断金戒毒胶囊

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亿帆医药(002019):创新药同比大幅增长 断金戒毒胶囊IB期临床达到终点
Xin Lang Cai Jing· 2025-09-12 00:36
Core Viewpoint - In the first half of 2025, the company's total revenue reached 2.635 billion yuan, a year-on-year increase of 0.11%, with innovative drugs Yilishu and Yinikang together generating sales growth of 169.57% compared to the same period last year. The net profit attributable to the parent company was 304 million yuan, up 19.91%, exceeding expectations [1][2][3]. Financial Performance - The company's total revenue for H1 2025 was 2.635 billion yuan, with a net profit of 304 million yuan, reflecting a year-on-year increase of 19.91%. The net profit excluding non-recurring items was 237 million yuan, up 32.21% [1][2]. - The pharmaceutical revenue was 2.254 billion yuan, accounting for 85.53% of total revenue, with a year-on-year growth of 3.99%. Raw material drug revenue was 302 million yuan, down 19.61% [2]. Product Performance - Sales of innovative drugs Yilishu and Yinikang increased significantly, with Yilishu's shipments growing by 96.02% and Yinikang's by 478.15% year-on-year [3]. - Yilishu has been approved in 34 countries and regions, with actual shipments in five countries. The product has received patent compensation approval in the Netherlands and Italy, extending its patent protection by five years [5]. R&D Progress - The company is advancing multiple research projects, including the innovative drug N-3C01, which is expected to enter the IND stage in Q3/Q4 2025 [7][19]. - The clinical trial results for the innovative drug Duanjin Jiedu Capsule have met expectations, indicating significant market potential [1][12][18]. Market Strategy - The company is focusing on global market commercialization and building a biopharmaceutical ecosystem, with a goal of achieving 1 billion yuan in sales for Yilishu in 2025 [17]. - The overseas pharmaceutical revenue reached 331.99 million yuan, a year-on-year increase of 6.46%, with significant contributions from key products [10]. Future Catalysts - Yilishu's sales are expected to reach 1 billion yuan in 2025, with a significant reduction in production costs anticipated after the approval of a new production site [17]. - The Duanjin Jiedu Capsule's clinical trial results are expected to facilitate the implementation of the next clinical plan [18].
上市公司把民间验方做成了戒毒药?官宣后股价下跌
Di Yi Cai Jing· 2025-08-21 11:16
Group 1 - The core product, Duanjin Detox Capsule, is developed based on folk remedies for treating opioid addiction and preventing relapse, with key ingredients including Kouwen and Yangjinhua [2] - The clinical trial results indicate that the product met its expected goals, showing significant efficacy in detoxification and relapse prevention, with a one-year relapse rate potentially as low as 30% [2] - The company reported high relapse rates among heroin users, with 77.7% relapsing within three months and over 95% within six months after detoxification [2] Group 2 - The company has applied for breakthrough therapy designation for the product, with an expected approval result around September 20, 2023, following a 45-working-day review period [2] - There are uncertainties regarding the approval from the National Medical Products Administration for market launch, and the company will actively promote the research project in accordance with national regulations [3]
上市公司把民间验方做成了戒毒药?官宣后股价下跌
第一财经· 2025-08-21 10:23
Core Viewpoint - The article discusses the Phase I clinical trial results of Yifan Pharmaceutical's "Duanjin Detox Capsule," which is designed for opioid addiction treatment. Despite achieving expected results, the company's stock price fell over 2% on the announcement day [3]. Group 1: Product Overview - The Duanjin Detox Capsule is a traditional Chinese medicine capsule developed based on folk experience, primarily composed of "Gouwen" and "Yangjinhua." It aims to treat opioid addiction and prevent relapse [3]. - The product is indicated for clearing toxins and calming the mind, specifically targeting symptoms of opioid substance addiction [3]. Group 2: Clinical Trial Results - According to Yifan Pharmaceutical, the relapse rate for heroin and other opioid dependents is significantly high, with a 77.7% relapse rate within three months and over 95% within six months after detoxification [3]. - The company claims that the Duanjin Detox Capsule shows promising efficacy in detoxification treatment for various levels of heroin dependence, with a one-year relapse rate potentially as low as 30% [3]. Group 3: Regulatory Status - Yifan Pharmaceutical applied for breakthrough therapy designation for the product on July 15, 2025, and expects to receive approval results around September 20, 2025, based on a 45-working-day review period [3]. - The company acknowledges that there are uncertainties regarding the approval from the National Medical Products Administration and commits to actively advancing the project in compliance with national regulations [4].
