基石药业-B(02616.HK)：中国国家药监局批准泰吉华(阿伐替尼片)新药上市申请
格隆汇3月31日丨基石药业-B(02616.HK)发布公告，中国国家药品监督管理局批准泰吉华（阿伐替尼片）新药上市申请，用于治疗血小板衍生生长因子受体A(PDGFRA)外显子18突变（包括PDGFRA D842V突变）不可切除或转移性胃肠道间质瘤(GIST)成人患者。泰吉华由基石药业合作伙伴Blueprint Medicines公司开发，该药是中国首个用于治疗PDGFRA外显子18突变型GIST患者的精准治疗药物，其通过专门的设计来针对该疾病的驱动基因。
基石药业董事长、执行董事兼首席执行官江宁军博士表示：泰吉华是基石药业同月内获批上市的第二款产品，该产品是针对PDGFRA外显子18突变型GIST的同类首创药物。此次获批是对基石药业整个团队努力的充分肯定。公司感谢所有参与泰吉华临床研究的患者和研究者的付出和贡献，同时，也非常感谢国家药监局为泰吉华获批而开展的优先审评审批工作，旨在致力于共同解决中国癌症患者迫切的尚未被满足的医疗需求。随着公司两款精准治疗药物的相继获批上市，公司将继续不遗余力的为全球癌症患者带来更多同类首创和同类最优的肿瘤治疗药物。
北京大学肿瘤医院副院长沈琳教授表示：一直以来，PDGFRA外显子18突变的GIST患者缺乏治疗药物。泰吉华在PDGFRA外显子18突变的中国晚期GIST患者中表现出了非常好的抗肿瘤活性，且安全性和耐受性良好。泰吉华在国内获批，无疑将为这部分患者带来巨大的生存获益。
据悉，泰吉华是一种激酶抑制剂，已获中国国家药品监督管理局批准，用于治疗携带PDGFRA外显子18突变（包括PDGFRA D842V突变）的不可切除性或转移性GIST成人患者。在美国，美国食品药品监督管理局批准其以商品名AYVAKITTM上市销售，用于治疗携带PDGFRA外显子18突变（包括PDGFRA D842V突变）的不可切除性或转移性GIST成人患者。在欧盟，欧洲药品管理局批准其以商品名AYVAKYT上市销售，用于治疗携带PDGFRA D842V突变无法切除或转移性胃肠道间质瘤成人患者阿伐替尼在中国、美国、欧盟还未获批用于其他适应症，或者其它地区的医疗监管机构均还未对阿伐替尼的任何适应症做出批准决定。
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