Yuekang Pharmaceutical (688658.SH): Subsidiary YKYY018's indication for nebulized inhalation therapy for the treatment and prevention of human parainfluenza virus infection has received FDA approval for clinical trials

MaticHoleFiller · 2026-03-29T05:56:22+00:00

Gelonghui, March 24 — Yuekang Pharmaceutical (688658.SH) announced that its wholly-owned subsidiary Beijing Yuekang Kechuang Medical Technology Co., Ltd. (hereinafter referred to as "Yuekang Kechuang") recently received a letter from the U.S. Food and Drug Administration (FDA) indicating approval to proceed with clinical trials for YKYY018 inhalation aerosol for the treatment and prevention of human parainfluenza virus (Study May Proceed Letter, IND number: 180432).YKYY018 inhalation aerosol is an internationally original membrane fusion inhibitor drug independently developed by the company based on a full-process AI platform. The product was approved by the U.S. Food and Drug Administration (FDA) in November 2025 and by the National Medical Products Administration (NMPA) in December 2025 for YKYY01.

MaticHoleFiller

2026-03-29 05:56:22

On March 24, Gelonghui reported that Yuyuan Pharmaceutical (688658.SH) announced that its wholly-owned subsidiary Beijing Yuyuan Kechuang Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Yuyuan Kechuang”) recently received a notification from the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) regarding the approval of the clinical trial application for YKYY018 nebulized inhalation solution for the treatment and prevention of human metapneumovirus (Study May Proceed Letter, IND No.: 180432).

YKYY018 nebulized inhalation solution is an internationally original membrane fusion inhibitor drug independently developed by the company based on its full-process AI platform. This product received approval letters for clinical trials for the prevention and treatment of respiratory syncytial virus infections from both the FDA and the National Medical Products Administration (NMPA) in November and December 2025, respectively. The clinical Phase I study for the YKYY018 project targeting respiratory syncytial virus (RSV) infection is steadily advancing. The recent approval for the treatment and prevention indications of human metapneumovirus signifies an expansion of the pipeline layout from a single virus to a comprehensive coverage of important respiratory virus spectrum, providing more comprehensive prevention and treatment options for high-risk groups such as infants and the elderly.

This product has a novel mechanism of action, capable of specifically binding to the heptapeptide repeat sequence region 1 (HR1) of the pre-fusion F protein of respiratory syncytial virus and human metapneumovirus, inhibiting the formation of the homologous 6-HB between the virus’s own HR1 and HR2 domains, thereby blocking the fusion process between the virus and host cells, achieving antiviral effects with dual functions of treatment and prevention. The company has obtained core patent authorization for this product and holds its global exclusive rights.

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