复宏汉霖宣布地舒单抗BILDYOS和BILPREVDA获英国批准上市

中国上海，2025年11月11日——复宏汉霖（2696.HK）宣布，英国药品和健康产品管理局（MHRA）已批准地舒单抗注射液（60 mg/mL）BILDYOS（denosumab）和地舒单抗注射液（120mg/1.7mL）BILPREVDA（denosumab）的上市许可，两款产品分别为PROLIA（地舒单抗）和XGEVA（地舒单抗）的生物类似药，覆盖原研药在英国已获批的所有适应症^1,2。

复宏汉霖首席商务发展官兼高级副总裁曹平

此次英国获批有望进一步提升地舒单抗生物类似药BILDYOS和BILPREVDA的可及性，为更多有骨健康管理需求的患者带来新的治疗选择。在此前产品已于美国和欧盟获批的基础上，这次批准再次体现了公司在全球标准下完善的注册与质量体系，也彰显了我们持续致力于满足临床对可负担生物药需求的承诺。未来，复宏汉霖将继续与Organon密切合作，推动有品质、可负担的生物药在全球范围内更广泛的可及，为更多患者带来福祉。

BILDYOS适用治疗骨折高风险的绝经后妇女及男性的骨质疏松症；骨折高风险的前列腺癌男性因激素剥夺导致的骨质流失；以及骨折高风险成年患者因长期全身糖皮质激素治疗导致的骨质流失。BILPREVDA适用于预防累及骨骼的晚期恶性肿瘤成人的骨相关事件，以及治疗不可手术切除或手术切除后可能导致严重功能障碍的骨巨细胞瘤患者，包括成人和骨骼发育成熟的青少年患者。

BILDYOS和BILPREVDA的获批是基于一整套全面数据的审查，其中包括结构与功能分析数据、临床药代动力学数据，以及一项临床对比研究。研究表明，BILDYOS和BILPREVDA在结构、生物活性以及疗效、安全性和免疫原性特征（蛋白质和其他生物药物引起免疫反应的内在能力）方面与英国已批准的另一种生物药（即“参考药物”）高度相似。

2022年，复宏汉霖与Organon签订许可与供应协议，授予Organon对包括BILDYOS 和BILPREVDA在内的多个生物类似药在除中国以外的全球区域的独家商业化权益³。

PROLIA和XGEVA为安进公司（Amgen, Inc.）在英国注册的商标。

【参考文献】

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.

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(复宏汉霖)