信達生物(01801.HK)PD-1抑制劑達伯舒聯合力比泰和鉑類用於治療肺癌的新適應症申請已獲國家藥監局受理
格隆匯4月24日丨信達生物(01801.HK)公佈，集團和禮來製藥共同開發的創新PD-1抑制劑達伯舒（信迪利單抗注射液）聯合力比泰（注射用培美曲塞二鈉）和鉑類用於非鱗狀非小細胞肺癌一線治療的新適應症申請（sNDA）已經正式獲中國國家藥品監督管理局（NMPA）受理。
基於獨立數據監控委員會進行的期中分析，達伯舒聯合力比泰和鉑類對比安慰劑聯合力比泰和鉑類，顯著延長了無進展生存期，達到預設的優效性標準。截至期中分析數據截止日，中位隨訪時間為8.9個月，試驗組和對照組由獨立影像學評審委員會評估的中位PFS分別為8.9個月和5.0個月，HR(95%CI)=0.482(0.362,0.643)，P＜0.00001。安全性特徵與既往報道的信迪利單抗研究結果一致，無新的安全性信號。
在中國，肺癌的發病率和死亡率均居所有癌症之首，其中有近半數nsqNSCLC患者無表皮生長因子受體敏感突變或ALK基因重排，致使對靶向藥物無效，仍有大量尚未滿足的有效治療方案需求。該項信迪利單抗聯合化療的研究證明其在此類患者人羣中顯著延緩了疾病進展。公司將積極配合監管機構，儘快將該高質量療法帶給更多有需要的患者。
據悉，達伯舒是集團和禮來在中國共同合作研發的具有國際品質標準的創新藥物。NMPA已批准其用於治療至少經過二線系統化療的復發╱難治性經典型霍奇金淋巴瘤，併入選2019版中國臨牀腫瘤學會淋巴瘤診療指南。2019年11月，達伯舒成為唯一一個進入國家新版醫保目錄的PD-1抑制劑。
達伯舒是一種人類免疫球蛋白G4(IgG4)單克隆抗體，能特異性結合T細胞表面的PD-1分子，從而阻斷導致腫瘤免疫耐受的PD-1╱程序性死亡受體配體1(Programmed Death-Ligand1,PD-L1)通路，重新激活T細胞殺死腫瘤細胞。目前公司正在開展超過20多項臨牀研究（其中10多項是註冊臨牀試驗），以評估信迪利單抗在各類腫瘤適應症中的有效性和安全性。
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