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復星醫藥(02196.HK):抗人T細胞兔免疫球蛋白用於預防造血幹細胞移植術後的移植物抗宿主病(GvHD)獲臨牀試驗批准

格隆匯9月22日丨復星醫藥(02196.HK)公吿,公司控股子公司上海復星醫藥產業發展有限公司於近日收到國家藥品監督管理局關於同意其獲許可產品抗人T細胞兔免疫球蛋白(以下簡稱“該藥品”,中國境內商標:復可舒 、英文商品名:Grafalon )用於預防造血幹細胞移植術後的移植物抗宿主病(GvHD)的臨牀試驗批准。復星醫藥產業擬於條件具備後於中國境內(不包括港澳台地區,下同)開展該藥品新增適應症的臨牀試驗。

該藥品為已上市的治療用生物製品,由復星醫藥產業於 2022 年 9 月獲瑞士Neovii Pharmaceuticals AG 許可於區域內(即中國內地及港澳台地區)及約定領域內獨家臨牀開發和商業化。截至本公吿日,該藥品於中國境內已獲批適應症為實體器官移植(SOT)中排斥反應的預防,以及在皮質激素治療效果不滿意的情況下,用於治療急性排斥危象。該藥品用人體 Jurkat 細胞系的 T-淋巴母細胞免疫兔獲得血清經分離而成。

截至本公吿日,除該藥品外,於中國境內已上市同類療法的其它產品包括 Genzyme EuropeB.V.的兔抗人胸腺細胞免疫球蛋白和武漢中生毓晉生物醫藥有限責任公司的抗人 T細胞豬免疫球蛋白。根據 IQVIA CHPA 最新數據,2022年,該等產品在中國境內的銷售金額約為人民幣 6.40 億元。

截至2023年8月,集團現階段針對該藥品的累計研發投入約為人民幣3,065萬元(未經審計;包括許可費)。

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