基石药业-B(02616.HK)在2020年CSCO年会上公布其CS1001两项重要研究资料
格隆汇 9 月 24日丨基石药业-B(02616.HK)发布公告，基石药业在2020年中国临床肿瘤协会(“CSCO”)学术年会上公布了抗PD-L1单克隆抗体舒格利单抗(CS1001)的两项重要研究资料，分别为1)舒格利单抗单药治疗复发或难治性结外自然杀伤细胞/T细胞淋巴瘤(“R/RENTKL”)的CS1001-201研究和2)舒格利单抗联合化疗治疗胃腺癌或胃食管交界处腺癌(“GE/GEJ”)的CS1001-101研究。舒格利单抗是由基石药业开发研究药物，如近期研究及早前报告相关资料表明，舒格利单抗在多种实体瘤和淋巴瘤中表现出良好的疗效及安全性，包括在近期针对非小细胞肺癌(“NSCLC”)患者进行的关键性III期试验中显示出积极结果。
基石药业首席医学官杨建新博士表示：“我们很高兴看到舒格利单抗单药和联合化疗在R/RENKTL和GC/GEJ患者中持续展现了优异的抗肿瘤活性和良好的安全性。CS1001-201是全球首个针对R/RENKTL的抗PD-L1注册临床研究，目前研究正在由中国扩展至美国。舒格利单抗联合XELOX方案在GC/GEJ患者中取得的优异结果，使我们对于正在进行的舒格利单抗联合XELOX方案用于GC/GEJ患者的III期试验CS1001-303研究(NCT03802591)充满信心。我们会继续全力推进舒格利单抗的研发，尽早惠及更多肿瘤患者。”
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公司授权引进的OmniRat?转基因动物平台产生，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，这使得舒格利单抗在安全性方面具有独特的优势。
舒格利单抗已在中国完成I期临床试验剂量爬坡。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，基石药业计划近期向中国国家药品监督管理局递交新药上市申请。
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