3SBio Announces 2025 Annual Results: Dual Engines of Innovative R&D and Global Collaboration Propel Revenue Past RMB 10 Billion Milestone

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SHANGHAI, March 31, 2026 /PRNewswire/ -- 3SBio Inc. (01530.HK) today released its 2025 annual results announcement. Fueled by the dual core engines of breakthroughs in innovative R&D and strategic global collaboration, the company delivered a high-quality performance with both quantitative and qualitative growth: annual revenue hit RMB 17.7 billion, a historic breakthrough past the RMB 10 billion mark, representing a 94.3% year-on-year (YoY) increase; net profit attributable to shareholders of the parent company reached RMB 8.48 billion, surging 305.8% YoY; adjusted net profit attributable to shareholders of the parent company stood at RMB 8.45 billion, a 264.6% YoY rise. The company's profitability achieved a leap-forward growth, demonstrating robust growth momentum.

In 2025, the company's R&D expenditure amounted to RMB 1.52 billion, a 14.6% YoY increase, providing solid support for the advancement of its innovative drug pipeline. As of the end of 2025, 3SBio's total financial resources soared to RMB 20.4 billion, its interest-bearing debt ratio dropped to 9.8%, and comprehensive financial costs contributed a positive RMB 230 million to the company, further optimizing the asset-liability structure. Abundant cash flow and a sound capital structure have fortified the financial foundation for the company's long-term development. Adhering to its stable dividend policy, the company declared a 2025 final dividend of HKD 0.25 per share, delivering solid shareholder returns to convey confidence in its long-term growth.

During the reporting period, 3SBio entered into a global licensing collaboration with Pfizer with a total deal value of over US$6 billion, receiving an upfront payment of US$1.4 billion and a US$100 million equity investment, setting a new record for the highest upfront payment in a single out-licensing transaction for a Chinese innovative drug. Its core product TPIAO® secured approval for a new indication; three novel drugs were successively approved for marketing and three products entered the New Drug Application (NDA) stage. The company has built a multi-domain innovative pipeline matrix, further consolidating its global competitiveness and leading position in core therapeutic areas, and injecting strong impetus into its high-quality development.

I. Groundbreaking Global Collaboration with Pfizer Sets a New Record for Chinese Innovative Drug Out-licensing

2025 marked a pivotal breakthrough in 3SBio's globalization strategy, as the company entered into a global collaboration with Pfizer for its proprietary PD-1/VEGF bispecific antibody SSGJ-707—a landmark event in China's biopharmaceutical industry.

Under the collaboration agreement, 3SBio granted Pfizer exclusive global development and commercialization rights to SSGJ-707, with the total potential deal value exceeding US$6 billion. The company is also entitled to tiered double-digit royalties based on the product's global cumulative sales. The US$1.4 billion upfront payment plus US$100 million equity investment has set a new record for the highest upfront payment in a single out-licensing transaction of a Chinese innovative drug to date. This landmark collaboration not only attests to the high recognition of international pharmaceutical giants for the R&D quality, standards and systems of Chinese innovative drugs, but also fully demonstrates the core global competitiveness of 3SBio and even China's biopharmaceutical innovation as a whole.

Notably, 3SBio retains the right to supply SSGJ-707 bulk drug substance for clinical and commercial use in China and across the globe. To date, the first batch of SSGJ-707 bulk drug substance for global clinical development has been successfully delivered, marking the official entry of the collaboration into the substantive implementation phase and accelerating the global commercialization progress of the product.

Leveraging Pfizer's world-class global clinical resources, the global clinical development of SSGJ-707 is progressing at a brisk pace. Nine international multi-center clinical trials have been initiated, covering a broad spectrum of high-incidence tumors including squamous/non-squamous non-small cell lung cancer, metastatic colorectal cancer, extensive-stage small cell lung cancer, gastroesophageal junction cancer, transformed small cell lung cancer, locally advanced/metastatic hepatocellular carcinoma, locally advanced/metastatic urothelial carcinoma, and locally advanced/metastatic renal cell carcinoma. Going forward, the two parties will continue to expand the product's indications and combination therapy regimens, fully unlocking the global clinical value and commercial growth potential of this core innovative asset.

II. Fruition of Innovation at Scale Builds a New Growth Engine

From 2025 to early 2026, 3SBio entered a period of intensive product approvals. With three novel drugs launched successively, core products gaining new indication approvals, commercialized products included in the National Reimbursement Drug List and authoritative clinical guidelines, and multiple candidates advancing to the NDA stage, the company has accelerated the translation of multi-dimensional innovation value into growth drivers, fueling sustained performance growth.

