In China, about 20 million children and adolescents are suffering from attention deficit hyperactivity disorder (ADHD), and methylphenidate hydrochloride sustained-release tablets are the first-line treatment for ADHD .A pharmaceutical company has the import drug approval number for this variety, and the corresponding trade name is Zhunzhuda.

　　However, the strict control of dyne and the high price of raw materials have led to frequent supply shortages and even out-of-stock situations, which often cause patients and parents to face medication anxiety .(SZ003020, stock price 32.42 yuan, market capitalization 6.166 billion yuan) announced the official launch of its product, Liyoujia. This is the first generic methylphenidate hydrochloride extended-release tablet in China, breaking the monopoly of Zhongzhuda in the ADHD treatment market.

　　A representative from Lifang Pharmaceuticals told a reporter from the National Business Daily via WeChat on September 5th that after the official launch of Liyoujia, the company will actively apply for reasonable production volumes based on market demand to ensure uninterrupted supply. "There are no issues with our production capacity. Our goal is to seize market opportunities and meet domestic demand," the representative said.

　　Original research drugs are frequently out of stock

　　According to the "Pediatric Expert Consensus on Early Identification, Standardized Diagnosis, and Treatment of Attention Deficit Hyperactivity Disorder" published in the Chinese Journal of Pediatrics, ADHD is a common, chronic neurodevelopmental disorder that begins in childhood and can affect adulthood. Statistics show that the prevalence of ADHD among children in my country is 6.26%, but only about 10% seek medical attention.

　　Zhu Haiqiao, chief physician of pediatrics at Zhejiang Provincial People's Hospital, is one of the earliest doctors in China to specialize in the diagnosis and treatment of childhood ADHD. In a recent WeChat interview with a reporter from the National Business Daily, Zhu explained that, to date, there's no single, short-term cure for ADHD, and therefore requires comprehensive treatment, combining medication with behavioral therapy and long-term chronic disease management.

　　ADHD treatments primarily include central nervous system stimulants and non-central nervous system stimulants. Methylphenidate preparations are commonly used as central nervous system stimulants, with methylphenidate hydrochloride extended-release tablets being the first-line treatment for ADHD patients aged 6 and above. Among non-central nervous system stimulants, atomoxetine hydrochloride is the first-line treatment.

　　He recalled that as early as the 1980s, methylphenidate was used clinically in China to treat ADHD, initially using the white tablet Ritalin. The disadvantage of this drug is its short half-life, with each dose lasting only two to three hours. Patients need to take it at least twice a day to maintain a stable effect. However, for younger patients, "frequent medication management" is extremely difficult, and its efficacy is greatly reduced.

　　Zhuzhongda entered the Chinese market in August 2005. This product, characterized by innovations in dosage form design and sustained-release technology, presents a high R&D barrier. Zhu Haiqiao explained that compared to other dosage forms, long-acting controlled-release formulations offer a slow release of drug effects, typically lasting 12 hours, and only requiring a single morning dose. They demonstrate significant advantages in both compliance and clinical efficacy.

　　In recent years, demand for methylphenidate hydrochloride extended-release tablets in the domestic market has continued to grow rapidly. According to the "Yaozhi Database," sales of this drug in sample domestic hospitals in 2023 were estimated to be approximately 350 million yuan, and further increased to approximately 430 million yuan in the first three quarters of 2024.

　　However, as a central nervous system stimulant, Zhunchengda is classified as a Class I psychotropic drug in China and is subject to strict control. Johnson & Johnson previously stated that global demand for Zhunchengda has been growing since 2023 due to various factors. Although the company plans to supply the drug throughout 2024, global demand is expected to exceed the company's production capacity.

　　"The market supply of this medicine has always been irregular and often out of stock. Patients have to switch to other alternatives, but the alternatives are not as effective as this medicine," said Zhu Haiqiao.

　　A representative from Lifang Pharmaceutical told the National Business Daily that sales of methylphenidate hydrochloride extended-release tablets exceeded 500 million yuan last year. However, due to unstable supply, the imported brand-name drug has not been widely adopted in the domestic market.

