Innovation-driven, Steady Advancement
SHANGHAI, Aug. 21, 2026 /PRNewswire/ — Today, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (hereinafter referred to as “Sunshine Guojian”, stock code: 688336.SH), a pioneer in China’s antibody therapeutics, released its 2026 interim report. In the first half of 2026, Sunshine Guojian pursued its dual-engine strategy of “In-house R&D plus External Collaboration”, drove growth through innovation, delivered solid performance, advanced its R&D pipeline efficiently, and secured successive approvals for multiple products, demonstrating a positive development trajectory.
Solid Growth in Performance and Continued Progress in External Collaboration
In the first half of 2026, Sunshine Guojian delivered solid performance growth, with total operating revenue reaching RMB 866 million, representing a year-on-year increase of 34.84%; net profit attributable to equity holders of the Company amounted to RMB 371 million, up 95.10% year-on-year; net profit attributable to equity holders of the Company excluding non-recurring gains and losses stood at RMB 260 million, up 65.15% year-on-year; basic earnings per share reached RMB 0.41, up 95.24% year-on-year. Sunshine Guojian continued to increase its innovative R&D investment, with R&D expenses rising 32.41% year-on-year to RMB 245 million.
Based on its strong confidence in stable operations and future growth, Sunshine Guojian proposed an interim profit distribution plan for 2026: a cash dividend of RMB 0.42 (tax inclusive) per 10 shares for the first half of 2026, with no conversion of capital reserve into share capital and no bonus share issue. This reflects Sunshine Guojian’s robust cash flow and sustainable profitability foundation, while sharing its growth with shareholders.
The PF-08634404 (SSGJ-707) program, in collaboration with Pfizer, has initiated 9 global multicenter clinical trials covering multiple solid tumor indications, including non-small cell lung cancer and colorectal cancer, with the clinical development significantly accelerated. As several clinical milestones are successively achieved and overseas commercialization is subsequently realized, various clinical and regulatory milestone payments, as well as global sales revenue sharing, will continue generating returns, which is expected to bring sustained and solid cash flow to Sunshine Guojian, and further reinforce its overall financial position.
Continued Breakthroughs Across the R&D Pipeline, Poised for Milestone Realization
In the first half of 2026, Sunshine Guojian accelerated the advancement of clinical studies for its R&D programs, and achieved multiple milestone events, continuously building a new growth driver. As of the report date, Yisaituo® (Amdokitug Injection) and Yisaina® (Anflekitug Injection), both independently developed by Sunshine Guojian, had been approved for marketing. The approval timeline for NDA of one key new autoimmune product is clearly visible, and multiple autoimmune programs have entered the NDA submission or mid-to-late-stage clinical phases.
Yisaituo® (Amdokitug Injection, R&D code: 608) was approved for marketing by the National Medical Products Administration (NMPA) in February 2026 for 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. Currently, two additional indications for this product, both ankylosing spondylitis and non-radiographic axial spondyloarthritis, have entered Phase III clinical studies. The product is expected to further broaden its clinical applications in autoimmune diseases as new indications are continuously developed.
Yisaina® (Anflekitug Injection, R&D code: 613) was approved for marketing by the NMPA in August 2026 for acute flares of gouty arthritis in adult patients who are contraindicated for, intolerant of, or inadequately responsive to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine, and those are unsuitable for repeated use of corticosteroids. As the first in-house IgG1 kappa humanized anti-IL-1β monoclonal antibody marketed in China, Yisaina® holds broad market potential. The product demonstrates significant effects in pain relief and recurrence prevention, while maintaining a favorable safety and tolerability profile. It addresses an unmet clinical need among patients with limited response to conventional therapies, intolerance to corticosteroids or colchicine, and recurrent gout attacks.
One product’s NDA has been accepted for review. The marketing application for anti-IL-4Rα mAb injection (R&D code: 611) for moderate-to-severe atopic dermatitis in adults was submitted and accepted for review in February 2026.