Three Novel Drugs Approved, Enriching Clinical Treatment Options

  • Amdokitug Injection (Yisaituo®): Approved in February 2026 for the treatment of moderate-to-severe plaque psoriasis. The product features rapid onset of action as early as Week 2, leading PASI100 response at Week 12, and sustained skin lesion clearance at Week 52. It has no neutralizing antibodies detected, with an anti-drug antibody (ADA) rate of only 0.7% and a lower infection risk. A simplified maintenance dosing regimen of once every 8 weeks significantly reduces the annual dosing frequency for patients, alleviating the burden and psychological stress of long-term treatment, and substantially improving treatment adherence.
  • Loncipoetin Alfa Injection (NuPIAO®): Approved in March 2026 as the first domestic long-acting recombinant erythropoietin (EPO) biweekly formulation (a Class 1 innovative drug), indicated for hemodialysis patients with anemia caused by chronic kidney disease who are receiving erythropoietin therapy. Boasting an ultra-long half-life of 120 hours and low immunogenicity, the product is administered intravenously, making it more suitable for hemodialysis patients. Its biweekly dosing regimen drastically cuts down the dosing frequency, significantly improving patient treatment adherence and providing a more convenient therapeutic option for clinical practice.
  • Eltrombopag Ethanolamine Tablets: Approved in March 2026 for the treatment of immune thrombocytopenia (ITP) and severe aplastic anemia (SAA). The product provides a new oral treatment option for patients with hematological disorders, further improving 3SBio's commercial product portfolio in the hematology field.

Core Product Expands to New Indication, Unlocking Incremental Market Potential

 Recombinant Human Thrombopoietin(TPIAO®), the world's only commercialized recombinant human thrombopoietin product, obtained approval for a new indication in December 2025—for the treatment of chronic liver disease-related thrombocytopenia (CLDT) in patients scheduled to undergo surgery (including diagnostic procedures). This approval provides a rapid-acting, stable and safe platelet-boosting treatment for a large number of perioperative patients with chronic liver disease, further expanding the market coverage of this core product.

Commercialized Product Earns Authoritative Recognition, Accelerating Clinical Penetration

Paclitaxel Oral Solution (Liporaxel®) was officially included in the 2025 CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer as a Grade I recommendation (Category 1A) for the second-line treatment of advanced gastric cancer, and was also added to the 2025 National Reimbursement Drug List. Adopting an innovative lipid self-emulsifying drug delivery technology, the product revolutionizes gastric cancer treatment from "hospital-based infusion" to "home-based oral administration", greatly improving medication convenience for patients. Its NDA for the indication of relapsed or metastatic HER2-negative breast cancer has been submitted and accepted, which is expected to further open up its market space.

Three Products in NDA Stage, Delivering Abundant Follow-up Growth Momentum

  • 613 (Anti-IL-1β mAb): Its NDA for acute gouty arthritis was submitted and accepted in June 2025. The biologic penetration rate in China's acute gout market remains extremely low; as the second domestic product of its class to file an NDA, it enjoys a favorable competitive landscape and is poised to address significant unmet clinical needs with promising market prospects. A Phase II clinical trial for intermittent gouty arthritis is currently underway.
  • 611 (Anti-IL-4Rα mAb): Its NDA for moderate-to-severe atopic dermatitis in adults was submitted and accepted in February 2026. Non-head-to-head comparisons show its overall efficacy is superior to dupilumab. It supports long-acting dosing of once every two or four weeks, delivering stronger efficacy, higher patient adherence and better long-term disease control. Clinical development for additional indications including chronic rhinosinusitis with nasal polyps, chronic obstructive pulmonary disease, and adolescent and pediatric atopic dermatitis is well underway, continuously unlocking the pipeline's growth potential.
  • 601A (Anti-VEGF mAb): Its NDA for macular edema secondary to branch retinal vein occlusion (BRVO) was accepted in October 2025. The product demonstrates efficacy comparable to ranibizumab, with a favorable overall safety and tolerability profile, providing a new treatment option for ophthalmic clinical practice.

III. Building a Multi-Domain Innovative Pipeline Matrix to Consolidate Long-term Core Competitiveness

In 2025, 3SBio continued to ramp up R&D investment and built a rich and differentiated innovative pipeline matrix focusing on core therapeutic areas including hematology/oncology, autoimmune diseases, nephrology, dermatology, hair disorders and weight management. Multiple products are in key clinical stages with leading-edge target layouts, establishing solid technical and product barriers for the company's long-term development.