　　Liyoujia's first generic drug is launched

　　With original research drugs frequently out of stock, the demand for domestically produced generic drugs is growing. In fact, with regard to methylphenidate hydrochloride alone, several companies have already entered the market.

　　The official website of the State Food and Drug Administration shows that there are a total of China Resources Double CraneThree domestic companies, including Suzhou No. 1 Pharmaceutical Co., Ltd., hold production approvals for methylphenidate hydrochloride tablets. However, these are standard dosage forms, which are inferior to sustained-release formulations in terms of compliance, and the market size of the ADHD patients they target is also limited.

　　Because no other domestic companies have entered the clinical research or registration application stage for methylphenidate hydrochloride sustained-release tablets, the launch of Cube Pharmaceuticals' first generic product has been seen by many parents of sick children and doctors as a move to "fill the gap" in the market and is of milestone significance.

　　A question of widespread public concern is whether domestically produced generic drugs can rival the original branded drugs in terms of efficacy and stability. A representative from Lifang Pharmaceuticals stated that Liyoujia was developed with reference to the original branded drug, Zhunzhidalai, and that the two companies share the same technical approach and have also passed the generic drug consistency evaluation.

　　Zhu Haiqiao, speaking from a doctor's perspective, stated that if the drug passes the consistency evaluation, it would undoubtedly be a boon for ADHD patients. Furthermore, localization could lower drug costs, potentially reducing patient expenses.

　　In terms of pricing, the National Healthcare Security Administration currently sets a unified price for Liyoujia, which is approximately 20% lower than the original imported drug. While the original drug costs approximately 19 yuan per tablet, Liyoujia is priced at approximately 15.3 yuan per tablet, with each box containing 15 tablets (18mg each).

　　A representative from Lifang Pharmaceutical told the National Business Daily that both the production and sales of methylphenidate hydrochloride extended-release tablets require approval from the National Medical Products Administration (NMPA). Next year's production volume is expected to be reported to the provincial drug administration in October of this year, with final approval from the NMPA. There will be another opportunity for additional production in May of next year. This process must consider both meeting clinical drug demand and controlling the risk of drug abuse.

　　Currently not participating in centralized procurement

　　In the capital market, after Lifang Pharmaceuticals disclosed on April 14th that its Liyoujia product had been approved for listing, the company's stock price rose for five consecutive days. It's clear that Liyoujia is viewed by the capital market as a key product that is expected to drive Lifang Pharmaceuticals' future performance growth.

　　Shanxi SecuritiesThe research report commented that currently, only Zhunshida (Center Plus) is available in China, but its supply is unstable. With an average daily cost of approximately 20 yuan, Lifang Pharmaceutical's Liyoujia (Center Plus) has significant market potential.

　　A Shanxi Securities research report also points out that Cube Pharmaceuticals, with osmotic pump controlled-release technology at its core, has significant advantages in industrialization and is one of the few designated manufacturers of Class I psychotropic and anesthetic drugs in China. The company, with sustained-release formulations, particularly osmotic pump controlled-release technology, as its core, has established an osmotic pump controlled-release technology platform comprised of four key components: formulation technology, formulation evaluation technology, formulation engineering technology, and key equipment technology. The company is continuously improving its capabilities in the development and industrialization of osmotic pump formulations, establishing its unique advantages in the industrialization of sustained-release formulation technology.

　　Investors have another reason for their optimism about Liyoujia. Reporters have noted that centralized procurement has had a profound impact on Cube Pharmaceuticals. Cube Pharmaceuticals' semi-annual report disclosed that several of its major cardiovascular generic drugs were included in the centralized procurement. However, Liyoujia, due to its status as a narcotic drug (a combination of anesthetics and psychotropic drugs), is ineligible for centralized procurement, which benefits the company in terms of drug price stability.

The 2010 "Notice on Printing and Issuing the Specifications for Centralized Procurement of Drugs for Medical Institutions" explicitly stated that anesthetic drugs and Category I psychotropic drugs subject to special state management would not be included in the centralized procurement catalog. Since then, the industry has generally believed that the possibility of including narcotic drugs in centralized procurement is low. Although several local centralized procurement efforts have attempted to include narcotic drugs, none have materialized.
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