Sunshine Guojian continues to advance Phase III clinical trials for multiple products. Amdokitug Injection (R&D code: 608): Enrollment of all subjects in the Phase III clinical trial for ankylosing spondylitis has been completed. The first subject has been enrolled in the Phase III clinical trial for non-radiographic axial spondyloarthritis. Humanized anti-IL-5 monoclonal antibody injection (R&D code: 610): Enrollment of all subjects in the Phase III clinical trial for severe eosinophilic asthma in adults has been completed. Enrollment is ongoing in the Phase III clinical trial for severe eosinophilic asthma in adolescents. Anti-IL-4Rα mAb injection (R&D code: 611): Enrollment is ongoing in the Phase III clinical trial for chronic obstructive pulmonary disease. Enrollment of all subjects in the Phase III clinical trial for moderate-to-severe atopic dermatitis in adolescents aged 12 to 17 has been completed. The primary endpoint in the Phase III clinical trial for chronic rhinosinusitis with nasal polyps has been achieved, with significant efficacy demonstrated. The Phase III clinical trial for moderate-to-severe atopic dermatitis in children is being initiated. The interim analysis met the primary endpoint in the Phase III clinical trial evaluating combination treatment with topical corticosteroids for moderate-to-severe atopic dermatitis in adults. Anflekitug Injection (R&D code: 613): A Phase II multiple-dose dose-exploration study has been initiated for the intercritical gouty arthritis.
Early-stage clinical programs are progressing rapidly. The enrollment of all subjects in Phase Ib clinical study of recombinant humanized anti-BDCA2 monoclonal antibody injection (R&D code: 626) for systemic lupus erythematosus has been completed. Phase II clinical studies for systemic lupus erythematosus and cutaneous lupus erythematosus are being initiated. The Phase I clinical study of recombinant humanized anti-TL1A monoclonal antibody injection (R&D code: 627) for ulcerative colitis in healthy Chinese subjects via subcutaneous administration across all dose cohorts has been completed, and positive results were obtained. Enrollment in Part 1 of the Phase II clinical study for ulcerative colitis has been initiated. The IND application for OX40L/IL-31RA bispecific antibody injection (R&D code: 716) for atopic dermatitis has been approved by the NMPA and U.S. Food and Drug Administration (FDA). Enrollment of healthy Chinese subjects in a Phase I clinical study has been initiated.
Accelerated Translation of Cutting-Edge Targets, Deepening Commitment to Autoimmune Diseases
By deeply exploring the key immune pathways and regulatory nodes in disease onset and progression, and leveraging its structural biology, AI-assisted drug design, and high-throughput screening platforms, Sunshine Guojian continues to build a portfolio of next-generation high-value targets and innovative molecular formats, forming a diversified and differentiated product matrix encompassing bispecific antibodies, trispecific antibodies, oral peptides, and inhaled antibodies. Multiple innovative programs have now entered the IND or pivotal preclinical study stages, including CD3/BCMA/CD19 humanized trispecific antibody injection (R&D code: 717), recombinant anti-TL1A/IL-23 bispecific antibody injection (R&D code: 718), TSLP/IL-4R bispecific antibody inhalation (R&D code: 719), IL-23R oral peptide (R&D code: 629), among others.
Leveraging its world-class core technology platforms and innovation systems, Sunshine Guojian is moving beyond the traditional monoclonal antibody format and initiating multi-dimensional iteration of technological pathways. From discovery to development and from data to value, Sunshine Guojian is accelerating new drug R&D and enhancing clinical value. Sunshine Guojian is driving leapfrog progress in the autoimmune disease field through coordinated development of multiple products, establishing a full-cycle pipeline portfolio characterized by products that can be commercialized in the short term, provide meaningful support in the medium term, and deliver industry leadership over the long term.
Dr. Jing Lou, Chairman of the Board and Chief Executive Officer of 3S Bio Inc., and Chairman of Sunshine Guojian, stated: With Sunshine Guojian’s pipeline gradually entering a harvest phase, it has established a tiered innovation portfolio consisting of mature products that fortify the operational foundation, innovative products that foster growth momentum, and cutting-edge pipelines that underpin long-term development. Supported by a commercialization platform covering nearly 4,800 medical institutions, Sunshine Guojian has established an integrated sales network encompassing hospitals, dual-channel pharmacies, specialty DTP pharmacies, and Internet hospitals. Looking ahead, Sunshine Guojian will continue to increase investment in early-stage innovative R&D, take a forward-looking approach to building an end-to-end innovation system, identify targets with clinical advantages, steadily advance the development and launch of new products, and deliver high-quality innovative biologics to more patients faster.
