Hefei Lifeon Pharmaceutical (003020)
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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].
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].
对应患者约2300万人 这款频频断货的药物终于有了仿制药
Zhong Guo Jing Ying Bao· 2025-09-04 22:27
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].
立方制药国产多动症药上市,此前已收获五连板
Cai Jing Wang· 2025-09-03 08:06
Core Viewpoint - The launch of the long-acting methylphenidate sustained-release tablets by Hefei Lifan Pharmaceutical Co., Ltd. marks a significant development in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in China, with the potential to capture a substantial market share due to existing supply constraints from imported alternatives [1][4]. Group 1: Product Launch and Market Context - Hefei Lifan Pharmaceutical announced the official launch of its methylphenidate sustained-release tablets for ADHD on September 2, following approval from the National Medical Products Administration on April 14 [1][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% [1][3]. - Prior to Lifan's launch, the only approved long-acting methylphenidate product in China was from Johnson & Johnson, which has faced supply constraints due to increased global demand [4][5]. Group 2: Sales Performance and Market Share - Sales of Lifan's methylphenidate sustained-release tablets in domestic sample hospitals were approximately 350 million yuan in 2023, with an expected increase to about 430 million yuan in the first three quarters of 2024 [1][3]. - Analysts predict that Lifan's product could capture around 15% of the market share in its first year of sales, addressing the supply gap left by the imported product [4]. Group 3: Regulatory and Production Considerations - The production and distribution of methylphenidate sustained-release tablets are subject to strict regulatory controls, requiring approval from the National Medical Products Administration [5]. - Lifan has established an integrated supply system for the active pharmaceutical ingredient and the formulation, which is crucial for maintaining consistent supply and quality [5].
A股异动丨立方制药跌4% 股东高美华完成减持30万股
Ge Long Hui A P P· 2025-09-03 06:28
Core Viewpoint - Lifan Pharmaceutical (003020.SZ) experienced a decline of 4.02% to 33.45 yuan following the announcement of a completed share reduction plan by shareholder Gao Meihua, who reduced her holdings by 300,000 shares, representing 0.16% of the total shares [1] Group 1 - Lifan Pharmaceutical's stock price dropped significantly after the announcement [1] - Shareholder Gao Meihua has completed her share reduction plan [1] - The total number of shares reduced by Gao Meihua is 300,000 [1]
立方制药跌4% 股东高美华完成减持30万股
Xin Lang Cai Jing· 2025-09-03 06:28
Core Viewpoint - Lifan Pharmaceutical (003020.SZ) experienced a decline of 4.02% to 33.45 yuan following the announcement of a completed share reduction plan by shareholder Gao Meihua, who reduced her holdings by 300,000 shares, representing 0.16% of the total shares [1] Company Summary - Lifan Pharmaceutical's stock price dropped significantly after the announcement of the share reduction [1] - The reduction involved a total of 300,000 shares sold by shareholder Gao Meihua, indicating a strategic move in her investment [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].
立方制药: 关于股东减持计划实施完毕的公告
Zheng Quan Zhi Xing· 2025-09-02 16:26
Summary of Key Points Core Viewpoint - The announcement details the completion of a share reduction plan by shareholder Gao Meihua, who reduced her holdings in Hefei Lifan Pharmaceutical Co., Ltd. by 300,000 shares, representing 0.16% of the company's total share capital [1]. Shareholder Reduction Details - Gao Meihua executed the share reduction from July 28, 2025, to August 29, 2025, at an average price of 29.71 yuan per share [1]. - The reduction price ranged from 27.44 yuan to 37.00 yuan per share [1]. - Prior to the reduction, Gao Meihua held 6,444,703 shares (3.37% of total share capital), and after the reduction, she holds 6,144,703 shares (3.23% of total share capital) [1]. Compliance and Future Plans - The share reduction was consistent with previously disclosed intentions and plans, adhering to relevant regulations and guidelines [1]. - Gao Meihua has committed to considering personal and family financial needs before any future share reductions, with a requirement to announce any such plans three trading days in advance [1].
