諾誠健華(09969.HK)Tafasitamab聯合來那度胺治療復發/難治DLBC上市申請獲香港受理
諾誠健華(09969.HK)公布,「Tafasitamab」聯合來那度胺治療不適合自體幹細胞移植條件的後發/難治瀰漫性大B細胞淋巴瘤(DLBCL)成人患者的生物製品許可申請,已獲香港衛生署受理。
集團指,「Tafasitamab」是一款靶向CD19的Fc結構域優化的人源化單克隆抗體,除在博鰲樂城國際醫療旅遊先行區批准用於治療符合條件的DLBCL患者,「Tafasitamab」尚未在中國獲得國家藥品監督管理局批准任何適應症。今年7月,「Tafasitamab」聯合來那度胺治療復發/難治DLBCL在博鰲樂城開出首方。
「Tafasitamab」已獲美國食品藥品監督管理局(FDA)以及歐洲藥品管理局(EMA)有條件批准與來那度胺聯合治療不適合自體幹細胞移植條件的複發/難治瀰漫性大B細胞淋巴瘤(DLBCL)患者。
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