Core Viewpoint - Chengyi Pharmaceutical has received approval from the National Medical Products Administration for the registration certificate of Eicosapentaenoic Acid Ethyl Ester Soft Capsules [2] Group 1 - The approval signifies a regulatory milestone for the company, potentially enhancing its product portfolio [2] - The product is expected to contribute to the company's revenue growth and market presence in the pharmaceutical industry [2]

证券日报网讯 9月1日晚间，诚意药业发布公告称，2024年10月8日，公司通过回购专用证券账户以集中 竞价交易方式首次实施了股份回购。截至本公告披露日，公司本次股份回购计划实施完毕，公司已通过 集中竞价交易方式累计回购股份9，618，796股，占公司总股本的比例为2.94%。 （编辑 任世碧） ...

Core Viewpoint - Chengyi Pharmaceutical has successfully obtained the drug registration certificate for its EPA soft capsules, marking a significant step in the high-purity EPA formulation sector, which is expected to create a new blockbuster product for the company [1][3]. Company Summary - Chengyi Pharmaceutical's EPA soft capsules have received approval for use in lowering triglyceride levels in adult patients with severe hypertriglyceridemia [1]. - The company reported a substantial increase in net profit for the first half of 2025, with a year-on-year growth of 47.03% and 54.21%, reaching 112 million yuan and 111 million yuan respectively, driven by rising sales of joint-related medications [1]. - The successful approval of the EPA soft capsules positions Chengyi Pharmaceutical to leverage its integrated advantages in high-purity EPA raw materials and formulations [1][3]. Industry Summary - The market for lipid-regulating agents is expanding, driven by an aging population and lifestyle changes, leading to a rise in chronic diseases such as cardiovascular diseases and metabolic syndromes [2]. - The prevalence of hyperlipidemia among adults in China has increased from 18.6% in 2002 to 35.6% in 2020, indicating a growing health burden [2]. - The global lipid-lowering drug market reached $33.12 billion in 2023 and is projected to grow to approximately $46.58 billion by 2033, with China's sales of lipid-regulating agents exceeding 22 billion yuan in 2023 [2]. - Current mainstream lipid-lowering medications, primarily statins and fibrates, have significant side effects, creating a demand for safer long-term treatment options [3]. - The approval of Chengyi Pharmaceutical's high-purity EPA drug fills a gap in the domestic market, potentially capturing a share of the 20 billion yuan lipid-lowering drug market and becoming a new pillar of the company's performance [3].

Summary of Key Points Core Viewpoint - Chengyi Pharmaceutical (603811.SH) has completed its share repurchase plan, reaching the lower limit of the repurchase amount as of the announcement date [1] Group 1: Share Repurchase Details - The company has repurchased a total of 9,618,796 shares through centralized bidding, which accounts for 2.94% of the total share capital [1] - The highest transaction price was 8.36 CNY per share, while the lowest was 7.25 CNY per share, with an average transaction price of 7.94 CNY per share [1] - The total amount paid for the repurchased shares was 76,397,831.64 CNY, excluding transaction fees [1]

Core Viewpoint - Chengyi Pharmaceutical (603811.SH) has received approval from the National Medical Products Administration for the registration certificate of Eicosapentaenoic Acid Ethyl Ester Soft Capsules, aimed at reducing triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) [1] Group 1 - The product is intended for use in conjunction with dietary control to lower triglyceride levels in patients with severe hypertriglyceridemia [1] - It is also indicated for adult patients with confirmed cardiovascular disease or diabetes with two or more other cardiovascular risk factors, combined with hypertriglyceridemia (≥150 mg/dL), to reduce the risk of cardiovascular events such as myocardial infarction, stroke, coronary artery revascularization, and unstable angina requiring hospitalization [1] - The impact of this product on the risk of pancreatitis in patients with severe hypertriglyceridemia has not yet been evaluated [1]

