Core Viewpoint - Huahai Pharmaceutical's subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HB0043 in the United States, marking a significant advancement in the treatment of autoimmune diseases [1] Group 1: Product Development - HB0043 is a recombinant humanized IgG1 bispecific antibody targeting both IL-17A and IL-36R, demonstrating high binding and blocking activity [1] - The drug is developed for treating various difficult-to-treat autoimmune diseases, showing stronger efficacy than monoclonal antibodies in animal models for conditions like atopic dermatitis, idiopathic pulmonary fibrosis, diabetic nephropathy, and neutrophilic asthma [1] - HB0043 is the world's first bispecific antibody targeting IL-17A and IL-36R, potentially overcoming the limitations of existing single-target therapies [1] Group 2: Market Potential - Current IL-17A inhibitors and IL-36R monoclonal antibodies have shown positive effects in multiple indications, but their single-dimensional intervention may still be insufficient for some patients [1] - HB0043's innovative dual-target approach is expected to be widely applicable in various Th17 and IL-36 related immune-mediated diseases, showcasing a first-in-class advantage with broad potential [1]

Core Viewpoint - Huahai Pharmaceutical's subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HB0043 in the United States, marking a significant advancement in the treatment of autoimmune diseases [1] Group 1: Product Development - HB0043 is a recombinant humanized IgG1 bispecific antibody targeting both IL-17A and IL-36R, demonstrating high binding and blocking activity [1] - The drug is developed for treating various difficult-to-treat autoimmune diseases, showing stronger efficacy in animal models compared to monoclonal antibodies [1] - HB0043 is the world's first bispecific antibody targeting IL-17A and IL-36R, potentially overcoming the limitations of existing single-target therapies [1] Group 2: Market Potential - Current IL-17A inhibitors and IL-36R monoclonal antibodies have shown positive effects in multiple indications, but there are still limitations in their single-dimensional intervention for some patients [1] - The dual-target approach of HB0043 is expected to provide new treatment strategies for immune-mediated inflammatory skin diseases and fibrotic diseases [1] - The innovative mechanism of HB0043 positions it as a first-in-class (FIC) product with broad potential applications in Th17 and IL-36 related immune-mediated diseases [1]

| 股票代码：600521 | 公告编号：临 | 2025-101 号 | | --- | --- | --- | | 债券代码：110076 | | | | 股票简称：华海药业 债券简称：华海转债 | | | 浙江华海药业股份有限公司 关于下属子公司获得药物临床试验许可的公告 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。 二、药物的其他相关情况 2025 年 5 月，公司下属子公司华奥泰获得新西兰药品和医疗器械安全管理局、健 康及残疾伦理委员会批准在新西兰开展注射用 HB0043 的 I 期临床试验。具体内容详 见公司于 2025 年 5 月 24 日刊登在中国证券报、上海证券报、证券时报、证券日报及 上海证券交易所网站（www.sse.com.cn）上的《浙江华海药业股份有限公司关于下属 子公司获得药物临床试验许可的公告》（公告编号：临 2025-062 号）。 近日，浙江华海药业股份有限公司（以下简称"华海药业"或"公司"）的下属 子公司上海华奥泰生物药业股份有限公司（以下简称"华奥泰"）获得美国食品药品 监督管 ...

Core Viewpoint - Huahai Pharmaceutical's subsidiary Huao Tai has received FDA approval to conduct Phase I clinical trials for the injectable drug HB0043, targeting pyogenic hidradenitis [1] Company Summary - Huahai Pharmaceutical (stock code: 600521) announced on September 17 that its subsidiary Huao Tai has obtained approval from the U.S. Food and Drug Administration (FDA) [1] - The drug HB0043 is indicated for the treatment of pyogenic hidradenitis [1] Industry Summary - The approval for HB0043 marks a significant step for Huahai Pharmaceutical in expanding its product offerings in the U.S. market [1] - The focus on pyogenic hidradenitis indicates a strategic move to address unmet medical needs within dermatological conditions [1]

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]