The pharmaceutical industry has learned that Hangzhou Yirui Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Yirui Pharma”) has recently received approval from the National Medical Products Administration (NMPA) to conduct clinical trials in China for its YR001 topical ointment, following the completion of Phase 1 clinical trials in the United States.

YR001 topical ointment is a potential First-in-Class new drug independently developed by Yirui Pharma for the treatment of autoimmune skin diseases. It is a highly selective small molecule inhibitor of the potassium ion channel Kv1.3, 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, Yirui Pharma plans to develop it as a first-line treatment for mild to moderate AD patients, including children and infants. The YR001 topical ointment was approved by the U.S. FDA for clinical trials in January 2023 and successfully completed Phase 1 clinical trials in the United States at the end of October, demonstrating good safety and tolerability in all subjects. YR001 topical ointment is the first Kv1.3 inhibitor in China to enter the clinical stage, and it is at a similar clinical stage as the small molecule Kv1.3 inhibitor DES-7114 (oral) from pharmaceutical giant Eli Lilly, both leading internationally.

About Atopic Dermatitis and YR001 Topical Ointment

Atopic dermatitis (AD) is the most common and recurrent inflammatory skin disease globally, characterized mainly by dry skin and intense itching, with chronic, recurrent, and inflammatory features that severely affect patients’ quality of life. There are 170 million patients worldwide, including 70 million in China. Children and infants are the high-incidence population for AD, accounting for more than 80% of the total patient population, and there is a lack of safe and effective long-term treatment drugs. Steroid hormones and non-targeted or targeted immunosuppressants have significant side effects and are mainly used to treat moderate to severe AD patients, making them unsuitable for treating children, especially infants. Additionally, mild to moderate patients account for more than 90% of the total AD population, and there is still a clinical need to develop safe, effective, and long-term first-line drugs. Yirui Pharma’s YR001 topical ointment is a selective immunomodulator that will meet the high safety requirements for children and infant medication, with a very promising market outlook.

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 strives to develop into a new drug R&D enterprise with a forward-looking vision, core technology, and international competitiveness, aiming to provide new first-line drugs for the unmet clinical needs of hundreds of millions of patients worldwide.