中国生物制药(01177.HK)抗肿瘤药甲磺酸伊马替尼通过一致性评价
格隆汇8月1日丨中国生物制药(01177.HK)宣布,公司附属公司正大天晴药业集团股份有限公司的抗肿瘤药"甲磺酸伊马替尼胶囊"(商品名称"格尼可®")获得中华人民共和国国家药品监督管理局批准通过仿制药质量和疗效一致性评价。
甲磺酸伊马替尼是一种Bcr-Abl酪氨酸激酶抑制剂,用yu 治疗慢性髓性白血病(CML)的急变期、加速期或α-干扰素治疗失败的慢性期患者。甲磺酸伊马替尼胶囊口服吸收生物利用度高、疗效好,而且副作用少、安全性高;相对骨髓移植等其他治疗方式而言,甲磺酸伊马替尼治疗的总生存率明显提高,也更为经济和安全。目前,甲磺酸伊马替尼已成为国际上一线治疗慢性期成人费城染色体阳性(Ph+)的慢性髓性白血病的首选治疗方法。
集团开发的甲磺酸伊马替尼胶囊格尼可,2013年获批国内首仿上市,自此销售快速增长,2018年度销售收入突破人民币2.4亿元、销售量达1,000余万粒。通过了一致性评价,格尼可获确认其品质和疗效与原研药一致,可实现原研药的临床替代,能为患者提供优质低价的用药选择,同时也使该产品在市场拓展、医保支付等层面上可获得更多优势。
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