China's First Generic Methylphenidate Extended-Release Tablets Launched for ADHD Treatment

Source: China Newsweek

Need to use it in a standardized way rather than hype it as a "smart drug"

On September 2, the first generic version of Methylphenidate Hydrochloride Extended-Release Tablets produced in China commenced commercial sales. The drug, which belongs to the first category of psychotropic substances, was approved for marketing by the National Medical Products Administration in April this year. It is primarily used for treating Attention Deficit Hyperactivity Disorder (ADHD).

ADHD is a common neurodevelopmental disorder in school-age children, with 30%-50% of patients experiencing symptoms that persist into adulthood. Patients typically exhibit inattention, hyperactivity, and impulsivity, struggle to complete tasks, or experience extreme emotional irritability.

The first generic drug was produced by Hefei Lifeon Pharmaceutial Co., Ltd.Hefei Lifeon Pharmaceutial Co．，Ltd．Hefei Lifeon Pharmaceutical Co., Ltd. (hereinafter referred to as "Lifeon Pharma") developed the drug, which is a generic version of Concerta produced by Xian Janssen Pharmaceutical Ltd. (hereinafter referred to as "Xian Janssen"), a subsidiary of Johnson & Johnson in the United States. It is reported that the price of Lifeon Pharma’s generic drug is about 20% lower than that of the original drug and has been included in the scope of medical insurance reimbursement.

Several clinical psychiatrists from Class III, Grade A hospitals in China told China Newsweek that the drug has not yet entered the hospital. Lu Zheng, chief expert of the Center for Psychiatric Medicine at Tongji Hospital affiliated with Tongji University, explained to China Newsweek that after a new drug is launched, it usually needs to go through the hospital's Pharmaceutical Affairs Committee’s data review, meeting discussions, public announcements, and other processes before entering the hospital, which generally takes several months before it can be applied clinically.

Increase in Treatment Drugs

Before Lifon Pharmaceutical's drug entered the market, the only extended-release methylphenidate hydrochloride tablet approved in China was Concerta. Concerta was first approved by the U.S. Food and Drug Administration (FDA) in August 2000 and received approval for marketing in China in August 2005. In 2021, its target population was expanded to include both adults and adolescents, and it was included in China’s national medical insurance catalog.

From 2023 to last year, the drug began experiencing supply shortages, with inventory tensions and stockouts reported in hospitals across multiple regions in China. In June of last year, Xian Janssen publicly responded that since 2023, due to various factors, global demand for Concerta had been continuously increasing and was expected to exceed the company’s production capacity. In 2024, demand in the Chinese market surged significantly. Despite the company ramping up its supply, it still faced pressure and challenges in meeting the demand.

In the view of Zheng Yi, the chief expert in child psychiatry at Beijing Anding Hospital affiliated with Capital Medical University, even if Lifang Pharmaceutical's drug enters the market later, it will not have a significant impact on the overall ADHD treatment drug market. "Concerta is no longer the only essential drug for clinical treatment of ADHD," he further explained to China Newsweek. Since the beginning of this year, the number of approved ADHD treatment drugs in China has been increasing, especially those suitable for children. Overall, the current supply of ADHD treatment drugs on the market is already relatively sufficient to meet the basic medication needs.

What medications are available for ADHD treatment? The "Expert Consensus on the Diagnosis and Treatment of Adult Attention Deficit Hyperactivity Disorder in China (2023 Edition)" (hereinafter referred to as the "Consensus"), released in July 2023, points out that ADHD treatment medications are divided into two main categories: central stimulant medications and non-stimulant medications. Among them, the only stimulant medication currently approved for adult ADHD indications in China is the long-acting methylphenidate sustained-release formulation.

Zheng Yi pointed out that China has also introduced methylphenidate-class medications for treating ADHD from the United States, such as Adhansia, which is suitable for ADHD patients aged 6 years and above. Non-stimulant medications include atomoxetine. Currently, atomoxetine is only approved in China for the treatment of children and adolescents with ADHD. Its imported original research drug has been included in the medical insurance, but it is difficult to purchase in the domestic market; clinically, generic drugs are mostly used.

Reporters searched for "Methylphenidate" drugs on the official website of the National Medical Products Administration and found that currently, including Hefei Lifeon Pharmaceutical Co., Ltd.'s Methylphenidate Hydrochloride Sustained-Release Tablets, there are seven "Methylphenidate" products in China that have obtained approval numbers from the National Medical Products Administration. Among them, four drugs were approved for marketing this year, including Henan Zhongshuai Pharmaceutical Co., Ltd.’s (hereinafter referred to as "Zhongshuai Pharmaceutical") Dexmethylphenidate Hydrochloride Sustained-Release Capsules, Suzhou No. 1 Pharmaceutical Co., Ltd.’s Injectable Methylphenidate Hydrochloride, etc. Zheng Yi stated that Suzhou No. 1 Pharmaceutical's Methylphenidate Hydrochloride Tablets (Immediate-Release Formulation) also returned to the market this year. This drug was approved more than 30 years ago but was once discontinued due to raw material restrictions.

"Methylphenidate, currently used for ADHD treatment, is mainly administered in extended-release formulations in clinical settings," Zheng Yi mentioned. However, this does not mean that immediate-release formulations are necessarily less effective than extended-release ones. Wang Zhe, the chief pharmacist at the Department of Pharmacy of Xiehe Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, told *China Newsweek*, "There is no superiority between methylphenidate immediate-release and extended-release formulations; each has clear clinical indications." For instance, some children with social difficulties may require prolonged medication, making extended-release formulations a better choice. Meanwhile, for children who only struggle with attention during study sessions, immediate-release formulations suffice.

