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Yiling Pharmaceutical Secures NMPA Approval for Phase I Study of G201-Na in Premenopausal Women
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a single-center, randomized, double-blind, placebo-controlled Phase I clinical study. This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of G201-Na in premenopausal healthy adult women. G201-Na:…
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Gritgen Therapeutics Commences Operations of Commercial GMP Facilities in Suzhou
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Suzhou-based gene therapy specialist, Gritgen Therapeutics Co., Ltd, has announced the validation completion and initiation of operations at its commercial Good Manufacturing Practice (GMP) facilities located in the Suzhou Industrial Park. This development marks a significant step forward for the company in advancing its capabilities in gene therapy production. Facility…
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GenFleet Therapeutics’ CDK9 Inhibitor SLS009 Earns Orphan Drug Status for AML
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Shanghai-based biotechnology company GenFleet Therapeutics has announced that its CDK9 inhibitor, SLS009 (GFH009), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation is a significant milestone, recognizing the drug’s potential to address a rare and…
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Cochlear’s Artificial Cochlear Sound Processor Gains NMPA Approval for Marketing in China
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Australia-based Cochlear has received marketing approval from the National Medical Products Administration (NMPA) for its artificial cochlear sound processor, as announced by the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration. This innovative product is designed to convert received sounds and transmit electrical stimulation to the auditory nerve through…
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Jiangsu Recbio Forms Strategic Cooperation for Vaccine Production in Zimbabwe
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China-based Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced a tripartite strategic cooperation agreement with the Zimbabwe National Biotechnology Authority (Zimbabwe NBA) and the International Centre for Genetic Engineering and Biotechnology China Regional Research Centre (ICGEB). This collaboration aims to enhance vaccine production capabilities in Zimbabwe, starting with the…
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Roche’s Forimtamig Receives Tacit Approval for Multiple Myeloma Clinical Trials
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The Center for Drug Evaluation (CDE) has indicated that Swiss pharmaceutical giant Roche (SWX: ROG) has secured tacit clinical trial approval for its Category 1 biologic product, forimtamig (RG6234), in the treatment of multiple myeloma (MM). Promising Efficacy in Phase I Trials Forimtamig is a bispecific antibody (BsAb) designed to…
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Sanofi Partners with BioMap to Accelerate AI-Driven Drug Discovery
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France-based pharmaceutical giant Sanofi (EPA: SAN) has entered into a strategic partnership with US biotech firm BioMap, an AI-driven drug discovery platform founded by Robin Li, CEO of Chinese internet leader Baidu (NASDAQ: BIDU; HKG: 9888), and Wei Liu, CEO of Baidu Ventures. The collaboration includes an upfront payment of…
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Sino Biopharmaceutical Sells 84.2% Stake in Shanghai CP General Pharmaceutical
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China-based biotech company Sino Biopharmaceutical Ltd (HKG: 1177) has announced the sale of an 84.2% stake in its former subsidiary, Shanghai CP General Pharmaceutical Co., Ltd. This strategic divestiture is expected to generate approximately RMB 290 million (USD 40 million) for the company. Focus on Core Competencies Amid Financial Losses…
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