Guoxin Securities: Vitiligo has a large number of unmet clinical needs and will usher in a drug-intensive POC phase with new mechanisms

The Zhitong Finance App learned that Guoxin Securities released a research report saying that the vitiligo field is about to enter an intensive POC phase with new drug mechanisms, and domestically produced innovative drugs have the potential to go overseas. The bank predicts that the global vitiligo market is expected to reach a space of several billion US dollars, covering different patient groups with topical preparations and systematic medication. Molecules targeting inflammatory pathways are in the advanced stages of development, and systemic drugs are about to enter the commercialization stage. Novel mechanistic drugs targeting TRM have entered the POC phase and have potential differentiating advantages.

Guoxin Securities's main views are as follows:

Vitiligo has a large number of unmet clinical needs

Vitiligo is a chronic autoimmune disease. Its main characteristic is the reduction or loss of melanocytes. The clinical presentation is depigmented spots (leukoplakia) with relatively clear boundaries. According to estimates, there are more than 20 million patients with vitiligo worldwide; currently, only one topical preparation has been approved for marketing by the FDA, and patients have large unmet clinical needs. The pathogenesis of vitiligo is mainly related to IFNgamma-mediated inflammatory pathways and activation of tissue-resident memory T (TRM) cells. Oral administration of JAK1/JAK3/TYK2 inhibitors, IL15/CD122 monoclonal antibodies, and other innovative drugs targeting the core pathogenesis are in the clinical development stage and have shown good therapeutic potential.

JAK/TYK2 inhibitors: Entering the commercialization phase

Jak1/jak2/jak3 plays a key role in IFN-gamma-mediated inflammatory effects and TRM immune memory maintenance. Rucotinib (Jak1/2i) cream is the only FDA-approved vitiligo treatment, and has achieved good color correction in mild to moderate patients. Kangzhe Pharmaceutical and Incyte reached a cooperation agreement to have commercialization rights for rucotinib cream in Greater China. Upadacitinib (jAK1i) /Povorcitinib (jAK1i) /Ritlecitinib (jAK3/teci) all obtained positive results in phase 3 clinical trials, and JAK inhibitors were clinically proven in vitiligo. Nuochengjianhua's Soficitinib (TYK2/jak1i) has obtained excellent efficacy data in the phase 2 clinical trial of vitiligo, and is expected to become a strong competitor in the field of vitiligo.

IL15/CD122 pathway: showing initial therapeutic potential

TRM is the core cause of progression and recurrence in patients with vitiligo. IL15/CD122 is a key factor in TRM maintenance and activation; blocking the combination of IL15 and CD122 may have the characteristics of maintaining efficacy and preventing recurrence after discontinuation of the drug while improving disease progression. Forte's FB122 (CD122 monoclonal antibody) read good ph1b clinical data in 2026, and was later purchased by Argenx for about 2.2 billion US dollars. Zhixiang Jintai's GR2301 (IL15 monoclonal antibody), Cinda Biotech's IBI3013 (IL15 monoclonal antibody), and Xiansheng Pharmaceutical's SIM0725 (CD122 monoclonal antibody) are leading the way and have the potential to compete in the global market.

Other mechanisms/targets: Pipeline is in early development

New-mechanism drugs, including EB-06/ACT-777991, which blocks core chemokines (CXCL10/CXCR3), anifrolumab/EI-001, which reduces upstream immune activation (IFNAR1/IFNγ), and DR-01/BG-A3004, which directly removes effector lymphocytes (KLRD1/KLRG1), are being clinically treated for vitiligo indications.

Risk warning: R&D progress falls short of expectations, clinical data falls short of expectations