立优加®盐酸哌甲酯缓释片首发上市 立方制药持续发力高壁垒市场
Zheng Quan Shi Bao Wang· 2025-09-02 15:11
Core Viewpoint - Lifan Pharmaceutical has launched its self-developed sustained-release methylphenidate hydrochloride tablets, marking a significant milestone in the company's growth and innovation strategy [1][2]. Group 1: Product Launch and Market Position - The sustained-release methylphenidate hydrochloride tablets, named Liyoujia, received approval from the National Medical Products Administration in April 2025 and are primarily used for treating Attention Deficit Hyperactivity Disorder (ADHD) [1]. - The product utilizes advanced three-layer osmotic pump technology for precise controlled release, ensuring rapid onset and stable efficacy throughout the day [1]. - Currently, Lifan Pharmaceutical is one of the few domestic manufacturers of anesthetic and first-class psychotropic drugs, benefiting from policy barriers and a comprehensive supply chain management system [1][2]. Group 2: Market Potential and Sales Performance - The prevalence of ADHD among adults in China is approximately 3%, while the rate for children is as high as 6.26%, indicating a significant market opportunity for methylphenidate formulations [2]. - Sales of methylphenidate sustained-release tablets in domestic sample hospitals reached approximately 350 million yuan in 2023, with an expected increase to about 430 million yuan in the first three quarters of 2024 [2]. Group 3: Strategic Partnerships and Distribution - During the launch ceremony, Lifan Pharmaceutical signed cooperation agreements with major pharmaceutical distribution companies, ensuring rapid access to medical institutions across the country [2]. - The company aims to enhance patient accessibility to medications through its partnerships with leading pharmaceutical distribution networks [2]. Group 4: Research and Development Focus - Lifan Pharmaceutical emphasizes that research and development are now viewed as core assets rather than costs, focusing on products with technical, regulatory, and financial barriers [3]. - The company plans to balance self-research and external collaborations, aiming to develop improved new drugs while also introducing first-class new drugs through partnerships [3]. - In 2024, the company's R&D investment is projected to reach approximately 93.49 million yuan, accounting for 6.16% of its revenue [2].
立优加盐酸哌甲酯缓释片首发上市 立方制药持续发力高壁垒市场
Zheng Quan Shi Bao Wang· 2025-09-02 14:59
Core Viewpoint - Lifan Pharmaceutical's self-developed Liyoujia® methylphenidate sustained-release tablets have been launched after receiving drug registration certification in April this year, marking a significant milestone for the company [2]. Group 1: Product Launch and Market Position - The Liyoujia® methylphenidate sustained-release tablets are classified as a first-class psychotropic drug and are primarily used for treating Attention Deficit Hyperactivity Disorder (ADHD) [2]. - The product utilizes advanced three-layer osmotic pump technology for precise controlled release, ensuring rapid onset and stable efficacy throughout the day [2]. - Currently, Lifan Pharmaceutical is one of the few domestic manufacturers of anesthetic and first-class psychotropic drugs, leveraging policy barriers and a comprehensive supply chain management advantage [2]. Group 2: Market Potential and Sales Data - The prevalence of adult ADHD in China is approximately 3%, while the prevalence in children is as high as 6.26%, indicating a significant market opportunity for methylphenidate formulations [3]. - The sales revenue of methylphenidate sustained-release tablets in domestic sample hospitals was about 350 million yuan in 2023, with an increase to approximately 430 million yuan in the first three quarters of 2024 [3]. Group 3: Strategic Partnerships and Distribution - During the launch ceremony, Lifan Pharmaceutical signed cooperation agreements with major pharmaceutical distribution companies to enhance the accessibility of Liyoujia® across various medical institutions in China [3]. Group 4: R&D Investment and Strategic Focus - Lifan Pharmaceutical has been increasing its R&D investment, which is expected to reach 93.49 million yuan in 2024, accounting for 6.16% of its revenue [3]. - The company is focusing on product areas with technological, regulatory, and financial barriers to maintain a competitive edge in the market [4]. - The strategic approach includes a balance of self-research and external collaboration to enhance the product pipeline and ensure predictable profitability in the Chinese market [5].