中國生物製藥(01177.HK):"注射用地西他濱"獲通過一致性評價
格隆匯 3 月 12日丨中國生物製藥(01177.HK)宣佈,集團研製的抗血液腫瘤藥"注射用地西他濱"(商品名:晴維可)(規格:10mg、25mg、50mg)已獲中華人民共和國國家藥品監督管理局頒發藥品補充申請批准通知書,通過了仿製藥質量和療效一致性評價。
地西他濱是一種去氧核糖核酸(DNA)甲基化特異性抑制劑,通過摻入DNA中抑制DNA甲基轉移酶,引起DNA低甲基化和細胞分化或凋亡而發揮抗腫瘤作用。地西他濱在治療高危骨髓增生異常綜合症(MDS)、難治及複發率高的急性髓性白血病(AML)和慢性粒細胞白血病(CML)的臨牀應用中表現出良好的療效。
自2012年上市至今,集團研製的注射用地西他濱生產量及銷售量逐年增加。此次通過了一致性評價,其可成為進口製劑的替代產品的價值受到肯定,為廣大臨牀醫生和患者提供了治療骨髓增生異常綜合症又一重要選擇。
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