恒瑞醫藥(600276.SH):子公司獲得藥物臨牀試驗批准通知書
格隆匯11月26日丨恒瑞醫藥(600276.SH)公吿,近日,江蘇恒瑞醫藥股份有限公司(以下簡稱“公司”)子公司蘇州盛迪亞生物醫藥有限公司收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發關於注射用SHR-A2009、SHR-8068注射液的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
注射用SHR-A2009是公司自主研發的一款以HER3為靶點的抗體藥物偶聯物,可特異性結合腫瘤細胞表面上的HER3,進而被內吞至細胞內並轉運至溶酶體中,水解釋放遊離毒素,殺傷腫瘤細胞。全球尚未有同類藥物獲批上市。截至目前,注射用SHR-A2009相關項目累計已投入研發費用約4,992萬元。
SHR-8068注射液是公司引進的一款全人源抗CTLA-4單克隆抗體,可增強抗腫瘤免疫效應。目前全球共有兩款同類產品獲批上市,分別是伊匹木單抗和替西木單抗,經查詢,2022年伊匹木單抗全球銷售額約為21億美元。截至目前,SHR-8068注射液相關項目累計已投入研發費用約為8,757萬元。
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