恆瑞醫藥(600276.SH):注射用SHR-A1904治療晚期實體瘤獲美國FDA臨牀試驗資格
格隆匯9月24日丨恆瑞醫藥(600276.SH)公佈,近日,公司收到美國食品藥品監督管理局(“美國FDA”)關於同意注射用SHR-A1904治療晚期實體瘤的臨牀研究的函,公司將於近期開展 I/IIa 期臨牀試驗。
此次獲得美國FDA臨牀試驗資格後,注射用SHR-A1904治療晚期實體瘤的臨牀研究計劃在美國、澳洲和亞太地區開展。根據美國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗資格後,尚需開展臨牀試驗並經美國 FDA 審評審批通過後方可生產上市。
本品為靶向腫瘤特異性抗原的抗體藥物偶聯物,通過與腫瘤細胞表面的靶抗原結合,使得藥物被內吞進入細胞後釋放小分子毒素殺傷腫瘤細胞。目前全球尚未有同類藥物獲批上市,亦無相關銷售數據。截至目前,SHR-A1904 相關研發項目累計已投入研發費用約5310萬元。
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