SinoMab (03681.HK) Achieves Approximately 43.3% Year-over-Year Decrease in Annual Losses for 2025, Marking Significant Progress in Pipeline Advancement

During the year, loss for the year was approximately RMB105.0 million, decreased by RMB80.1 million from RMB185.1 million for the year ended 31 December 2024. The Company focused on SM17 Phase 1b clinical, transformation bridging study and preparation of Phase 2 clinical trial in 2025, of which the cost was less than large scale clinical studies in 2024. As at 31 December 2025, total funding available to use was approximately RMB351.5 million, representing a significant increase compared to RMB141.4 million as at 31 December 2024. During the year, the Group gained support from well-known institutional investors including Foresight, Fullgoal, and E Fund, completed two rounds of new share subscriptions under general mandate and successfully raised an aggregate amount of approximately HK$493.7 million in net proceeds. This drove net cash flows from financing activities for the Reporting Period to approximately RMB329.4 million, providing sufficient funding to support subsequent R&D and clinical advancement.

SM17 Achieves Multiple Breakthroughs

SM17 is a global first-in-class humanised monoclonal antibody (mAb) targeting the receptor for IL-25, which is capable of modulating Type II allergic reaction by targeting the receptor of a critical “alarmin” molecule interleukin-25 (IL-25). The compound has the potential for treating atopic dermatitis (AD), Inflammatory Bowel Disease (IBD), asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and idiopathic pulmonary fibrosis (IPF).

In the field of atopic dermatitis (AD), SM17 precisely targets upstream drivers of Type 2 immune responses by blocking IL-25, a key “alarmin” cytokine, thereby suppressing the inflammatory cascade at its source. While currently approved AD therapies, including biologics, can significantly improve Eczema Area and Severity Index (EASI) scores and patients’ quality of life, current drugs under development or on the market cannot simultaneously meet the clinical needs for rapid itch relief, skin lesion recovery, and good safety profiles, indicating substantial unmet market demand. SM17’s key innovation lies in its upstream modulation of the Th2 inflammatory cytokine pathway via IL-25 receptor inhibition, thereby suppressing multiple downstream pathogenic signaling pathways. Preclinical studies have demonstrated its potential for rapid itch relief, significant skin lesion recovery, and a favorable safety profile, directly addressing the key limitations of current therapies.

In April 2025, SM17 achieved encouraging positive results in a Phase 1b study in China for the treatment of moderate to severe atopic dermatitis (AD): 12-week topline data after unblinding showed that in the high dose group, 91.7% of patients achieved pruritus relief (NRS-4), 75% achieved skin healing (EASI 75), and 41.7% achieved clear or almost clear signs of AD (IGA0/1). These results significantly outperform IL-4/IL-13 monoclonal antibodies and demonstrate a significantly better safety and tolerability profile than Janus Kinase inhibitors (JAK inhibitors), making SM17 potentially the first-in-class and best-in-class therapeutics which can simultaneously achieve rapid onset of action on pruritic relief, skin healing with a good safety profile. Study results of SM17 were published in various leading international journals. Phase 2 clinical trial for AD is expected to be entered into as early as mid-2026.

On 11 December 2025, an Investigational New Drug application (“IND”) for SM17 in the indication of IBD was filed with and accepted by the Center for Drug Evaluation (the “CDE”) of the National Medical Products Administration of China (“NMPA”), and the IND was subsequently approved in February 2026. This IND submission represents an important step toward expanding SM17’s therapeutic scope beyond AD to IBD, including Crohn’s disease (“CD”) and ulcerative colitis (“UC”), which are chronic, debilitating conditions with significant unmet medical needs. In October 2025, the first cohort of healthy subjects was dosed in a Phase 1 bridging clinical trial for the route of administration conversion in China. As of 31 December 2025, a total of 30 healthy subjects had been enrolled and our follow-up visits for all healthy subjects were completed in February 2026. This bridging study is expected to be completed by the second quarter of 2026. Data from this study will be leveraged to support the progression of the IBD indication directly to Phase 2 clinical development.

Early-Stage Pipelines Drive Continuous Innovation Growth

In terms of early-stage pipeline development, the Company continues to make steady progress. In June 2025, Its partner, Everest Medicines, has announced positive results from the Phase Ib/IIa clinical trial of EVER001 (SinoMab’s SN1011) for the treatment of primary membranous nephropathy (PMN), further enhancing the commercial value of the pipeline.

