康方生物(09926)：国家药监局受理开坦尼®用于一线治疗宫颈癌的新适应症上市申请

智通财经04-24

智通财经APP讯，康方生物(09926)发布公告，国家药品监督管理局(NMPA)已于近期正式受理由本公司自主研发的全球首创双特异性抗体开坦尼®(卡度尼利，PD-1/CTLA-4)联合含铂化疗联合或不联合贝伐珠单抗一线治疗持续、复发或转移性宫颈癌的新适应症上市申请(sNDA)。

开坦尼®已于2022年6月获得NMPA批准用于治疗既往接受过含铂化疗治疗失败的复发或转移性二/三线宫颈癌患者。本次sNDA是基于AK104–303研究，该研究显示，开坦尼®对于全人群(无论PD-L1表达水平)患者均获益显著。本次sNDA意味着开坦尼®将推进至宫颈癌一线治疗领域，为晚期宫颈癌全人群患者带来广泛的获益。

这是开坦尼®第三个适应症的上市申请。于2024年1月，开坦尼®联合化疗用于一线治疗胃或胃食管结合部(G/GEJ)腺癌的sNDA获得NMPA受理，将为胃癌全人群患者(无论PD-L1表达水平)带来更优效安全的治疗选择。

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