InnoCare Announces Approval of a Phase II Clinical Trial of TYK2 Inhibitor ICP-488 for Sjögren’s Syndrome in China

BEIJING, May 07, 2026 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a Phase II clinical trial of its novel TYK2 inhibitor ICP-488 for the treatment of Sjögren’s syndrome.

ICP-488 is an oral, potent, and selective TYK2 allosteric inhibitor. By binding to the TYK2 JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN, and other inflammatory cytokines, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases. As Sjögren’s syndrome is associated with the aberrant activation of TYK2 pathways, ICP-488 is expected to provide a novel therapeutic option for patients.

Sjögren’s syndrome is a chronic inflammatory autoimmune disease characterized by lymphoproliferation and progressive exocrine gland injury. Its main clinical manifestations include salivary and lacrimal gland dysfunction, as well as multisystem and multi-organ involvement, which significantly impacts patients’ quality of life. In China, the prevalence of Sjögren’s syndrome ranges from 0.33% to 0.77%, with an estimated population of 5 million. Currently, there are no approved targeted therapies for Sjögren’s syndrome globally.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said, “ICP-488 demonstrates broad therapeutic potential across multiple autoimmune diseases. The approval of the Phase II clinical trial for Sjögren’s syndrome further enriches our pipeline in autoimmune therapeutics. The Company has fortified its powerful discovery engine on cutting-edge global targets for the development of autoimmune therapeutics through B-cell and T-cell pathways, with the aim of delivering first-in-class and/or best-in-class treatments to address the massive unmet clinical needs and strong market potential in China and globally.”

About InnoCare Pharma

InnoCare (SSE: 688428; HKEX: 9969) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.

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