Hematology/Oncology: Multi-pronged Layout of Bispecific/Trispecific Antibodies to Forge Differentiated Competitive Advantages

  • 705 (Anti-PD-1/HER2 BsAb): Currently in Phase II clinical development for HER2-positive advanced solid tumors, it is the only candidate in China actively advancing clinical trials for this target, boasting significant differentiated advantages.
  • 706 (Anti-PD-1/PD-L1 BsAb): Phase II clinical trials for advanced non-small cell lung cancer and advanced gastrointestinal tumors are ongoing, covering high-incidence tumor types with smooth clinical progress.
  • 708 (Anti-PD-1/TGF-β BsAb), 709 (Anti-PD-1/LAG3 BsAb), SSS59 (Anti-MUC17/CD3/CD28 Tri-specific Ab) and SPGL008 (Anti-B7H3 Ab/IL15Rα sushi-IL15 Fusion Protein) for advanced solid tumors are all in Phase I clinical trials; SSS57 (Long-acting ActRIIB-Ig Trap) for myelodysplastic syndrome (MDS)-related anemia is also in Phase I. The hierarchical pipeline layout in hematology/oncology is continuously improved, reserving high-quality assets for the company's long-term growth.

Autoimmune Diseases: Multiple Products in Key Clinical Stages, Leading Domestic R&D Progress

  • 610 (Anti-IL-5 mAb): Under Phase III clinical development for eosinophilic asthma, it ranks first in China in terms of R&D progress for this target and is poised for early commercialization.
  • 626 (Anti-BDCA2 Ab): Currently in Phase Ib clinical trial for systemic lupus erythematosus (SLE), addressing critical unmet clinical needs in the autoimmune disease field.
  • 627 (Anti-TL1A mAb): Phase II clinical trial for ulcerative colitis (UC) has been initiated, laying out the company's presence in the core inflammatory bowel disease (IBD) track.
  • A portfolio of early-stage pipeline assets is advancing rapidly, including 716 (Anti-OX40L/IL-31RA Bispecific Antibody for atopic dermatitis), 717 (CD3/CD19/BCMA for SLE/lupus nephritis/rheumatoid arthritis), 718 (TL1A/IL-23 for IBD), 719 (IL-4R/TSLP for asthma/chronic obstructive pulmonary disease) and 629 (IL-23R for psoriasis/IBD). These candidates fully cover mainstream and cutting-edge targets in the autoimmune disease field, building a deep technical moat for the company.

Nephrology: Focusing on Core Clinical Needs, Pioneering Domestic Layout of Emerging Targets

  • SSS55 (C3b-targeting Bi-functional Fusion Protein ): Phase I clinical trials have been initiated for paroxysmal nocturnal hemoglobinuria (PNH), complement-mediated kidney disease (CMKD) and periodontitis. 3SBio is the only company in China actively advancing R&D for this target, filling a critical clinical gap in the domestic market.
  • SSS68 (Long-acting anti-April/BAFF BsAb): Its Investigational New Drug (IND) application for IgA nephropathy has been approved in the US. As the only domestic long-acting bispecific antibody in clinical development targeting the APRIL/BAFF pathway, it features significant differentiated competitive advantages.

Dermatology, Hair Disorders & Weight Management: Forward-looking Layout in High-potential Tracks

  • WS2403 (Semaglutide Injection): Phase III clinical trials for the weight management indication are currently underway.
  • WS204 (Clascoterone): Phase III clinical trials for moderate-to-severe acne vulgaris in patients aged 12 and above are currently underway.
  • SSS67 (Anti-ActRIIA/ActRIIB BsAb): Its IND application for overweight/obesity has been approved in the US. As the only innovative biased bispecific antibody in China to enter the IND stage for this indication, it represents the company's forward-looking layout in the blue ocean of metabolic disease treatment.

Remarks from Dr. Lou Jing, Chairman and CEO of 3SBio

"2025 marked the conclusion of the 14th Five-Year Plan period. Under the coordinated governance of medical insurance, healthcare and pharmaceuticals, China's biopharmaceutical industry has witnessed several landmark changes: commercial health insurance has opened up multi-payment channels for innovative drugs, and Chinese innovative drug out-licensing deals have achieved remarkable results. Our proprietary SSGJ-707 set a new record with a 24% upfront payment ratio in its global out-licensing deal, a testament to the global competitiveness of Chinese biopharmaceutical innovation.

In 2026, the biopharmaceutical industry has been designated as a national emerging pillar industry in China. Driven by national policies, the industry is accelerating its transformation from a major pharmaceutical manufacturing country to a global pharmaceutical powerhouse, and 3SBio's innovation potential has gained wide international recognition.

Building on over 30 years of industry expertise and accumulation, we remain committed to the principle of integrity and innovation. We will continue to deepen our layout in oncology, autoimmune diseases, nephrology and other core therapeutic areas, increase investment in cutting-edge innovation, continuously optimize our R&D pipeline, and accelerate the launch and market promotion of new products such as Liporaxel®, Yisaituo® and NuPIAO®. Guided by our mission to 'make innovative biopharmaceuticals accessible to all', we will strive to bring more high-quality innovative drugs to the market at an early date, benefiting patients worldwide."


Source: 3SBio Inc. Related Stocks: HongKong:1530

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