• 08 Jan 2026
• Admin
• News Article

China Approves Azstarys for ADHD, Expanding Treatment Options for Pediatric Patients

Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) has secured regulatory approval in China for Azstarys, a once-daily ADHD medication combining immediate and extended symptom control.

China’s National Medical Products Administration (NMPA) has approved serdexmethylphenidate chloride and dexmethylphenidate hydrochloride capsules (Azstarys) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged six years and older.

What Is Azstarys?

Azstarys is a central nervous system stimulant designed to provide both rapid onset and all-day symptom coverage.

How it works

• Combines:
  - Immediate-release dexmethylphenidate (d-MPH) for fast symptom relief
  - Serdexmethylphenidate (SDX), a prodrug that converts slowly to d-MPH
• Delivers:
  - Early onset of action
  - Sustained therapeutic levels throughout the day
• Once-daily dosing, reducing the need for multiple administrations

Azstarys received US FDA approval in March 2021, making China its latest major regulatory milestone.

Addressing a Large Unmet Need in China

ADHD remains underdiagnosed and undertreated in China.

Key facts

• Prevalence in Chinese children and adolescents: ~6.4%
• Affected population: over 23 million individuals
• Symptom persistence:
  - 60–80% into adolescence
  - ~50% into adulthood

Current treatment options are limited. Many patients discontinue therapy due to:

• Suboptimal efficacy
• Safety or tolerability concerns
• Inconvenient dosing regimens

This approval introduces a new pharmacological option that aims to balance efficacy, safety, and convenience.

Phase III Data That Supported Approval

In a pivotal phase III clinical trial in Chinese ADHD patients, Azstarys:

• Met primary and key secondary endpoints
• Showed statistically significant and clinically meaningful improvements versus placebo
• Demonstrated consistent benefit across all assessment time points

With ongoing supply constraints and reliance on traditional single-agent therapies, regulators viewed Azstarys as a meaningful addition to the ADHD treatment landscape.

A First-in-Class Profile for China

Azstarys is positioned as the first ADHD medication in China to offer:

• Rapid onset of symptom control
• Sustained, full-day coverage
• A dual-mechanism formulation in a single capsule

This “rapid onset + all-day coverage” profile could reshape prescribing patterns, particularly for pediatric patients who require stable symptom control during school hours.

Expert Perspectives from Chinese Investigators

Professor Yi Zheng, Beijing Anding Hospital and lead investigator, highlighted the long-term impact of ADHD and the lack of innovative options in China. He noted that Azstarys offers clinicians a new tool, especially for patients who do not respond well or tolerate existing therapies.

Professor Jing Liu, Peking University Sixth Hospital and lead investigator, emphasized that expanding treatment options supports more standardized and optimized ADHD care. She added that new therapies encourage broader improvements in long-term outcomes for pediatric mental health.

About ArkBio

Founded in 2014, ArkBio is a global biotech company focused on respiratory and pediatric diseases.

Key assets in its pipeline

• Ziresovir (AK0529): First direct-acting RSV antiviral with positive pivotal phase III data
• AK3280: Potential best-in-class therapy for idiopathic pulmonary fibrosis with positive phase II results

Bottom Line

The NMPA approval of Azstarys marks a significant advance for ADHD treatment in China, introducing a once-daily option that combines rapid symptom relief with sustained control.

For clinicians, patients, and caregivers facing limited choices, Azstarys represents a new, clinically differentiated alternative with the potential to improve adherence and long-term outcomes.