Portfolio News
2025/12/11
SinoMab (03681.HK) Achieves Key Regulatory Milestone as NMPA Accepts IND Applica on for SM17, a Novel IL-25 Receptor An body for Inflammatory Bowel Disease
(11 December 2025 - Hong Kong) SinoMab BioScience Limited (“SinoMab” or the “Company”,
Stock code: 03681.HK), is pleased to announce an Inves ga onal New Drug applica on (“IND”) for
SM17 in the indica on of Inflammatory Bowel Disease (“IBD”) has been filed with and accepted by
the Center for Drug Evalua on (the “CDE”) of the Na onal Medical Products Administra on
(“NMPA”) of China. This milestone represents an important advancement in the development of
SM17.
Upon approval of this IND applica on, the Phase 1 clinical trial data in healthy volunteers that the Company has completed or is currently conduc ng may be leveraged to support the progression of the IBD indica on directly to Phase 2 clinical development. This IND submission represents an important step toward expanding SM17’s therapeu c scope beyond atopic derma s (“AD”) to IBD, including Crohn’s disease (“CD”) and ulcera ve coli s (“UC”), which are chronic, debilita ng condi ons with significant unmet medical needs.
According to the data of an independent market research ins tu on, the global annual cost of IBD management is esmated to exceed USD 34 billion. In addi on, current therapies, including TNF blockers, an-integrins, and IL-12/23 inhibitors, do not fully address the needs of 20–50% of pa ents due to primary non-response or secondary loss of response within 1–2 years, par cularly in those with fistulizing CD or extensive luminal disease. This challenge is largely a ributable to the significant heterogeneity of IBD pathological pathways, which makes single-cytokine targe ng insufficient for all pa ent subsets, and is further compounded by the absence of an-fibro c ac vity in these therapies, allowing progressive ssue remodeling to con nue in complicated cases. Long-term use also raises safety concerns, including increased risks of infec on and malignancy.
Dr. Shui On LEUNG, Execu ve Director, Chairman and Chief Execu ve Officer of SinoMab, comments: "The IND for SM17 in the indica on of IBD is a great milestone of the development of this innova ve drug. Expanding SM17’s indica on from AD to IBD represents a significant opportunity to address unmet medical needs in a disease area of substan al clinical and commercial importance. In addi on, SM17 has mul-mechanis c profile differen a ng it from current single-pathway therapies and provides a novel op on for pa ents with refractory or complex disease phenotypes. At the same me, we further believe that therapies targe ng upstream of the Th2 inflammatory cytokine pathway, such as the IL-25 receptor, may have broad effects on skin inflamma on, suppor ng SM17’s poten al as a differen ated, safer, and more effec ve product for the treatment of AD.”
SM17 is a novel, first-in-class humanized IgG4-κ monoclonal an body designed to modulate Type II inflammatory responses by targe ng the receptor of interleukin 25 (IL-25), an “alarmin” molecule central to Type 2 immunity. By binding to the IL-25 receptor (IL-17RB) on Type 2 innate lymphoid cells (ILC2s) and Th2 cells, SM17 blocks IL-25-induced signaling cascades and suppresses downstream cytokines including IL-4, IL-5, and IL-13. This mechanism posi ons SM17 as a promising candidate for UC, where IL-25 plays a pro-inflammatory role. Furthermore, SM17 offers poten al benefits in CD through two complementary mechanisms: modula on of Th17-driven inflamma on and an an-fibro c effect, which may help address complica ons such as strictures and fistulas. This mul-mechanis c profile differen ates SM17 from current single-pathway therapies and provides a novel op on for pa ents with refractory or complex disease phenotypes.
IL-25 is a cri cal cytokine implicated in the pathogenesis of IBD, including CD and UC. These chronic inflammatory disorders of the diges ve tract arise from dysfunc onal immune response to normally harmless commensal bacteria. Depending on the dominant T-helper cell subsets, these responses can be categorized into Th1-, Th2-, or Th17-driven pathways, each associated with dis nct cytokine profiles. Pa ents with IBD suffer from symptoms such as severe diarrhea, abdominal pain, rectal bleeding and weight loss, o en complicated by fistulas, strictures and colectomy in advanced stages. Beyond physical morbidity, the relapsing nature of IBD significantly impairs quality of life, with high rates of anxiety, depression and work produc vity loss.
