打破垄断！ 立方制药多动症仿制药上市

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].