Salute e Benessere
ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA
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.
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.
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.
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"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."
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 , the first direct-acting RSV antiviral with positive pivotal phase III results, and , an FDA-approvedADHD therapeutic drug.
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.
For more information about the company, please visit our website www.arkbiosciences.com
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