Group 1 - The core announcement is about the change of the sponsor representatives for Huahai Pharmaceutical's public offering of convertible bonds and stock issuance to specific targets [2] - The new sponsor representatives are Wang Yiming and Pan Xuan [2] - This change was officially announced on the evening of September 23 [2]

浙江华海药业股份有限公司 | 证券代码：600521 | 证券简称：华海药业 公告编号：临 2025-104 号 | | --- | --- | | 债券代码：110076 | 债券简称：华海转债 | 浙江华海药业股份有限公司 董事会 二零二五年九月二十三日 附：王一鸣女士简历 王一鸣女士：保荐代表人，2007 年开始从事投资银行业务，具有证券从业资 格和保荐代表人资格，曾负责或参与五芳斋、杭华股份、建业股份、黄海机械、达 刚路机首次公开发行上市，鑫富药业、赤天化公开增发，巨化股份、杭氧股份、宝 信软件非公开发行股票，杭氧股份、中国银河、三花智控、华海药业、公元股份、 宝信软件可转换公司债券，华海药业向特定对象发行股票，巨化股份配股等项目。 关于变更保荐代表人的公告 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个别及连带责任。 浙江华海药业股份有限公司（以下简称"公司"）于近日收到保荐机构浙商证 券股份有限公司（以下简称"浙商证券"）出具的《浙商证券股份有限公司关于变 更浙江华海药业股份有限公司持续督导保荐代表人的函》，公司公开发行可 ...

Core Points - The company has received the drug registration certificate for Carbetocin Sodium Injection from the National Medical Products Administration, indicating compliance with drug registration requirements [1][4] - Carbetocin Sodium Injection is indicated for bleeding diseases in the urinary system, upper digestive tract, respiratory tract, and gynecology, with significant efficacy in the urinary system [2][4] - The company has invested approximately RMB 7.12 million in the research and development of Carbetocin Sodium Injection [3] Drug Information - Drug Name: Carbetocin Sodium Injection - Dosage Form: Injection - Specification: 5ml: 25mg - Registration Category: Class 3 Chemical Drug - Approval Number: National Drug Approval No. H20255532 [1][2] Market Impact - The approval of Carbetocin Sodium Injection enhances the company's product line and market competitiveness, contributing positively to its business development [4] - The domestic market sales forecast for Carbetocin Sodium Injection in 2024 is approximately RMB 250 million [2]

Group 1 - The core viewpoint of the news is that Huahai Pharmaceutical's stock has experienced a decline of 5.08% over three consecutive days, with the current stock price at 21.28 CNY per share and a total market capitalization of 31.862 billion CNY [1] - Huahai Pharmaceutical, established on February 28, 2001, and listed on March 4, 2003, specializes in the research, production, and sales of various types of generic drugs, biological drugs, innovative drugs, and specialty raw materials [1] - The company's main business revenue composition includes finished drug sales at 61.86%, raw materials and intermediates sales at 36.75%, other sales at 0.78%, and technical services at 0.62% [1] Group 2 - From the perspective of fund holdings, Jin Yuan Shun An Fund has a significant position in Huahai Pharmaceutical, with its Jin Yuan Shun An Medical Health Mixed A Fund (007861) holding 86,200 shares, accounting for 3.07% of the fund's net value [2] - The fund has incurred a floating loss of approximately 98,300 CNY today, with a total floating loss of 103,400 CNY during the three-day decline [2] - The Jin Yuan Shun An Medical Health Mixed A Fund was established on July 29, 2021, with a current scale of 33.4541 million CNY and has achieved a year-to-date return of 23.6% [2]

Core Viewpoint - Huahai Pharmaceutical's stock has experienced fluctuations, with a year-to-date increase of 24.68% but a recent decline in the last five trading days by 6.91% [1] Financial Performance - For the first half of 2025, Huahai Pharmaceutical reported revenue of 4.516 billion yuan, a year-on-year decrease of 11.93%, and a net profit attributable to shareholders of 409 million yuan, down 45.30% year-on-year [2] - The company has cumulatively distributed 2.989 billion yuan in dividends since its A-share listing, with 1.016 billion yuan distributed in the last three years [3] Stock Market Activity - As of September 23, Huahai Pharmaceutical's stock price was 21.97 yuan per share, with a market capitalization of 32.895 billion yuan [1] - The stock has seen significant trading activity, with a net outflow of 22.9883 million yuan in principal funds on September 23, and a total trading volume of 166 million yuan [1] Shareholder Structure - As of June 30, 2025, the number of shareholders decreased by 16.37% to 52,400, while the average circulating shares per person increased by 18.71% to 27,781 shares [2] - Among the top ten circulating shareholders, notable changes include an increase in holdings by China Europe Medical Health Mixed A and a decrease by Hong Kong Central Clearing Limited [3] Business Overview - Huahai Pharmaceutical, established on February 28, 2001, and listed on March 4, 2003, specializes in the research, production, and sales of various dosage forms of generic drugs, biological drugs, innovative drugs, and specialty raw materials [1] - The company's revenue composition includes 61.86% from finished drug sales, 36.75% from raw materials and intermediates, and 0.78% from other sources [1]

Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received the drug registration certificate for Carbetocin Injection from the National Medical Products Administration, which is expected to enhance the company's product line and market competitiveness [1][4]. Drug Basic Information - Drug Name: Carbetocin Injection - Dosage Form: Injection - Specification: 5ml: 25mg (calculated as C??H??N?NaO?S·3H?O) - Registration Category: Class 3 Chemical Drug - Approval Number: National Drug Approval Number H20255532 - The drug is approved for domestic production [1][2]. Market Potential - Carbetocin Injection is used for treating bleeding diseases in the urinary system, upper digestive tract, respiratory tract, and gynecology, with significant efficacy in the urinary system. It can also be used for the prevention and treatment of surgical bleeding [2]. - The domestic market sales forecast for Carbetocin Injection in 2024 is approximately RMB 250 million [2]. R&D Investment - The company has invested approximately RMB 7.12 million in the R&D project for Carbetocin Injection [3]. Impact on the Company - The approval of Carbetocin Injection as a Class 3 Chemical Drug is equivalent to passing the consistency evaluation, which enriches the company's product line and positively impacts its operational development [4].

Core Viewpoint - The company is accelerating its investment in innovative drugs to achieve its third industrial transformation and upgrade strategy, emphasizing cash flow management and resource optimization [1] Group 1: Innovation and Development - The company has increased its investment in innovative drugs through multiple channels and resources to expedite development [1] - HB0025, a dual antibody developed by the company's subsidiary, has submitted an application for a confirmatory phase III clinical trial for advanced or recurrent endometrial cancer, marking a critical step towards domestic phase III clinical development [1] - The phase II clinical data for non-small cell lung cancer shows significant efficacy, with expectations to initiate phase III clinical trials domestically within the year [1] Group 2: Financial Management - The company maintains a stable cash flow from its core business, providing continuous support for research and development [1] - The financial structure is robust, with smooth financing channels that ensure strong backing for R&D investments [1] - Continuous optimization of resource allocation is aimed at maximizing the value of potential research pipelines [1] Group 3: Market Strategy - The overseas rights transfer of innovative drug products is part of the company's long-term strategy to expand into international markets and realize the value of R&D achievements [1]

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2025-103 | | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | 浙江华海药业股份有限公司 关于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个别及连带责任。 浙江华海药业股份有限公司（以下简称"公司"）于近日收到国家药品监督管 理局（以下简称"国家药监局"）核准签发的卡络磺钠注射液的《药品注册证书》， 现将相关情况公告如下： 一、药品的基本情况 药品名称：卡络磺钠注射液 剂型：注射剂 规格：5ml：25mg（按 C₁₀H₁₁N₄NaO₅S·3H₂O 计） 申请事项：药品注册（境内生产） 注册分类：化学药品 3 类 申请人：浙江华海药业股份有限公司 药品批准文号：国药准字 H20255532 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。 二、药品其他相关情况 截至目前，公司在卡络磺钠注射液研 ...

Core Viewpoint - Huahai Pharmaceutical has received the drug registration certificate for Carbenoxolone Sodium Injection from the National Medical Products Administration, which is expected to impact its revenue positively in the upcoming year [1] Company Summary - Huahai Pharmaceutical's revenue composition for the year 2024 is as follows: finished drug sales account for 60.32%, raw materials and intermediates sales account for 38.19%, technical services account for 0.66%, other businesses account for 0.55%, and other industries account for 0.28% [1] - As of the report date, Huahai Pharmaceutical has a market capitalization of 33.6 billion yuan [1]

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the marketing of Carbetocin Injection, which is indicated for various bleeding disorders in the urinary system, upper digestive tract, respiratory tract, and obstetrics [1] Group 1 - The approved product, Carbetocin Injection, is effective for treating bleeding diseases, particularly in the urinary system [1] - The injection can also be used for the prevention and treatment of surgical bleeding [1]