InnoCare Announces Approval of Phase II/III Clinical Trial of Novel TYK2 Inhibitor Soficitinib for Chronic Spontaneous Urticaria in China
BEIJING, Dec. 17, 2025 (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/III clinical trial of novel TYK2 inhibitor soficitinib (ICP-332) for the treatment of chronic spontaneous urticaria (CSU).
Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including atopic dermatitis, vitiligo, prurigo nodularis, CSU, and more. TYK2 plays a key role in the JAK-STAT signaling pathway and is critical in the pathogenesis of inflammatory diseases.
Soficitinib blocks signaling pathways such as lL-4, IL-13, IL-31, and other cytokines that drive mast cell activation and inflammation, reducing itch and wheals in CSU.
CSU is characterized by recurrent wheals and itch, with a disease course typically lasting two to five years, and in some patients, even exceeding five years. China has a large population of CSU patients, a condition that is prone to recurrent episodes. The intense nighttime itching severely disrupts daily life. Long-term, systematic, and standardized treatment is therefore essential for disease control.
There are approximately 50 million CSU patients worldwide1, and the global CSU treatment market is expected to reach $3 billion in 20292.
Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “InnoCare's pipeline under development covers ten major autoimmune diseases, with our TYK2 inhibitors deeply positioned in the field of dermatology. We are accelerating the clinical development of soficitinib to address huge unmet medical needs. We hope this innovative drug will benefit more autoimmune disease patients as early as possible.”
About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
1 DOI: 10.1007/s12325-025-03172-0
2 The Business Research Company
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