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恆瑞醫藥(600276.SH):SHR7280片治療前列腺癌獲批臨牀
格隆匯 06-25 15:40

格隆匯6月25日丨恆瑞醫藥(600276.SH)宣佈,公司近日收到國家藥監局準簽發關於SHR7280片的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。

根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年4月16日受理的SHR7280片符合藥品註冊的有關要求,同意該藥品在前列腺癌患者中進行臨牀試驗。

SHR7280是一種口服小分子GnRH受體拮抗劑,可以阻斷內源性GnRH與GnRH受體的結合,抑制黃體生成素和卵泡刺激素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。

目前Myovant Sciences和輝瑞合作開發的Relugolix成人晚期前列腺癌適應症已在美國獲批上市,國內尚無該適應症的口服同類產品獲批上市。經查詢EvaluatePharma數據庫,Relugolix 2020年全球銷售數據約為5400萬美元。

截至目前,SHR7280相關研發項目累計已投入研發費用約為5038萬元。

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