復宏漢霖地舒單抗BILDYOS與TUZEMTY獲加拿大衞生部上市批准

2026年3月24日，復宏漢霖（2696.HK）宣佈，加拿大衞生部已批准地舒單抗注射液（60 mg/mL）BILDYOS、地舒單抗注射液（120 mg/1.7 mL）TUZEMTY（美國及歐洲商品名：BILPREVDA）的上市申請，兩款產品分別為PROLIA（地舒單抗）和XGEVA（地舒單抗）的生物類似藥，涵蓋原研產品在加拿大的所有已批適應症。

復宏漢霖首席商務發展官兼高級副總裁

曹平表示

加拿大對這兩款生物類似藥的批准，是這兩款藥物繼美國、歐盟與英國獲批之后的又一重要監管里程碑，也是復宏漢霖與Organon合作的重要里程碑。我們攜手將共同願景轉化為切實成果，為加拿大患者提供新的治療選擇，並進一步彰顯我們對長期可及性與價值的共同承諾。

BILDYOS（地舒單抗注射液）已獲批用於以下適應症：絕經后婦女的高風險骨質疏松症；骨折高風險的男性骨質疏松患者的增加骨量治療；增加骨量治療及預防骨折高風險的糖皮質激素引起的女性與男性骨質疏松症；接受雄激素剝奪治療（ADT）的骨折高風險的非轉移性前列腺癌男性患者的增加骨量治療；以及接受芳香酶抑制劑輔助治療的非轉移性乳腺癌女性患者的增加骨量治療。

TUZEMTY（地舒單抗注射液）已獲批用於以下適應症：降低多發性骨髓瘤患者以及乳腺癌、前列腺癌、非小細胞肺癌及其他實體瘤骨轉移患者發生骨相關事件的風險；用於治療不可切除或手術切除可能導致嚴重功能障礙的成人及骨骼發育成熟青少年骨鉅細胞瘤；以及用於治療對靜脈注射雙膦酸鹽治療無效的惡性腫瘤相關高鈣血癥。

加拿大衞生部批准BILDYOS與TUZEMTY的上市申請是基於遞交的全面的結構與功能分析、非臨牀與臨牀藥代動力學結果，以及一項臨牀比對研究，結果顯示BILDYOS與TUZEMTY和原研藥PROLIA及XGEVA的安全性、純度和效力方面高度相似。

復宏漢霖已於2022年與Organon達成授權許可和供應合作，授予其對包括BILDYOS（地舒單抗注射液）和TUZEMTY（地舒單抗注射液）在內的多個生物類似藥在除中國以外的全球區域進行獨家商業化的權益。Organon預計將於今年內在加拿大上市銷售BILDYOS（地舒單抗注射液）和TUZEMTY（地舒單抗注射液）。

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個國家和地區獲批上市，其中7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、4款產品獲得歐盟EC上市授權，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40余個市場獲批上市；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。

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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(復宏漢霖 動態寶)