China has approves a new drug for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older, offering rapid and all-day symptom control.
This was announced by Shanghai Ark Biopharmaceutical, which said that China’s National Medical Products Administration (NMPA) has approved the New Drug Application for Serdexmethylphenidate Chloride and Dexmethylphenidate Hydrochloride Capsules (Azstarys).
Azstarys is a central nervous system stimulant that combines immediate-release dexmethylphenidate with a prodrug form, serdexmethylphenidate, designed to provide both rapid onset and extended symptom control throughout the day.
After ingestion, the immediate-release component works quickly, while the prodrug gradually converts in the lower gastrointestinal tract, maintaining therapeutic levels for sustained effect. The drug was first approved by the US FDA in March 2021.
ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood.
"ADHD is one of the most common neurodevelopmental disorders in childhood, with potential impact lasting into adulthood, posing long-term challenges to learning, social functioning, and family life. While the prevalence in Chinese children is around 6.4%, treatment options—especially innovative ones balancing efficacy and safety—remain insufficient.
"The approval of Azstarys provides clinicians with a new therapeutic tool. We anticipate its real-world application will help improve the treatment landscape for ADHD patients in China, offering new hope particularly for those with suboptimal response or tolerance to existing therapies,” said Professor Yi Zheng, Chief Expert at Beijing Anding Hospital, Capital Medical University, and Lead Principal Investigator of the Azstarys Phase III trial in China.
In a pivotal Phase III trial in Chinese patients, Azstarys met both primary and key secondary endpoints, showing statistically significant and clinically meaningful improvements in core ADHD symptoms compared to placebo at all assessment points.
The drug’s dual mechanism offers clinicians a first-in-China option combining rapid onset with all-day coverage, addressing a critical gap in ADHD treatment.
“We are committed to advancing standardized diagnosis and treatment for pediatric mental disorders in China. Comprehensive intervention is essential for ADHD, with pharmacotherapy being a foundational component. The approval of a new drug not only increases options but also prompts deeper reflection on optimizing treatment strategies.
"We hope the introduction of Azstarys will enrich ADHD treatment approaches and contribute to better long-term outcomes, which is the ultimate goal of our clinical research,” added Professor Jing Liu, Director of the Child Psychiatry Center, Peking University Sixth Hospital, and Lead Principal Investigator of the Azstarys Phase III trial in China.
