Lynk Pharmaceuticals Co., Ltd. ("Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on immune and inflammatory diseases, announced that its internally developed Class 1 innovative drug candidate, LNK01004 ointment, has received approval from the National Medical Products Administration (NMPA) to initiate Phase II clinical studies for the treatment of vitiligo and chronic hand eczema (CHE) in China.

Vitiligo is an autoimmune skin disorder characterized by depigmented or hypopigmented patches on the skin. Lesions occurring on exposed or sensitive body areas often impose significant psychological and emotional burdens on patients, substantially affecting quality of life. Current treatment strategies primarily focus on halting disease progression, promoting skin repigmentation and preventing relapse, however, there remains no curative therapy for vitiligo.

CHE is a common and recurrent inflammatory skin disease characterized by symptoms including erythema, vesicles, scaling, and pruritus. In severe cases, patients may also experience pain and impaired hand function, resulting in a significant impact on daily activities, work productivity, and quality of life. Currently, treatment options for moderate-to-severe or persistent CHE remain limited, representing significant unmet medical needs.

LNK01004 ointment is a third-generation soft pan-JAK inhibitor with the potential to become a first-in-class therapy, capable of modulating multiple inflammatory cytokine-related signaling pathways simultaneously. Unlike conventional JAK inhibitors, LNK01004 ointment was designed to have low systemic exposure and skin-restricted distribution, aiming to achieve an optimal balance between pan-JAK inhibition and controlled systemic exposure in order to maximize efficacy and safety. Its carefully optimized molecular design enables favorable skin penetration while ensuring rapid metabolism and clearance following systemic absorption, resulting in a short plasma half-life and minimal systemic exposure. In addition, the compound demonstrates strong tissue selectivity, with exposure largely confined to skin following topical administration, making it potentially suitable for long-term use. Preclinical studies have clearly demonstrated skin-restricted characteristics and favorable pharmacological activity. In a Phase II clinical study in atopic dermatitis, LNK01004 ointment also demonstrated encouraging efficacy and a favorable safety profile.

Dr. Zhao-Kui (ZK) Wan, Co-founder, Chairman and Chief Executive Officer of Lynk Pharmaceuticals, said: "LNK01004 ointment is one of the Company's key innovative programs in the immune-mediated inflammatory skin diseases (IMIDs) space. Current treatment options for vitiligo and CHE continue to face significant challenges in long-term disease management. With its unique skin-restricted molecular design and ability to modulate multiple inflammatory pathways, LNK01004 has the potential to provide a novel therapeutic option for patients. The approvals to initiate clinical studies for both vitiligo and CHE not only enrich the company's pipeline portfolio in IMIDs, but also further validate the broad development potential of LNK01004 across skin disease indications. We will continue to accelerate the clinical development program and strive to bring safer and more effective innovative therapies to patients as quickly as possible."