Indication: Respiratory Syncytial Virus (RSV) infection

Drug: Ziresovir (AK0529)

Project Name: Randomized, double-blind, placebo-controlled Phase III clinical trial in hospitalized infants with RSV infection

Background: Ziresovir (AK0529) is a novel small molecule inhibitor of RSV fusion protein that inhibits virus invasion into human cells by binding to the virus's F protein. It can also block the virus from fusing between cells to avoid forming "syncytia", a characteristic of RSV infecting cells, thereby achieving antiviral effects. This study has been approved by the National Medical Products Administration (NMPA) and published on the Chinese clinical trial registration platform (Publication Number: CTR20240557).

￭ RSV infected infants

￭ Age: 1-24 months

￭ Virological test positive for RSV within 36 hours before administration

This study is conducted in 17 hospitals across China. For more information, please log in to the Drug Clinical Trial Registration and Publicity Platform for information of the research centers (Registration Number: CTR20240557).

http://www.chinadrugtrials.org.cn/index.html

Indication: Attention Deficit Hyperactivity Disorder (ADHD)

Drug: Serdexmethylphenidate and Dexmethylphenidate Capsule (AK0901)

Project Name: A multicenter, randomized, double-blind, placebo-controlled Phase III study to investigate the efficacy, safety, and tolerability of orally administered AK0901 capsules in children aged 6-12 years old with attention deficit hyperactivity disorder

Background: Serdexmethylphenidate/Dexmethylphenidate Capsules (AK0901) is the first and only new drug containing both immediate release dexmethylphenidate (IR d-MPH) and the prodrug serdexmethylphenidate (SDX). It is a central nervous system stimulant that acts by blocking the reuptake of dopamine and norepinephrine neurotransmitters in the brain, increasing their concentration between synapses and improving neurotransmitter transmission efficiency, thereby alleviating symptoms of ADHD. As a prodrug, SDX is only activated after reaching the lower gastrointestinal tract and gradually converted into active ingredients to exert its effects within a day. This study has been approved by the National Medical Products Administration and published on the clinical trial registration platform (publication number: CTR20240367).

￭ Age: 6~12 years old

￭ Meets DSM-5 diagnostic criteria for ADHD (attention deficit or hyperactivity/impulsivity or combined attention deficit and hyperactivity/impulsivity) and is confirmed through the K-SADS-PL-C DSM-5

This study is conducted in 9 hospitals in Beijing, Shanghai, Jinan, Hangzhou and Wuxi. For more information, please log in to the Drug Clinical Trial Registration and Publicity Platform for information of the research centers (Registration Number: CTR20240367).

http://www.chinadrugtrials.org.cn/index.html