復星醫藥(02196.HK):阿達木單抗注射液新增適應症補充申請獲批
格隆匯5月22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“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(以下合稱“復宏漢霖”)自主研發的漢達遠®(即阿達木單抗注射液,以下簡稱“該藥品”)新增(1)多關節型幼年特發性關節炎、(2)兒童斑塊狀銀屑病、(3)克羅恩病、及(4)兒童克羅恩病4項適應症(以下合稱“本次新增適應症”)的補充申請於近日獲國家藥品監督管理局批准。
該藥品為集團(即公司及控股子公司/單位,下同)自主研發的阿達木單抗生物類似藥。截至本公吿日,該藥品已獲批的適應症包括(1)類風濕關節炎、(2)強直性脊柱炎、(3)銀屑病、(4)葡萄膜炎、(5)多關節型幼年特發性關節炎、(6)兒童斑塊狀銀屑病、(7)克羅恩病、及(8)兒童克羅恩病。截至2024年4月,本集團現階段針對該藥品的累計研發投入約為人民幣28,866萬元(未經審計)。
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