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CSPC’s ALMB-0168 Receives NMPA Approval for Osteoarthritis Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its pipeline drug candidate ALMB-0168 in osteoarthritis. ALMB-0168, a connexin 43-targeted monoclonal antibody developed in-house by subsidiary AlaMab Therapeutics Inc., is under development to treat acute…
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RemeGen’s RC108 Receives FDA Go-Ahead for Phase I Clinical Study
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China-based biopharma RemeGen Ltd (HKG: 9995) has announced receiving approval from the US FDA to initiate a Phase I clinical study for its antibody drug conjugate (ADC) RC108 in c-Met positive advanced solid tumors. This marks a significant step forward in the global development of RC108, building on its existing…
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Simcere Receives NMPA Clearance for SIM0348 Clinical Study
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its SIM0348, a bispecific antibody (BsAb) targeting TIGIT and PVRIG in advanced malignant solid tumors. Mechanism of Action and DesignSIM0348 is designed to block the interaction between…
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Skynor Medical Raises RMB 100 Million in Financing Round for Market Expansion
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Skynor Medical, a Shanghai-based manufacturer of nerve and peripheral blood vessel implantation and interventional devices, has reportedly raised RMB 100 million (USD 14.37 million) in a new financing round. Investors include Zhangjiang Hi-Tech Park Development, Pudong Capital, Zhangjiang Haoheng Innovative Equity Investment, and Suxin Venture Capital. The proceeds will be…
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Sichuan Kelun Completes RMB 1.5 Billion Financing Round for Kelun-Biotech
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced the completion of a financing round at RMB 1.5 billion (USD 215.53 million) for its subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Kelun maintains majority control of the subsidiary with a 59.75% stake, increased from 55.41%. Merck, Sharp & Dohme (MSD;…
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Everest Medicines’ Nefecon Receives Priority Review Recommendation from CDE
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China-based Everest Medicines (HKG: 1952) has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review status for the New Drug Application (NDA) of Nefecon (targeted-release formulation-budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk…
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BrightGene Receives NMPA Approval for BGM0504 Clinical Trial
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China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its BGM0504, a dual agonist targeting GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin-stimulating polypeptide). The targeted indications for BGM0504 are weight loss and type…
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Anhui Anke Biotechnology Receives NMPA Approval for AK2017 Clinical Study
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China-based Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human growth hormone Fc fusion protein injection AK2017. The drug will be assessed for treating children with growth deficiencies due to endogenous…
