SinoMab BioScience Limited Receives IND Approval from NMPA for First-in-Class SM17 in Inflammatory Bowel Disease

Key Highlights

• IND Approval: SinoMab BioScience Limited has received Investigational New Drug (IND) approval from the National Medical Products Administration of China (NMPA) for SM17, its first-in-class (FIC) therapeutic product, to treat inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC).
• Expansion of Therapeutic Scope: This approval marks a major milestone, expanding the application of SM17 beyond its existing focus on atopic dermatitis (AD) to include IBD. This potentially multiplies the commercial and clinical opportunities for the company.
• Significant Unmet Medical Need: IBD, including CD and UC, are chronic and debilitating conditions with substantial unmet medical needs. The global annual cost for IBD management exceeds USD34 billion, reflecting the sizable market opportunity.

Clinical Development Progress

• Bridging Study: The company has completed follow-up visits for a Phase I bridging study in healthy volunteers evaluating subcutaneous administration of SM17. These data will be critical for supporting further clinical development for IBD indications, especially as the company prepares for Phase II studies.
• Ongoing Formulation Studies: SM17 is currently completing an intravenous-to-subcutaneous formulation bridging study, expected to conclude as early as the first quarter of this year.
• Upcoming Clinical Trials: A Phase II clinical trial for atopic dermatitis is anticipated to commence as early as the second quarter of this year, demonstrating the company’s parallel progress in multiple indications.

Mechanism of Action: Differentiation from Competitors

SM17 is a novel, humanized IgG4-k monoclonal antibody that targets the IL-25 receptor (IL17RB), a key modulator of Type 2 inflammatory responses. By binding specifically to IL17RB on Type 2 innate lymphoid cells (ILC2s) and Th2 cells, SM17 inhibits IL-25-mediated signaling and suppresses downstream cytokines such as interleukin-4, interleukin-5, and interleukin-13. This positions SM17 as a differentiated therapy, potentially more effective for patients with refractory or complex IBD phenotypes.

The multi-mechanistic profile of SM17 could offer benefits not only in UC, where IL-25 has a pro-inflammatory role, but also in CD, by modulating Th17-associated inflammation and potentially exerting anti-fibrotic effects. This could help manage complications such as strictures and fistulas, for which current therapies are inadequate.

Market and Competitive Implications

• Unmet Need: Existing therapies for IBD, including TNF blockers, anti-integrin agents, and IL-12/23 inhibitors, fail to achieve durable responses in 20–50% of patients. The need for therapies with anti-fibrotic activity is especially pronounced.
• Strategic Opportunity: Expansion of SM17’s indication from AD to IBD represents a significant opportunity to address these unmet needs, which could have substantial clinical and commercial impact for shareholders.
• Pipeline Differentiation: Targeting upstream regulators of the Type 2 inflammatory pathway, such as the IL-25 receptor, may position SM17 as a safer and more effective alternative to current treatments.

Key Information for Shareholders

• Potential Share Price Sensitivity: The IND approval for IBD is a material development, representing entry into large, under-served markets and de-risking the clinical pipeline for SM17. This is a significant positive catalyst that could impact share value.
• Ongoing Updates: The company will continue to provide updates to shareholders and potential investors on material developments as required by regulatory authorities.

Board and Management

The announcement was authorized by Dr. Shui On Leung, Executive Director, Chairman, and Chief Executive Officer, with the support of a board comprising executive, non-executive, and independent non-executive directors.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should make their own decisions based on their individual circumstances and consult with professional advisors as needed. The information is based on SinoMab BioScience Limited’s public disclosure as of 24 February 2026 and may be subject to change without notice.

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