By: IPP Bureau
Last updated : December 27, 2025 8:30 am
CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions
InnoCare Pharma, a leading biopharmaceutical company focused on cancer and autoimmune diseases, has announced that China’s Center for Drug Evaluation (CDE) has approved its Investigational New Drug (IND) application to begin a phase II clinical trial of ICP-488, a novel TYK2 inhibitor, for cutaneous lupus erythematosus (CLE).
ICP-488 is an oral, potent, and selective TYK2 allosteric inhibitor that targets the JH2 domain to block key inflammatory signals, including IL-23, IL-12, and type 1 IFN. By doing so, it aims to curb the pathological processes driving autoimmune and inflammatory diseases.
CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions and, in some cases, can progress to systemic lupus with multi-organ involvement.
Dr Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, said, “ICP-488 has demonstrated favorable efficacy and safety in the phase II clinical trial for psoriasis, and enrollment for the phase III study is nearing completion.
"CLE is the second indication we are developing for this asset. Compared with injectable biologics, InnoCare’s highly selective TYK2 inhibitor is an oral small-molecule drug that offers patients a more convenient treatment option. We will accelerate the clinical development of ICP-488 to address unmet medical needs.”
The approval marks a significant milestone for InnoCare as it expands the clinical development of ICP-488 beyond psoriasis, highlighting the company’s commitment to innovative, patient-friendly therapies for autoimmune diseases.