信達生物(01801.HK)擬與MD Anderson共同開發PD-1抑制劑達伯舒® (信迪利單抗注射液)用於治療多種罕見癌症
格隆匯5月19日丨信達生物－Ｂ(01801.HK)發佈公告，公司與美國德州大學MD Anderson癌症中心(“MD Anderson”)達成了一項戰略合作協議，以在美國聯合開發創新抗PD-1單克隆抗體達伯舒® (信迪利單抗注射液)用於治療多種罕見癌症。MD Anderson在開展臨牀研究甚至其他中心不常見的罕見癌症臨牀研究方面擁有獨特經驗，使得這項聯合開發成為可能。這些研究將使公司有機會獲得美國食品藥品監督管理局批准信迪利單抗的多個罕見癌症適應症。此外，公司也在獨立負責信迪利單抗更大癌症適應症的上市申請工作。信迪利單抗進入美國將拓寬罕見癌症類型患者的治療選擇，目前這類患者中很多缺乏有效的標準療法。
根據該協議，公司和MD Anderson將共同承擔信迪利單抗的開發活動費用，其中可能包括將由MD Anderson開展的多項臨牀研究試驗。
公告表示，達伯舒® (信迪利單抗注射液)是集團和禮來製藥在中國共同合作研發的具有國際品質標準的創新藥物。國家藥品監督管理局(“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® (信迪利單抗注射液)成為唯一一個進入國家新版醫保目錄的PD-1抑制劑。2020年4月，NMPA受理了達伯舒聯合力比泰® (注射用培美曲塞二鈉)和鉑類化療一線治療非鱗狀非小細胞肺癌的新增適應症申請。2020年5月，達伯舒聯合健擇® (注射用吉西他濱)和鉑類化療一線治療鱗狀非小細胞肺癌的3期ORIENT-12研究達到主要研究終點，達伯舒單藥二線治療晚期╱轉移性食管鱗癌的ORIENT-2研究也達到主要研究終點。
此外，達伯舒® (信迪利單抗注射液)是一種人類免疫球蛋白G4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╱程式性死亡受體配體1(Programmed Death-Ligand 1, PD-L1)通路，重新啟動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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