At the same time, multiple early-stage R&D programs are progressing steadily. Anti-CGC antibody is an in-house developed, first-in-class humanised anti-γc antibody. Our in vitro assays suggested that our antibody could suppress inflammation and autoimmunity driven B, T and NK cell activation. Animal studies demonstrated that our antibody could be a potential therapeutic agent for the treatment of vitiligo, alopecia areata and possibly other autoimmune diseases through the modulation of immune cell expansion, autoreactivity and tissue infiltration. We are currently in the process of CMC optimisation and toxicology studies for our antibody and plan to submit our IND application for the treatment of alopecia areata by the fourth quarter of 2026 at the earliest.

Bispecific antibody candidate is a novel, bispecific antibody targeting Receptor activator of the nuclear factor kappa-B ligand (RANKL) and sclerostin for bone-related indications. bsAb processes differential mechanisms of action tailored for the treatment of osteoporosis. Our in-house in vitro and in vivo studies demonstrated our candidate to have enhanced efficacy over market-approved antibodies such as Denosumab and Romosozumab. We are currently in the process of optimising CMC and testing toxicity in non-human primates and plan to submit our IND application by the first half of 2027 at the earliest.

Expanding Strategic Partnerships and Gaining Strong Industry Recognitions

In August 2025, the Company entered into a comprehensive strategic cooperation agreement with Sun Yat-sen University Institute of Advanced Studies Hong Kong Limited (“SYSU-IAS”). Under the cooperation agreement, the Company enjoys direct access to SYSU-IAS’s comprehensive laboratory facilities and valuable data resources, as well as access to primate and non-primate animal studies supply resources, to accelerate the development of innovative drugs and promote the translation of scientific research into clinical applications worldwide. Furthermore, the Company is actively exploring the feasibility of using artificial intelligence (AI) technology for new target identification.

In January 2026, the Company was invited to participate in the J.P. Morgan Healthcare Conference, where it shared its progress in the autoimmune field with multiple multinational pharmaceutical companies (MNCs) and investors.

With the support of our strong R&D capabilities, extensive pipeline assets and refined operational management, we are thrilled to obtain renowned awards during the year, including the 2nd “New Quality Productive Forces Enterprise Award” jointly presented by the Greater Bay Area Family Office Association and the Hong Kong International Family Office Association, as well as the “Most Valuable Pharmaceutical Company Award” presented by Zhitong Finance.

Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab, comments: "In 2025, we demonstrated the global competitiveness of our innovative pipeline with solid clinical data. The outstanding performance of SM17 in AD and its indication expansion to IBD signify our continuous transition from single-product R&D to the realisation of platform value. Looking ahead to 2026, the biopharmaceutical industry has been accelerating into the “Biotech 3.0 Era”, which is characterised by innovation-driven development, multidisciplinary integration, and intelligent processes across the entire supply chain. We are well-positioned to capture the historic opportunity of the rapid growth of out-licensing deals in China’s biopharmaceutical industry, continue to advance the clinical development of our core pipelines, and deepen our international partnership footprint. Relying on our solid cash reserves, full-spectrum capabilities across the industry chain and the principle of differentiated innovation, we strive to maximize the returns of shareholders in the long run and provide life-changing breakthrough therapies for patients.”

About SinoMab BioScience Limited

SinoMab BioScience Limited (Stock Code: 03681.HK) is a pioneer in the research and development of first-in-class and potential best-in-class therapeutic antibody drugs, focusing on autoimmune diseases, neurodegenerative disorders, and other debilitating diseases, committed to addressing unmet medical needs. SinoMab has consistently focused on developing therapeutic antibodies targeting novel targets and employing innovative mechanisms, aiming to achieve differentiated clinical outcomes in areas where existing therapies have shown limited efficacy. Its rich R&D pipeline includes: SM17, which has demonstrated exceptional anti-pruritic effects, skin clearance rates, and safety profiles in the treatment of AD, with potential applications in asthma and idiopathic pulmonary fibrosis (IPF); its flagship anti-CD22 antibody, Suciraslimab , which has been clinically validated for efficacy in rheumatoid arthritis (RA) and is currently undergoing clinical evaluation for systemic lupus erythematosus (SLE) and Alzheimer's disease; another innovative anti-CGC (common gamma chain) monoclonal antibody, which is preparing to enter clinical studies for the treatment of alopecia areata and vitiligo; and a bispecific monoclonal antibody developed by SinoMab that simultaneously stimulates bone growth and inhibits bone loss for the treatment of osteoporosis. With breakthrough efficacy as its core pursuit, SinoMab continuously redefines patient care standards and maintains a leading position in the field of breakthrough therapies. 

This press release is issued by Zhenzhuo Group on behalf of SinoMab BioScience Limited.

Investor and Media Inquiries

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Phone: (852) 5316 9995
Email: ir_sinomab@zhenzhuoglobal.com