基石药业-B(02616.HK)与EQRx公司全球战略合作协议提前通过美国HSR法案等待期正式生效
格隆汇 11 月 20日丨基石药业-B(02616.HK)发布公告，基石药业于2020年10月27日刊发公告，内容涉及与EQRx Inc.(“EQRx公司”)签订的舒格利单抗(CS1001，抗PD-L1单抗)及CS1003(抗PD-1单抗)独家许可协议。基石药业宣布此前与EQRx公司达成的全球战略合作协议已提前得到美国联邦贸易委员会许可，通过美国1976 Hart-Scott-Rodino反托拉斯改进法(“HSR”)的等待期。至此，该合作协议的全部条件已具备，交易正式生效。
如公告所述，在基石药业与EQRx公司达成的全球战略合作中，基石药业将独家授权EQRx公司在大中华区以外地区开发和商业化舒格利单抗(CS1001，抗PD-L1单抗)及CS1003(抗PD-1单抗)这两款处于后期研发阶段的肿瘤免疫治疗药物。根据协议条款，基石药业将获得1.5亿美元的首付款，及最高可达11.5亿美元的里程碑付款以及额外的分级特许权使用费。EQRx公司将获得舒格利单抗和CS1003在除中国大陆、中国台湾、中国香港和中国澳门(“大中华区”)以外的全球市场的独家商业化权利。基石药业将保留CS1003在大中华区的开发和商业化权利，并将继续探索其作为单药和联合疗法的骨架产品的发展前景。
根据披露，舒格利单抗是由基石药业开发的在研抗PD-L1单克隆抗体。舒格利单抗由美国Ligand Pharmaceuticals公司(纳斯达克股份交易代码：LGND)授权引进的OmniRat®转基因动物平台，该平台可实现全人源抗体的一站式生产。作为一种全人源全长抗PD-L1单克隆抗体，舒格利单抗是一种最接近人体的天然G型免疫球蛋白4(“IgG4”)单抗药物。与同类药物相比，舒格利单抗在患者体内产生免疫原性及相关毒性的风险更低，这使得舒格利单抗具有独特的优势。
舒格利单抗已在中国完成I期剂量递增研究。在Ia期和Ib期研究中，舒格利单抗在多个瘤种中均表现出良好的抗肿瘤活性和耐受性。目前，舒格利单抗正在进行多项临床试验，除了一项美国桥接性I期研究外，在中国，舒格利单抗正开展一项针对多个癌种的多臂Ib期研究、一项淋巴瘤注册性II期研究和四项分别在III/IV期非小细胞肺癌(“NSCLC”)、胃癌和食管癌患者的III期注册性临床试验。其中舒格利单抗治疗IV期NSCLC患者的III期临床试验达到主要终点，新药上市申请已经获得中国国家药品监督管理局受理。
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