复宏汉霖地舒单抗BILDYOS与TUZEMTY获加拿大卫生部上市批准

2026年3月24日，复宏汉霖（2696.HK）宣布，加拿大卫生部已批准地舒单抗注射液（60 mg/mL）BILDYOS、地舒单抗注射液（120 mg/1.7 mL）TUZEMTY（美国及欧洲商品名：BILPREVDA）的上市申请，两款产品分别为PROLIA（地舒单抗）和XGEVA（地舒单抗）的生物类似药，涵盖原研产品在加拿大的所有已批适应症。

复宏汉霖首席商务发展官兼高级副总裁

曹平表示

加拿大对这两款生物类似药的批准，是这两款药物继美国、欧盟与英国获批之后的又一重要监管里程碑，也是复宏汉霖与Organon合作的重要里程碑。我们携手将共同愿景转化为切实成果，为加拿大患者提供新的治疗选择，并进一步彰显我们对长期可及性与价值的共同承诺。

BILDYOS（地舒单抗注射液）已获批用于以下适应症：绝经后妇女的高风险骨质疏松症；骨折高风险的男性骨质疏松患者的增加骨量治疗；增加骨量治疗及预防骨折高风险的糖皮质激素引起的女性与男性骨质疏松症；接受雄激素剥夺治疗（ADT）的骨折高风险的非转移性前列腺癌男性患者的增加骨量治疗；以及接受芳香酶抑制剂辅助治疗的非转移性乳腺癌女性患者的增加骨量治疗。

TUZEMTY（地舒单抗注射液）已获批用于以下适应症：降低多发性骨髓瘤患者以及乳腺癌、前列腺癌、非小细胞肺癌及其他实体瘤骨转移患者发生骨相关事件的风险；用于治疗不可切除或手术切除可能导致严重功能障碍的成人及骨骼发育成熟青少年骨巨细胞瘤；以及用于治疗对静脉注射双膦酸盐治疗无效的恶性肿瘤相关高钙血症。

加拿大卫生部批准BILDYOS与TUZEMTY的上市申请是基于递交的全面的结构与功能分析、非临床与临床药代动力学结果，以及一项临床比对研究，结果显示BILDYOS与TUZEMTY和原研药PROLIA及XGEVA的安全性、纯度和效力方面高度相似。

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BILDYOS（地舒单抗注射液）和TUZEMTY（地舒单抗注射液）在内的多个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。Organon预计将于今年内在加拿大上市销售BILDYOS（地舒单抗注射液）和TUZEMTY（地舒单抗注射液）。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至2026年初，公司共有10款产品在全球60个国家和地区获批上市，其中7款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、4款产品获得欧盟EC上市授权，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。

在创新驱动方面，复宏汉霖依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器（包括多特异性TCE）、抗体偶联药物（ADC）以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳（Best-in-Class）潜力，并在全球同步推进30余项临床研究。核心产品H药 汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）作为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，正加速全球布局，已在全球40余个市场获批上市；同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。

Health Canada Approves Henlius’ BILDYOS (Denosumab Injection) and TUZEMTY (Denosumab Injection), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively

SHANGHAI, China – March 24, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that Health Canada has approved BILDYOS (denosumab) injection 60 mg/mL and TUZEMTY (denosumab, trade name: BILPREVDA in the U.S. and Europe) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference product.

“The approvals in Canada mark another significant regulatory milestone of the products following prior approvals in the U.S., EU and the UK, as well as a key milestone in our collaboration with Organon,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “Together, we’ve translated our shared vision into tangible outcomes—bringing a new treatment option to patients in Canada and reinforcing our joint commitment to long-term access and value.”

BILDYOS (denosumab injection) has been approved for the treatment of osteoporosis in postmenopausal women at high risk of fracture, to increase bone mass in men with osteoporosis at high risk for fracture, the treatment and prevention of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer.

TUZEMTY (denosumab injection) has been approved for reducing the risk of developing skeletal-related events in patients with multiple myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumors; for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and for the treatment of hypercalcemia of malignancy that is refractory to intravenous bisphosphonate.

BILDYOS (denosumab injection) and TUZEMTY (denosumab injection) were approved based on the review of a comprehensive data package, which included structural and functional analytical data, nonclinical and clinical pharmacokinetic data, and a comparative clinical study demonstrating no clinically meaningful differences from reference products PROLIA and XGEVA in terms of safety, purity, and potency.

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including BILDYOS (denosumab injection) and TUZEMTY (denosumab injection). The agreement covers exclusive global commercialization rights except for China. BILDYOS (denosumab injection) and TUZEMTY (denosumab injection) are expected to be commercialized in Canada by Organon later this year.

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and four products authorized by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.

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(复宏汉霖 动态宝)