INNOCARE (09969) surged more than 4%, reaching HK$13.69 by the time of writing, with a trading volume of HK$37.91 million. On December 18, the company announced via its official WeChat account that its self-developed novel TYK2 inhibitor, soficitinib (ICP-332), has received approval from China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) to proceed with Phase II/III clinical trials for treating chronic spontaneous urticaria (CSU).

Soficitinib is a highly effective and selective oral TYK2 inhibitor developed by INNOCARE for treating various T-cell-related autoimmune diseases. Its current indications focus on dermatology, targeting conditions such as atopic dermatitis, vitiligo, prurigo nodularis, and urticaria.

As a member of the Janus kinase (JAK) family, TYK2 plays a critical role in the JAK-STAT signaling pathway and is involved in inflammatory pathogenesis. Soficitinib alleviates itching and wheal formation by blocking cytokine signaling pathways—such as IL-4, IL-13, and IL-31—that drive mast cell activation and inflammatory responses, thereby improving CSU symptoms.

Global data indicates approximately 50 million CSU patients worldwide, with the market expected to reach $3 billion by 2029.