中国生物制药(01177.HK):抗肿瘤药“盐酸安罗替尼胶囊”获批第四个适应症
格隆汇2月4日丨中国生物制药(01177.HK)发布公告,集团自主研发的抗肿瘤药“盐酸安罗替尼胶囊”(“安罗替尼”)(商品名:福可维)已获中国国家药品监督管理局颁发药品注册证书,批准用于治疗甲状腺髓样癌。这是继晚期非小细胞肺癌、软组织肉瘤、小细胞肺癌后,安罗替尼获批的第四个适应症。新适应症的获批,标志着安罗替尼成为国内首个可用于治疗甲状腺髓样癌的靶向药。
甲状腺癌是最常见的内分泌恶性肿瘤,也是近年来发病率增长最快的肿瘤之一。而甲状腺髓样癌起源于分泌降钙素的甲状腺滤泡旁细胞,约占所有甲状腺癌的1-2%,却占甲状腺癌死亡率的13.4%,国内尚无新药在该领域获批,患者迫切需要治疗药物。作为首个在国内获批治疗甲状腺髓样癌的小分子多靶点受体酪氨酸激酶抑制剂,安罗替尼打破了甲状腺髓样癌无药可治的僵局,为临床医生提供了治疗选择,造福甲状腺髓样癌患者。
此外,安罗替尼与化疗、PD-1、PD-L1的联合用药正在广泛布局,目前有20余项临床试验进入二期或三期临床。安罗替尼单药也有针对10多个癌种的临床研究进入二期或三期临床。随着适应症的不断拓展,安罗替尼将成为集团的拳头品种,不断为集团创新药研发注入新鲜血液。
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