亿帆医药戒毒胶囊审批结果未出
Xin Lang Cai Jing· 2025-08-21 07:27
Group 1 - The clinical trial results for the detoxification capsule developed by Yifan Pharmaceutical (002019.SZ) have met the expected goals as of August 20 [1] - Following the announcement, the company's stock price fell by over 1% during trading on August 21, attributed to industry-wide adjustments after previous significant gains [1] - The product has applied for breakthrough therapy designation, with an expected approval result around September 20, based on a 45-working-day review period [1] Group 2 - The company acknowledges uncertainties regarding the approval for market launch by the National Medical Products Administration [1] - Yifan Pharmaceutical is committed to actively advancing the research project in accordance with national regulations and will fulfill information disclosure obligations regarding project progress [1]
民间验方成戒毒良药?亿帆医药:突破性疗法预计9月20日左右出审批结果
Di Yi Cai Jing· 2025-08-21 07:19
Core Viewpoint - The approval of the Duanjin Detox Capsule by the National Medical Products Administration remains uncertain despite achieving expected results in Phase I clinical trials, leading to a decline in the company's stock price [1][3]. Group 1: Product Development and Clinical Trials - The Duanjin Detox Capsule is developed based on folk remedies for treating opioid addiction, with main ingredients including Kouwen and Yangjinhua [1]. - The company has invested approximately 98.283 million yuan in the development of the Duanjin Detox Capsule since starting clinical trials in 2019 [1]. - Three clinical studies have been completed, involving 114 healthy adult participants, demonstrating good safety and tolerability of the capsule [3]. Group 2: Market Context and Efficacy - The relapse rate for opioid users after detoxification is high, with 77.7% relapsing within three months and over 95% within six months [2]. - Clinical findings indicate that the Duanjin Detox Capsule shows promising efficacy in preventing relapse, with a one-year relapse rate as low as 30% for treated individuals [2]. - The capsule is expected to provide at least 12 weeks of sustained relapse prevention effects after a short-term use of 21 days [2]. Group 3: Financial Impact and Company Performance - The company reported a revenue of 2.635 billion yuan in the first half of 2025, a year-on-year increase of 0.11%, and a net profit of 304 million yuan, up 19.91% [4]. - The company anticipates that the approval and subsequent market launch of the Duanjin Detox Capsule will have a significant positive impact on its future performance [3].
亿帆医药(002019.SZ):在研产品断金戒毒胶囊Ib期临床试验结果达到预期目标
Ge Long Hui A P P· 2025-08-19 13:12
断金戒毒胶囊是根据民间经验组方探索研发的一种用于阿片类物质成瘾防复吸治疗的中药胶囊,主要成 分为钩吻与洋金花。功能主治:祛邪攻毒,安神定志。用于阿片类毒品毒瘀未清证,可解除毒瘾,防止 复吸。症见渴求毒品、心慌烦躁、入睡困难、易醒早醒、神疲乏力、肌肉关节疼痛、食欲减退等。 截至报告披露日,断金戒毒胶囊已完成临床研究共3项,均在国内开展,包括1项以健康人为受试者的单 剂量递增的I期临床研究,1项以健康人为受试者的多剂量递增的I期临床研究,以及1项以健康人为受试 者的食物影响临床研究。共计114例健康成年男性或女性受试者至少使用一个剂量的断金戒毒胶囊,剂 量0.04g/次到1.2g/次,健康受试者单次、多次口服断金戒毒胶囊安全性和耐受性良好,与空腹状态相比, 健康受试者食用高脂餐后,钩吻素甲、钩吻素己、钩吻素子、东莨菪碱的吸收速度、吸收程度轻微变 化,但无显著影响。 截至报告披露日,公司对断金戒毒胶囊的研发投入约人民币9,828.30万元。 格隆汇8月19日丨亿帆医药(002019.SZ)公布,公司全资子公司宿州亿帆药业有限公司于近日完成在研品 种断金戒毒胶囊在中国开展的适应症为阿片类物质成瘾的防复吸治疗的Ib期《 ...
