基石药业-B(02616.HK)：PD-L1抗体舒格利单抗治疗T细胞淋巴瘤获美国FDA授予孤儿药资格认定
格隆汇 10 月 19日丨基石药业-B(02616.HK)发布公告，美国食品药品监督管理局(“FDA”)授予其PD-L1舒格利单抗(CS1001)孤儿药资格，用于治疗T细胞淋巴瘤。这是继2020年7月美国FDA授予其抗PD-1单抗CS1003用于治疗肝细胞癌的孤儿药资格后，基石药业免疫疗法产品线获得美国FDA授予的第二个孤儿药资格认定。
美国FDA孤儿药资格认定源自“孤儿药法案”，是美国FDA鼓励开发用于治疗罕见病创新药的措施。凡获得孤儿药资格认定的新药，其赞助人可获得七年市场独占权。除此之外，美国FDA对孤儿药有税费优惠、减免处方药使用者费用、研发资助、方案协助和快速审批通道等一系列的配套措施。
CS1001-201研究是一项评估舒格利单抗单药治疗复发或难治性(「R/R」)结外自然杀伤细胞/T细胞淋巴瘤(“ENKTL”)有效性及安全性的单臂、多中心、II期关键性研究，研究主要终点为独立影像评估委员会评估的客观缓解率(「ORR」)。于2020年8月31日，II期关键性研究的试验性新药申请已经通过美国FDA的审评，并取得了开展研究的许可函。
基石药业首席医学官杨建新博士表示：“T细胞淋巴瘤包含不同的病理亚型，ENKTL是其中预后较差的一种亚型，患者正面临着显着的未被满足的治疗需求，舒格利单抗相比现有药物的疗效资料是一个巨大的突破。此次美国FDA授予舒格利单抗孤儿药资格，充分证明了这款药物的巨大临床价值。我们将继续全力推进该研究，并与美国FDA和中国国家药品监督管理局密切协作，力争早日把舒格利单抗带给全球患者。”
在中国，ENKTL约占所有淋巴瘤的6%。R/R ENKTL恶性程度高且侵袭性强，预后较差，一年生存率不足20%。目前在中国获批的靶向单药治疗完全缓解率(“CR”)约为6%。CS1001-201研究作为全球首个针对R/RENKTL的舒格利单抗单药治疗研究，在2020年中国临床肿瘤协会年会上，口头汇报了最新的研究结果。截至2020年7月1日，在38例疗效可评估患者中，ORR为44.7%，CR为31.6%，中位缓解持续时间为16.8个月，67.8%的缓解持续时间超过一年。接受给药的43例患者，中位总生存期19.7个月，一年生存率为55.5%。
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