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Ascletis Pharma’s Denifanstat Advances to Phase III for Severe Acne Vulgaris Treatment
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Ascletis Pharma Inc., (HKG: 1672) a China-based biotechnology company, has announced the commencement of a Phase III trial for its drug candidate denifanstat (ASC40), intended to assess its efficacy in treating severe acne vulgaris. The trial, a randomized, double-blind, placebo-controlled, and multi-center study, will be conducted at hospitals across China,…
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Sino Medical Secures Market Approval in Taiwan for NC Rockstar Coronary Catheter
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Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that its NC Rockstar non-compliant coronary artery balloon dilation catheter has received market approval in Taiwan, China. This innovative device, which includes a TIP head, balloon protective sheath, balloon, and inner tube, is designed for balloon catheter dilation of autologous coronary…
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Luye Pharma’s Lurbinectedin for Metastatic SCLC Wins Macau Regulatory Nod
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that Macau’s medical products administration bureau has approved a market approval filing for the firm’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients experiencing tumor progression during or after platinum-based chemotherapy. The approval is…
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Yantai Dongcheng Pharmaceutical Gets NMPA Green Light for FAP-Targeting Radiotherapeutic Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to proceed with a clinical study for its radiotherapeutic drug, 177Lu-LNC1004, which targets advanced solid tumors. The drug is designed to treat fibroblast activation protein (FAP)-positive…
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Tonghua Dongbao Pharmaceuticals Secures NMPA Approval for Biosimilar Liraglutide
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) GLP-1 receptor agonist Victoza (liraglutide), which is indicated for blood sugar control in type 2 diabetes patients.…
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Simcere Pharmaceutical’s SIM0501 Receives FDA Approval for Advanced Solid Tumor Clinical Trial
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Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its cancer drug candidate SIM0501, which targets advanced solid tumors. The company’s clinical filing was previously accepted for review by China’s National Medical Products Administration (NMPA) in…
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WuXi Biologics Shares Plunge 22% on Slower CDMO Industry Growth and Revenue Shortfall
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WuXi Biologics (HKG: 2269) experienced a 22% decline in its share price on Monday, December 4, 2023, following an investor presentation that disclosed the contract development manufacturing organization (CDMO) industry’s growth has slowed to single digits, down from over 15% in recent years. The company’s business update revealed that its…
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Abbisko Therapeutics Strikes Licensing Deal with Merck KGaA for CSF-1R Inhibitor Pimicotinib
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced a licensing agreement with German pharmaceutical giant Merck KGaA for its in-house developed colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021). According to the agreement, Merck will secure an exclusive license to commercialize pimicotinib in mainland China, Hong…
