復宏漢霖(02696.HK)：美國食品藥品管理局(FDA)批準HLX14(地舒單抗，美國商品名：BILDYOS以及BILPREVDA)兩個產品用於特定人羣骨質疏鬆症治療等8項適應症
格隆匯9月1日丨復宏漢霖(02696.HK)公告，近日，集團收到美國食品藥品管理局（FDA）的批準函，BILDYOS以及BILPREVDA兩個產品的生物製品許可申請(BLA)獲FDA批準，該等商品名由N.V. Organon於美國註冊商標。
獲批適應症具體包括：產品一： BILDYOS(60 mg/mL)：(1)骨折高風險的絕經後婦女的骨質疏鬆症治療；(2)骨折高風險的男性骨質疏鬆症的增加骨量治療；(3)糖皮質激素引起的骨折高風險的男性與女性骨質疏鬆症的治療；(4)接受雄激素剝奪治療的骨折高風險的非轉移性前列腺癌男性患者的增加骨量治療；(5)接受芳香化酶抑制劑輔助治療的骨折高風險的乳腺癌女性患者的增加骨量治療；
及產品二： BILPREVDA(120 mg/1.7 mL)：(1)預防多發性骨髓瘤患者和實體腫瘤的骨轉移患者中發生骨相關事件的風險；(2)不可手術切除或手術切除後可能導致嚴重功能障礙的骨鉅細胞瘤患者的治療，包括成人和骨骼發育成熟的青少年患者；(3)接受雙膦酸鹽治療後出現的難治性惡性腫瘤高鈣血癥的治療。
此次FDA的批準主要是基於對HLX14（地舒單抗）（HLX14）與其參照藥(Prolia)一系列比對研究數據的全面審查，包括分析相似性研究及臨牀比對研究。這些研究數據充分證明瞭HLX14與其參照藥在質量、安全性和有效性方面的高度相似。根據FDA發佈的行業指南《證明與參照藥生物相似性方面的科學考慮》，HLX14獲準用於參照藥Prolia和XGEVA在美國已獲批的所有適應症。同時，集團HLX14相關生產場地和設施亦接受了FDA的批準前檢查(Pre-License Inspection, PLI)，該等生產場地和設施均符合FDA的cGMP要求。
根據IQVIA MIDAS的最新數據（由IQVIA提供，IQVIA是全球醫藥健康產業專業信息和戰略諮詢服務提供商），2024年度，地舒單抗於全球範圍內的銷售額約爲74.62億美元。
BILDYOS、BILPREVDA獲批上市之後，集團累計已有六款產品於海外獲批上市，三款產品於美國獲批上市，全球商業化落地進一步深化。本次獲批，代表國際主流市場對於公司產品的又一認可，將進一步推進公司國際化佈局的進程，提升公司產品的國際影響力。
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