BEIJING, Dec. 17, 2025 — InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focused on cancer and autoimmune diseases, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application. This approval allows the company to initiate a Phase II/III clinical trial for its novel TYK2 inhibitor, soficitinib (ICP-332), targeting chronic spontaneous urticaria (CSU).
Soficitinib is a potent and highly selective TYK2 inhibitor in development for several T-cell mediated autoimmune conditions. Its current development targets are strategically focused on the expansive dermatology market, encompassing atopic dermatitis, vitiligo, prurigo nodularis, and CSU, among others. TYK2 is a crucial component of the JAK-STAT signaling pathway and is integral to the development of inflammatory diseases.
By inhibiting signaling pathways driven by cytokines such as IL-4, IL-13, and IL-31, soficitinib blocks mast cell activation and inflammation, thereby alleviating the itch and hives associated with CSU.
CSU is marked by the recurring appearance of itchy hives, with the condition typically persisting for two to five years, and sometimes longer. China is home to a significant number of CSU patients, and the disease is known for its recurrent nature. Severe itching, often worse at night, can profoundly impact a patient’s quality of life, making long-term, systematic, and standardized treatment vital for effective management.
Globally, there are an estimated 50 million CSU patients1, and the worldwide market for CSU treatments is projected to grow to $3 billion by 20292.
Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, stated, “InnoCare’s development pipeline addresses ten major autoimmune diseases, with our TYK2 inhibitors holding a strong position in dermatology. We are expediting the clinical development of soficitinib to meet substantial unmet medical needs. Our goal is for this innovative therapy to reach and help more patients with autoimmune diseases at the earliest opportunity.”
About InnoCare
InnoCare is a commercial-stage biopharmaceutical company dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class medicines for cancers and autoimmune diseases with significant unmet needs in China and globally. The company maintains operations 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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