Guosen: There is significant unmet clinical demand for vitiligo, which will see a concentration of new mechanism drugs entering the POC stage.

Guosen has released a research report stating that the field of vitiligo is about to enter a concentrated POC stage for new mechanism drugs, with the potential for domestic innovative drugs to go overseas. The firm anticipates that the global vitiligo market could reach several billion dollars, with topical formulations and systemic medications covering diverse patient populations. Molecules targeting inflammatory pathways are in the late stages of development, while systemic medications are about to enter the commercialization phase. New mechanism drugs targeting TRM are entering the POC stage and show potential differentiated advantages. Guosen's main points are as follows: There is a significant unmet clinical demand in vitiligo Vitiligo is a chronic autoimmune disease characterized primarily by a reduction or loss of melanocytes, clinically manifested as relatively well-defined depigmented patches (white spots). It is estimated that there are over 20 million vitiligo patients globally; currently, only one topical formulation has been approved for market release by the FDA, and there is a significant unmet clinical demand among patients. The pathogenesis of vitiligo is mainly associated with the IFN-mediated inflammatory pathway and the activation of tissue-resident memory T (TRM) cells. Oral JAK1/JAK3/TYK2 inhibitors, IL15/CD122 monoclonal antibodies, and other innovative drugs targeting the core pathogenesis are in clinical development and have shown promising therapeutic potential. JAK/TYK2 inhibitors: entering the commercialization phase JAK1/JAK2/JAK3 play a critical role in IFN--mediated inflammatory effects and the maintenance of TRM immune memory. Ruxolitinib (JAK1/2i) cream is the only FDA-approved treatment for vitiligo, achieving good repigmentation results in patients with mild to moderate conditions. CMS and Incyte have reached a collaboration agreement granting commercialization rights for ruxolitinib cream in Greater China. Upadacitinib (JAK1i)/Povorcitinib (JAK1i)/Ritlecitinib (JAK3/TECi) have all yielded positive results in Phase 3 clinical trials, validating the clinical efficacy of JAK inhibitors in vitiligo. InnoCare Pharma's Soficitinib (TYK2/JAK1i) has achieved excellent efficacy data in Phase 2 trials for vitiligo, showing promise as a strong competitor in the field. IL15/CD122 pathway: initially demonstrates therapeutic potential TRM is a core reason for the progression and relapse of vitiligo patients, and IL15/CD122 are key factors in the maintenance and activation of TRM; blocking the binding of IL15 and CD122 may improve disease progression while having potential characteristics for maintaining efficacy after withdrawal and preventing relapse. Forte's FB122 (CD122 monoclonal antibody) is expected to report positive phase 1b clinical data in mid-2026 and was subsequently acquired by Argenx for approximately $2.2 billion. Zhixiang Jintai's GR2301 (IL15 monoclonal antibody), INNOVENT BIO's IBI3013 (IL15 monoclonal antibody), and SIMCERE PHARMA's SIM0725 (CD122 monoclonal antibody), among others, are leading in development progress and hold potential for competition in the global market. Other mechanisms/targets: pipelines in early research and development stages New mechanism drugs, including EB-06/ACT-777991 (which blocks core chemokines CXCL10/CXCR3), anifrolumab/EI-001 (which reduces upstream immune activation via IFNAR1/IFN), and DR-01/BG-A3004 (which directly clears effector lymphocytes KLRD1/KLRG1), are undergoing clinical trials for vitiligo indication. Risk warning: research and development progress may not meet expectations; clinical data may fall short of expectations.