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石药集团(01093.HK)注射用重组抗HER2和CD3人源化双特异性抗体获FDA临床试验批准
格隆汇 09-02 17:05

格隆汇9月2日丨石药集团(01093.HK)发布公告,集团非全资附属公司武汉友芝友生物制药有限公司自主研发的注射用重组抗 HER2和CD3人源化双特异性抗体(M802)获得美国食品药品监督管理局(美国FDA)批准在美国进行临床试验。

M802为在友芝友生物自主开发的YBODY双特异性抗体技术平台上研发的品种,为国内首个招募T细胞并靶向HER2阳性乳腺癌和胃癌等的双靶向特异性抗体,具有有效招募和激活T 细胞并同时具有靶向和免疫疗法的优势。

M802项目已经获得中国和美国的发明专利授权,于2017年获得国家药品监督管理局 (NMPA)颁发的临床批件,正在中国开展临床试验,此次美国临床试验的批准将为友芝友生物开展创新药物国际合作和进军国际市场提供有力支持。

M802是友芝友生物开发的一款针对乳腺癌、胃癌等恶性疾病的双抗药物,其生产工艺稳定、质量可控,产品质量符合中美药典的要求。在临床前药理药效研究中,M802已被验证可有效激活T细胞,增加CD3阳性细胞对HER2阳性细胞的识别、结合和免疫杀伤能力,抑制HER2介导的下游信号分子MAKT及AKT的磷酸化,对HER2阳性肿瘤细胞的增殖有显着的抑制作用,并具有ADCC和CDC作用。

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