Today, 3SBio Inc. (01530.HK) announced its interim results. In the first half of 2025, 3SBio achieved a net profit attributable to owners of approximately RMB 1.358 billion, a year-on-year increase of 24.6%; revenue of RMB 4.356 billion; gross profit of approximately RMB 3.716 billion; R&D cost of RMB 548 million, a 15% increase compared to the same period last year; and EBITDA adjusted for non-operating items of approximately RMB 1.610 billion. The financial structure was further optimized, with interest-bearing debt nearly halved. The leverage ratio decreased from 19.7% at the end of the previous year to 9.9%. Operating net cash flow annually was RMB 970 million, and cash on hand was nearly RMB 8 billion.

Landmark Deal Achieved, Setting a "Value Benchmark" for Chinese Innovation

From May to July, 3SBio announced a significant collaboration with Pfizer, granting Pfizer global rights to the PD-1/VEGF bispecific antibody SSGJ-707. 3SBio received an upfront payment of USD 1.5 billion, including Pfizer’s completed subscription of ordinary shares worth USD 100 million, potential future milestone payments exceeding USD 4.8 billion, and tiered double-digit sales royalties.

Pfizer will initiate global Phase III clinical trials for SSGJ-707 in non-small cell lung cancer (NSCLC) and multiple other cancers in the U.S. and globally as soon as possible. 3SBio retains global supply rights for clinical and commercial products and will be the preferred manufacturer of SSGJ-707 in mainland China and one of the manufacturers supplying SSGJ-707 to regions outside China and the U.S.

SSGJ-707 is a PD-1/VEGF bispecific antibody developed by 3SBio based on its proprietary CLF2 platform, simultaneously inhibiting both PD-1 and VEGF targets. In preclinical studies, SSGJ-707 demonstrated excellent target affinity and tumor inhibition. Interim Phase II clinical data showed that SSGJ-707 achieved outstanding objective response rate (ORR) and disease control rate (DCR) in treating NSCLC patients, demonstrating significant anti-tumor activity and favorable safety both as a monotherapy and in combination with chemotherapy, with best-in-class potential.

Deep Focus on Four Major Therapeutic Areas, Rich Pipeline of Promising Candidates

According to the announcement, 3SBio’s R&D pipeline includes 30 investigational products, comprising 14 in hematology and oncology, 10 in autoimmune diseases and ophthalmology, 3 in nephrology, 2 in dermatology, and 1 in metabolism. To date, 13 new drugs have advanced to Phase III clinical trials or the New Drug Application (NDA) submission stage.

In oncology, the anti-PD-1/HER2 bispecific antibody SSGJ-705 has been approved for Phase II clinical trials for the treatment of advanced malignant solid tumors expressing HER2. Preclinical studies showed that SSGJ-705 exhibited better synergistic effects and efficacy compared to the combination of two corresponding monoclonal antibodies against PD-1 and HER2. The anti-PD-1/PD-L1 bispecific antibody SSGJ-706 has been approved for two Phase II clinical trials for the treatment of digestive system tumors and non-small cell lung cancer. Additionally, the company’s independently developed SSS59, the world’s first anti-MUC17/CD3/CD28 trispecific antibody, has entered Phase I clinical trials for solid tumors. SPGL008 is an IL15 bifunctional molecule targeting tumors via a B7H3 monoclonal antibody. As a novel global exclusive product, SPGL008 has also been approved for Phase I clinical trials for solid tumor indications.

Rapid Progress in Autoimmune Pipeline, Multiple Products Nearing Harvest. The NDA applications for the anti-IL-17A monoclonal antibody SSGJ-608 for plaque psoriasis and the anti-IL-1β monoclonal antibody SSGJ-613 for acute gouty arthritis have been submitted and accepted. The Phase III clinical trial of the anti-IL-4Rα monoclonal antibody SSGJ-611 for adult atopic dermatitis has met its primary endpoint. The anti-IL-5 monoclonal antibody SSGJ-610 for severe eosinophilic asthma has entered Phase III clinical trials. SSGJ-626, the first domestically developed anti-BDCA2 monoclonal antibody, has received IND approvals in both China and the U.S. for the treatment of systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). SSGJ-627, the first anti-TL1A monoclonal antibody approved for clinical trials in China, has entered Phase I clinical studies.

In nephrology, long-acting products are being comprehensively deployed around dialysis patients and anemia indications, further strengthening the company’s leadership in this field. The NDA for the long-acting erythropoietin SSS06 for the treatment of anemia in dialysis patients has been submitted to the National Medical Products Administration (NMPA) and accepted. Phase II clinical trials for anemia due to chemotherapy in cancer (CIA) are ongoing. Phase II clinical studies for the HIF inhibitor SSS17 for renal anemia in non-dialysis patients and anemia after orthopedic surgery have been initiated.

Expanding Product Portfolio to Provide Better Disease Solutions

The paclitaxel oral solution, developed by 3SBio in collaboration with HaiHe Biopharma, has been included in the preliminary review list for the 2025 National Reimbursement Drug List (NRDL) adjustment. Patient enrollment for the Phase III clinical trial of the weight loss indication for semaglutide injection, a product developed in collaboration with HYBio Pharmaceutical, has been completed. In the first half of 2025, the company signed a collaboration agreement with DualityBio, obtaining commercialization rights for multiple indications of the HER2 ADC drug DB-1303 in mainland China, Hong Kong, and Macau.

Looking ahead, 3SBio will continue to focus on its core therapeutic areas, including nephrology, hematology and oncology, autoimmune diseases, and dermatology, persistently implementing a dual strategy of in-house R&D and external collaboration. The company will actively seek promising innovative drug collaboration opportunities to strengthen its pipeline. Leveraging its mature biopharmaceutical R&D, registration, commercial production, and sales capabilities, 3SBio will also contribute to the R&D, approval, and market value realization of more high-quality innovative drug products.

Dr. Lou Jing, Chairman and CEO of 3SBio, stated: "Looking back at the past six months, the global pharmaceutical industry has faced both opportunities and challenges. We have remained committed to our mission of 'Making Innovative Biopharmaceuticals Accessible,' maintaining steady development in a complex environment and achieving encouraging progress in multiple key areas. Particularly exciting is the breakthrough data from several clinical studies in our core therapeutic areas such as oncology and autoimmune diseases. Through out-licensing, we have reached an important milestone in product internationalization, injecting strong momentum for the company's long-term development. These achievements not only validate the technical strength of our R&D platform but also signify the accelerating value realization of our innovative pipeline, laying a solid foundation for sustained future growth. Looking ahead, we will continue to increase investment in innovative R&D, deepen global collaborations, and accelerate the development and commercialization of cutting-edge products, enabling Chinese innovative drugs to bring more treatment benefits to patients and create long-term value for society."

Cautionary Note and Forward-Looking Statements

This press release contains forward-looking statements, such as those relating to business or products outlook, or Company’s intent, plans, beliefs, expectation and strategies. These forward-looking statements are based on information currently available to the Company and are stated herein on the basis of the outlook at the time of this press release. They are based on certain expectations, assumptions and premises, some of which are subjective or beyond our control. These forward-looking statements may prove to be incorrect or may not be realized in the future. With respect to any new product or new indication, we cannot guarantee that we will be able to successfully develop or eventually launch and market such product or indication. Underlying the forward-looking statements is a large number of risks and uncertainties. Further information regarding such risks and uncertainties may be found in our other public disclosure documents. The scientific information involved may only be preliminary and empirical. Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company.