InnoCare Pharma's novel TYK2 inhibitor ICP-488 receives CDE approval for Phase II clinical trial in treating Sjögren's syndrome

InnoCare Pharma (SSE code: 688428; HKEX code: 09969) today announced that the company’s self-developed novel TYK2 inhibitor (ICP-488) for the treatment of Sjögren's syndrome has received approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) to proceed with Phase II clinical trials.

ICP-488 is an orally administered, highly selective TYK2 allosteric inhibitor. By specifically binding to the TYK2 JH2 domain, it blocks abnormal signal transduction of inflammatory cytokines such as IL-23, IL-12, and type I interferon, thereby suppressing pathological processes in autoimmune and inflammatory diseases. Sjögren's syndrome is associated with abnormal activation of the TYK2-mediated signaling pathway, and ICP-488 is expected to provide a new therapeutic option for patients.

Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocyte proliferation and progressive exocrine gland damage. The main clinical manifestations include impaired function of salivary and lacrimal glands, along with involvement of multiple systems and organs, significantly reducing patients' quality of life. Currently, the prevalence rate of Sjögren's syndrome in China is between 0.33% and 0.77%[1], with an estimated patient population of approximately five million. Globally, there are no approved targeted therapies for Sjögren's syndrome, representing a significant unmet clinical need.

Dr. Jisong Cui, Co-founder, Chairman, and CEO of InnoCare Pharma, stated: 'ICP-488 demonstrates extensive potential in multiple autoimmune disease areas, and the approval of this Phase II clinical trial for Sjögren's syndrome further expands our company's autoimmune disease treatment portfolio. We will continue exploring cutting-edge global targets such as B-cell and T-cell pathways to develop innovative autoimmune disease treatments with differentiated advantages, advance more autoimmune indications through clinical development, and bring safe, effective, and convenient innovative treatment options to patients worldwide.'

Drying Syndrome Study Group of the Rheumatology and Immunology Physicians Branch of the Chinese Medical Doctor Association et al. Clinical Practice Guidelines for Primary Sjögren's Syndrome [J]. Chinese Journal of Internal Medicine, 2023, 62(9): 1059-1067.

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