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康方生物(09926.HK)治療胃癌藥物新適應症上市申請獲內地受理
阿思達克 01-05 08:44
康方生物(09926.HK)公佈,國家藥監局(NMPA)已於近日正式受理,由公司自主研發的全球首創雙特異性抗體開坦尼(卡度尼利,PD-1/CTLA-4)聯合XELOX化療方案(奧沙利鉑和卡培他濱)一線治療不可手術切除的局部晚期、復發或轉移性胃或胃食管結合部(G/GEJ)腺癌的新適應症上市申請(sNDA)。 是次新適應症上市申請是基於AK104–302,一項隨機、雙盲、多中心的III期臨牀試驗,主要研究終點爲總生存期(OS)。
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