Summary of Key Points Core Viewpoint - Zhejiang Chengyi Pharmaceutical Co., Ltd. has successfully completed its share repurchase plan, utilizing a total of approximately 76.4 million yuan to buy back 9,618,796 shares, which represents 2.94% of its total share capital. The repurchased shares will be used for employee stock ownership plans or equity incentives [1][3]. Group 1: Share Repurchase Plan - The share repurchase plan was first disclosed on October 1, 2024, with a planned implementation period from September 30, 2024, to September 29, 2025 [1]. - The expected repurchase amount ranges from 50 million yuan to 100 million yuan [1]. - The repurchase was conducted through centralized bidding, with the actual repurchase price ranging from 7.25 yuan to 8.36 yuan per share, and an average price of 7.94 yuan per share [3]. Group 2: Implementation Status - As of the announcement date, the company has reached the lower limit of the repurchase amount, completing the share repurchase plan [3]. - The total amount paid for the repurchased shares was 76,397,831.64 yuan, excluding transaction fees [3]. - The company used its own funds and a special bank loan for the repurchase, ensuring that the operation would not significantly impact its business, finances, or future development [3]. Group 3: Shareholder Transactions - There were no stock trading activities by the actual controller, major shareholders, directors, supervisors, or senior management from the date of the initial disclosure of the repurchase plan until the announcement date [3]. Group 4: Future Plans for Repurchased Shares - The repurchased shares will be used for employee stock ownership plans, as approved in a board meeting held on August 11, 2025 [4][5].

Overview - Zhejiang Chengyi Pharmaceutical Co., Ltd. has received the drug registration certificate for Eicosapentaenoic Acid Ethyl Ester Soft Capsules from the National Medical Products Administration [1][2] Drug Information - The drug is approved for use in lowering triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) and is indicated for use in conjunction with statins for patients with cardiovascular disease or diabetes with multiple cardiovascular risk factors [1] - The drug has been classified as a Class 4 chemical drug and is considered to have passed the consistency evaluation for generic drugs [2] Company Impact - The company has invested a total of 15.603 million yuan in the research and development of Eicosapentaenoic Acid Ethyl Ester Soft Capsules [2]

诚意药业公告，近日收到国家药监局核准签发的二十碳五烯酸乙酯软胶囊《药品注册证书》。该药品在 控制饮食的基础上，用于降低重度高甘油三酯血症（≥500mg/dL）成年患者的甘油三酯（TG）水平。 与他汀类药物联合使用，用于确诊心血管疾病或糖尿病伴≥2种其他心血管疾病危险因素，合并高甘油 三酯血症（≥150mg/dL）的成年患者，以降低心血管事件风险。公司二十碳五烯酸乙酯软胶囊的研发投 入共计1560.3万元。 ...

二、回购实施情况 （一）2024 年 10 月 8 日，公司通过回购专用证券账户以集中竞价交易方式 首次实施了股份回购，并披露了首次回购股份情况，具体内容详见公司于 2024 年 10 月 9 日在上海证券交易所网站（www.sse.com.cn）披露的《浙江诚意药业股份 有限公司关于以集中竞价方式首次回购公司股份的公告》（公告编号：2024-033）。 证券代码：603811 证券简称：诚意药业 公告编号：2025-050 浙江诚意药业股份有限公司 关于回购完成暨回购实施结果的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示： | 回购方案首次披露日 | 2024/10/1 | | --- | --- | | 回购方案实施期限 | 2024.9.30~2025.9.29 | | 预计回购金额 | 5,000万元~10,000万元 | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 | | | □用于转换公司可转债 | | | □为维护公司价值及股东权益 | | 累计已回购股数 | 961.8 ...

证券代码： 603811 证券简称：诚意药业 公告编号：2025-049 浙江诚意药业股份有限公司 关于二十碳五烯酸乙酯软胶囊获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 一、概况 近日，浙江诚意药业股份有限公司（以下简称"公司"）收到国家药品监督 管理局（以下简称"国家药监局"）核准签发的二十碳五烯酸乙酯软胶囊（以下 简称"本品"）《药品注册证书》（证书编号：2025S02619、2025S02620），现 将具体情况公告如下： 二、药品的基本情况 1、药品名称：二十碳五烯酸乙酯软胶囊 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准注册，发给药品注册证书。质量标准、说明书、 标签及生产工艺照所附执行。药品生产企业应当符合药品生产质量管理规范要求 方可生产销售。 1 2、剂型：胶囊剂 3、规格：0.5g；1.0g 4、证书编号：2025S02619；2025S02620 5、药品注册标准编号：YBH20232025 6、申请事项：药品注册(境内生产) ...