Sunshine Guojian Posts 95% Profit Surge as Two Autoimmune Antibodies Win NMPA Approval
核心洞察
Sunshine Guojian reported first-half 2026 total operating revenue of RMB866 million, up 34.84% year-on-year, with net profit surging 95.10% to RMB371 million.
Two self-developed antibodies, Yisaituo (Amdokitug) (搜索) for plaque psoriasis (搜索) and Yisaina (Anflekitug) (搜索) for acute gouty arthritis (搜索), received NMPA marketing approval in 2026.
The anti-IL-4Rα (搜索) antibody (code 611) for atopic dermatitis (搜索) had its NDA accepted in February 2026, with multiple Phase III trials completing enrollment or meeting primary endpoints.
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (stock code: 688336.SH), a pioneer in China's antibody therapeutics, released its 2026 interim report, delivering a 95.10% year-on-year surge in net profit attributable to equity holders to RMB371 million, alongside total operating revenue of RMB866 million, up 34.84% year-on-year. The results reflect the company's "In-house R&D plus External Collaboration" dual-engine strategy, with two self-developed antibodies securing marketing approval and a dense pipeline of clinical milestones reached during the first half of 2026.
Financial Performance and Shareholder Returns
In the first half of 2026, Sunshine Guojian delivered solid performance growth. Net profit attributable to equity holders excluding non-recurring gains and losses stood at RMB260 million, up 65.15% year-on-year, while basic earnings per share reached RMB0.41, up 95.24% year-on-year. The company continued to increase innovative R&D investment, with R&D expenses rising 32.41% year-on-year to RMB245 million.
Based on strong confidence in stable operations and future growth, the company proposed an interim profit distribution plan of RMB0.42 (tax inclusive) per 10 shares in cash dividends, with no conversion of capital reserve into share capital and no bonus share issue.
Dual Product Approvals Mark Harvest Period for Autoimmune Pipeline
Sunshine Guojian's self-developed Yisaituo (Amdokitug Injection, R&D code: 608) received marketing approval from China's National Medical Products Administration (NMPA) in February 2026 for adult patients with moderate-to-severe plaque psoriasis (搜索) who are candidates for systemic therapy or phototherapy. The product offers core advantages including robust and rapid clearance of skin lesions, low immunogenicity, favorable safety and tolerability profile, and convenient administration. Two additional indications—ankylosing spondylitis (搜索) and non-radiographic axial spondyloarthritis (搜索)—have both entered Phase III clinical studies, with the ankylosing spondylitis indication having completed enrollment of all subjects.
Yisaina (Anflekitug Injection, R&D code: 613) received NMPA marketing approval in August 2026 for acute flares of gouty arthritis (搜索) in adult patients who are contraindicated for, intolerant of, or inadequately responsive to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine, and those unsuitable for repeated use of corticosteroids. As the first in-house IgG1 kappa humanized anti-IL-1β (搜索) monoclonal antibody marketed in China, Yisaina 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.
Anti-IL-4Rα Antibody Advances Toward Commercialization
The marketing application for the anti-IL-4Rα (搜索) monoclonal antibody injection (R&D code: 611) for moderate-to-severe atopic dermatitis (搜索) in adults was submitted and accepted for review in February 2026. Clinical progress for this product has been particularly notable: the chronic obstructive pulmonary disease (搜索) indication Phase III study continues enrollment; the adolescent (ages 12–17) moderate-to-severe atopic dermatitis Phase III trial has completed all subject enrollment; the chronic rhinosinusitis with nasal polyps (搜索) Phase III study has met its primary endpoint with significant efficacy; the pediatric moderate-to-severe atopic dermatitis Phase III trial is being initiated; and the Phase III interim analysis for combination therapy with topical corticosteroids in adult moderate-to-severe atopic dermatitis has met its primary endpoint.
Broad Pipeline Advancement Across Autoimmune and Inflammatory Diseases
The anti-IL-5 (搜索) humanized monoclonal antibody injection (R&D code: 610) for adult severe eosinophilic asthma (搜索) has completed all subject enrollment in its Phase III trial, while the adolescent indication Phase III trial continues enrollment.
In early-stage programs, the recombinant anti-BDCA2 (搜索) humanized monoclonal antibody injection (R&D code: 626) for systemic lupus erythematosus (搜索) has completed all subject enrollment in its Phase Ib study, with Phase II trials for both this indication and cutaneous lupus erythematosus being initiated. The recombinant anti-TL1A (搜索) humanized monoclonal antibody injection (R&D code: 627) for ulcerative colitis (搜索) has completed all dose cohorts of the Phase I subcutaneous administration study in healthy Chinese subjects with positive results, and the Phase II Part 1 clinical study for ulcerative colitis has begun enrollment. The OX40L (搜索)/IL-31RA (搜索) bispecific antibody injection (R&D code: 716) for atopic dermatitis (搜索) has obtained investigational new drug (IND) approvals from both China's NMPA and the U.S. FDA, with the Phase I clinical study in healthy Chinese subjects now enrolling.
Frontier Pipeline Diversification and Pfizer Collaboration
By deeply exploring key immune pathways and regulatory nodes in disease pathogenesis, and leveraging structural biology, AI-assisted drug design, and high-throughput screening platforms, Sunshine Guojian continues to build next-generation high-value targets and innovative molecular formats, forming a diversified product matrix spanning bispecific antibodies, trispecific antibodies, oral peptides, and inhaled antibodies. Multiple innovative programs have entered IND or key preclinical research stages, including the CD3/BCMA/CD19 humanized trispecific antibody injection (R&D code: 717), recombinant anti-TL1A (搜索)/IL-23 bispecific antibody injection (R&D code: 718), TSLP/IL-4R bispecific antibody inhalation formulation (R&D code: 719), and IL-23R oral peptide (R&D code: 629).
The PF-08634404 (SSGJ-707) (搜索) program, in collaboration with Pfizer, has initiated nine global multicenter clinical trials covering multiple solid tumor indications, including non-small cell lung cancer (搜索) and colorectal cancer (搜索), with clinical development significantly accelerated. As clinical milestones are achieved and overseas commercialization is realized, clinical and regulatory milestone payments and global sales revenue sharing are expected to bring sustained cash flow to the company.
Dr. Jing Lou, Chairman of the Board and Chief Executive Officer of 3S Bio Inc. (搜索), 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, the company has established an integrated sales network encompassing hospitals, dual-channel pharmacies, specialty DTP pharmacies, and Internet hospitals.