New 'Smart Drug' Option Approved for ADHD Treatment, But Misuse Remains a Concern

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 public attention to the condition. ADHD is no stranger to some parents. Medications like methylphenidate, used to treat the disorder, were once colloquially referred to as "smart drugs" and even gained popularity among groups without a proper diagnosis.

There are also new developments in this field at present.

On January 6, ArkBio announced that its compound lisuride methylphenidate capsule (trade 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 prospectus of ArkBio, 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 to this drug 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 Recognition, 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) as second-line and third-line drugs, respectively.

Jiemian News retrieved data from the Mosec·Pharmaceuticals Database showing that, based on total hospital terminal sales, the annual sales of Methylphenidate Hydrochloride exceeded 500 million yuan in 2024. Johnson & Johnson almost entirely dominates the market share. Its extended-release Methylphenidate Hydrochloride tablet "Concerta," an older drug that was launched in China in 2005, received additional indications for adults and adolescents in 2021. Notably, although the patent for this drug has long expired, it was once the only extended-release Methylphenidate formulation available in China.

The imitation barrier of Focalin lies in the oral osmotic pump controlled-release technology. Based on this, the medication only needs to be taken once a day, and the drug can maintain a steady release for 12 hours, reducing the risk of drug abuse and addiction. For pediatric patients, it offers better compliance and relatively does not affect schooling. In comparison, Suzhou First Pharmaceutical, which has already been approved,CR Double-CraneThe methylphenidate hydrochloride tablets produced by companies such as ArkBio are immediate-release formulations, requiring administration 2-3 times daily.

Interface News excerpt from the 2020 "Pediatric Expert Consensus on the Early Recognition, Standardized Diagnosis, and Treatment of Attention Deficit Hyperactivity Disorder"

However, a year or two ago, reports of Adderall shortages also appeared in the media.

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

Until April 2025,Cube PharmaceuticalsThe announcement stated that the first generic version of its extended-release methylphenidate hydrochloride tablets (brand name: Li Youjia) has been approved. It also mentioned that, apart from the imported Concerta, no other company's product of this variety has entered the clinical research or registration application stage, which means 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 hit the upper limit for five consecutive trading days. In the same September, the drug began to be marketed.

In other long-acting formulations, in December 2023 and January 2024, YooHoo Pharmaceuticals' 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 to YooHoo Pharmaceuticals 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 drug developed by Novartis 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 ability, nor will it make normal children smarter.

In addition, the diagnosis of ADHD has detailed criteria and procedures. Meanwhile, methylphenidate (including compound formulations containing dexmethylphenidate and d,l-threo-methylphenidate) is classified as a Schedule I psychotropic medication in China, and only licensed physicians with the appropriate qualifications are authorized to prescribe such drugs. Drug abuse poses health risks.