Hangzhou Yirui Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Yirui Pharma”) announced the successful completion of the Phase I clinical trial of YR001 topical formulation in the United States. YR001 demonstrated favorable safety and tolerability in all subjects. This significant milestone marks an important advancement for Yirui Pharma in the field of small molecule innovative targeted therapies for autoimmune skin diseases.

The Phase I clinical trial of YR001 in the United States was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of YR001 in healthy adult volunteers (NCT05718921).

In this clinical trial, a total of 54 subjects were enrolled, and no serious adverse reactions, dose-limiting toxicities, or local skin intolerances were observed. Additionally, human pharmacokinetic data indicated that the drug was predominantly localized to the skin.

The success of this clinical trial lays a solid foundation for Yirui Pharma’s small molecule innovative targeted drug development program. The company will continue to advance the next phase of clinical trials to evaluate the efficacy and safety of the drug. Yirui Pharma will work closely with regulatory agencies and partners to accelerate the development process and provide patients with more effective and safer treatment options.

About YR001: YR001 is a small molecule Kv1.3 inhibitor topical ointment intended for the treatment of atopic dermatitis (AD) and psoriasis. Based on its target mechanism, drug properties, and multiple safety aspects of the administration route, this drug holds promise as a future treatment for mild to moderate AD patients, including children and infants, who represent a high-incidence population. Meanwhile, Yirui Pharma has successfully developed an oral formulation of YR001, which is soon to be submitted for clinical trials for the treatment of autoimmune inflammatory bowel disease (IBD). YR001 is the first Kv1.3 inhibitor in China to enter the clinical stage and is internationally leading in its development, being at a similar clinical development stage as DES-7114, an oral formulation targeting the same pathway from pharmaceutical giant Eli Lilly.

About Yirui Pharma: A Biotech company focused on the research and development of small molecule innovative targeted drugs, committed to source innovation through low-cost, high-efficiency, and effective risk control R&D strategies. The core team consists of former executives from a German new drug R&D company and overseas returnees with doctoral degrees. The company is self-research oriented, with differentiated layouts in the fields of autoimmune diseases, diabetic complications, and chronic inflammatory diseases, innovating in drug targets, indications, administration methods, and treatment populations to maximize the fulfillment of clinical needs. Yirui Pharma is dedicated to developing into an internationally competitive new drug R&D enterprise with core technologies, striving to provide new first-line drugs for the unmet clinical needs of hundreds of millions of patients worldwide.