China Approves Azstarys for ADHD Treatment, Offering First Dual-Mechanism Therapy for 23 Million Affected Patients
Key Insights
China's National Medical Products Administration (search) has approved Azstarys, a once-daily ADHD (search) medication combining immediate-release and prodrug technologies for patients 6 years and older.
The approval addresses a significant unmet need in China, where ADHD (search) affects approximately 6.4% of children and adolescents, totaling over 23 million individuals.
Azstarys demonstrated statistically significant improvements in core ADHD (search) symptoms in a pivotal Phase III trial, becoming the first medication in China to provide both rapid onset and sustained symptom control.
Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio (search)) announced that China's National Medical Products Administration (search) (NMPA) has approved Azstarys® (Serdexmethylphenidate Chloride and Dexmethylphenidate Hydrochloride Capsules) for treating Attention Deficit Hyperactivity Disorder (search) (ADHD (search)) in patients 6 years of age and older. This approval marks a significant milestone in addressing the substantial treatment gap for ADHD patients in China, where the condition affects over 23 million individuals.
Innovative Dual-Mechanism Technology
Azstarys® represents a breakthrough in ADHD (search) treatment through its unique dual-mechanism approach. Each once-daily capsule contains serdexmethylphenidate (SDX), a prodrug of dexmethylphenidate, co-formulated with immediate-release dexmethylphenidate (d-MPH) in a fixed ratio. This combination is specifically designed to provide both rapid and extended symptom control throughout the day.
The medication's pharmacokinetic profile delivers immediate therapeutic benefits through the rapid absorption of the immediate-release d-MPH component, while SDX is gradually converted to d-MPH in the lower gastrointestinal tract, supporting sustained therapeutic exposure. This dual approach positions Azstarys® as the first ADHD (search) medication in China to deliver both rapid onset and sustained symptom control, filling a critical clinical gap in the treatment landscape.
Addressing Substantial Unmet Medical Need
ADHD (search) represents a significant public health challenge in China, with prevalence rates of approximately 6.4% among children and adolescents. The condition is characterized by age-inappropriate levels of inattention and/or hyperactivity-impulsivity, with symptoms persisting into adolescence for 60%-80% of patients and into adulthood for roughly half of cases.
Current ADHD (search) treatment options in China are notably limited, with available medications failing to fully meet clinical needs in terms of both efficacy and safety for many patients. The approval addresses a critical therapeutic void, as some patients discontinue treatment due to suboptimal response, side effects, or dosing inconvenience. Historical supply constraints for traditional single-agent therapies have further complicated the treatment landscape.
Robust Clinical Evidence
In a pivotal Phase III clinical trial conducted in Chinese patients with ADHD (search), Azstarys® successfully met both primary and key secondary endpoints. The study demonstrated statistically significant and clinically meaningful improvements in core ADHD symptoms compared to placebo at all assessment time points, providing robust evidence for the medication's efficacy in the Chinese patient population.
Professor Yi Zheng, Chief Expert at Beijing Anding Hospital (search), Capital Medical University (search), and Lead Principal Investigator of the Azstarys® Phase III trial in China, emphasized the clinical significance of this approval: "ADHD (search) 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."
Clinical Expert Perspectives
Professor Jing Liu, Director of the Child Psychiatry Center at Peking University Sixth Hospital (search) and Lead Principal Investigator of the Azstarys® Phase III trial, highlighted the broader implications for ADHD (search) 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."
The clinical experts anticipate that Azstarys®'s real-world application will help improve the treatment landscape for ADHD (search) patients in China, offering new hope particularly for those with suboptimal response or tolerance to existing therapies.
Regulatory and Commercial Context
Azstarys® previously received U.S. FDA approval in March 2021 as a once-daily treatment option for patients with ADHD (search) 6 years of age and older. The medication is a registered trademark of Corium, LLC in the United States, and ArkBio (search) has now entered the commercial launch phase in China following the NMPA approval.
ArkBio (search), founded in 2014, operates as a global biotech company focused on developing innovative therapeutics for respiratory and pediatric diseases. The company has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, and the Institute of Microbiology of Chinese Academy of Sciences.