 ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPAPUDONG, China - June 15, 2025 - PRLog -- 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/
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. Azstarys® is a registered trademark of Corium in the United States. For more information about the company, please visit our website: http://www.arkbiosciences.com Investor Inquiries：IR@arkbiosciences.com End
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