信達生物-B(01801.HK)：達伯舒®(信迪利單抗注射液)列入新版國家醫保目錄
格隆匯11月28日丨信達生物-B(01801.HK)宣佈，根據2019年11月28日國家醫療保障局的最新公告，集團與禮來公司共同開發的創新藥物達伯舒®(IBI-308，通用名：信迪利單抗注射液)被列入新版國家醫保目錄乙類範圍。根據官方公告顯示，信迪利單抗是唯一成功列入國家醫保目錄的PD-1抑制劑。(醫保報銷細則等相關資訊，以政府公示資訊為準。)
達伯舒®(信迪利單抗注射液)進入新版國家醫保目錄證明其符合國家醫療保障局對藥品的臨牀價值、病人獲益、創新程度等方面的認可。信迪利單抗能夠進入新版國家醫保目錄，將進一步幫助患者使用能夠負擔得起的新型免疫治療藥物，提高生命品質。
接下來，公司將和各方繼續緊密配合推進醫保政策落地，加速信迪利單抗進入醫院的渠道，並持續與多方共同探索創新支付方式，力爭讓更多患者可以享受到科學進步的健康成果。
公告顯示，達伯舒®(信迪利單抗注射液)是集團和禮來在中國共同合作研發的具有國際品質的創新生物藥。其上市申請已正式獲得國家藥品監督管理局的批准，獲批的第一個適應症是復發╱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(CSCO)淋巴瘤診療指南。達伯舒®(信迪利單抗注射液)於2019年11月成為唯一一個進入新版國家醫保目錄的PD-1抑制劑。
達伯舒®(信迪利單抗注射液)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╱程式性死亡受體配體1(Programmed Cell Death-1 Ligand-1, PD-L1)通路，重新啟動淋巴細胞的抗腫瘤活性，從而達到治療腫瘤的目的。目前集團有超過二十多個臨牀研究(其中8項是註冊臨牀試驗)正在進行，以探討信迪利單抗在其它實體腫瘤上的抗腫瘤安全性及有效性。集團同時正在美國開展信迪利單抗注射液的臨牀研究工作。
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