復星醫藥(02196.HK)子公司地舒單抗注射液產品獲歐盟批上市許可申請
復星醫藥(02196.HK)公佈,控股子公司「上海復宏漢霖生物技術股份有限公司」及其控股子公司自主研發的 BILDYOS(規格 60 mg/mL)、BILPREVDA(120 mg/1.7mL)兩個地舒單抗注射液產品(項目代號:HLX14)的上市許可申請(MAAs)獲歐盟委員會(即EuropeanCommission)批準。據此,BILDYOS及BILPREVDA於所有歐盟成員國及冰島、列支敦士登和挪威(分別爲歐洲經濟區國家)獲得集中上市許可。
HLX14爲集團(即公司及控股子公司/單位,下同)自主研發的地舒單抗生物類似藥,擬用於治療骨折高風險的絕經後婦女的骨質疏鬆症及/或與參照藥藥品標籤相符的其他適應症。
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