YiRui Pharma Announces Successful Completion of Phase I Clinical Trial for YR001 in the U.S.

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

Yirui Pharma’s YR001 Phase I clinical trial in the United States is 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. No serious adverse events, dose-limiting toxicities, or local skin intolerance were observed. Furthermore, human pharmacokinetic data indicated that the drug was confined to cutaneous distribution.

The success of this clinical trial has laid 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 drug’s efficacy and safety. Yirui Pharma will work closely with regulatory authorities and partners to accelerate the drug’s development process and provide patients with more effective and safer treatment options.

YR001 is a topical ointment formulation of a small-molecule Kv1.3 inhibitor, indicated for the treatment of atopic dermatitis (AD) and psoriasis. Given its favorable safety profile derived from its target mechanism, drug properties, and route of administration, YR001 holds promise as a therapeutic option for mild-to-moderate AD patients, including children and infants, among whom the disease prevalence is high. Meanwhile, Yirui Pharma has successfully developed an oral formulation of YR001 and is preparing to submit an Investigational New Drug (IND) application for clinical trials targeting inflammatory bowel disease (IBD). As the first Kv1.3 inhibitor in China to enter clinical development, YR001 is at the forefront of global R&D efforts and is in a similar stage of clinical development to DES-7114, an oral agent with the same target from the pharmaceutical giant Eli Lilly.

Yirui Pharma is a biotech company focused on the research and development of innovative small-molecule targeted therapies, committed to driving source innovation through cost-effective, high-efficiency, and risk-controlled R&D strategies. Its core team comprises former executives from German new drug development companies and PhDs who have returned from Europe and the United States. With independent R&D as its primary driver, the company has established a differentiated portfolio in areas such as autoimmune diseases, diabetic complications, and chronic inflammatory diseases. It pursues multi-dimensional innovation in drug targets, indication selection, administration routes, and patient populations, striving to maximize the fulfillment of clinical needs. Yirui Pharma is dedicated to evolving into an international new drug R&D enterprise with core technologies and competitiveness aligned with global frontiers, aiming to provide novel first-line treatments to address the unmet clinical needs of hundreds of millions of patients worldwide.