InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced  that the first patient has been dosed in the Phase II/III clinical trial of novel TYK2 inhibitor soficitinib (ICP-332) for the treatment of chronic spontaneous urticaria (CSU).

Currently, patient enrollment has been completed in the Phase III registrational clinical trial of soficitinib for the treatment of moderate to severe atopic dermatitis (AD), and in the Phase II clinical trial for the treatment of vitiligo. In addition, clinical trials of soficitinib for the treatment of psoriasis and nodular prurigo are also progressing rapidly.

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. 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, and the condition is prone to recurrent episodes. Intense nighttime itching can severely disrupt patients’ daily lives. 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, “We are delighted to see the rapid progress of our five clinical trials for the TYK2 inhibitor. We hope this innovative drug will benefit more autoimmune patients as soon as possible and address their significant unmet medical needs.”