复星医药子公司复宏汉霖地舒单抗BILDYOS与TUZEMTY在加拿大商业化上市，提升骨健康治疗可及性

中国上海和加拿大魁北克省柯克兰市，2025年6月23日——复星医药子公司复宏汉霖（2696.HK）与Organon加拿大今日宣布，地舒单抗注射液（60 mg/mL）BILDYOS®、地舒单抗注射液（120 mg/1.7 mL）TUZEMTY®已正式在加拿大实现商业化上市，涵盖原研药PROLIA和XGEVA所有加拿大已获批适应症。地舒单抗适用于多种适应症，可通过增强骨骼强度发挥作用，用于治疗骨质疏松症以及肿瘤相关骨事件的治疗。

Organon加拿大总裁兼董事总经理Dominic Bégin表示：“此次上市标志着我们在提升加拿大骨健康治疗可及性迈出了重要一步。随着两款生物类似药的推出，将进一步拓展多个治疗领域的用药选择，其中包括主要影响女性群体的骨质疏松症，目前加拿大约有230万人受其影响1。这一进展彰显了Organon持续拓展生物类似药产品组合、提升治疗可及性，并支持患者需求及医疗体系发展的长期承诺。”

BILDYOS®与TUZEMTY®此次在加拿大上市，进一步丰富了加拿大患者的治疗选择，并通过持续提升生物类似药的可及性帮助降低医疗成本。两款产品进一步充实了Organon在加拿大不断扩展的生物类似药产品组合。该产品组现已涵盖包括肿瘤在内的五大治疗领域，并包括多款上市超过九年的产品。

复宏汉霖国际市场首席商务官

Darius Panaligan表示

“

BILDYOS®与TUZEMTY®在加拿大实现商业化上市标志着我们与Organon的合作取得又一重要进展。我们携手将共同愿景转化为切实成果，为加拿大患者带来新的治疗选择，也彰显了双方对于持续提升药物可及性的共同承诺。

”

两款产品在加拿大上市也进一步体现了Organon长期致力于推动高性价比治疗方案普及，并以患者需求为中心持续推动女性健康发展的承诺。

加拿大骨质疏松症协会（Osteoporosis Canada）主席兼首席执行官Dr. Famida Jiwa表示：“这两款地舒单抗疗法进入市场将进一步增强医疗体系韧性，并为临床医生和患者在骨质疏松症治疗选择与疾病管理方面提供更大的灵活性。”

2022年，复宏汉霖与Organon达成许可与供应协议，授予其对包括 BILDYOS®与TUZEMTY®在内的多款生物类似药在除中国以外全球范围内的独家商业化权利。

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余个国家和地区获批上市，其中8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、5款产品获得欧盟EC批准，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50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（通用名：dulpatatug）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。

关于Organon

Organon（纽约证券交易所代码：OGN）是一家全球化医疗健康公司，以提供创新性的药品和解决方案，实现更健康的每一天为使命。Organon在全球提供超过70种药物和医疗解决方案，并持续推动这些亟需疗法在超140个市场的广泛可及，重点业务包括女性健康、经典产品和生物类似药，专注于为女性特有疾病、对女性影响重大或不同的疾病寻求解决方案。

Organon CANADA and henlius Expand Access to Denosumab Treatments With LAUNCH OF BILDYOS® (Denosumab Injection) and TUZEMTY® (Denosumab Injection), Biosimilars to PROLIA and XGEVA

The launch expands Organon’s biosimilars portfolio in Canada to eight products spanning five therapeutic areas

KIRKLAND, QC, Canada & SHANGHAI, China  – June 23, 2026 – Organon Canada and Shanghai Henlius Biotech, Inc. (2696.HK) today announced that BILDYOS® (denosumab injection) 60 mg/1 mL and TUZEMTY® (denosumab injection) 120 mg/1.7 mL, biosimilars to PROLIA and XGEVA, respectively, are now available in Canada for all indications of reference products. Used across several indications, denosumab products treat osteoporosis and bone events associated with cancer by helping to strengthen bones.

“The approvals represent an important step toward helping broaden access to bone-care treatments in Canada. These biosimilars will introduce additional treatment options across several therapeutic areas, including osteoporosis, which predominantly affects women and impacts 2.3 million Canadians,”1 said Dominic Bégin, President and Managing Director at Organon Canada. “This development reinforces Organon’s commitment to expanding its biosimilar portfolio, improving treatment accessibility, and helping to strengthen the healthcare system while supporting patients in need.”

With this launch, Organon reinforces its commitment to offering patients in Canada more treatment options and helping to reduce healthcare costs by increasing access to biosimilars. BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection) have joined Organon’s growing biosimilars portfolio in Canada, which spans five therapeutic areas, including oncology, and includes products with more than nine years of market experience.

“The availability of BILDYOS® and TUZEMTY® marks an important step in our collaboration with Organon,” said Darius Panaligan, Chief Commercial Officer, International Markets of Henlius. “Together, we’ve translated our shared vision into tangible outcomes, helping to bring new treatment options to patients in Canada and reinforcing our joint commitment to long-term access.”

These product launches reflect Organon’s long-standing commitment to expanding access to cost-effective treatments and advancing women’s health through a patient-centered approach.

“The addition of new approved denosumab therapies help reinforce a resilient healthcare system and supports clinicians and patients in navigating osteoporosis treatment options with greater flexibility,” said Dr. Famida Jiwa, President and CEO, Osteoporosis Canada.

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.

For more information about these products, including important safety information, visit: BILDYOS_PM-E.pdf and TUZEMTY_PM-E.pdf

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 over 60 countries and regions worldwide, including eight 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 five products approved 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 50 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 dulpatatug (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.

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/.

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health, Biosimilars and General Medicines, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. For more information, visit https://www.organon.com/canada-en/ and connect with us on LinkedIn.

参考文献

References

1. What is osteoporosis? Osteoporosis Canada. 2024. Accessed April 27, 2026. https://osteoporosis.ca/what-is-osteoporosis/

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