证券代码：002019 证券简称：亿帆医药 公告编号：2025-055 亿帆医药股份有限公司 关于缩宫素注射液获得塔吉克斯坦注册批文的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 亿帆医药股份有限公司（以下简称"公司"）全资子公司SciGen Pte. Ltd.于 2025年8月26日收到塔吉克斯坦国家卫生与社会保障部核准签发的上市注册批文， 批准公司化药产品缩宫素注射液在塔吉克斯坦上市销售。现将相关情况公告如下： 一、药品注册主要信息 二、产品简介 缩宫素注射液适用于引产、催产，以及产后及流产后因宫缩无力或缩复不良 而引起的子宫出血；了解胎盘储备功能（催产素激惹试验）。2024年3月19日， 缩宫素注射液在国内获批上市。公司于2025年3月向塔吉克斯坦国家卫生与社会 保障部递交了化药产品注册申请，并于2025年8月获得塔吉克斯坦国家卫生与社 会保障部的注册批准。 三、对公司的影响及风险提示 亿帆医药股份有限公司董事会 2025年8月28日 本次缩宫素注射液获得塔吉克斯坦药品注册批文，是公司继生物创新药、中 药实现海外注册后首个境内自有化药产品实现海外 ...

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]

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].

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]

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].

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《 ...

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]

证券代码：002019 证券简称：亿帆医药 公告编号：2025-054 亿帆医药股份有限公司 关于在研产品断金戒毒胶囊Ib期临床试验结果达到预期目 标的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 亿帆医药股份有限公司（以下简称"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《TFL（统计分析报告表）》，根据临床试验数据结果分析， 证明断金戒毒胶囊在阿片类物质成瘾的患者中安全性、耐受性和药代动力学特征 良好，同时也显示了断金戒毒胶囊相比于安慰剂在阿片类物质成瘾康复期患者上 预防复吸、改善行为控制与提升康复质量方面的疗效趋势明显，标志着断金戒毒 胶囊在阿片类物质成瘾康复期患者的Ib期临床试验结果达到预期目标。现将相关 情况公告如下。 一、断金戒毒胶囊基本情况 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 ...

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]

Summary of YiFan Pharmaceutical Conference Call Company Overview - **Company**: YiFan Pharmaceutical - **Date**: August 15, 2025 Key Points Industry Performance - The domestic pharmaceutical market in the first half of 2025 showed a dichotomy, with traditional drug formulations under significant pressure while innovative drug companies exhibited notable growth potential [10][17]. Financial Performance - YiFan Pharmaceutical achieved revenue of **26.35 billion** yuan in the first half of 2025, showing slight growth compared to the previous year [3]. - Net profit increased by nearly **20%**, attributed to product structure transformation and high-margin products [3][16]. - Drug revenue accounted for approximately **80%** of total revenue, up from **40%** three years ago [16]. Product Performance - Key products in the first half of 2025 included: - **YiliShu**: Sales close to **500 million** yuan, with a target of **1 billion** yuan for the year [7]. - **Dinggan Cross-linked Sodium Hyaluronate**: Expected to double in sales volume [2]. - **Hiroda**: Revenue around **400 million** yuan, with a slight decline in price but stable gross margin due to production efficiency [9]. - **Children's Qingtiao**: Experienced a **30%-40%** decline due to demand and macroeconomic factors [8]. Innovation and R&D - Significant progress in innovative drug commercialization, with **YiliShu** achieving sales in over **40 countries** and receiving regulatory approval to shorten administration time in China [2][11]. - R&D investments increased, with the completion of Phase 1 clinical trials for a traditional Chinese medicine and advancements in several new drug projects [12][14]. Market Strategy - The company is implementing a differentiated pricing strategy globally, with the highest prices in the U.S. at **$4,600** per unit, followed by Europe and China [31][35]. - Plans to enter approximately **160 countries**, focusing on both high-price and competitive pricing markets [34][21]. Supply Chain and Production - The company optimized its international supply chain, transferring filling and packaging to FDA GMP-compliant facilities in China, significantly reducing production costs [4][28]. - Achieved EMA GMP and PIX certifications, enhancing product acceptance in international markets [13]. Future Outlook - The company anticipates stable growth in the second half of 2025, driven by increased sales of self-owned and innovative products [19][20]. - Long-term expectations for **YiliShu** and **Dinggan Cross-linked Sodium Hyaluronate** are optimistic, with significant market potential due to aging populations and clinical advantages [20][25]. Challenges and Opportunities - The company is aware of challenges posed by U.S.-China trade tensions but has strategies in place to mitigate risks, including adjusting transaction structures and leveraging potential tariff exemptions [38][46]. - The internationalization strategy includes expanding existing networks and exploring new markets, particularly in regions with high population but lower economic levels [39][45]. Conclusion - YiFan Pharmaceutical is positioned for growth through innovative products, strategic market expansion, and optimized operations, with a strong focus on R&D and international market penetration [14][47].