复星医药(02196.HK)子公司治疗乳腺癌新药获美国FDA快速通道审评认证
复星医药(02196.HK)(600196.SH)公布,旗下控股子公司复星弘创(苏州)医药科技收到美国食品药品监督管理局(FDA)关於新药ORIN1001用於治疗复发性、难治性、转移性乳腺癌(包括三阴乳腺癌)获得快速通道审评认证的函。
该新药为集团自主研发的具有新(酉每)型靶点、新作用机制和新化学结构类型的首创小分子药物,用於治疗晚期实体瘤,其第一个探索中的适应症为复发性、难治性、转移性乳腺癌。截至昨日(16日),在全球范围内尚无与该新药同类型产品上市。
截至今年5月,集团现阶段针对该新药已累计研发投入约4,547万元人民币。
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