InnoCare Announces NMPA Approval of a Phase II Clinical Trial of TYK2 Inhibitor ICP-488 for Cutaneous Lupus Erythematosus

BEIJING, Dec. 23, 2025 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a phase II clinical trial of its novel TYK2 inhibitor ICP-488 for the treatment of cutaneous lupus erythematosus (CLE).

ICP-488 is an oral, potent, and selective TYK2 allosteric inhibitor. By binding to the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN, and other inflammatory cytokines, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases.

CLE is a common type of lupus erythematosus, an autoimmune disease that primarily manifests as cutaneous lesions. It is characterized by diverse skin lesions. Some CLE patients may progress to systemic lupus erythematosus with damages to multiple organs.

Dr. Jasmine Cui, the 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.”

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.