恆瑞醫藥(600276.SH):SHR5126片獲得臨牀試驗通知書
格隆匯2月24日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限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。
藥品名稱:SHR5126片;劑型:片劑;規格:25mg、100mg;申請事項:臨牀試驗;申請人:江蘇恆瑞醫藥股份有限公司、上海恆瑞醫藥有限公司;受理號:CXHL1900399、CXHL1900400;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,2019年12月5日受理的SHR5126片符合藥品註冊的有關要求,同意按照提交的方案開展臨牀試驗。
2019年12月5日,公司向國家藥監局遞交本品臨牀試驗申請獲受理。SHR5126是一種新型、強效、高選擇性的口服A2AR拮抗劑,能顯著抑制人A2AR活性,抑制細胞核內pCREB水平,進一步增強免疫檢查點藥物激活腫瘤浸潤性CD8+T細胞,通過分泌IFNγ等發揮抑制腫瘤細胞生長的作用,擬用於治療實體瘤患者。
目前,國內外在研的口服小分子A2AR拮抗劑共有3個,分別為Corvus開發的CPI-444,諾華開發的PBF-509和阿斯利康開發的AZD4635。其中,除PBF-509已進入II期臨牀試驗階段外,其他均處於I/Ib期臨牀試驗階段。國內外現無同類產品上市銷售,亦無銷售數據。
截至目前,該產品項目已投入研發費用約為2308萬元人民幣。
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,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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