Currently, SM17 is undergoing bridging clinical trials for dosage form conversion, which is expected to be completed as early as the end of February next year, and it is expected to enter Phase 2 clinical trials for AD by mid-2026. We will con nue to update our shareholders and poten al investors on material progress in accordance with applicable regulatory requirements.
Upon approval of this IND applica on, the Phase 1 clinical trial data in healthy volunteers that the Company has completed or is currently conduc ng may be leveraged to support the progression of the IBD indica on directly to Phase 2 clinical development. This IND submission represents an important step toward expanding SM17’s therapeu c scope beyond atopic derma s (“AD”) to IBD, including Crohn’s disease (“CD”) and ulcera ve coli s (“UC”), which are chronic, debilita ng condi ons with significant unmet medical needs.
According to the data of an independent market research ins tu on, the global annual cost of IBD management is esmated to exceed USD 34 billion. In addi on, current therapies, including TNF blockers, an-integrins, and IL-12/23 inhibitors, do not fully address the needs of 20–50% of pa ents due to primary non-response or secondary loss of response within 1–2 years, par cularly in those with fistulizing CD or extensive luminal disease. This challenge is largely a ributable to the significant heterogeneity of IBD pathological pathways, which makes single-cytokine targe ng insufficient for all pa ent subsets, and is further compounded by the absence of an-fibro c ac vity in these therapies, allowing progressive ssue remodeling to con nue in complicated cases. Long-term use also raises safety concerns, including increased risks of infec on and malignancy.
Dr. Shui On LEUNG, Execu ve Director, Chairman and Chief Execu ve Officer of SinoMab, comments: "The IND for SM17 in the indica on of IBD is a great milestone of the development of this innova ve drug. Expanding SM17’s indica on from AD to IBD represents a significant opportunity to address unmet medical needs in a disease area of substan al clinical and commercial importance. In addi on, SM17 has mul-mechanis c profile differen a ng it from current single-pathway therapies and provides a novel op on for pa ents with refractory or complex disease phenotypes. At the same me, we further believe that therapies targe ng upstream of the Th2 inflammatory cytokine pathway, such as the IL-25 receptor, may have broad effects on skin inflamma on, suppor ng SM17’s poten al as a differen ated, safer, and more effec ve product for the treatment of AD.”
SM17 is a novel, first-in-class humanized IgG4-κ monoclonal an body designed to modulate Type II inflammatory responses by targe ng the receptor of interleukin 25 (IL-25), an “alarmin” molecule central to Type 2 immunity. By binding to the IL-25 receptor (IL-17RB) on Type 2 innate lymphoid cells (ILC2s) and Th2 cells, SM17 blocks IL-25-induced signaling cascades and suppresses downstream cytokines including IL-4, IL-5, and IL-13. This mechanism posi ons SM17 as a promising candidate for UC, where IL-25 plays a pro-inflammatory role. Furthermore, SM17 offers poten al benefits in CD through two complementary mechanisms: modula on of Th17-driven inflamma on and an an-fibro c effect, which may help address complica ons such as strictures and fistulas. This mul-mechanis c profile differen ates SM17 from current single-pathway therapies and provides a novel op on for pa ents with refractory or complex disease phenotypes.
IL-25 is a cri cal cytokine implicated in the pathogenesis of IBD, including CD and UC. These chronic inflammatory disorders of the diges ve tract arise from dysfunc onal immune response to normally harmless commensal bacteria. Depending on the dominant T-helper cell subsets, these responses can be categorized into Th1-, Th2-, or Th17-driven pathways, each associated with dis nct cytokine profiles. Pa ents with IBD suffer from symptoms such as severe diarrhea, abdominal pain, rectal bleeding and weight loss, o en complicated by fistulas, strictures and colectomy in advanced stages. Beyond physical morbidity, the relapsing nature of IBD significantly impairs quality of life, with high rates of anxiety, depression and work produc vity loss.
Currently, SM17 is undergoing bridging clinical trials for dosage form conversion, which is expected to be completed as early as the end of February next year, and it is expected to enter Phase 2 clinical trials for AD by mid-2026. We will con nue to update our shareholders and poten al investors on material progress in accordance with applicable regulatory requirements.
