基石藥業-B(02616.HK)與EQRx公司全球戰略合作協議提前通過美國HSR法案等待期正式生效
格隆匯 11 月 20日丨基石藥業-B(02616.HK)發佈公告，基石藥業於2020年10月27日刊發公告，內容涉及與EQRx Inc.(“EQRx公司”)簽訂的舒格利單抗(CS1001，抗PD-L1單抗)及CS1003(抗PD-1單抗)獨家許可協議。基石藥業宣佈此前與EQRx公司達成的全球戰略合作協議已提前得到美國聯邦貿易委員會許可，通過美國1976 Hart-Scott-Rodino反托拉斯改進法(“HSR”)的等待期。至此，該合作協議的全部條件已具備，交易正式生效。
如公告所述，在基石藥業與EQRx公司達成的全球戰略合作中，基石藥業將獨家授權EQRx公司在大中華區以外地區開發和商業化舒格利單抗(CS1001，抗PD-L1單抗)及CS1003(抗PD-1單抗)這兩款處於後期研發階段的腫瘤免疫治療藥物。根據協議條款，基石藥業將獲得1.5億美元的首付款，及最高可達11.5億美元的里程碑付款以及額外的分級特許權使用費。EQRx公司將獲得舒格利單抗和CS1003在除中國大陸、中國台灣、中國香港和中國澳門(“大中華區”)以外的全球市場的獨家商業化權利。基石藥業將保留CS1003在大中華區的開發和商業化權利，並將繼續探索其作為單藥和聯合療法的骨架產品的發展前景。
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 Pharmaceuticals公司(納斯達克股份交易代碼：LGND)授權引進的OmniRat®轉基因動物平台，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，這使得舒格利單抗具有獨特的優勢。
舒格利單抗已在中國完成I期劑量遞增研究。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期非小細胞肺癌(“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，新藥上市申請已經獲得中國國家藥品監督管理局受理。
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