中生制药(01177.HK):抗肿瘤药“来那度胺胶囊”通过一致性评价
格隆汇10月29日丨中国生物制药(01177.HK)宣布,集团的抗肿瘤药“来那度胺胶囊”(商品名:安显)(规格为:5mg及10mg)已获得中华人民共和国国家药品监督管理局颁发药品补充申请批准通知书,通过了仿制药质量和疗效一致性评价,为来那度胺胶囊该两个规格国内第二家通过一致性评价。至此,集团的来那度胺胶囊的所有上市规格(5mg、10mg及25mg)均通过了一致性评价。
来那度胺是人工合成的谷氨酸衍生物,具有抑制血管生成和免疫调节的作用。来那度胺与地塞米松合并用于曾至少接受过一次其他治疗形式的多发性骨髓瘤患者的治疗。由于治疗效果好、安全性高、给药方式方便等优势,来那度胺已成为靶向治疗多发性骨髓瘤的首选药物。
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