Aikang Bio's ADHD Drug 'Aizhida' Approved in China, Adding a New Option to the So-Called 'Smart Drugs' Market

Interface News reporter |Chen Yang

Interface News Editor |Xie Xin

At the end of 2025, during Luo Yonghao's Technology Innovation Sharing Conference, Luo Yonghao appeared on stage more than 40 minutes late. He later mentioned on Weibo that he has ADHD (Attention Deficit Hyperactivity Disorder), which once again drew attention to the condition. ADHD is no stranger to some parents, and methylphenidate, a drug used to treat the disorder, was once colloquially referred to as"Smart Drugs", or evenAlso popular among groups without strict diagnosis。

There are also new developments in this field at present.

On January 6, ArkBio announced that its compound lisuride methylphenidate capsule (brand name: Aizhida) was approved by the National Medical Products Administration for the treatment of ADHD patients aged 6 years and above. This is also the first product of ArkBio to enter the commercialization stage.

According to the ArkBio prospectus, this compound preparation contains 30% immediate-release d-MPH (dextro-methylphenidate) and 70% SDX (serdexmethylphenidate, a prodrug of dextro-methylphenidate). After gastrointestinal absorption, serdexmethylphenidate is converted into dextro-methylphenidate. This design allows for the gradual release of dextro-methylphenidate throughout the day, quickly controlling symptoms through dextro-methylphenidate and extending treatment duration through serdexmethylphenidate, achieving stable all-day control of ADHD symptoms.

This compound preparation was developed by Commave and was approved in the U.S. in March 2021 (brand name: AZSTARYS). In December of the same year, ArkBio acquired the rights for Greater China for a total price of $105.5 million.

ADHD is a common chronic neurodevelopmental disorder that begins in childhood and can persist into adulthood. Its main characteristics are attention deficits and/or hyperactivity-impulsivity that are disproportionate to the developmental level. The global prevalence of ADHD in children is approximately 7.2%, with 60%-80% continuing into adolescence, and 50.9% persisting into adult ADHD. The prevalence of ADHD in Chinese children is 6.26%, affecting about 23 million people, but the medical consultation rate is only about 10%.

The Interface News noted that in terms of drug treatment, according to the "Pediatric Expert Consensus on the Early Identification, Standard Diagnosis, and Treatment of Attention Deficit Hyperactivity Disorder" published in 2020, central nervous system stimulants such as methylphenidate formulations and selective norepinephrine reuptake inhibitors like atomoxetine are first-line treatment drugs. The "Chinese Expert Consensus on the Diagnosis and Treatment of Adult Attention Deficit Hyperactivity Disorder (2023 Edition)" recommends long-acting methylphenidate sustained-release formulations as first-line treatment drugs, with atomoxetine and α2-adrenergic receptor agonists (such as clonidine and guanfacine) being second- and third-line drugs, respectively.

According to a search in the Mosearch·Pharmaceuticals database by The Paper, the annual sales of Methylphenidate Hydrochloride in 2024 exceeded 500 million yuan based on total terminal hospital sales. Johnson & Johnson almost dominates the entire market share. Its extended-release tablets of Methylphenidate Hydrochloride, "Concerta," is an older drug that was launched domestically in 2005 and gained new indications for adults and adolescents in 2021. Notably, although the patent for this drug has long expired, it was once the only extended-release formulation of Methylphenidate available in China.

The barrier to generic production of Focalin lies in the oral osmotic pump controlled-release technology. Based on this, the medication only needs to be taken once a day, allowing the drug to maintain a steady release for 12 hours, reducing the risk of drug abuse and addiction. For pediatric patients, this results in better compliance and relatively less impact on schooling. In comparison, Suzhou First Pharmaceutical, which has already been approved,...CR Double-CraneThe methylphenidate hydrochloride tablets produced by companies such as Johnson & Johnson are all immediate-release formulations, requiring administration 2-3 times daily.

And a year or two ago, news of the shortage of Concerta also appeared in the media.

In July 2024, Xi'an Janssen, a subsidiary of Johnson & Johnson, issued a statement saying that Concerta is a Class I psychotropic drug under national control, and its main raw materials for production are subject to global regulation. Since 2023, the global demand for Concerta has continued to grow. Although the company plans to supply the drug throughout 2024, it is expected that global demand will exceed the company's production capacity. To alleviate the supply shortage, Xi'an Janssen planned at that time to transfer the packaging process of Concerta for the Chinese market from overseas to the Xi'an plant in order to accelerate the supply speed in China.

Until April 2025,Lifang PharmaceuticalAnnouncement: The First Generic Drug of Its Extended-Release Methylphenidate Hydrochloride Tablets (Brand Name: Li You Jia) Approved, and it was mentioned that apart from the imported Concerta, no other companies have products of this variety entering the clinical research or registration application stage. In other words, the market competition is relatively low. Meanwhile, the company also controls the raw materials for methylphenidate. This news once drove the company's stock price to rise by the daily limit for five consecutive trading days. In the same September, the drug began to be marketed and sold.

In other long-acting formulations, in December 2023 and January 2024, Yu Pharma's methylphenidate hydrochloride extended-release chewable tablets and methylphenidate hydrochloride extended-release dry suspension were successively approved by the National Medical Products Administration. These two drugs were introduced by Yu Pharma from Tris Pharma.

In January 2025, Zhongshuai Pharmaceutical's first generic product, Dexmethylphenidate Hydrochloride Extended-Release Capsules, was also approved in China. The corresponding original Novartis drug was approved in the U.S. in 2005 but is currently not sold in China. In August of the same year, Zhongshuai Pharmaceutical was acquired by CR Double-Crane.

So far, both Methylphenidate Hydrochloride Sustained-Release Tablets and Dexmethylphenidate Hydrochloride Sustained-Release Capsules have been included in the medical insurance. It remains to be seen how the market landscape for long-acting Methylphenidate formulations will change in the future.

However, it is important to note that calling methylphenidate drugs "smart drugs" is somewhat misleading. Feng Xuemei, a clinical pharmacist in the Neurology Department of the Children's Hospital affiliated with the Capital Institute of Pediatrics, has pointed out in an article that for children with ADHD, this type of medication can improve attention through its stimulating effect on the brain, but it does not enhance memory or analytical abilities, nor will it make normal children smarter.

In addition, the diagnosis of ADHD has detailed criteria and procedures. Meanwhile, methylphenidate (including compound formulations containing d-threo-methylphenidate and d-methylphenidate) is classified as a Schedule I psychotropic medication in China, and licensed physicians must obtain corresponding qualifications before prescribing such drugs. Drug abuse poses health risks.