InnoCare Receives NMPA Approval for Phase II Study of TYK2 Inhibitor ICP-488 in Sjögren’s Syndrome

(SeaPRwire) –   BEIJING, May 7, 2026 — InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focused on treating cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a Phase II clinical trial of ICP-488, an investigational TYK2 inhibitor, for the treatment of Sjögren’s syndrome.

ICP-488 is an oral, potent, and selective allosteric inhibitor of TYK2. By targeting the JH2 domain of TYK2, it blocks signaling pathways associated with key inflammatory cytokines such as IL-23, IL-12, and type I interferons. This mechanism helps suppress the immune overactivation seen in autoimmune and inflammatory conditions. Given the central role of TYK2 pathway dysregulation in Sjögren’s syndrome, ICP-488 represents a promising new therapeutic approach for patients suffering from this condition.

Sjögren’s syndrome is a chronic autoimmune disorder marked by lymphocytic infiltration and progressive damage to exocrine glands, particularly the salivary and lacrimal glands. The disease often leads to dry mouth and eyes and can involve multiple organs and systems, significantly affecting patients’ quality of life. In China, the estimated prevalence ranges from 0.33% to 0.77%, corresponding to approximately five million affected individuals. To date, no targeted therapies have been approved for Sjögren’s syndrome worldwide.

Dr. Jasmine Cui, Co-Founder, Chairwoman, and CEO of InnoCare, stated, “ICP-488 shows strong potential as a treatment across a range of autoimmune diseases. Approval of the Phase II trial in Sjögren’s syndrome marks a significant advancement in our autoimmune pipeline. Our team has built a robust discovery platform targeting cutting-edge mechanisms—particularly those involving B-cell and T-cell signaling pathways—to develop first-in-class or best-in-class therapeutics that address major unmet medical needs and substantial market opportunities in China and globally.”

About InnoCare Pharma

InnoCare (SSE: 688428; HKEX: 9969) is a commercial-stage biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines for cancers and autoimmune diseases—two areas where significant unmet needs persist. The company maintains comprehensive drug discovery platforms and has built a diverse product pipeline that includes three approved drugs (orelabrutinib, tafasitamab, and zurletrectinib), over ten candidates currently in clinical trials, and several preclinical programs. With operations in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States, InnoCare continues to expand its global footprint. For more information, visit https://www.innocarepharma.com/en and follow us on LinkedIn.

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