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口服渗透泵控制技术(OROS技术)
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对应患者约2300万人 这款频频断货的药物终于有了仿制药
Core Viewpoint - The launch of the first generic version of methylphenidate extended-release tablets by Lifan Pharmaceutical marks a significant development in the ADHD treatment market in China, addressing the growing demand due to supply shortages of the original drug, "Zhuanzhuda" [2][3]. Group 1: Product Launch and Market Demand - Lifan Pharmaceutical announced the official launch of its first generic drug, methylphenidate extended-release tablets, on September 2 [2]. - The demand for methylphenidate extended-release tablets in China has been rapidly increasing, with sales in 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 [2]. - The original drug "Zhuanzhuda" has faced frequent shortages, prompting the need for a generic alternative [3]. Group 2: Challenges in Generic Drug Development - The core technology of the original drug, OROS (Osmotic Controlled Release Oral Delivery System), presents high barriers for generic manufacturers, which explains the delay in the launch of the generic version [2][5]. - The complex structure of "Zhuanzhuda," designed to mimic a specific drug release curve, makes it difficult to replicate, requiring precise control over multiple manufacturing processes [5]. - Previous attempts by other companies to produce generic versions of "Zhuanzhuda" resulted in reports of insufficient efficacy, leading to the withdrawal of FDA approvals [5][6]. Group 3: Market Context and Patient Needs - There are millions of ADHD patients in China, with an estimated prevalence of 6.26% among children and adolescents, translating to approximately 23 million patients [4]. - The ongoing supply issues with "Zhuanzhuda" have led to multiple notifications from hospitals regarding temporary suspensions of the drug, highlighting the urgent need for alternatives [3].