SHANGHAI, Aug. 21, 2026 /PRNewswire/ -- 3S Bio (01530.HK) today announced its interim results for the first half of 2026. During the period, the Company recorded revenue of RMB 4.53 billion, representing a year-over-year growth of 3.9%. Net profit attributable to equity holders of the Company reached RMB 1.15 billion, and adjusted operating net profit attributable to shareholders of the parent stood at RMB 1.44 billion, up 26.5% year-over-year. R&D expenses amounted to RMB 680 million, an increase of 24.9% year-over-year. The Company's financial resources totaled RMB 19.4 billion, providing a solid foundation for R&D investments and strategic initiatives. During the first half of the year, marketing approvals for core products were obtained in 23 countries globally, and overseas product sales surged by 43% year-over-year, primarily driven by the increasing market penetration of products such as rhEPO, Yisaipu, and rhTPO in multiple emerging economies.
Since the beginning of 2026, three Class 1 innovative drugs have been approved for marketing, and five products have advanced to the New Drug Application stage. The Company has successfully constructed a multi-therapeutic pipeline matrix, further consolidating its global competitiveness and advantages in core therapeutic areas. 3SBio has made significant progress in global partnerships, innovative R&D, and product commercialization, marching steadily toward high-quality development.
I. Global Multi-Center Clinical Trials of PF-08634404 (SSGJ-707) Progressing Concurrently
PF-08634404 (SSGJ-707) is an anti-PD-1/VEGF bispecific antibody independently developed by 3SBio, widely recognized as a highly promising next-generation immuno-oncology therapeutic. In 2025, 3SBio granted Pfizer the global development and commercialization rights to SSGJ-707, with a total potential deal value exceeding US$6 billion. The Company is also entitled to receive tiered, double-digit royalties based on cumulative global net sales. Notably, the US$1.4 billion upfront payment and US$100 million equity investment set a new record for the upfront payment of a single out-licensing transaction for a Chinese innovative drug. During the reporting period, the Company recognized RMB 850 million in Business Development revenue.
In 2026, Pfizer is fully accelerating the global multi-center clinical development of SSGJ-707. Nine global multi-center clinical trials have been initiated, covering multiple high-incidence cancers, including squamous/non-squamous non-small cell lung cancer, metastatic colorectal cancer, extensive-stage small cell lung cancer, gastroesophageal cancer, hepatocellular carcinoma, metastatic urothelial carcinoma, and renal cell carcinoma. Among these, two trials have advanced to Phase III, three are in Phase II, and four are in Phase I. As of August 19, 11 clinical trials for SSGJ-707 have been registered, activating over 1,361 clinical sites and expecting to enroll 5,016 patients across 23 countries and regions. Notably, 75 clinical sites in China are participating in nine clinical protocols, ranking second globally, behind only the United States. The Phase III trials cover a target patient population of 225,000 in the U.S., underpinning its subsequent commercial potential. Moving forward, the indication expansions and combination therapy regimens for SSGJ-707 will be continuously explored to fully unlock its global clinical value and commercial growth potential.
II. Intensive Realization of Innovation Value, Building New Growth Engines
In the first half of 2026, 3SBio saw a wave of concentrated milestones across its innovative pipeline. Three Class 1 innovative drugs were successively approved for marketing, and five products progressed to the NDA stage, rapidly translating innovative momentum into performance drivers.
Three internally developed Class 1 innovative biologics were approved for marketing:
Yisaituo® (amdokitug injection) was approved in February, indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. With core advantages including robust and rapid clearance of skin lesions, low immunogenicity, favorable safety and tolerability profile, and convenient administration, Yisaituo® is poised to reshape psoriasis treatment expectations. The product is expected to further broaden its clinical applications in autoimmune diseases as new indications are continuously developed.
NuPIAO® (loncipetin alfa injection) was approved for marketing in March 2026 as the first long-acting recombinant EPO biweekly formulation in China, indicated for the treatment of anemia in hemodialysis patients with chronic kidney disease. The product features an ultra-long half-life of 120 hours and low immunogenicity. The intravenous administration route is highly suitable for hemodialysis patients, and the "once every two weeks" dosing regimen significantly improves patient compliance and convenience.
Yisaina® (anflekitug injection) was approved in August, as the first self-developed IgG1/κ humanized anti-IL-1β monoclonal antibody in China, indicated for the treatment of acute gouty arthritis in adults. The product offers differentiated clinical value with rapid pain relief, long-lasting prevention of recurrence, and a favorable safety profile, serving as a preferred alternative to traditional corticosteroid therapy and a novel precision anti-inflammatory option for gout.
Five products in the NDA stage are poised for launch: 3SBio has established a robust pipeline of five products currently under NDA review, covering therapeutic areas such as atopic dermatitis, ophthalmology, breast cancer, and weight management. Among them,
NDAs have been accepted for
611 (anti-IL-4Rα mAb) for moderate-to-severe atopic dermatitis in adults, and
601A (anti-VEGF mAb) for macular edema following branch retinal vein occlusion. In-licensed products, including
Liporaxel® Paclitaxel Oral Solution for HER2-negative breast cancer,
DB-1303 (HER2 ADC) for HER2-positive breast cancer, and
WS2403 (GLP-1 receptor agonist) for chronic weight management in overweight or obese adults, have also advanced to the NDA stage. These products are expected to be approved sequentially, providing substantial product reserves for the Company's sustainable growth.
III. Constructing a Multi-Therapeutic Pipeline Matrix to Solidify Long-Term Core Competitive Advantages
3SBio's R&D pipeline continues to expand, featuring 25 key investigational drug candidates across core therapeutic areas including hemoncology, autoimmune diseases, nephrology, dermatology, and weight management.
