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国内首款仿制“聪明药”上市:2300万ADHD患者受惠,但需严防药物滥用
Guan Cha Zhe Wang· 2025-09-10 12:08
Core Insights - The first domestic generic version of "Zhuanzhu Da" has been officially launched in early September, produced by Lifang Pharmaceutical, with the generic name "Liyoujia" [1] - The original drug, methylphenidate extended-release tablets, is a first-line treatment for ADHD, developed by Johnson & Johnson, and has been in use in China since 2005 [1][2] - The patent for "Zhuanzhu Da" expired in 2012, but due to technical barriers, the first generic drug was only launched this year [1][2] - The launch of "Liyoujia" is expected to alleviate the supply shortage of the original drug and enhance production autonomy [1][3] Industry Overview - ADHD, or Attention Deficit Hyperactivity Disorder, affects approximately 23 million children in China, with a prevalence rate of 6.26% among children, but only about 10% of patients seek clinical treatment [2] - The adult ADHD prevalence rate in China is around 3% [2] - The demand for ADHD medication is significant due to the large patient population in China [2] Market Dynamics - There have been reports of drug shortages for "Zhuanzhu Da" in some regions, prompting the manufacturer, Xi'an Janssen, to enhance global production capacity and shift packaging operations to China by Q2 2025 [3] - "Liyoujia" utilizes advanced three-layer permeation pump technology for precise controlled release, ensuring stable efficacy throughout the day [3] Regulatory Environment - Methylphenidate is classified as a first-class psychotropic drug in China, subject to strict regulations throughout its production and distribution [4][5] - Only qualified physicians can prescribe this medication, and patients must present a red prescription to obtain it [5] - The drug's mechanism of action involves regulating specific neurotransmitter systems in the brain, improving cognitive and behavioral symptoms in patients with attention deficits [5] Social Implications - The term "smart drug" has been misleadingly used in some circles, leading to misuse among non-ADHD patients, which can result in addiction and other serious side effects [6][7] - Recent initiatives by multiple government departments aim to prevent the misuse of psychotropic drugs among youth, emphasizing the importance of adhering to medical advice [7]
打破垄断! 立方制药多动症仿制药上市
Mei Ri Jing Ji Xin Wen· 2025-09-07 11:59
Core Insights - The article discusses the introduction of a generic version of methylphenidate extended-release tablets, named "Liyoujia," by Lifan Pharmaceutical, which is expected to disrupt the market currently dominated by the imported drug "Zhuanzhuda" [1][4]. Group 1: Market Overview - Approximately 20 million children and adolescents in China are affected by Attention Deficit Hyperactivity Disorder (ADHD), with a prevalence rate of 6.26% among children [1][2]. - The original drug "Zhuanzhuda" has been the only approved methylphenidate extended-release product in China for the past 20 years, leading to supply shortages and high prices [1][3]. - The sales of methylphenidate extended-release tablets in domestic sample hospitals reached approximately 350 million yuan in 2023, with a projected increase to about 430 million yuan in the first three quarters of 2024 [3]. Group 2: Product Launch and Impact - Lifan Pharmaceutical's "Liyoujia" is the first domestic generic version of methylphenidate extended-release tablets, which is expected to alleviate supply issues and reduce costs for patients [1][4][5]. - The pricing of "Liyoujia" is set at approximately 15.3 yuan per tablet, which is about 20% lower than the original drug priced at around 19 yuan per tablet [5][7]. - The launch of "Liyoujia" is seen as a significant milestone in the ADHD treatment market, as it is expected to meet the growing demand and provide a more stable supply of medication [4][5]. Group 3: Regulatory and Market Dynamics - The production and sales of methylphenidate extended-release tablets require approval from the National Medical Products Administration, with plans for production volume to be reported in October [6]. - Lifan Pharmaceutical's "Liyoujia" is not subject to centralized procurement due to its classification as a first-class psychotropic drug, which is expected to stabilize its pricing in the market [7][8]. - The company has established a unique advantage in the production of controlled-release formulations, which is critical for the effective management of ADHD [7].
多动症原研药频断货,国产仿制药上市有望缓解2000万患者用药焦虑 厂商称“技术路径完全一致”
Mei Ri Jing Ji Xin Wen· 2025-09-05 11:29
Core Viewpoint - The launch of "Liyoujia," a generic version of methylphenidate extended-release tablets by Lifan Pharmaceutical, breaks the monopoly of Johnson & Johnson's "Zhuanzhuda" in the ADHD treatment market in China, addressing the supply issues faced by patients [1][8]. Group 1: Market Demand and Supply - Approximately 20 million children and adolescents in China suffer from ADHD, with a prevalence rate of 6.26% among children, but only about 10% seek treatment [3][4]. - The sales of methylphenidate extended-release tablets reached approximately 350 million yuan in 2023 and are projected to grow to about 430 million yuan in the first three quarters of 2024 [4]. - The original drug "Zhuanzhuda" frequently experiences supply shortages due to strict regulations and high raw material costs, leading to patient anxiety regarding medication availability [1][5][6]. Group 2: Product Comparison and Pricing - "Liyoujia" is priced approximately 20% lower than the original drug, with the original priced at about 19 yuan per tablet and "Liyoujia" at approximately 15.3 yuan per tablet [8][11]. - The production and sales of methylphenidate extended-release tablets require approval from the National Medical Products Administration, with plans for production volume to be reported in October [8][10]. Group 3: Regulatory Environment and Market Position - As a first-class psychotropic drug, "Zhuanzhuda" is subject to strict regulations, and its global demand has been increasing, which exceeds the production capacity of Johnson & Johnson [5][11]. - "Liyoujia" is not subject to centralized procurement due to its classification as a psychotropic drug, which is expected to stabilize its pricing in the market [11].