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

(SeaPRwire) –   BEIJING, May 07, 2026 — InnoCare Pharma (HKEX: 9969; SSE: 688428), a prominent biopharmaceutical company focused on treating cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application. This approval allows InnoCare to proceed with a Phase II clinical trial for ICP-488, its novel TYK2 inhibitor, intended for the treatment of Sjögren’s syndrome.

ICP-488 is an orally administered, potent, and selective allosteric inhibitor of TYK2. By binding to the TYK2 JH2 domain, ICP-488 effectively blocks the signal transduction of inflammatory cytokines such as IL-23, IL-12, and type 1 IFN, thereby suppressing the pathological processes associated with autoimmune and inflammatory diseases. Given that Sjögren’s syndrome is linked to the abnormal activation of TYK2 pathways, ICP-488 is anticipated to offer a new therapeutic option for patients.

Sjögren’s syndrome is a chronic inflammatory autoimmune condition characterized by lymphoproliferation and progressive damage to exocrine glands. Its primary clinical manifestations include impaired function of salivary and lacrimal glands, along with multisystem and multi-organ involvement, which significantly diminishes patients’ quality of life. In China, the prevalence of Sjögren’s syndrome ranges from 0.33% to 0.77%, affecting an estimated 5 million people. Currently, there are no approved targeted therapies for Sjögren’s syndrome available globally.

Dr. Jasmine Cui, Co-Founder, Chairwoman, and CEO of InnoCare, stated, “ICP-488 demonstrates extensive therapeutic potential across various autoimmune diseases. The approval of the Phase II clinical trial for Sjögren’s syndrome further enhances our pipeline of autoimmune therapeutics. The Company has strengthened its robust discovery engine, focusing on cutting-edge global targets for the development of autoimmune treatments through B-cell and T-cell pathways, with the goal of delivering first-in-class and/or best-in-class therapies to address the substantial unmet clinical needs and strong market potential in China and worldwide.”

About InnoCare Pharma

InnoCare (SSE: 688428; HKEX: 9969) is a commercial-stage biopharmaceutical company dedicated to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with significant unmet medical needs globally. 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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