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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]