2025年12月2日，复宏汉霖(2696.HK)宣布，公司自主研发的地舒单抗HLX14(重组抗RANKL全人单克隆抗体注射液)60 mg/mL规格的上市注册申请(NDA)，已获国家药品监督管理局(NMPA)药品审评中心受理，拟用于治疗骨折高风险的绝经后妇女、男性及糖皮质激素诱导的骨质疏松症，覆盖原研普罗力®于中国大陆境内已获批上市的所有适应症。此前，HLX14已于美国、欧盟和英国获批上市，是首个成功出海的“中国籍”地舒单抗。

数据显示，我国50岁以上女性骨质疏松症患病率高达32.1%[1]，意味着超过三分之一的绝经后女性深受其扰;而同年龄段男性的患病率也为6.46%[2],[3]。此外，长期使用糖皮质激素导致的骨质疏松症同样是继发性骨质疏松的首要原因，存在未满足的治疗需求。HLX14为复宏汉霖按照中国、欧盟和美国等生物类似药相关法规自主开发的地舒单抗生物类似药。本次HLX14的NDA主要基于HLX14对比原研普罗力®产生的数据，包括分析相似性研究及非临床和临床比对研究。这些数据都充分证明了HLX14与原研药在质量、安全性和有效性方面的高度相似。

复宏汉霖已于2022年与Organon达成授权许可和供应合作，授予其对包括HLX14在内的两款候选生物类似药在除中国以外的全球区域进行独家商业化的权益，协议覆盖美国、欧盟、加拿大等市场。2025年下半年，HLX14两个产品 BILDYOS®(60 mg/mL)和BILPREVDA®(120mg/1.7mL)相继获得美国食品药品监督管理局(FDA)、欧洲药品管理局(EMA)和英国药品和健康产品管理局(MHRA)批准上市，成为首个国际获批的“中国籍”地舒单抗。

未来，复宏汉霖将继续致力于满足临床对可负担生物药需求的承诺，为全球更多患者带来更多优质、可及、可负担的产品和治疗方案。

【参考文献】

[1] 国家卫健委《中国骨质疏松症流行病学调查报告》(2023)

[2] 李梅, 章振林, 夏维波. 应重视常见疾病男性骨质疏松症的诊断与治疗. 中华骨质疏松和骨矿盐疾病杂志, 2022, 15(5): 449-454. doi:10.3969/j.issn.1674-2591.2022.05.002

[3] 中华医学会骨质疏松和骨矿盐疾病分会. 男性骨质疏松症诊疗指南. 中华骨质疏松和骨矿盐疾病杂志, 2020, 13(5): 381-395. doi:10.3969/j.issn.1674-2591.2020.05.001

关于复宏汉霖

复宏汉霖(2696.HK)是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市10款产品，4个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范(GMP)标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药 汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®(斯鲁利单抗，欧洲商品名：Hetronifly®)、自主研发的中美欧三地获批单抗生物类似药汉曲优®(曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®)、国内首个生物类似药汉利康®(利妥昔单抗)、地舒单抗生物类似药Bildyos®和Bilprevda®，以及帕妥珠单抗POHERDY®。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

Henlius’ Denosumab HLX14 New Drug Application Accepted by NMPA

Shanghai, China – December 2, 2025 – Henlius (2696.HK) announced today that the New Drug Application (NDA) for its independently developed Denosumab biosimilar HLX14 in the 60 mg/mL formulation (recombinant anti-RANKL human monoclonal antibody injection), has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The indications involved in the NDA encompass all approved and marketed indications for the reference drug Prolia® in Chinese mainland, encompassing the treatment of osteoporosis in postmenopausal women, men, and glucocorticoid-induced patients, all at high risk of fracture. HLX14 has already received marketing approvals in the United States, European Union, and the United Kingdom, making it the first Denosumab developed in China to successfully enter international markets.

Data shows that the morbidity rate of osteoporosis among women over 50 years old in China is as high as 32.1%[1], meaning that more than one-third of postmenopausal women are deeply affected by it; while the morbidity rate among men of the same age group is 6.46%[2],[3]. In addition, long-term use of glucocorticoids leading to osteoporosis is also the primary cause of secondary osteoporosis, with unmet therapeutic needs.

HLX14 is a denosumab biosimilar independently developed by Henlius in accordance with the NMPA, EMA, FDA, and other international biosimilar guidelines. The NDA of HLX14 was based on the data generated by HLX14 in comparison with its reference drug Prolia®, which includes analytical similarity studies, nonclinical and clinical comparison studies. These data demonstrated that HLX14 is highly similar to its reference drug in terms of quality, safety and efficacy.

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including HLX14. The agreement covers exclusive global commercialization rights except for China. In the second half of 2025, the two products of HLX14, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7mL), received approvals from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), becoming the first “China-developed” Denosumab to achieve global market entry.

Looking ahead, Henlius remains committed to addressing clinical needs by providing high-quality, affordable biopharmaceuticals and expanding patient access to effective treatment options worldwide.

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, 10 products have been approved for marketing across multiple countries and regions, and 4 marketing applications have been accepted for review in China 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, denosumab Bildyos® and Bilprevda®, and pertuzumab Poherdy®. 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 https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.