恆瑞醫藥(600276.SH):擬用於晚期惡性腫瘤治療的SHR2150注射液獲批臨牀試驗
格隆匯3月17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、蘇州盛迪亞生物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。
2019年12月13日,恆瑞醫藥和子公司上海恆瑞醫藥有限公司、蘇州盛迪亞生物醫藥有限公司向國家藥監局遞交的臨牀試驗申請獲受理。
SHR2150注射液擬用於晚期惡性腫瘤的治療。其它同類藥物尚處於臨牀開發階段,從作用機制和目前研發進展來看,此類藥物與其他藥物(免疫檢查點抑制劑和靶向藥物等)聯用治療晚期惡性腫瘤具有良好的開發前景。國內外尚無同類產品獲批上市,亦無相關銷售數據。
截至目前,該產品項目已投入研發費用約為4038萬元人民幣。
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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