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奧賽康(002755.SZ):子公司注射用奈達鉑首家通過仿製藥一致性評價
格隆匯 01-25 20:35

格隆匯 1 月 25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”)核准簽發的注射用奈達鉑《藥品補充申請批准通知書》,批準該藥品首家通過仿製藥質量和療效一致性評價。

奈達鉑是一種烷化劑類抗腫瘤藥,進入細胞水解後與DNA結合,通過阻礙DNA的複製發揮抗腫瘤作用。奈達鉑由日本鹽野製藥公司研發,於1995年在日本上市,規格為10mg50mg100mg子公司研製的注射用奈達鉑(奧先達®)20049月在國內首批上市,商品名:奧先達®,規格有10mg20mg50mg100mg20194子公司首家向CDE提交注射用奈達鉑10mg注射用奈達鉑50mg質量一致性評價補充申請,近期首家獲得注射用奈達鉑10mg、注射用奈達鉑50mg藥品補充註冊批件

鉑類抗癌藥物是當今惡性腫瘤化療的基石,奈達鉑是新型第二代鉑類抗癌藥物,可用於治療頭頸部癌、小細胞肺癌、非小細胞肺癌、食管癌、膀胱癌、精巢(睾丸)腫瘤、卵巢癌、宮頸癌等實體瘤。由於奈達鉑與順鉑沒有完全交叉耐,可以有效治療對鉑類耐藥的腫瘤患者;奈達鉑的毒性與順鉑不一樣,它的劑量限制性毒性為骨髓抑制所引起的血小板降低,腎毒性與胃腸道不良反應比順鉑稍輕。PDB數據庫顯示2019年中國樣本醫院銷售額達2億元,有較好的臨牀需求和市場潛力

據國家相關政策,通過一致性評價的藥品品種,質量和療效等同原研產品,在醫保支付及醫療機構採購方面將予以適當支持。在國家鼓勵優先採購和使用通過一致性評價的產品的政策背景下,注射用奈達鉑通過仿製藥一致性評價有利於進一步增強該藥品的技術優勢,提升市場競爭力,擴大市場份額。

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