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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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CDE Releases 70th Batch of Generic Reference Preparations for Public Feedback
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The Center for Drug Evaluation (CDE) has released the 70th batch of chemical generic reference preparations, marking a significant update in the generic drug sector. This batch includes 18 new specifications and updates to 23 previously published specifications. The document is open for public feedback until June 15, 2023, ensuring…
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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…
