China NMPA Grants Priority Review to ArkBio's ADHD Drug Azstarys Application

SHANGHAI, June 15, 2025 – Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announced that the National Medical Products Administration (NMPA) has officially accepted their New Drug Application for Azstarys, an extended-release capsule combining serdexmethylphenidate and dexmethylphenidate, and has granted it Priority Review status. Azstarys is designed to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in individuals aged six years and older.

Azstarys, known as AK0901, represents a pioneering advancement in ADHD treatment by combining immediate-release dexmethylphenidate with the prodrug serdexmethylphenidate. Initially approved by the U.S. FDA in 2021, this medication introduces a novel approach with its dual-phase release profile, providing both rapid relief and prolonged symptom control. This innovation sets a high standard in ADHD management, offering safety, efficacy, and ease of use, making it a potentially leading treatment option.

The pharmacokinetic properties of Azstarys include a biphasic release mechanism. The immediate-release component delivers symptom relief within 30 minutes, effectively managing core ADHD symptoms quickly. Meanwhile, serdexmethylphenidate ensures extended control by gradually converting into dexmethylphenidate in the intestines, offering up to 13 hours of therapeutic effect and reducing the risk of evening symptom rebound. This stable release profile supports patients throughout the day, from morning activities to evening routines, while minimizing sleep disruptions.

An inherent design feature of Azstarys is its abuse-deterrent formulation, achieved through the slow conversion of serdexmethylphenidate in the gastrointestinal tract. This aspect limits peak plasma concentrations of dexmethylphenidate and reduces the potential for misuse through non-oral routes, addressing a significant public health concern in ADHD pharmacotherapy.

The efficacy and safety of Azstarys have been validated through a multicenter Phase III trial conducted in eight prominent clinical hospitals across China. The trial demonstrated statistically significant improvements in both primary and secondary efficacy endpoints compared to placebo. No drug-related serious adverse events were reported, reaffirming the drug's favorable safety and tolerability for long-term use, especially in pediatric settings.

Azstarys introduces a transformative approach to ADHD treatment in China, offering a new standard of care by combining rapid onset with all-day symptom control in a single dose. Its anticipated approval in China would mark the introduction of the first ADHD combination medication to the market, providing enhanced options for patients, families, and healthcare providers.

Dr. Jim Wu, CEO of ArkBio, emphasized the significance of the NDA acceptance and Priority Review designation by the NMPA, highlighting the regulatory authority’s favorable view of their scientific and clinical achievements. He acknowledged the unmet needs in ADHD treatment in China and expressed gratitude for the support from investigators, trial participants, collaborators, and the NMPA. Dr. Wu looks forward to making this important therapeutic accessible in the Chinese market.

ArkBio, founded in 2014, is a global biotechnology company committed to developing innovative treatments for respiratory, infectious, and pediatric diseases. The company has built core technology platforms and a distinguished R&D pipeline through both internal research and external partnerships. Its key assets include ziresovir (AK0529), a direct-acting RSV antiviral with positive Phase III results, and Azstarys (AK0901), an FDA-approved ADHD therapeutic. Collaborations with multinational pharmaceutical companies, academic institutions, and venture capital firms have bolstered its strategic growth and innovation efforts.