Four Consecutive Daily Trading Limits! A Niche Generic Drug Sparks Frenzied Market Rally

The original research and development company of Methylphenidate Hydrochloride Extended-Release Tablets is Janssen, a subsidiary of Johnson & Johnson, and the trade name is Concerta.

The drug was first approved by the U.S. FDA in August 2000 and subsequently received approval for marketing in China in 2005, where it is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children.

In 2021, its indications were expanded to include adults and adolescents, and it was included in China's medical insurance directory.

According to the "Expert Consensus on the Diagnosis and Treatment of Adult Attention Deficit Hyperactivity Disorder in China (2023 Edition)", the prevalence rate of adult ADHD in China is approximately 3%. Long-acting methylphenidate sustained-release formulations, with their good tolerability and significant efficacy, have been recommended as a first-line treatment for adult ADHD patients.

At present, the entire market already hasChina Resources Double-Crane, Tonghua Renmin Pharmaceutical, and Suzhou D&Y Pharmaceutical have been approved to produce Methylphenidate Hydrochloride Tablets (immediate-release tablets), but they do not involve extended-release formulations.

This approval from Hefei Lifeon Pharmaceutical Co., Ltd. is the first of its kind currently on the market.Methylphenidate Hydrochloride TabletsGeneric drug approval for sustained-release formulations.

By precisely matching the API self-produced to the formulation process requirements, the drug release profile is consistent with the originator drug (22% release in the first hour, followed by a sustained release over 18 hours).

Generally speaking, the approval of a generic drug, even if it's the first generic, rarely arouses much interest in the market.

The background of this dramatic stock price movement triggered by Hefei Lifeon Pharmaceutial Co., Ltd. with a generic drug is the original research drug.The Shortage of Methylphenidate Hydrochloride Sustained-Release Tablets in the Chinese Market.

The API production of Methylphenidate Hydrochloride is highly concentrated in multinational pharmaceutical companies such as Johnson & Johnson (Xi'an Janssen) and Novartis. The global raw material supply is under strict regulation and has limited capacity, leading to a fragile supply chain with weak risk resistance.

Previously, Johnson & Johnson's subsidiary Xi'an Janssen publicly stated that since 2023, the global demand surge has exceeded its production capacity, and the raw material supply in the Chinese market has been particularly tight.

Media reports indicate that due to the difficulty in supplying the drug, some elementary school patients have no choice but to stop taking it during winter and summer vacations, saving the medication to be taken after the start of the school term.

Even so, the performance of original research drugs in the Chinese market remains impressive:In 2023, the sales revenue of sample hospitals in China was approximately 350 million yuan, and in the first three quarters of 2024, the sales revenue further increased to about 430 million yuan.

Hefei Lifeon Pharmaceutial Co., Ltd. has the independent production capability for methylphenidate hydrochloride API and is among the few companies in China that master the key raw material production process.

Due toMethylphenidate Hydrochloride belongs to the first class of psychotropic drugs, and the Chinese government imposes extremely strict regulations on the production qualification approval. Hefei Lifeon Pharmaceutical Co., Ltd. canEstablishThe integrated supply system of methylphenidate hydrochloride raw materials and formulations is indeed a moat with barriers.

According to the information disclosed by Hefei Lifeon Pharmaceutical Co., Ltd.'s official WeChat account, besidesProducts outside the company,In China, there is only one approved imported drug license number for Methylphenidate Hydrochloride Extended-Release Tablets, and no other companies have entered the clinical research or registration application stage.

Although no other company currently produces tablets, extended-release capsules have already been approved and launched by competitors.

In January 2025, an announcement by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration revealed that Henan Zhongshuai Pharmaceutical Industry's application for extended-release dexmethylphenidate hydrochloride capsules has been successfully approved for marketing.

Dexmethylphenidate hydrochloride is the dextrorotatory isomer of methylphenidate, the capsuleContaining 50% immediate-release pellets and 50% delayed-release pellets, the first release takes effect in 30 minutes, the second release begins approximately 5 hours later, with the efficacy lasting for 12 hours.

Only 0.8 yuan per day

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