European Commission (EC) Approves Henlius and Organon's BILDYOS® (denosumab) and BILPREVDA® (denosumab), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively

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SHANGHAI and JERSEY CITY, N.J., Sept. 19, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) 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 EC approvals of BILDYOS and BILPREVDA mark a pivotal moment in expanding access to essential bone care treatments for millions of Europeans, particularly women, who are disproportionately affected by osteoporosis," said Nico Van Hoecke, Head, International Commercial at Organon.^[3],[4] "These biosimilars may offer additional treatment options across several therapeutic areas associated with bone loss, including osteoporosis, and reflect Organon's commitment to advancing women's health through access to important medicines.^[4] These approvals, following those in the United States, not only expand the global reach of these biosimilars but also support the sustainability of Europe's health care systems."^[5],[6]

"These approvals are a testament to the strong collaboration between Henlius and Organon aimed at meeting the needs of both patients and the health care system in Europe," said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. "Through our commitment to scientific excellence and product quality, we're building on approvals in the United States to bring these biosimilar treatment options to people who need them around the world."^[6]

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 EU (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).^[4]

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.^[7]

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.

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 and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about expectations regarding the business opportunities and prospects for BILDYOS and BILPREVDA. Forward-looking statements may be identified by words such as "will," "potential," "aim," "explore," "opportunity," "expect," "future," "working to," or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to market BILDYOS and BILPREVDA; factors that could adversely affect the level of demand for BILDYOS and BILPREVDA (including trade protection measures and import or export licensing requirements; changes in US and foreign federal, state, and local governmental funding allocations, including the timing and amounts allocated to Organon's customers and business partners; and economic factors); the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid, and health care reform, pharmaceutical reimbursement, and pricing in general; manufacturing difficulties or delays; restructurings or other disruptions at the FDA and other government agencies; efficacy, safety, or other quality concerns; and future actions of third-parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits, and forgoing health care insurance coverage. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon's filings with the SEC, including Organon's most recent Annual Report on Form 10-K and subsequent SEC filings (including Organon's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025), available at the SEC's Internet site (www.sec.gov). References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.

PROLIA and XGEVA are trademarks registered in Europe by Amgen, Inc.; Organon is not associated with this trademark owner.

SOURCE Henlius