科倫藥業(002422.SZ)：TROP2 ADC蘆康沙妥珠單抗(sac-TMT)新增適應症上市申請獲受理

智通財經

07/30

智通財經APP訊，科倫藥業(002422.SZ)發布公告，科倫博泰靶向人滋養細胞表面抗原2(TROP2)的抗體偶聯藥物(ADC)蘆康沙妥珠單抗(sac-TMT，亦稱SKB264/MK-2870)(佳泰萊®)的一項新增適應症上市申請已獲中國國家藥品監督管理局(NMPA)藥品審評中心(CDE)受理，用於程序性細胞死亡配體1(PD-L1)綜合陽性評分(CPS)<10或早期階段接受過程序性細胞死亡蛋白-1(PD-1)/PD-L1抑制劑的復發或轉移性三陰性乳腺癌(TNBC)的一線治療。這是蘆康沙妥珠單抗(sac-TMT)獲NMPA受理的第六項適應症上市申請。

此前，蘆康沙妥珠單抗(sac-TMT)用於一線治療不可手術切除的局部晚期、復發或轉移性PD-L1陰性TNBC已獲NMPA授予突破性療法認定(BTD)。本次新增適應症上市申請亦已納入優先審評審批程序，成為蘆康沙妥珠單抗(sac-TMT)納入該程序的第六項上市申請。納入優先審評審批程序有望進一步加快審評及上市進程，使這一創新治療方案更早惠及患者。

免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。

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