基石药业-B(02616.HK)：国家药监局批准普吉华新药上市申请
格隆汇3月24日丨基石药业-B(02616.HK)公布，中国国家药品监督管理局批准普吉华（普拉替尼胶囊）新药上市申请，用于既往接受过含铂化疗的转染重排(RET)基因融合阳性的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的治疗。普拉替尼由基石药业合作伙伴Blueprint Medicines公司开发，是中国第一个获批上市的选择性RET抑制剂，同时也是基石药业首个商业化上市的产品。
ARROW研究是一项旨在评估普拉替尼在RET融合阳性NSCLC、RET突变型甲状腺髓样癌和其他RET融合的晚期实体瘤患者中的安全性、耐受性和有效性的全球I/II期临床研究。ARROW研究资料显示，普拉替尼在经含铂化疗的RET融合阳性的NSCLC中国患者中显示出了优越和持久的抗肿瘤活性，总体缓解率(ORR) 为56%，中位缓解持续时间(DOR)未达到，6个月的DOR率为83%。安全性及耐受性良好，未出现与普拉替尼相关的不良事件导致的终止治疗或死亡。
基石药业董事长、执行董事兼首席执行官江宁军博士表示：“这是一个历史性的重要时刻，普吉华的获批印证了基石药业立足解决患者未满足的临床痛点与诉求的决心，并体现了基石药业将创新药物快速推向市场的能力。公司感谢所有为普吉华的临床开发做出贡献的患者和研究者们，以及国家药监局为普吉华的获批而开展的优先审评审批工作，同时也非常感谢各级政府给予的支持。公司将继续全力推进普吉华在中国的研发，更广泛地评估其在包括一线NSCLC、甲状腺癌和其它实体瘤患者中的疗效，尽快惠及更多患者”。
ARROW研究主要研究者、广东省人民医院吴一龙教授表示：“在肺癌精准治疗领域，RET靶点的研发是一个巨大的突破。ARROW研究的优异资料结果有力支援了此次普吉华?在中国获批，并有望改变国内RET融合阳性NSCLC患者的治疗标准”。
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