InnoCare has dosed the first patient in a global Phase II trial of its selective and potent tyrosine kinase 2 (TYK2) inhibitor, soficitinib (ICP-332), for treating prurigo nodularis in China.
Soficitinib is in development for treating multiple T-cell related autoimmune disorders.
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The indications currently under development include prurigo nodularis, atopic dermatitis, vitiligo, and urticaria, addressing needs within the dermatology sector.
TYK2 is a key component of the JAK-STAT signalling pathway and is involved in the pathology of inflammatory diseases.
The chronic inflammatory skin condition prurigo nodularis is characterised by skin nodules and severe itching, significantly affecting the patient’s quality of life.
Soficitinib works by inhibiting cytokine pathways including IL-4, IL-13 and IL-31, resulting in inhibition of skin inflammation and reduced neurogenic itch responses.
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By GlobalDataInnoCare co-founder, chairwoman and CEO Dr Jasmine Cui said: “InnoCare’s pipeline under development now covers ten major autoimmune diseases, with a particular focus on dermatological conditions. The Phase II clinical study of Soficitinib for moderate-to-severe atopic dermatitis demonstrated outstanding efficacy and a strong safety profile.
“The data has been released as a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting. We are accelerating global clinical development to bring innovative therapies to more autoimmune patients as early as possible.”
InnoCare develops therapies for cancers and autoimmune diseases with unmet medical needs worldwide, with operations in Beijing, Guangzhou, Hong Kong, Nanjing, Shanghai and the US.
In July 2025, the China National Medical Products Administration’s Center for Drug Evaluation (CDE) granted approval to the investigational new drug application of InnoCare Pharma to initiate a trial of ICP-B794, a B7-H3 targeted antibody-drug conjugate.
