Medical Products Administration (NMPA) in China has issued market approval to Lanzhou Kejin Taiji Corporation, Ltd. for its carbon ion therapy system, marking it as the second home-grown carbon ion therapy system in the country designed for the treatment of malignant solid tumors. Enhanced Features of the New…
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HighTide Therapeutics Inc. Plans Hong Kong IPO to Fund Clinical Development
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China-based HighTide Therapeutics Inc. has announced plans to make an initial public offering (IPO) on the Hong Kong Stock Exchange, with further details to be disclosed at a later stage. The proceeds from the IPO will be directed towards the clinical development, regulatory filing, and post-approval studies for its core…
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Shanghai Duoning Biotechnology Partners with Wuhan Kaide Jinuo for Gene Therapy R&D
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China’s Shanghai Duoning Biotechnology Co., Ltd has announced a strategic licensing deal with compatriot firm Wuhan Kaide Jinuo Biotechnology Co., Ltd. The collaboration aims to establish a professional research team focused on the development and research of the adenovirus technology platform, with the goal of creating an integrated solution for…
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Guangdong Zhongsheng Pharma Initiates Phase IIb Study for ZSP1601 in NASH
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the first subject enrollment in a Phase IIb clinical study for its Category 1 drug ZSP1601, targeting non-alcoholic steatohepatitis (NASH). The study, set to be conducted across over 30 centers in China, will involve subjects stratified into randomized groups based…
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Novartis’s Iptacopan on Track for Priority Review Status in China for PNH Treatment
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China’s Center for Drug Evaluation (CDE) website has indicated that Swiss pharmaceutical giant Novartis’ (NYSE: NVS) iptacopan is likely to receive priority review status for the treatment of adult paroxysmal nocturnal hemoglobinuria (PNH). This potential award highlights the fact that iptacopan is a clinically urgently needed innovative drug addressing a…
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CSPC Pharmaceutical Group Partners with China Unicom for Digital Transformation
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced a strategic partnership with Chinese mobile network giant China Unicom to empower the company’s digital transformation efforts. The collaboration will span across various fields, including novel drug research and clinical trials, smart manufacturing and production operations, smart marketing and logistics, management,…
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Novo Nordisk’s Semaglutide for Weight Loss Accepted for Review by China’s NMPA
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Denmark-headquartered Novo Nordisk (NYSE: NVO) has announced that its market filing for the glucagon-like peptide-1 (GLP-1) analogue semaglutide has been accepted for review by the National Medical Products Administration (NMPA) in China, with the targeted indication being weight loss. Semaglutide’s Mechanism and Existing ApprovalsSemaglutide, a subcutaneous injection version of a…
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Qilu Pharmaceutical Gains Temporary FDA Approval to Import Cisplatin Amid US Shortage
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Qilu Pharmaceutical, a China-based firm, has benefited from the effects of drug shortages in the United States. According to a notice on the US FDA website, Qilu has been temporarily authorized to import the chemotherapy drug cisplatin to the US market, despite its product not being officially approved. Timing and…
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CStone Pharmaceuticals and Blueprint Medicines’ Ayvakit Wins FDA Approval for ISM Treatment
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Partners CStone Pharmaceuticals (HKG: 2616) and Blueprint Medicines have announced that the US FDA has approved Ayvakit (avapritinib), a tyrosine kinase inhibitor, for the treatment of adults with indolent systemic mastocytosis (ISM). ISM is a rare hematologic disorder that can lead to a range of debilitating symptoms across multiple organ…
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Neurophth Biotechnology Partners with Sinopharm Group to Commercialize Gene Therapy NFS-01
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced a strategic partnership with compatriot firm Sinopharm Group to jointly advance the marketing and commercialization of Neurophth’s NFS-01, an ophthalmic gene therapy targeting ND4 mutation in Leber’s Hereditary Optic Neuropathy (LHON) disease. Neurophth is aiming for NFS-01 to achieve a first-of-its-kind…
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Sirnaomics Initiates Phase I Clinical Trial for Anticoagulant Drug Candidate STP122G
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Sirnaomics Ltd (HKG: 2257) has announced the first systemic dosing of a Phase I clinical trial for its leading RNAi drug candidate, STP122G, an anticoagulation treatment. STP122G, developed using Sirnaomics’ GalNAc RNAi delivery platform technology GalAhead, targets Factor XI and has broad applicability across various disease indications, including the potential…
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CANbridge Pharmaceuticals’ Maralixibat Approved by NMPA for Alagille Syndrome
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China-based rare disease specialist CANbridge Pharmaceuticals Inc., (HKG: 1228) has announced receiving market approval from the National Medical Products Administration (NMPA) for its drug maralixibat (CAN108). The drug is approved to treat pruritus due to cholestasis in patients with Alagille Syndrome (ALGS) aged 1 year and above. Understanding Alagille Syndrome…
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Innovent Biologics Partners with Merck KGaA to Test KRAS Inhibitor Combo in NSCLC
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China-based Innovent Biologics (HKG: 1801) has announced a clinical study and supply agreement with German pharmaceutical giant Merck KGaA (NYSE: MRK). The collaboration aims to explore the combination of Innovent’s KRAS G12C inhibitor, IBI351, and Merck’s Erbitux (cetuximab) in patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS…
