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奧賽康(002755.SZ):注射用地西他濱通過仿製藥一致性評價
格隆匯 05-26 19:52

格隆匯5月26日丨奧賽康(002755.SZ)公佈,公司的全資子公司江蘇奧賽康藥業有限公司(“子公司”)於近日收到國家藥品監督管理局(“藥監局”)核准簽發的注射用地西他濱《藥品補充申請批准通知書》,批該藥品通過仿製藥質量和療效一致性評價。

地西他濱由衞材製藥(Eisai)研製和開發,於1964年首次被合成,1996被批准用於治療骨髓增生異常綜合徵(MDS),之後大量的研究證實了地西他濱的有效性。2006年被美國食品藥品監督管理局及歐洲批准上市用於治療MDS2010FDA批准5天給藥方案治療MDS2008年在國內批准進口上市用於治療骨髓異常增生綜合徵(MDS);2012年被歐洲藥管局批准用於治療老年急性髓系白血病。該品種系CDE“舉手發言”核查品種,我公司首批通過了現場核查並獲批上市,於2013222日取得注射用地西他濱(規格:50mg)生產批件,批准文號為國藥準字H201330802015215日取得注射用地西他濱(規格:25mg)生產批件,批准文號為國藥準字H20153037

地西他濱是通過磷酸化後直接摻入DNA,抑制DNA甲基化轉移酶,引起DNA低甲基化和細胞分化或凋亡而發揮抗腫瘤作用。地西他濱誘導腫瘤細胞的低甲基化,從而恢復控制細胞分化和增殖基因的正常功能。在快速分裂的細胞中,摻入DNA的地西他濱可與DNA甲基轉移酶共價結合從而產生細胞毒性作用。而非增殖期細胞則對地西他濱相對不敏感。PDB數據庫顯示2020年樣本醫院銷售額為1.69億元,臨牀需求大,市場規模可觀。

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