石药集团(01093.HK)附属自主研发注射剂批准在美国进行临床试验
石药集团(01093.HK)公布,非全资附属武汉友芝友生物制药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,於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。
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