It has been learned that recently, the company's subsidiary, Beijing Yuekang Kechuang Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Yuekang Kechuang"), received a letter from the U.S. Food and Drug Administration approving the clinical trial of YKYY018 nebulizer for the prevention and treatment of respiratory syncytial virus (RSV) infection, and two Drug Clinical Trial Approval Notices issued by the National Medical Products Administration approving the use of YKYY018 nebulizer for post-exposure prophylaxis after contact with patients with respiratory syncytial virus and for the treatment of RSV infection. The company will conduct Phase I clinical trials of this product.

Respiratory syncytial virus (RSV) is a ubiquitous and infectious enveloped RNA virus that causes respiratory illnesses, particularly affecting vulnerable groups such as children, the elderly, and those with compromised immune systems. Currently, there are no approved treatments for RSV infection worldwide, indicating a significant and urgent unmet clinical need.

YKYY018 nebulized inhaler is an internationally original membrane fusion inhibitor drug independently developed by Yuekang Science & Technology Co., Ltd. based on its full-process AI platform. This product has a novel mechanism of action: YKYY018 nebulized inhaler specifically binds to the heptapeptide repeat region 1 (HR1) of the F1 subunit of the respiratory syncytial virus fusion protein (F protein), inhibiting the formation of homologous 6-HB between the HR1 and HR2 domains of the virus itself, blocking the fusion process between the virus and host cells, achieving an antiviral effect, and possessing both therapeutic and preventative functions. The company has obtained core patent authorization for this product and owns its global exclusive rights.

Preclinical studies have shown that the product has significant inhibitory effects on multiple respiratory syncytial virus strains (RSV Along, RSV A2, RSV B9320 and RSV B18537) and multiple prevalent clinical strains, with good safety and tolerability.

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