YKYY018 nebulized inhaler, a subsidiary of Yuekang Pharmaceutical (688658.SH), obtained FDA clinical trial approval

Zhitongcaijing · 11/27/2025 08:17

Zhitong Financial App News, Yuekang Pharmaceutical (688658.SH) issued an announcement. Beijing Yuekang Kechuang Pharmaceutical Technology Co., Ltd. (“Yuekang Kechuang”), a wholly-owned subsidiary of the company, recently received a letter from the US Food and Drug Administration (“FDA”) regarding approval of YKYY018 atomized inhaler to conduct clinical trials for the prevention and treatment of respiratory syncytial virus (RSV) infection (May Study Procedure Letter, IND number: 178457).

YKYY018 nebulized inhaler is an internationally original membrane fusion inhibitor drug independently developed by Yuekang Kechuang based on a full-process AI platform to prevent and treat RSV infections. This product has a novel mechanism of action. YKYY018 atomized inhaler can bind specifically to the heptapeptide repeat sequence region 1 (HR1) of the F1 subunit of respiratory syncytial virus fusion protein (F protein), inhibit the formation of homologous 6-HB between the HR1 and HR2 domains of the virus itself, block the fusion process between the virus and host cells, achieve antiviral effects, and has the dual functions of treatment and prevention. The company has obtained a core patent license for this product and has exclusive global rights.