Organon Canada and Henlius Expand Access to Denosumab Treatments With Launch of BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection), Biosimilars to PROLIA and XGEVA

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

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KIRKLAND, Quebec & SHANGHAI — 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.

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“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.”

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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.

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“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.”

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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.

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“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.

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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.

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

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About Henlius

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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.

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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 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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Contacts

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