Shanghai Ark Biopharmaceutical Co., Ltd. has received marketing authorization from China’s National Medical Products Administration (NMPA) for its innovative ADHD treatment, Aizhida. This approval, announced on January 8, 2026, allows Aizhida, a combination of Serdexmethylphenidate Chloride and Dexmethylphenidate Hydrochloride capsules, to be prescribed to patients aged six and older in China.
Aizhida is designed as a central nervous system stimulant for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Each capsule delivers a dual-action formula, combining immediate-release dexmethylphenidate with serdexmethylphenidate, a prodrug that provides extended symptom control throughout the day. The immediate-release component ensures a rapid onset of effect, while the prodrug gradually converts to dexmethylphenidate in the gastrointestinal tract, allowing for sustained therapeutic exposure.
The drug was previously approved by the U.S. Food and Drug Administration in March 2021, establishing its efficacy as a once-daily treatment option for ADHD in similar patient demographics. ADHD is recognized as a chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood, with symptoms including inattention and hyperactivity-impulsivity. In China, the prevalence of ADHD among children and adolescents is approximately 6.4%, affecting over 23 million individuals.
Current treatment options in China are inadequate, with many patients experiencing suboptimal responses to existing medications, leading to discontinuation of treatment. The approval of Aizhida addresses this significant unmet need, providing a new alternative for both clinicians and patients.
Clinical Trial Success and Innovative Mechanism
In a pivotal Phase III clinical trial involving Chinese patients with ADHD, Aizhida achieved both primary and key secondary endpoints, demonstrating statistically significant improvements in core ADHD symptoms compared to a placebo. This robust data underscores the need for additional effective treatment options in China, where traditional single-agent therapies have faced historical supply constraints.
Aizhida’s unique combination of immediate-release and prodrug-based technologies positions it as a potential leader in transforming the ADHD treatment landscape in China. As the first medication to offer both rapid onset and all-day coverage, it meets a critical gap in existing therapies.
Professor Yi Zheng, Chief Expert at Beijing Anding Hospital and Lead Principal Investigator of the Aizhida Phase III trial, emphasized the importance of this approval. “ADHD poses long-term challenges to learning and social functioning, especially in a population where prevalence is around 6.4%,” he stated. “The introduction of Aizhida provides clinicians a new therapeutic tool that addresses the pressing need for effective treatment options.”
Adding to this perspective, Professor Jing Liu, Director of the Child Psychiatry Center at Peking University Sixth Hospital, highlighted the necessity for comprehensive intervention strategies. “The approval of Aizhida is a significant advancement in our efforts to optimize treatment strategies for pediatric mental disorders,” he said. “We hope this new drug will enhance ADHD management and contribute to better long-term outcomes.”
About Ark Biopharmaceutical
Founded in 2014, Ark Biopharmaceutical is a global biopharmaceutical company dedicated to developing innovative therapies for respiratory and pediatric diseases. The company has established a diverse research and development pipeline, which includes key drug candidates such as ziresovir (AK0529), an antiviral treatment for respiratory syncytial virus, and AK3280, aimed at treating idiopathic pulmonary fibrosis.
The approval of Aizhida marks a significant milestone for Ark Biopharmaceutical, which is poised to launch the product commercially. The company has also formed strategic partnerships with several multinational pharmaceutical firms and academic institutions, reinforcing its commitment to advancing healthcare solutions worldwide.
For further details, visit Ark Biopharmaceutical’s official site at www.arkbiosciences.com.
