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恆瑞醫藥(600276.SH):用於標準治療失敗的晚期惡性腫瘤藥注射用SHR-1802獲批臨牀試驗
格隆匯 11-21 15:35

格隆匯11月20日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗。

注射用SHR-1802為我公司自主研發和生產的人源化單克隆抗體,可激活和促進抗腫瘤T細胞應答,發揮抗腫瘤作用,用於標準治療失敗的晚期惡性腫瘤。

經查詢,國內外現無同類產品上市銷售,亦無銷售數據。國外有MGD-013relatlimab等產品處於臨牀試驗階段,國內有IBI-110LBL-007等產品處於臨試驗階段。

截至目前,該產品項目已投入研發費用約為1666萬元人民幣。

根據我國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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