恆瑞醫藥(600276.SH):SHR7280片獲批開展臨牀試驗
格隆匯2月23日丨恆瑞醫藥(600276.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發關於 SHR7280片的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年11月21日受理的SHR7280片符合藥品註冊的有關要求,同意開展臨牀試驗。具體為在伴有月經過多的子宮肌瘤受試者中探索SHR7280片的最佳有效治療劑量以及該劑量SHR7280片的有效性和安全性的多中心、隨機、雙盲、平行分組、安慰劑對照的II/III期臨牀研究(方案編號:SHR7280-301)。
SHR7280是一種口服小分子促性腺激素釋放激素(GnRH)受體拮抗劑,可以阻斷內源性GnRH與GnRH受體的結合,抑制黃體生成素(LH)和卵泡刺激素(FSH)等促性腺激素的合成和釋放,降低睾酮和雌二醇等性激素水平。雌二醇激素水平過高可導致子宮肌瘤的發生和發展,因此通過調控GnRH受體,降低LH和FSH水平,可以治療子宮肌瘤。國外有口服小分子GnRH拮抗劑Elagolix (艾伯維,商品名Orilissa)與Relugolix (Myovant Sciences,商品名 Orgovyx)已獲批子宮肌瘤適應症,國內尚無該適應症的口服同類產品獲批上市。經查詢Evaluate Pharma數據庫,2020年Elagolix與Relugolix的全球銷售額合計約1.8億美元。截至目前,SHR7280相關研發項目累計已投入研發費用約8007萬元。
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