亿帆医药:在研产品断金戒毒胶囊Ib期临床试验结果达到预期目标
Zheng Quan Shi Bao Wang· 2025-08-19 12:04
Core Viewpoint - Yifan Pharmaceutical's subsidiary has successfully completed Phase Ib clinical trials for its drug, Duanjin Detoxification Capsule, demonstrating safety, tolerability, and pharmacokinetic characteristics in patients with opioid addiction [1] Group 1: Clinical Trial Results - The Duanjin Detoxification Capsule has shown a significant trend in preventing relapse, improving behavioral control, and enhancing rehabilitation quality compared to a placebo in patients recovering from opioid addiction [1] - The clinical trial results indicate that the drug meets the expected goals for Phase Ib trials in opioid addiction recovery patients [1] Group 2: Company Development - Yifan Pharmaceutical's full subsidiary, Suzhou Yifan Pharmaceutical Co., Ltd., is responsible for the development and clinical trials of the Duanjin Detoxification Capsule [1]
亿帆医药:断金戒毒胶囊Ib期临床试验结果达到预期目标
Xin Lang Cai Jing· 2025-08-19 11:51
Core Viewpoint - Yifan Pharmaceutical's subsidiary, Suzhou Yifan Pharmaceutical Co., Ltd., has completed Phase Ib clinical trials for the drug "Duanjin Detoxification Capsule" aimed at treating opioid addiction relapse prevention in China, demonstrating good safety, tolerability, and pharmacokinetic characteristics [1] Group 1: Clinical Trial Results - The clinical trial results indicate that Duanjin Detoxification Capsule shows a significant trend in preventing relapse, improving behavioral control, and enhancing rehabilitation quality compared to a placebo in patients recovering from opioid addiction [1] - The trial results met the expected goals, suggesting a positive outlook for the drug's potential market entry [1] Group 2: Financial Impact - The recent trial results are not expected to have a significant impact on the company's short-term performance; however, approval and market launch of Duanjin Detoxification Capsule could positively influence future earnings [1]
亿帆医药上半年创新药销售收入同比增长169.57%
Zheng Quan Shi Bao Wang· 2025-08-14 13:47
Core Insights - In the first half of 2025, the company achieved total revenue of 2.635 billion yuan, a year-on-year increase of 0.11%, and a net profit attributable to shareholders of 304 million yuan, up 19.91% [1] - The sales revenue of innovative drugs saw a significant increase of 169.57%, contributing to a substantial rise in the company's non-net profit margin [1][2] Financial Performance - The company's operating cash flow net amount reached 286 million yuan, reflecting a remarkable growth of 98.99% year-on-year [1] - The revenue from proprietary (including imported) pharmaceutical products grew by 7.22%, indicating an optimization of the revenue structure and an increase in profit margins [2] Innovative Drug Development - The company has successfully launched key innovative products in 34 countries or regions, with the innovative drug Yilishu entering the U.S. market at a terminal price of $4,600 per unit [2][3] - Yilishu has been approved for sale in 34 countries, with commercial cooperation established in over 40 countries, including the U.S., Germany, and Brazil [3] Research and Development - The company is advancing multiple indications for the investigational project F-652 and has completed preclinical research for the N-3C01 project, which targets bladder cancer and solid tumors [4] - The focus remains on developing long-acting fusion proteins and bispecific/multispecific antibody new drugs [4] Business Development Initiatives - The establishment of a global business development center aims to enhance the management of high-value assets and facilitate international collaborations [5] - The company has signed several cooperation agreements for the sales of various drugs in regions such as Colombia, Mexico, and the Philippines, indicating a proactive approach to market expansion [6]
亿帆医药(002019):产品结构优化 创新药商业化持续推进
Xin Lang Cai Jing· 2025-05-07 12:40
Core Insights - The company reported a significant increase in revenue and net profit for 2024, with total revenue reaching 5.16 billion yuan, a year-on-year growth of 26.84%, and a net profit of 386 million yuan, up 170.04% [1] - The company continues to optimize its product structure and has effectively controlled expenses, with a notable improvement in expense ratios [1] Financial Performance - In 2024, the company achieved a total revenue of 5.16 billion yuan, with pharmaceutical-related revenue accounting for 4.26 billion yuan, representing over 80% of total revenue [1] - The proprietary pharmaceutical products generated 3.664 billion yuan, a year-on-year increase of 50.64%, and accounted for 71.02% of total revenue, an increase of 11.23 percentage points from the previous year [1] - For Q1 2025, the company reported revenue of 1.327 billion yuan, a slight increase of 0.05%, and a net profit of 153 million yuan, up 4.83% [1] Product Development and Innovation - The innovative drug Yilishu has received approvals from multiple regulatory bodies and has been launched in 34 countries, with over 270,000 units shipped [2] - In Q1 2025, revenue from innovative drug products increased by 327.73%, with Yilishu shipments growing by 293.64% [2] - The company is advancing several clinical trials, including F-652 for alcohol-related liver disease and a pediatric flu treatment [2] Investment Outlook - The company is expected to continue its growth trajectory, with projected revenues of 6.183 billion yuan, 7.108 billion yuan, and 7.683 billion yuan for 2025-2027, representing year-on-year growth rates of 19.83%, 14.96%, and 8.08% respectively [3] - Net profits for the same period are forecasted to be 614 million yuan, 712 million yuan, and 853 million yuan, with corresponding EPS of 0.50, 0.59, and 0.70 yuan [3] - The current stock price corresponds to PE ratios of 22.81, 19.68, and 16.43 for 2025-2027 [3]