In January this year, the extended-release capsule of dexmethylphenidate hydrochloride developed by Zhongshuai Pharmaceutical was approved for marketing by the National Medical Products Administration. In July, the drug was prescribed for the first time at Qilu Children's Hospital of Shandong University. Dexmethylphenidate can be considered as the "purified version" of methylphenidate. To achieve the same therapeutic effect, the required dose is half that of methylphenidate.

The Phase III clinical trial of this drug adopted a double-blind randomized controlled design, led by Zheng Yi. According to him, it took sixteen to seventeen years to successfully develop this drug. Currently, his team has also initiated some new projects for ADHD treatment drugs, all of which are still under research. "In the future, there will be no shortage of such drugs in the market; these types of drugs will only increase."

Not Equal to "Smart Drugs"

According to the statistics from the Yaoke database, the sales of Methylphenidate Hydrochloride Extended-Release Tablets in Chinese hospitals were approximately 350 million yuan in 2023. In the first three quarters of 2024, the sales of this drug further increased to about 430 million yuan.

Globally, the same is true, with the number of prescriptions for ADHD medications increasing every year. According to a 2023 BBC report, the number of adults receiving prescription treatment for ADHD has increased sevenfold over the past decade. In March this year, a study published in *BMJ Mental Health* found that since the outbreak of the COVID-19 pandemic, the number of prescriptions for ADHD medications has increased by 18% annually. Among them, methylphenidate-based drugs are the most commonly prescribed.

At present, the term ADHD is often a hot topic on social platforms. Reporters searching on platforms like Xiaohongshu and Douyin found a large number of related posts or videos. As societal awareness of ADHD increases, clinicians in the past mostly diagnosed and treated children with ADHD, but now more and more adults are also being diagnosed with ADHD. The "Consensus" released in July 2023 pointed out that, based on existing literature, the prevalence rate of adult ADHD in China is approximately 3%. Lu Lin, an academician of the Chinese Academy of Sciences and former president of Peking University Sixth Hospital, is one of the corresponding authors of this consensus.

Lu Zheng Claims Recent Years Have Seen No Shortage of Adult ADHD Patients in Outpatient Clinics, Including College Students, White-Collar and Gold-Collar Workers

In 2007 and 2015, the "Guidelines for the Prevention and Treatment of Attention Deficit Hyperactivity Disorder in Children" and the "China Guidelines for the Prevention and Treatment of Attention Deficit Hyperactivity Disorder" (hereinafter referred to as the "Guidelines"), led by Zheng Yi, were successively released. "In fact, there were quite a few adult ADHD patients in the past, but they did not receive enough attention at that time," Zheng Yi told China Newsweek. He noted that after 2013, relevant guidelines in China no longer emphasized the concept of "childhood ADHD," as ADHD is a disease that affects the entire life cycle. When he participated in the compilation of the Guidelines, he changed the term "child patient" from previous guidelines to "patient."

The section on adult ADHD in the "Guidelines" was written by Lu Zheng. Lu Zheng stated that many ADHD patients are prone to being overlooked or misdiagnosed, especially adult ADHD patients, as they often have comorbidities with other psychiatric disorders, such as depression, anxiety disorders, bipolar disorder, insomnia, excessive internet use, or alcohol addiction. "This actually increases the complexity of diagnosing and treating the condition."

The hospital where Wang Zhe works does not currently prescribe medications related to ADHD treatment. This is because the diagnosis of hyperactivity disorder requires strong professional expertise and is a highly specialized field. An industry insider told China News Weekly that, unless they are doctors specifically working in this area, many people are simply unable to accurately assess whether a patient meets the diagnostic criteria. Such diagnoses must be made by specialist doctors, as general practitioners are not qualified for this task.

The "Consensus" points out that functional impairments in adult ADHD patients are more extensive and severe. In addition to medication, non-pharmacological treatment methods such as health education, cognitive behavioral therapy, and lifestyle training can be considered as auxiliary approaches. "However, compared to medication, the evidence for most non-pharmacological treatments for adult ADHD is currently insufficient, with poorer efficacy when used alone. Most guidelines and consensus statements abroad recommend combining them with pharmacotherapy."

Long-acting methylphenidate sustained-release preparations are first-line treatment drugs for ADHD, classified as strictly controlled national Schedule I psychotropic substances in China. They can only be purchased with a red prescription issued by a psychiatrist or pediatric specialist, and both production and distribution are under strict supervision by drug regulatory authorities. Some patients abuse them to enhance focus, which has also given this drug a widely known nickname, the "smart drug."

"I don't recommend calling this type of medication 'smart drugs,'" said Wang Zhe, explaining that this term could easily mislead parents. The long-acting methylphenidate sustained-release formulation is essentially a stimulant. For children with ADHD, due to the impact of the condition, they often struggle with poor academic performance, lack of focus, or constant restlessness, making it nearly impossible for them to study effectively. After taking the medication, they may become calmer, more focused on their studies, and their grades might improve, which can create the illusion of "becoming smarter." However, this has nothing to do with actual intelligence; it’s merely the drug alleviating the symptoms. As for individuals without ADHD, whether taking this medication offers any benefits remains uncertain, but the potential side effects are certainly numerous.

Lu Zheng stated that the reason for the strict management of Schedule I psychotropic drugs is that prolonged use or high doses may lead to addiction in patients. He noted that clinicians always control the dosage when prescribing. General hospitals can only prescribe 3 to 7 days' worth of medication at a time, while specialized hospitals can prescribe up to one month’s supply. When patients return for follow-up visits, doctors will adjust the dosage or renew the prescription based on their condition to prevent stockpiling of the drugs.

Published on September 15, 2025, Issue No. 1204 of China Newsweek magazine

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