Chinese biotech company Shanghai Ark Biopharmaceutical Co Ltd (ArkBio) announced on Sunday 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.

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 US FDA in 2021, Azstarys represents a new generation of methylphenidate medications.

According to ArkBio, 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.