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長春高新(000661.SZ):子公司水溶性黃體酮注射液獲批臨牀
格隆匯 02-07 16:38

格隆匯2月7日丨長春高新(000661.SZ)公佈,近日,公司控股子公司金賽藥業收到了國家藥品監督管理局關於水溶性黃體酮注射液臨牀試驗批准通知書。

根據《中華人民共和國藥品管理法》及有關規定,經審查,2022年11月15日受理的水溶性黃體酮注射液符合藥品註冊的有關要求,同意開展臨牀試驗。申請的適應症為適用於輔助生殖技術(ART)治療中無法使用或不耐受陰道製劑但需要額外黃體酮的女性。

輔助生殖健康為公司重點領域,黃體酮是臨牀維持妊娠常用且必需的藥物,水溶性黃體酮注射液具有更高的生物利用度和更少的注射痛疼感,能更好的滿足患者臨牀治療的依從性。

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