復星醫藥(600196.SH):阿達木單抗注射液的上市註冊申請獲批准
格隆匯 12 月 7日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海復宏漢霖生物技術股份有限公司及其控股子公司研製的阿達木單抗注射液(即重組抗TNFα全人單克隆抗體注射液,商品名稱:漢達遠®;以下簡稱“該新藥”)用於治療類風濕關節炎、強直性脊柱炎、銀屑病的上市註冊申請獲國家藥品監督管理局批准。
該新藥為集團自主研發的單抗生物類似藥,主要用於類風濕關節炎、強直性脊柱炎、銀屑病的治療。該新藥的生產場地及設施已通過上海市藥品監督管理局的GMP符合性現場檢查。
截至2020年10月,集團現階段針對該新藥累計研發投入約人民幣26410萬元(未經審計)。
該新藥此次獲上市註冊批准,可以為類風濕關節炎、強直性脊柱炎、銀屑病患者帶來更多的治療選擇,並豐富了集團產品線。預計該新藥本次獲上市註冊批准不會對集團現階段業績產生重大影響。
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