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恆瑞醫藥(600276.SH):SHR7280片獲批開展臨牀試驗
格隆匯 09-16 18:56

格隆匯9月16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,202179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。

方案編號:SHR7280-201探索進行輔助生殖技術(ART)治療的女性受試者中口服不同劑量SHR7280片在控制性超促排卵(COH)過程中的有效性、安全性及耐受性的多中心、開放II期臨牀研究。

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 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。在輔助生殖治療過程中應用SHR7280可抑制早發黃體生成素峯,提高治療成功率。國內外尚無該適應症的口服同類產品獲批上市。

截至目前,SHR7280相關研發項目累計已投入研發費用約6429萬元。

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