Shanghai, China, October 15th, 2026 – Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that results from the pivotal phase 3 trial of  Azstarys™ (serdexmethylphenidate chloride and dexmethylphenidate hydrochloride capsules) in Chinese children aged 6–12 years with attention-deficit/hyperactivity disorder (ADHD) have been published in CNS Drugs. The study met its primary endpoint and the prespecified criterion for bridging efficacy consistency, with a favorable safety and tolerability profile.

The randomized, double-blind, placebo-controlled study was co-led by Professor Yi Zheng of Beijing Anding Hospital, Capital Medical University and Professor Jing Liu of Peking University Sixth Hospital, and conducted at eight clinical sites across China to evaluate the efficacy and safety of Azstarys™ in Chinese children with ADHD.

Results showed that Azstarys™ significantly improved core ADHD symptoms compared with placebo, with improvements also observed across multiple secondary endpoints. Most treatment-emergent adverse events were mild to moderate in severity and transient; and no serious drug-related adverse events were reported. These findings provide clinical evidence supporting the use of Azstarys™ in Chinese children with ADHD.

Azstarys™ is the world’s first and only formulation to combine immediate-release dexmethylphenidate (d-MPH) with the prodrug serdexmethylphenidate (SDX), offering both rapid onset and sustained symptom control. The product was approved by the U.S. Food and Drug Administration (FDA) in March 2021 and by China’s National Medical Products Administration (NMPA) in December 2025 for the treatment of ADHD in patients aged 6 years and older. Azstarys™ will provide a new treatment option for children and adults with ADHD in China, with the potential to improve patients' learning, social and family functioning and contribute to advancing ADHD care in China.

Qilu Pharmaceutical is responsible for the exclusive commercialization of Azstarys™ in mainland China. A commercial launch is expected before the end of 2026.

Original article: DOI: 10.1007/s40263-026-01341-5

Azstarys™ is the trade name approved in the United States for AK0901 (serdexmethylphenidate chloride and dexmethylphenidate hydrochloride capsules).

About ADHD

Attention-deficit/hyperactivity disorder (ADHD) is a common chronic neurodevelopmental disorder that begins in childhood and may persist into adulthood, characterized primarily by developmentally inappropriate inattention and/or hyperactivity–impulsivity. In China, the prevalence of ADHD among children and adolescents is approximately 6.4%, with the estimated number of patients exceeding 23 million. ADHD impairs learning and can affect multiple other areas of functioning. Treatment options, particularly innovative therapies that balance efficacy and safety, remain limited, leaving significant unmet medical needs.

About ArkBio

ArkBio is a commercial-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of respiratory and pediatric diseases. Founded in 2014, the company has established proprietary technology platforms and a differentiated innovative R&D pipeline through internal innovation and strategic collaborations.

Key R&D pipeline assets include: ziresovir (AK0529), the first direct-acting antiviral for RSV with positive phase 3 results; AK3280, a potentially best-in-class anti-fibrotic agent with positive phase 2 results for the treatment of idiopathic pulmonary fibrosis, currently in a phase 3 trial; Azstarys™ (AK0901), approved in China for the treatment of ADHD and is in the commercialization stage. The company also has multiple drug candidates with first-in-class or best-in-class potential under clinical or preclinical development.

ArkBio has established strategic partnerships with multinational and domestic pharmaceutical companies including Roche, Genentech, and Qilu Pharmaceutical; leading academic institutions including The Scripps Research Institute and the Institute of Microbiology, Chinese Academy of Sciences; and other domestic and international biotech companies and CROs.

For more information, please visit: www.arkbiosciences.com

Investor Inquiries: IR@arkbiosciences.com