復星醫藥子公司復宏漢霖地舒單抗BILDYOS與TUZEMTY在加拿大商業化上市，提升骨健康治療可及性

中國上海和加拿大魁北克省柯克蘭市，2025年6月23日——復星醫藥子公司復宏漢霖（2696.HK）與Organon加拿大今日宣佈，地舒單抗注射液（60 mg/mL）BILDYOS®、地舒單抗注射液（120 mg/1.7 mL）TUZEMTY®已正式在加拿大實現商業化上市，涵蓋原研藥PROLIA和XGEVA所有加拿大已獲批適應症。地舒單抗適用於多種適應症，可通過增強骨骼強度發揮作用，用於治療骨質疏松症以及腫瘤相關骨事件的治療。

Organon加拿大總裁兼董事總經理Dominic Bégin表示：「此次上市標誌着我們在提升加拿大骨健康治療可及性邁出了重要一步。隨着兩款生物類似藥的推出，將進一步拓展多個治療領域的用藥選擇，其中包括主要影響女性群體的骨質疏松症，目前加拿大約有230萬人受其影響1。這一進展彰顯了Organon持續拓展生物類似藥產品組合、提升治療可及性，並支持患者需求及醫療體系發展的長期承諾。」

BILDYOS®與TUZEMTY®此次在加拿大上市，進一步豐富了加拿大患者的治療選擇，並通過持續提升生物類似藥的可及性幫助降低醫療成本。兩款產品進一步充實了Organon在加拿大不斷擴展的生物類似藥產品組合。該產品組現已涵蓋包括腫瘤在內的五大治療領域，幷包括多款上市超過九年的產品。

復宏漢霖國際市場首席商務官

Darius Panaligan表示

「

BILDYOS®與TUZEMTY®在加拿大實現商業化上市標誌着我們與Organon的合作取得又一重要進展。我們攜手將共同願景轉化為切實成果，為加拿大患者帶來新的治療選擇，也彰顯了雙方對於持續提升藥物可及性的共同承諾。

」

兩款產品在加拿大上市也進一步體現了Organon長期致力於推動高性價比治療方案普及，並以患者需求為中心持續推動女性健康發展的承諾。

加拿大骨質疏松症協會（Osteoporosis Canada）主席兼首席執行官Dr. Famida Jiwa表示：「這兩款地舒單抗療法進入市場將進一步增強醫療體系韌性，併爲臨牀醫生和患者在骨質疏松症治療選擇與疾病管理方面提供更大的靈活性。」

2022年，復宏漢霖與Organon達成許可與供應協議，授予其對包括 BILDYOS®與TUZEMTY®在內的多款生物類似藥在除中國以外全球範圍內的獨家商業化權利。

關於復宏漢霖

復宏漢霖（2696.HK）是一家國際化創新生物製藥企業，致力於為全球患者提供高品質、可負擔的生物藥，產品覆蓋腫瘤、自身免疫疾病、眼科疾病等領域。自2010年成立以來，公司已構建涵蓋全球研發、臨牀、註冊、生產及商業化的全產業鏈平臺，擁有全球員工近4,000人，並在中國、美國和日本等多地設有運營及分支機構。依託生物類似藥形成的穩健現金流反哺創新研發，復宏漢霖正穩步邁入「全球化2.0」階段，持續打造可複製、可持續的全球增長模式。截至2026年初，公司共有10款產品在全球60余個國家和地區獲批上市，其中8款已在中國獲批。在歐美主流生物藥市場，復宏漢霖亦取得多項里程碑式突破，已有4款產品獲得美國FDA批准、5款產品獲得歐盟EC批准，充分體現了公司在研發體系、質量管理及生產能力方面已全面對標國際最高標準。

在創新驅動方面，復宏漢霖依託上海、美國等多地協同佈局的研發體系，構建了多元化、平臺化的創新技術矩陣，覆蓋免疫檢查點抑制劑、免疫細胞銜接器（包括多特異性TCE）、抗體偶聯藥物（ADC）以及AI驅動的早期研發平臺等前沿方向。目前，公司擁有50余項處於早期階段的創新資產，其中約70%具備同類最佳（Best-in-Class）潛力，並在全球同步推進30余項臨牀研究。核心產品H藥 漢斯狀®（斯魯利單抗，歐洲商品名：Hetronifly®）作為全球首個獲批一線治療小細胞肺癌的抗PD-1單抗，正加速全球佈局，已在全球50個市場獲批上市；同時，多款潛力創新資產，包括PD-L1 ADC HLX43及新表位HER2單抗HLX22（通用名：dulpatatug）正全面推進全球關鍵性臨牀研究。依託通過中、歐、美三地GMP認證的生產體系，復宏漢霖已建成總產能達84,000升的生物藥生產平臺，形成覆蓋全球六大洲的穩定供應網絡。未來，復宏漢霖將始終堅持以患者為中心，聚焦未滿足的臨牀需求，持續推動創新成果向臨牀價值與患者可及轉化，在全球生物醫藥創新生態中創造長期而穩健的價值。

關於Organon

Organon（紐約證券交易所代碼：OGN）是一家全球化醫療健康公司，以提供創新性的藥品和解決方案，實現更健康的每一天為使命。Organon在全球提供超過70種藥物和醫療解決方案，並持續推動這些亟需療法在超140個市場的廣泛可及，重點業務包括女性健康、經典產品和生物類似藥，專注於為女性特有疾病、對女性影響重大或不同的疾病尋求解決方案。

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.

參考文獻

References

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

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