SHANGHAI & SHAOXING, China – July 9, 2025 – Leadingtac Pharmaceutical Co., Ltd. ("Leadingtac"), a clinical-stage biotech company focused on innovative drug discovery for autoimmune diseases and oncology, announced today it has dosed the first patient in its Phase Ic clinical trial of LT-002 for the treatment of moderate-to-severe hidradenitis suppurativa (HS).

This achievement follows the recent first-patient-dosing in a parallel study for atopic dermatitis (AD) and marks a significant expansion of the LT-002 clinical program into multiple inflammatory skin diseases.

The Phase Ic trial in HS is a multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple doses of LT-002 in patients with moderate-to-severe HS. The results will provide the foundation of dose selection and study design for subsequent Phase II development.

"Dosing the first patients in both our HS and AD trials in quick succession is a testament to our team's execution capabilities," said Dr. Yan Feng, Founder and CEO of Leadingtac. "We are moving at full speed to bring this innovative IRAK4 degrader to patients. Based on its promising profile, we plan to explore the full potential of LT-002 across a range of IRAK4-mediated autoimmune diseases. We look forward to seeing its efficacy and safety validated in these patient populations."

About Hidradenitis Suppurativa (HS) 

Hidradenitis Suppurativa (HS) is a chronic, painful, and recurrent inflammatory skin disease that involves occlusion of hair follicles, typically in areas such as the axillae and groin. The condition, which often begins after puberty, is characterized by deep-seated inflammatory lesions, abscesses, and sinus tracts that can lead to significant scarring and severely impact a patient's quality of life. The pathogenesis is complex, involving inflammation driven by neutrophils and bacterial colonization.

HS affects approximately 1% of the global population. While the prevalence in Asian populations has been historically lower, a multicenter study in China showed a prevalence of 0.033%. With the anti-TNF drug adalimumab being the only approved therapy and benefiting only about half of patients, a significant unmet clinical need remains for new, more effective treatments.

About Leadingtac 

Leadingtac is a leading company in the field of targeted protein degradation (PROTAC) drug discovery and development in China. Founded in late 2019, Leadingtac has established R&D centres in Shanghai and Shaoxing. The company has developed the unique SPUD® (Specific Protein Ubiquitination and Degradation) technology platform for the efficient screening of proteasomal degradation, new E3 ligase ligands, and lysosomal degradation.

Nano-SPUD® for Target Proteins

Nano-SPUD® for E3 Ligases

Lyso-SPUD® for Lysosome

Based on this platform, Leadingtac has developed its first-in-pipeline IRAK4 degrader, LT-002, for the treatment of autoimmune diseases. The program has received IND clearance from both the CDE (China) and FDA (US), ranking first in China and second globally in terms of development progress for this target class.

Leadingtac's follow-on pipeline targets the JAK-STAT pathway, KRAS, and other 'undruggable' proteins for the treatment of autoimmune diseases and solid tumors, including lung, pancreatic, and colorectal cancers.