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多动症原研药频断货 国产首仿药来了
Jing Ji Guan Cha Wang· 2025-09-07 04:55
Core Viewpoint - Lifan Pharmaceutical has launched its first generic drug, Liyoujia Methylphenidate Sustained-Release Tablets, breaking the market monopoly of Johnson & Johnson's product for ADHD treatment in China [1][2]. Group 1: Product Launch - Lifan Pharmaceutical's Liyoujia Methylphenidate Sustained-Release Tablets are now available for sale, targeting the ADHD treatment market [1]. - The product's pricing is approximately 20% lower than the imported original drug, and it is eligible for insurance reimbursement [1]. Group 2: Market Context - For the past 20 years, Johnson & Johnson was the sole provider of this medication in China, marketed as "Zhuanzhuda" [1]. - The demand for Methylphenidate Sustained-Release Tablets has been rapidly increasing, with sales in domestic sample hospitals reaching approximately 350 million yuan in 2023 and projected to grow to about 430 million yuan in the first three quarters of 2024 [1]. Group 3: Supply and Regulatory Aspects - The production and sales of Liyoujia require approval from the National Medical Products Administration (NMPA) [2]. - The expected production volume for next year will be reported to the provincial drug administration in October, with a final approval from the NMPA, and an additional opportunity for volume increase in May [2]. Group 4: Supply Issues - There have been frequent shortages of the original drug over the past year, with multiple notifications from hospitals regarding temporary suspensions of the product [1].
国产“聪明药”正式上市
券商中国· 2025-09-03 01:07
Core Viewpoint - The launch of the domestic version of methylphenidate extended-release tablets by Hefei Lifan Pharmaceutical Co., Ltd. is expected to stabilize the supply of ADHD treatment in China, addressing the significant market potential and current supply shortages of existing medications [2][4]. Group 1: Market Potential and Demand - The ADHD market in China shows a prevalence rate of approximately 3% among adults and 6.26% among children, translating to around 23 million children affected, with only about 10% receiving clinical treatment [2][3]. - The global ADHD medication market was valued at $14.31 billion in 2023 and is projected to reach $18.6 billion by 2030, with a compound annual growth rate (CAGR) of 3.69% [3]. - The introduction of Lifan Pharmaceutical's product is anticipated to capture 15% of the market share in its first year [4]. Group 2: Product Details and Technology - Lifan Pharmaceutical's methylphenidate extended-release tablets utilize advanced three-layer osmotic pump controlled-release technology, ensuring rapid onset and stable efficacy throughout the day [5]. - The company has established an integrated supply system for the active pharmaceutical ingredient (API) and the formulation, enhancing its production capabilities [5]. Group 3: Supply Chain and Regulatory Environment - The original drug, Concerta, is currently the only approved long-acting methylphenidate product in China, facing supply constraints due to increased global demand and production limitations [4][6]. - The production and sale of methylphenidate extended-release tablets are subject to strict regulatory oversight, requiring approval from the National Medical Products Administration (NMPA) [6].