復星醫藥(600196.SH):重組抗CD73全人源單抗注射液在美獲批臨牀試驗
格隆匯5月31日丨復星醫藥(600196.SH)宣佈,近日,公司控股子公司Hengenix Biotech收到美國FDA關於同意重組抗CD73全人源單克隆抗體注射液(即HLX23)用於晚期實體瘤治療進行臨牀試驗的函(IND編號:153041)。Hengenix Biotech擬於條件具備後於美國進行該新藥的臨牀試驗。
該新藥為集團自主研發的抗CD73(胞外-5'-核苷酸酶)創新型全人源IgG2單克隆抗體藥物,擬用於晚期實體瘤治療(包括黑色素瘤、非小細胞肺癌、肝細胞癌等)。截至該公吿日,全球範圍內尚無靶向CD73的單克隆抗體藥品上市。
截至2021年4月,集團現階段針對該新藥累計研發投入約為人民幣6293萬元(未經審計)。
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