ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA

SHANGHAI, June 16, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted its New Drug Application (NDA) for Azstarys (serdexmethylphenidate/dexmethylphenidate extended-release capsules) and granted it Priority Review designation. The investigational therapeutic drug is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients aged six years and above.

First Methylphenidate Combination Drug Poised to Benefit Patients in China

Azstarys (AK0901) is the first and currently the sole globally approved ADHD combination therapeutic pairing immediate-release dexmethylphenidate (d-MPH) with the prodrug serdexmethylphenidate (SDX). Approved by the U.S. FDA in 2021, Azstarys represents a new generation of methylphenidate medications, providing a dual-phase release profile that offers both rapid onset and sustained symptom control. This novel formulation sets a new benchmark in the management of ADHD for safety, efficacy, and convenience of administering for patients, making it a potential best-in-class ADHD therapeutic drug.

Pharmacokinetic Property: Biphasic Release for Rapid Onset and Whole-Day Symptom Control

• Rapid onset: Immediate-release d-MPH ensures symptom relief within 30 minutes, offering fast control over core ADHD symptoms.
• Extended control: SDX is metabolized slowly into d-MPH in intestine over time, ensuring up to 13 hours of therapeutic effect with reduced risk of evening rebound symptoms.
• Stable Release Profile: Designed to support the full span of a patient's day—from school or work to evening activities—Azstarys enhances adherence and minimizes sleep disruptions, suiting both pediatric and adult populations.

Abuse-Deterrent Design

Azstarys incorporates an inherent abuse-deterrent design through the inclusion of SDX, which undergoes slow conversion in the gastrointestinal tract. This limits peak plasma concentrations of d-MPH and significantly reduces the potential for misuse via non-oral routes—a key public health consideration in ADHD pharmacotherapy.

Robust Clinical Efficacy and Safety Confirmed in China Phase III Trial

• In a multicenter Phase III trial spanning eight leading clinical hospitals in China, Azstarys demonstrated statistically significant improvements over placebo in primary and secondary efficacy endpoints.
• The study reported no drug related serious adverse events, affirming Azstarys's favorable safety and tolerability profile, critical for long-term use in pediatric settings.

Transforming ADHD Treatment Paradigm in China

As the third-generation methylphenidate therapy, Azstarys delivers a new standard of care in ADHD management by integrating rapid onset and full-day symptom control into a single dose. Its future approval in China would mark the introduction of the first ADHD combination medication to the market, offering a better option for patients, families, and physicians.

Dr. Jim Wu, CEO of ArkBio, stated,

"The acceptance of Azstarys' NDA and its designation for Priority Review by the NMPA reflect regulatory authority's favorable opinions in our science and clinical study results. ADHD remains critically underserved in China, and Azstarys is designed to directly meet the needs of patients who require both immediate symptom relief and sustained control. We are grateful to our investigators, trial participants, collaborators, and the NMPA for this milestone and we look forward to accelerating access to this important therapeutic in China market."

Azstarys® is a registered trademark of Corium, LLC in the United States.

About ArkBio

ArkBio is a global biotech company focused on developing innovative therapeutics for respiratory, infectious, and pediatric diseases. Founded in 2014, it has built core technology platforms and a differentiated R&D pipeline through in-house R&D efforts and external collaboration. Key drug assets include ziresovir (AK0529), the first direct-acting RSV antiviral with positive pivotal phase III results, and Azstarys (AK0901), an FDA-approvedADHD therapeutic drug.

ArkBio has established strategic partnerships with several multinational pharmaceutical companies and academic institutes, including Roche, Genentech, the Scripps Research Institute, the Institute of Microbiology of Chinese Academy of Sciences, domestic and international biotechnology companies, as well as venture capital institutions.

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