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基于全球III期MANEUVER研究的积极数据，中国国家药品监督管理局（NMPA）批准了贝捷迈®（盐酸匹米替尼胶囊）的全球首个新药上市申请，也是中国首个自主研发的腱鞘巨细胞瘤（TGCT）系统性治疗药物。默克作为我们的合作伙伴，拥有贝捷迈®在全球的商业化权益。贝捷迈®是和誉医药自主研发的1类新药，上市申请（NDA）获受理后仅6个多月即实现零发补批准。期间顺利通过国家药监局核查中心（CFDI）首次赴海...
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Based on the positive global Phase III MANEUVER study, the NMPA has granted the world's first regulatory approval for pimicotinib.
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CARBOGEN AMCIS Shanghai Site Awarded Drug Manufacturing License from Chinese NMPA
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IND approval in China allows Shanghai Henlius Biotech, Sermonix’s Chinese development partner for oral lasofoxifene, to enroll ELAINE-3 trial patients in ChinaUnder strategic collaboration agreement...
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Burning Rock Received Breakthrough Device Designation from China’s NMPA for its Multi-Cancer Early Detection Test
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Registration with the NMPA, China’s Regulatory Equivalent to the FDA, is a Prerequisite to Marketing and Distribution BEIJING, July 10, 2023 (GLOBE NEWSWIRE) -- Shineco, Inc. (“Shineco” or the...
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Approval Provides Strong Support for the Product’s Marketing in China BEIJING, April 04, 2023 (GLOBE NEWSWIRE) -- Shineco, Inc. (“Shineco” or the “Company”; NASDAQ: SISI), a producer and...
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China National Medical Product Administration (NMPA) has granted Mabpharm approval to market INFLIXIMAB biobetter in China.Sorrento holds commercialization rights outside of China and intends to meet...
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BEIJING, China and CAMBRIDGE, Mass., July 07, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and...
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CAMBRIDGE, Mass. and BEIJING, China, May 30, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and...