Core Viewpoint - Huahai Pharmaceutical's subsidiary, Shanghai Huao Tai Biopharmaceutical Co., Ltd., has received FDA approval to conduct Phase I clinical trials for the injectable HB0043 in the United States, targeting autoimmune diseases [1] Group 1: Company Developments - The HB0043 is a recombinant humanized IgG1 bispecific antibody that targets both human interleukin-17A and human interleukin-36 receptor, demonstrating high binding and blocking activity [1] - The company has invested approximately 71.11 million yuan in the research and development of this project [1]

Core Viewpoint - Company Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of two new drugs, indicating a positive development in its product pipeline and potential revenue growth [1] Group 1: Drug Approvals - The company has obtained the drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets (II), which is indicated for the treatment of hypertension in adults who do not respond adequately to monotherapy [1] - The injection of Rosatadine Hydrochloride Acetate is approved for low-risk patients with upper gastrointestinal bleeding caused by conditions such as peptic ulcers and acute stress ulcers [1] - Both drugs are classified as chemical drugs of category 3, which allows them to be considered as having passed the consistency evaluation according to national policies [1]

| 股票简称：华海药业 股票代码：600521 | 公告编号：临 | 号 2025-100 | | --- | --- | --- | | 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"）核准签发的坎地沙坦酯氢氯噻嗪片（Ⅱ）和注射 用盐酸罗沙替丁醋酸酯的《药品注册证书》，现将相关情况公告如下： 一、坎地沙坦酯氢氯噻嗪片（Ⅱ）相关情况 药品名称：坎地沙坦酯氢氯噻嗪片（Ⅱ） 剂型：片剂 规格：每片含坎地沙坦酯 16mg 与氢氯噻嗪 12.5mg 申请事项：药品注册（境内生产） 药品批准文号：国药准字 H20255456 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。 坎地沙坦酯氢氯噻嗪片（Ⅱ）用于治疗高血压。本品不适用于高血压的初始治 疗，本品适 ...

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of two new drugs, which will enhance its product line and market competitiveness [1] Group 1: Regulatory Approval - The company has obtained the drug registration certificates for Candesartan Cilexetil and Rosatadine Acetate Injection from the National Medical Products Administration [1] - These drugs are classified as Category 3 chemical drugs, which are considered to have passed the consistency evaluation according to national policies [1] Group 2: Business Impact - The approval of these new drugs will enrich the company's product portfolio [1] - This development is expected to positively impact the company's operational growth and market competitiveness [1]

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of two new drugs, which will enhance its product line and market competitiveness [1] Group 1: Regulatory Approval - The company has obtained the drug registration certificates for Candesartan Cilexetil and Rosatadine Hydrochloride Injection from the National Medical Products Administration [1] - These drugs are classified as Category 3 chemical drugs, which are considered to have passed the consistency evaluation according to national policies [1] Group 2: Business Impact - The approval of these new drugs will enrich the company's product portfolio [1] - This development is expected to positively impact the company's operational growth and market competitiveness [1]

Core Viewpoint - Huahai Pharmaceutical has received approval from the National Medical Products Administration for the registration of two drugs: Candesartan Cilexetil and Hydrochlorothiazide Tablets (II) and Injectable Ranitidine Hydrochloride Acetate, indicating a significant advancement in its product portfolio and potential revenue growth in the domestic market [1] Group 1: Product Approvals - The company has obtained a drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets (II), which is used for treating hypertension, with an estimated domestic market sales amount of approximately 149 million yuan [1] - The Injectable Ranitidine Hydrochloride Acetate is indicated for low-risk patients with upper gastrointestinal bleeding, with an estimated domestic market sales amount of around 1.18 billion yuan [1] Group 2: R&D Investment - The company has invested approximately 11.28 million yuan in the research and development of Candesartan Cilexetil and Hydrochlorothiazide Tablets (II) [1] - For the Injectable Ranitidine Hydrochloride Acetate, the company has invested about 4.31 million yuan in its research and development [1]

