Shanghai Ark Biopharmaceutical Co., Ltd. has received approval from China’s National Medical Products Administration (NMPA) for its innovative ADHD treatment, Aizhida. The new drug application for the combination of Serdexmethylphenidate Chloride and Dexmethylphenidate Hydrochloride capsules is now authorized for use in patients aged six years and older.
Aizhida represents a significant advancement in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This central nervous system stimulant is designed to provide both rapid onset and extended symptom control. Each once-daily capsule combines a prodrug, serdexmethylphenidate (SDX), with immediate-release dexmethylphenidate (d-MPH) in a fixed ratio. This formulation allows for quick absorption of d-MPH, while SDX is gradually converted to d-MPH in the gastrointestinal tract, ensuring sustained therapeutic effects throughout the day.
The U.S. Food and Drug Administration (FDA) had previously approved Aizhida in March 2021, highlighting its potential as a once-daily treatment option for ADHD patients aged six and above. The disorder, which typically begins in childhood, is characterized by inattention and hyperactivity-impulsivity. In China, it is estimated that approximately 6.4% of children and adolescents are affected, translating to over 23 million individuals. Studies indicate that between 60% and 80% of these individuals experience persistent symptoms into adolescence, with about half continuing into adulthood.
Current treatment options for ADHD in China are limited, often failing to meet the clinical needs of many patients. Existing medications may lead to discontinuation due to inadequate responses, adverse effects, or dosing inconveniences. Aizhida aims to address these challenges by providing a new therapeutic option that can enhance treatment outcomes.
Pivotal Clinical Trials Demonstrate Efficacy
In a pivotal Phase III clinical trial conducted with Chinese patients suffering from ADHD, Aizhida met both primary and key secondary endpoints. The results showed statistically significant and clinically meaningful improvements in ADHD symptoms when compared to placebo across all assessment time points. Given the historical supply constraints of existing therapies, Aizhida’s approval offers a crucial new treatment avenue for both clinicians and patients.
The dual mechanism of Aizhida, which combines immediate-release and prodrug-based extended-release technologies, positions it uniquely within the ADHD treatment landscape. As the first medication in China to offer both rapid onset and sustained control of symptoms, it has the potential to reshape treatment paradigms.
Professor Yi Zheng, Chief Expert at Beijing Anding Hospital and Lead Principal Investigator of the Aizhida Phase III trial, remarked, “ADHD is one of the most common neurodevelopmental disorders in childhood, with potential impact lasting into adulthood. The approval of Aizhida provides clinicians with a new therapeutic tool, which we hope will significantly enhance the treatment landscape for ADHD patients in China.”
Broader Implications for ADHD Treatment
Professor Jing Liu, Director of the Child Psychiatry Center at Peking University Sixth Hospital and another lead investigator in the trial, emphasized the importance of comprehensive interventions for ADHD. “The approval of a new drug not only increases options but also prompts deeper reflection on optimizing treatment strategies. We hope Aizhida will enrich ADHD treatment approaches and contribute to better long-term outcomes,” he stated.
Ark Biopharmaceutical, founded in 2014, focuses on developing innovative therapeutics for respiratory and pediatric diseases. The company has established strategic partnerships with various international pharmaceutical companies and academic institutions, aiming to enhance its research and development pipeline. With Aizhida now entering the commercial launch phase, ArkBio is poised to make a significant impact on ADHD treatment in China and beyond.
For more information, visit Ark Biopharmaceutical’s official website at www.arkbiosciences.com.
