基石药业-B(02616.HK)：普拉替尼RET融合非小细胞肺癌适应症上市申请已获NMPA受理并纳入优先审评
格隆汇 9 月 7日丨基石药业-B(02616.HK)发布公告，国家药品监督管理局(“NMPA”)已受理基石药业普拉替尼胶囊(“普拉替尼”)的新药上市申请(“NDA”)并纳入优先审评，用于治疗经含铂化疗的RET融合阳性的非小细胞肺癌(“NSCLC”)患者。普拉替尼是由基石药业战略合作伙伴Blueprint Medicines Corporation(纳斯达克股份代号：BPMC)(“Blueprint Medicines”)开发的一款口服、强效和高选择性靶向致癌性RET变异(包括可预见的耐药突变)的在研药物。在基石药业正在开展的注册桥接试验中，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，并且安全性及耐受性良好，这一结果与先前ARROW研究中全球患者人群报告的资料结果一致。
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，针对RET靶点的研发是继EGFR、ALK、ROS1和NTRK等靶点后另一个巨大的突破。目前，国内尚无选择性RET抑制剂获批。对于RET融合阳性NSCLC患者，国内尚存在巨大未满足的临床治疗需求。普拉替尼在全球性试验以及在中国NSCLC患者中的研究结果令我们对其在国内的上市及其对患者带来的获益充满期待。”
基石药业董事长兼首席执行官江宁军博士表示：“我们很高兴看到NMPA已受理普拉替尼用于治疗经含铂化疗的RET融合阳性NSCLC的适应症上市申请，并将其纳入优先审评。这是基石药业今年在全球递交的第三个、中国大陆递交的第二个新药上市申请，充分表明了基石药业正在商业化战略转型的道路上加速迈进。我们期待普拉替尼早日在国内上市，为中国广大RET融合阳性NSCLC患者带来新的治疗希望。”
基石药业首席医学官杨建新博士表示：“我们很高兴看到普拉替尼在临床试验中展现了快速和持久的抗肿瘤活性以及良好的安全性及耐受性。值得一提的是，从我们与Blueprint Medicines Corporation达成合作到普拉替尼在国内成功递交上市申请仅用了2年时间。我们将继续全力推进普拉替尼在中国的研发进展，更广泛地评估该产品在未经含铂化疗的RET融合阳性的NSCLC、甲状腺髓样癌和其它实体瘤患者中的疗效，早日满足这部分癌症患者亟待解决的临床需求。”
根据基石药业和Blueprint Medicines签订的独家合作及授权授权合约，基石药业拥有普拉替尼单药或联合治疗在大中华地区(包括中国大陆、中国香港特别行政区、中国澳门特别行政区和中国台湾)的临床开发与商业化权利。在大中华地区外，Blueprint Medicines与罗氏和基罗氏集团成员Genentech达成了普拉替尼的全球合作。通过合作，罗氏将获得普拉替尼在大中华地区和美国以外市场的全球独家许可，以及在美国和Blueprint Medicines共同开发和商业化普拉替尼的权利。
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