Core Viewpoint - Huahai Pharmaceutical (600521.SH) has received approval from the National Medical Products Administration for the drug registration certificates of Candesartan Cilexetil and Hydrochlorothiazide Tablets (II) and Injectable Ranitidine Acetate, indicating a significant advancement in its product portfolio for hypertension treatment [1] Group 1: Product Approval - The company has obtained the drug registration certificate for Candesartan Cilexetil and Hydrochlorothiazide Tablets (II), which is intended for the treatment of hypertension [1] - This product is not suitable for initial treatment of hypertension but is applicable for adults with primary hypertension whose blood pressure cannot be effectively controlled by either Candesartan Cilexetil or Hydrochlorothiazide alone, or as a replacement therapy for the combination of both drugs at the same dosage [1]

Core Viewpoint - The company, Zhejiang Huahai Pharmaceutical Co., Ltd., is set to hold an investor briefing on September 22, 2025, to discuss its 2025 semi-annual performance and financial results, allowing for interactive communication with investors [2][3][4]. Group 1: Meeting Details - The investor briefing will take place on September 22, 2025, from 16:00 to 17:00 [4]. - The location for the meeting is the Shanghai Stock Exchange Roadshow Center, accessible online [4]. - The meeting will be conducted in an interactive online format, enabling real-time communication with investors [3][4]. Group 2: Participation Information - Investors can participate in the briefing by logging into the Shanghai Stock Exchange Roadshow Center on the scheduled date and time [6]. - Questions from investors can be submitted between September 15 and September 19, 2025, through the Roadshow Center's website or via the company's email [6][5]. - The company will address commonly asked questions during the briefing [6]. Group 3: Key Personnel - Key participants in the briefing include the company's President Chen Baohua, Vice President and Secretary of the Board Zhu Yonghua, CFO Zhang Mei, and Independent Director Deng Chuan [5]. Group 4: Contact Information - For inquiries, investors can contact Jin Min or Wang Huiting via phone or email [7].

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 2025-099 | | --- | --- | --- | --- | | 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 关于召开 2025 年半年度业绩说明会的公告 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： 投资者可于 2025 年 9 月 15 日（星期一）至 9 月 19 日（星期五）16:00 前 登录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 600521@huahaipharm.com 进行提问。公司将在说明会上对投资者普遍关注的问 题进行回答。 浙江华海药业股份有限公司（以下简称"公司"）已于 2025 年 8 月 26 日发 布公司 2025 年半年度报告，为便于广大投资者更全面深入地了解公司 2025 年半 年度经营成果、财务状况，公司计划于 2025 年 9 月 22 日（星期一）16:00-17:00 举行 2025 年半年度业绩说明会，就投资者关心的 ...

Core Insights - The market demand for chitosan is increasing due to growing concerns about food safety, healthcare, and environmental protection, with the market size in China projected to reach 758 million yuan in 2024, representing a year-on-year growth of 19.37% [1][7]. Industry Overview - Chitosan is a natural biodegradable biopolymer derived from chitin, primarily sourced from the shells of crustaceans and certain fungi and plants [2][4]. - The unique physical and chemical properties of chitosan, influenced by its degree of deacetylation, allow for a wide range of applications across various sectors [2][4]. Industry Chain - The upstream of the chitosan industry includes raw materials such as crustacean shells, insects, fungi, and chemicals like hydrochloric acid and sodium hydroxide [5]. - The midstream involves the production and manufacturing of chitosan, while the downstream applications span pharmaceuticals, food preservation, cosmetics, environmental protection, agriculture, textiles, and paper [5][6]. Market Size - The chitosan industry in China is expected to grow significantly, with applications in food preservation, medical materials, and as an eco-friendly alternative to traditional plastics [1][7]. Key Companies - Jiangsu Kangting Biotechnology Co., Ltd. is a major player in the chitosan industry, focusing on research, production, and sales, with a wide range of applications in health foods, medical devices, and agriculture [8][9]. - Shandong Weikang Biomedical Technology Co., Ltd. specializes in marine sugar bioengineering, emphasizing research and development in chitosan and its derivatives [9]. Industry Development Trends 1. Continuous technological innovation is crucial for industry upgrades, with new extraction methods like enzyme extraction and supercritical fluid extraction expected to replace traditional methods [10][11]. 2. The application of chitosan is expanding into emerging fields beyond traditional sectors, including its use as a natural preservative and in high-end medical products [10][11]. 3. The industry's strategic value is highlighted by the push for sustainable development and carbon neutrality, with international competition driving technological upgrades and collaborations [11].