基石藥業-B(02616.HK)在2020年CSCO年會上公佈其CS1001兩項重要研究資料
格隆匯 9 月 24日丨基石藥業-B(02616.HK)發佈公告，基石藥業在2020年中國臨牀腫瘤協會(“CSCO”)學術年會上公佈了抗PD-L1單克隆抗體舒格利單抗(CS1001)的兩項重要研究資料，分別為1)舒格利單抗單藥治療復發或難治性結外自然殺傷細胞/T細胞淋巴瘤(“R/RENTKL”)的CS1001-201研究和2)舒格利單抗聯合化療治療胃腺癌或胃食管交界處腺癌(“GE/GEJ”)的CS1001-101研究。舒格利單抗是由基石藥業開發研究藥物，如近期研究及早前報告相關資料表明，舒格利單抗在多種實體瘤和淋巴瘤中表現出良好的療效及安全性，包括在近期針對非小細胞肺癌(“NSCLC”)患者進行的關鍵性III期試驗中顯示出積極結果。
基石藥業首席醫學官楊建新博士表示：“我們很高興看到舒格利單抗單藥和聯合化療在R/RENKTL和GC/GEJ患者中持續展現了優異的抗腫瘤活性和良好的安全性。CS1001-201是全球首個針對R/RENKTL的抗PD-L1註冊臨牀研究，目前研究正在由中國擴展至美國。舒格利單抗聯合XELOX方案在GC/GEJ患者中取得的優異結果，使我們對於正在進行的舒格利單抗聯合XELOX方案用於GC/GEJ患者的III期試驗CS1001-303研究(NCT03802591)充滿信心。我們會繼續全力推進舒格利單抗的研發，儘早惠及更多腫瘤患者。”
根據披露，舒格利單抗是由基石藥業開發的在研抗PD-L1單克隆抗體。舒格利單抗由美國Ligand公司授權引進的OmniRat?轉基因動物平台產生，該平台可實現全人源抗體的一站式生產。作為一種全人源全長抗PD-L1單克隆抗體，舒格利單抗是一種最接近人體的天然G型免疫球蛋白4(“IgG4”)單抗藥物。與同類藥物相比，舒格利單抗在患者體內產生免疫原性及相關毒性的風險更低，這使得舒格利單抗在安全性方面具有獨特的優勢。
舒格利單抗已在中國完成I期臨牀試驗劑量爬坡。在Ia期和Ib期研究中，舒格利單抗在多個瘤種中均表現出良好的抗腫瘤活性和耐受性。
目前，舒格利單抗正在進行多項臨牀試驗，除了一項美國橋接性I期研究外，在中國，舒格利單抗正開展一項針對多個癌種的多臂Ib期研究、一項淋巴瘤註冊性II期研究和四項分別在III/IV期NSCLC、胃癌和食管癌患者的III期註冊性臨牀試驗。其中舒格利單抗治療IV期NSCLC患者的III期臨牀試驗達到主要終點，基石藥業計劃近期向中國國家藥品監督管理局遞交新藥上市申請。
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