科倫藥業(002422.SZ)地屈孕酮片獲得藥品註冊批准
格隆匯9月18日丨科倫藥業(002422.SZ)公佈,公司的化學藥品"地屈孕酮片"於近日獲得國家藥品監督管理局的藥品註冊批准。
據悉,地屈孕酮片為雅培開發,目前已在 100 多個國家獲批上市,用於治療內源性孕酮不足引起的相關疾病,如痛經、子宮內膜異位症、孕激素缺乏所致先兆性流產或習慣性流產及輔助生殖技術中的黃體支持等。地屈孕酮為結構和功能最接近天然孕激素的一種合成孕激素,與天然孕激素黃體酮相比,其生物利用度更高、給藥頻率更低且肝臟安全性更優;與傳統合成孕激素相比,其無雌激素、雄激素和皮質激素作用,不增加乳腺癌的發生風險。目前其已被中國《閉經診斷與治療指南(2023 版)》、中國《子宮內膜異位症診治指南(第三版)(2021)》、中國《孕激素維持妊娠與黃體支持臨牀實踐指南(2021)》和日本《臨牀實踐指南:子宮內膜異位症(第 3 版)(2022)》等國內外權威指南推薦廣泛用於多種婦產科疾病。地屈孕酮片為國家醫保乙類品種,2023 年中國銷售為 20.5 億元。
生殖健康為公司的重點核心領域,目前公司在該領域已有多個產品獲批上市,本次地屈孕酮片為國產前 3 家獲批,這將進一步提升公司在生殖健康領域的管線競爭力。

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