復宏漢霖宣佈地舒單抗BILDYOS和BILPREVDA獲英國批准上市

中國上海，2025年11月11日——復宏漢霖（2696.HK）宣佈，英國藥品和健康產品管理局（MHRA）已批准地舒單抗注射液（60 mg/mL）BILDYOS（denosumab）和地舒單抗注射液（120mg/1.7mL）BILPREVDA（denosumab）的上市許可，兩款產品分別為PROLIA（地舒單抗）和XGEVA（地舒單抗）的生物類似藥，覆蓋原研藥在英國已獲批的所有適應症^1,2。

復宏漢霖首席商務發展官兼高級副總裁曹平

此次英國獲批有望進一步提升地舒單抗生物類似藥BILDYOS和BILPREVDA的可及性，為更多有骨健康管理需求的患者帶來新的治療選擇。在此前產品已於美國和歐盟獲批的基礎上，這次批准再次體現了公司在全球標準下完善的註冊與質量體系，也彰顯了我們持續致力於滿足臨牀對可負擔生物藥需求的承諾。未來，復宏漢霖將繼續與Organon密切合作，推動有品質、可負擔的生物藥在全球範圍內更廣泛的可及，為更多患者帶來福祉。

BILDYOS適用治療骨折高風險的絕經后婦女及男性的骨質疏松症；骨折高風險的前列腺癌男性因激素剝奪導致的骨質流失；以及骨折高風險成年患者因長期全身糖皮質激素治療導致的骨質流失。BILPREVDA適用於預防累及骨骼的晚期惡性腫瘤成人的骨相關事件，以及治療不可手術切除或手術切除后可能導致嚴重功能障礙的骨鉅細胞瘤患者，包括成人和骨骼發育成熟的青少年患者。

BILDYOS和BILPREVDA的獲批是基於一整套全面數據的審查，其中包括結構與功能分析數據、臨牀藥代動力學數據，以及一項臨牀對比研究。研究表明，BILDYOS和BILPREVDA在結構、生物活性以及療效、安全性和免疫原性特徵（蛋白質和其他生物藥物引起免疫反應的內在能力）方面與英國已批准的另一種生物藥（即「參考藥物」）高度相似。

2022年，復宏漢霖與Organon簽訂許可與供應協議，授予Organon對包括BILDYOS 和BILPREVDA在內的多個生物類似藥在除中國以外的全球區域的獨家商業化權益³。

PROLIA和XGEVA為安進公司（Amgen, Inc.）在英國註冊的商標。

【參考文獻】

1.     PROLIA. Product Information. Amgen; 2025.

2.     XGEVA. Product Information. Amgen; 2025.

3.     Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta (Pertuzumab) and Prolia/Xgeva (Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed September 15, 2025. UK Medicines and Healthcare Products Regulatory Agency Approves BILDYOS (denosumab) and BILPREVDA (denosumab), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively

SHANGHAI, China – NOVEMBER 11, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has granted marketing authorization for BILDYOS (denosumab) injection 60 mg/mL and BILPREVDA (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products. ^1,2

「The UK approvals are expected to further enhance the accessibility of denosumab biosimilars BILDYOS and BILPREVDA, offering new options for bone health management,」 said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. 「Building on prior approvals in the U.S. and EU, this milestone reflects the company’s strong regulatory and quality systems under global standards and its ongoing commitment to addressing clinical needs for affordable biologic therapies. Henlius will continue to collaborate closely with Organon to advance the global availability of quality, affordable biologics for patients worldwide.」

BILDYOS is indicated for treatment of osteoporosis in postmenopausal women and in men at increased risk for fracture, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. BILPREVDA is indicated for the prevention of skeletal related events in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

BILDYOS and BILPREVDA were approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and a comparative clinical study demonstrating that BILDYOS and BILPREVDA are each a biological medicine highly similar to another biological medicine already approved in the UK (called 'reference medicine') in terms of structure, biological activity and efficacy, safety and immunogenicity profile (the intrinsic ability of proteins and other biological medicines to cause an immune response).

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including BILDYOS and BILPREVDA. The agreement covers exclusive global commercialization rights except for China. ³

PROLIA and XGEVA are trademarks registered in the UK by Amgen, Inc.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 9 products have been approved for marketing across multiple countries and regions, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab BILDYOS and BILPREVDA. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

To learn more about Henlius, visit and connect with us on LinkedIn at ·收藏 ·點贊 ·在看

(復宏漢霖)