復星醫藥(02196.HK)控股子公司獲疫苗臨牀試驗批准
格隆匯3月4日丨復星醫藥(02196.HK)公吿,上海復星醫藥(集團)股份有限公司(以下簡稱“本公司”)控股子公司復星安特金(成都)生物製藥有限公司(以下簡稱“復星安特金”)於近日收到國家藥品監督管理局關於24價肺炎球菌多糖結合疫苗(申請註冊分類:預防用生物製品1.4類;以下簡稱“24價肺炎疫苗”或“該疫苗”)的臨牀試驗批准。復星安特金擬於條件具備後於中國境內(不包括港澳台地區,下同)開展該疫苗的I期臨牀試驗。
該疫苗為集團(即公司及控股子公司/單位,下同)自主研發的預防用生物製品,擬用於預防由肺炎球菌血清型1、2、3、4、5、6A、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F和33F引起的感染性疾病。該疫苗採用本集團擁有自主知識產權的平台技術將多糖抗原與載體蛋白結合,可以在6周齡及以上人羣體內誘導產生針對多糖的T細胞依賴性免疫應答及免疫記憶。截至2025年1月,集團現階段針對該疫苗的累計研發投入約為人民幣0.44億元(未經審計)。
截至本公吿日期(即2025年3月4日),於全球範圍內尚無24價肺炎球菌多糖結合疫苗獲批上市。
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