Subsidiary YKYY018 of Youcare Pharmaceutical Group (688658.SH) receives FDA clinical trial approval for its nebulized inhalant.

Youcare Pharmaceutical Group (688658.SH) announced that its wholly-owned subsidiary, Beijing Yuekang Science and Technology Pharmaceutical Co., Ltd. (referred to as "Yuekang Science and Technology"), has recently received a letter from the U.S. Food and Drug Administration (FDA) approving the clinical trial of YKYY018 nebulized inhalation solution for the prevention and treatment of respiratory syncytial virus (RSV) infection (Study May Proceed Letter, IND Number: 178457). YKYY018 nebulized inhalation solution is an internationally original fusion inhibitor drug developed independently by Yuekang Science and Technology based on a full-process AI platform, used for the prevention and treatment of RSV infection. This product has a novel mechanism of action, as it specifically binds to the seven-peptide repeat sequence region 1 (HR1) of the fusion protein F1 subunit of the RSV, inhibiting the formation of the homologous 6-HB between the virus's HR1 and HR2 domains, blocking the fusion process between the virus and host cells, and achieving an antiviral effect with both therapeutic and preventive functions. The company has obtained core patent authorization for this product and holds its global exclusive rights.