Hemato-oncology: Strategic layout of bispecific antibodies/fusion proteins to establish differentiated advantages.
TPIAO® (recombinant human thrombopoietin injection) has been cleared by the U.S. FDA to initiate a global multi-center bridging clinical trial for the treatment of thrombocytopenia associated with chronic liver disease.
705 (anti-PD-1/HER2 bispecific antibody) has entered Phase II clinical trials for HER2-positive solid tumors, standing as the only drug with this target actively advancing in clinical stages in China, demonstrating significant differentiation.
706 (anti-PD-1/PD-L1 bispecific antibody) has entered Phase II trials for advanced non-small cell lung cancer and advanced gastrointestinal tumors.
708 (anti-PD-1/TGFβ bispecific antibody), 709 (anti-PD-1/LAG-3 bispecific antibody), and SPGL008 (anti-B7-H3 antibody/IL-15 fusion protein) are all in Phase I clinical trials for solid tumors.
SSS57 (long-acting ActRIIB-Ig Trap fusion protein) obtained IND clearance from the U.S. FDA for hematological disorders, marking the first innovative biased bispecific antibody entering clinical trials in China. The hemato-oncology pipeline is being continuously optimized, building a robust reserve of high-quality assets for long-term growth.
Nephrology: Focusing on core unmet needs with a first-in-China novel-target portfolio.
SSS55 (C3b bifunctional fusion protein) has entered Phase I trials for paroxysmal nocturnal hemoglobinuria, complement-mediated kidney diseases, and periodontitis, demonstrating Best-In-Class potential.
SSS68 (long-acting anti-APRIL/BAFF bispecific antibody) has obtained IND approvals in both China and the U.S. for IgA nephropathy, making it the only long-acting bispecific antibody for this indication to enter clinical trials in China.
Dermatology and Weight Management: Exploring new frontiers and expanding pipelines.
WS204 (clascoterone cream) is in Phase III clinical trials for moderate-to-severe acne vulgaris.
SSS67 (anti-ActRIIA/ActRIIB bispecific antibody) has entered Phase I trials for overweight/obesity.
Autoimmune Diseases: Multiple candidates entering pivotal trials, leading R&D in China.
Yisaituo® (amdokitug injection): Patient enrollment completed for the Phase III trial in ankylosing spondylitis; first patient enrolled in the Phase III trial for non-radiographic axial spondyloarthritis.
Yisaina® (anflekitug injection): Dose-exploration Phase II study for intermittent gouty arthritis has been initiated.
610 (anti-IL-5 mAb): Patient enrollment completed for the Phase III trial in severe eosinophilic asthma in adults; Phase III enrollment for severe eosinophilic asthma in adolescents is ongoing.
611 (anti-IL-4Rα mAb): NDA submitted and accepted for moderate-to-severe atopic dermatitis in adults.
626 (anti-BDCA2 mAb): Phase II trials for systemic lupus erythematosus and cutaneous lupus erythematosus are being initiated.
627 (anti-TL1A mAb): Phase II enrollment initiated for ulcerative colitis.
716 (OX40L/IL-31RA bispecific antibody): Obtained IND clearances in both China and the U.S. for atopic dermatitis, with Phase I enrollment initiated.
In the early-stage pipeline,
717 (CD3/BCMA/CD19 humanized trispecific antibody) for systemic lupus erythematosus/lupus nephritis/rheumatoid arthritis,
718 (anti-TL1A/IL-23 bispecific antibody injection) for inflammatory bowel disease,
719 (anti-TSLP/IL-4R bispecific antibody inhaler) for asthma/chronic obstructive pulmonary disease, and
629 (oral IL-23R peptide) for psoriasis/inflammatory bowel disease have all entered the IND or pre-clinical stages, showcasing the Company's forward-looking, end-to-end strategic layout in the autoimmune field.
IV. ESG Practices Receive Authoritative Recognition, Demonstrating Sustainable Development Capabilities
3SBio has consistently integrated Environmental, Social, and Governance principles into its entire operational and management processes. By continuously refining governance structures, fulfilling social responsibilities, and promoting green operations, the Company has achieved solid results in sustainable development, earning accolades from multiple authoritative platforms. In July 2026, 3SBio's Wind ESG rating was upgraded to "AA", placing it in the top 3.2% of the biotechnology industry, which fully validates its comprehensive strength in risk management, compliance operations, and corporate social responsibility practices. Concurrently, the Company's implemented public welfare initiatives were once again recognized as an "Excellent Case of Social Responsibility among Chinese Pharmaceutical Industrial Enterprises", reflecting the industry's acknowledgment of its dedication to philanthropy and corporate social responsibility.
Dr. Jing LOU, Chairman and Chief Executive Officer of 3SBio, commented:
"In early 2026, the biopharmaceutical sector was designated as a emerging strategic pillar industry in China. Amid the industry's ongoing shift toward high-quality growth, innovative R&D capabilities have emerged as the core engine driving sustained corporate expansion. Leveraging over 30 years of industry legacy, 3SBio stays true to its fundamental principles while actively pursuing innovation. The Company will continuously increase its R&D investment, deepen its focus on oncology, autoimmune diseases, and nephrology, optimize its R&D pipeline, and strengthen its talent pool. In the first half of this year, multiple approvals of key innovative drugs significantly expanded the Company's long-term growth prospects. Moving forward, we will continue to accelerate the regulatory approval process for our late-stage pipeline, bringing more innovative drugs with substantial clinical value to serve a broader patient population."
SOURCE 3SBio Inc.
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