Core Viewpoint - Chengyi Pharmaceutical (603811.SH) has received approval from the National Medical Products Administration for its supplementary application, confirming that its product, Dobutamine Hydrochloride Injection, has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved product, Dobutamine Hydrochloride Injection, is primarily used for heart failure caused by decreased myocardial contractility in organic heart disease, including low cardiac output syndrome following cardiac surgery, serving as a short-term supportive treatment [1]

证券代码： 603811 证券简称：诚意药业 公告编号：2025-051 浙江诚意药业股份有限公司 关于公司药品通过仿制药一致性评价的公告 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 | （NDSRI）进行风险评估和研 | 构（包括 WHO 等）发布的亚 | | --- | --- | | 究，采用高灵敏的分析方法 | 硝胺杂质相关技术要求及 | | （如 MS-MS）进行研究和确 | 相关亚硝胺杂质清单，继续 | | 认，制定合理的控制策略， | 对本品原料药和原料药杂 | | 必要时按补充申请申报。 | 质可能形成的亚硝胺杂质 | | | （NDSRI）进行风险评估和 | | | 研究，采用高灵敏的分析方 | | 法（如 | MS-MS）进行研究和 | | | 确认，制定合理的控制策 | | 报。 | 略，必要时按补充申请申 | 三、该药品的相关信息 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 管理局核准签发的《药品补充申请批准通知书》，公司生产的盐酸多巴酚丁胺注 射液（以下简称"本品 ...

Core Viewpoint - Chengyi Pharmaceutical (603811.SH) has received approval from the National Medical Products Administration for its supplemental drug application, indicating that its product, Dobutamine Hydrochloride Injection, has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved product, Dobutamine Hydrochloride Injection, is primarily used for heart failure caused by decreased myocardial contractility in organic heart disease [1] - The drug is also indicated for short-term support treatment in cases of low cardiac output syndrome following cardiac surgery [1]

诚意药业9月12日公告，近日，公司收到国家药品监督管理局核准签发的《药品补充申请批准通知 书》，公司生产的盐酸多巴酚丁胺注射液已通过仿制药质量和疗效一致性评价。盐酸多巴酚丁胺注射液 主要用于器质性心脏病时心肌收缩力下降引起的心力衰竭，包括心脏直视手术后所致的低排血量综合 征，作为短期支持治疗。 ...

Group 1 - The company announced that its product, Dopamine Hydrochloride Injection, has passed the consistency evaluation for generic drug quality and efficacy [1] - This drug is primarily used for heart failure caused by decreased myocardial contractility in organic heart disease, including low cardiac output syndrome after cardiac surgery, serving as a short-term supportive treatment [1] - As of the announcement date, there are a total of 31 manufacturers that have passed the consistency evaluation for Dopamine Hydrochloride Injection by the National Medical Products Administration [1]

Core Viewpoint - Chengyi Pharmaceutical (603811.SH) is preparing for the approval of its fish oil drug, expected by September 2025, which is why there are no performance data reflected in the company's semi-annual report for 2025 [1] Group 1 - The fish oil raw material is currently in the application preparation stage and has not yet received approval, thus production and sales activities have not commenced [1] - Sales of fish oil formulations are in the招商 (recruitment) phase, with the company actively negotiating with interested partner enterprises [1]

Core Viewpoint - Chengyi Pharmaceutical (603811.SH) is preparing for the approval of its fish oil drug, expected by September 2025, which is why there are no performance data reflected in the company's semi-annual report for 2025 [1] Group 1 - The fish oil raw material is currently in the application preparation stage and has not yet received approval, thus production and sales have not commenced [1] - Sales of fish oil formulations are in the招商 (recruitment) phase, with the company actively negotiating with interested partner enterprises [1]

Trading Information Summary - On September 5, 2025, Chengyi Pharmaceutical (603811) closed at 14.43 yuan, up 1.26%, with a turnover rate of 3.92%, a trading volume of 128,500 shares, and a transaction amount of 182 million yuan [1]. - On the same day, the net outflow of main funds was 5.15 million yuan, accounting for 2.83% of the total transaction amount; the net outflow of retail funds was 14.23 million yuan, accounting for 7.81%; while retail investors had a net inflow of 19.38 million yuan, accounting for 10.64% of the total transaction amount [1][3]. Company Announcement Summary - Chengyi Pharmaceutical will hold its second extraordinary general meeting of shareholders on September 15, 2025, to review amendments to several governance systems [1]. - The meeting will take place at 9:30 AM at the company's R&D building in Dongtou District, Wenzhou, and online voting will be conducted through the Shanghai Stock Exchange system [1]. - A total of 12 sub-proposals will be submitted for review, including revisions to the "Implementation Rules for Cumulative Voting at Shareholders' Meetings," "Independent Director Work Rules," and various management and decision-making systems [1]. - The revisions are based on the latest regulations from the Company Law, Securities Law, and guidelines for listed companies, with key changes including the unification of the term "shareholders' meeting" to "shareholders' assembly" and the transfer of supervisory responsibilities to the audit committee [1].

Group 1 - The company is holding its second extraordinary general meeting of shareholders on September 15, 2025, at 9:30 AM [3][4] - Shareholders must register and provide valid identification to participate in the meeting, and latecomers will not be counted in the voting [1][2] - The meeting will include a discussion on revising certain governance systems to enhance internal governance mechanisms [4][8] Group 2 - The proposed revisions include the removal of clauses related to the supervisory board and the transfer of its responsibilities to the audit committee [4][5] - Adjustments will be made to the terminology used in the governance documents, changing "shareholders' meeting" to "shareholders' assembly" [4] - The revisions are in accordance with the latest regulations from the China Securities Regulatory Commission and the Shanghai Stock Exchange [4][5]

股票简称：诚意药业 股票代码：603811 浙江诚意药业股份有限公司 2025 年第二次临时股东会 会议资料 2025 年 9 月 15 日 1/6 浙江诚意药业股份有限公司 2025 年第二次临时股东会 会议资料目录 | 序号 | 议案名称 | | --- | --- | | 1.00 | 关于修订公司部分治理制度的议案 | | 1.01 | 关于修订《股东会累积投票制实施细则》的议案 | | 1.02 | 关于修订《独立董事工作细则》的议案 | | 1.03 | 关于修订《子公司管理制度》的议案 | | 1.04 | 关于修订《募集资金管理制度》的议案 | | 1.05 | 关于修订《董事津贴管理办法》的议案 | | 1.06 | 关于修订《对外担保决策制度》的议案 | | 1.07 | 关于修订《对外投资管理制度》的议案 | | 1.08 | 关于修订《关联交易决策制度》的议案 | | 1.09 | 关于修订《防范控股股东及关联方占用公司资金制度》的议案 | | 1.10 | 关于修订《重大投资和经营决策制度》的议案 | | 1.11 | 关于修订《投资者关系管理制度》的议案 | | 1.12 | 关于 ...