康宁杰瑞制药-B(09966.HK):JSKN003获美国FDA批准开展一项治疗不限HER2表达水平的PROC的II期临床研究

智通财经
31 Jul
【康宁杰瑞制药-B(09966.HK):JSKN003获美国FDA批准开展一项治疗不限HER2表达水平的PROC的II期临床研究】智通财经APP讯,康宁杰瑞制药-B(09966.HK)发布公告,JSKN003已获美国食品药品监督管理局(FDA)批准,在美国开展一项II期临床研究(研究编号: JSKN003-202)。 JSKN003-202是JSKN003的一项随机、开放式标签、多中心的 II期临床研究,用于治疗铂耐药复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌(统称为铂耐药卵巢癌,PROC),且不限人表皮生长因子受体2(HER2)表达水平。此临床试验旨在评估JSKN003在上述人群中的疗效和安全性,并确定推荐 III期剂量。此次JSKN003-202获美国FDA批准,是公司推动创新管线全球开发的重要里程碑,将持续提升公司在抗肿瘤治疗领域的核心竞争力。

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