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 2025-102 号 债券代码：110076 债券简称：华海转债 关于向特定对象发行股票限售股上市流通公告 本次股票上市流通日期为2025 年 9 月 25 日。 一、本次限售股上市类型 （一）向特定对象发行股票同意注册情况 2024 年 4 月 2 日，浙江华海药业股份有限公司（以下简称"公司"）收到中国 证券监督管理委员会（以下简称"中国证监会"）出具的《关于同意浙江华海药业 股份有限公司向特定对象发行股票注册的批复》（证监许可[2024]480 号），同意公 司向特定对象发行股票的注册申请。 （二）股份登记情况 2025 年 3 月 25 日，公司向特定对象发行股票新增的 41,152,263 股股份在中 国证券登记结算有限责任公司上海分公司（以下简称"中国结算上海分公司"）办 理完毕股份登记、托管及限售手续。本次发行完成后，公司总股本由 1,466,755,541 股变更为 1,507,907,804 股。 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 ...

浙商证券股份有限公司（以下简称"保荐机构"）作为浙江华海药业股份有 限公司（以下简称"华海药业"或"公司"）向特定对象发行股票的保荐机构， 根据《证券发行上市保荐业务管理办法》《上海证券交易所股票上市规则》《上海 证券交易所上市公司自律监管指引第11号——持续督导》等法律法规的相关规定， 对华海药业向特定对象发行股票限售股上市流通的事项进行了核查，核查情况及 核查意见如下： 关于浙江华海药业股份有限公司 向特定对象发行股票限售股上市流通的核查意见 一、本次限售股上市类型 （一）向特定对象发行股票同意注册情况 浙商证券股份有限公司 二、本次限售股形成后至今公司股本数量变化情况 2024 年 4 月 2 日，华海药业收到中国证券监督管理委员会（以下简称"中 国证监会"）出具的《关于同意浙江华海药业股份有限公司向特定对象发行股票 注册的批复》（证监许可[2024]480 号），同意公司向特定对象发行股票的注册 申请。 （二）股份登记情况 2025 年 3 月 25 日，公司向特定对象发行股票新增的 41,152,263 股股份在中 国证券登记结算有限责任公司上海分公司（以下简称"中国结算上海分公司"） 办理完毕股份 ...

Core Viewpoint - Huahai Pharmaceutical announced that 41.1523 million restricted shares will be listed for circulation on September 25, 2025, following approval from the China Securities Regulatory Commission [1] Summary by Relevant Sections - **Share Issuance Details** - The issuance involves 41.1523 million restricted shares, which will be listed for circulation after a 6-month lock-up period [1] - The shares were registered with the China Clearing Shanghai Branch on March 25, 2025 [1] - **Shareholder Information** - The issuance involves 14 shareholders who have all fulfilled their lock-up commitments [1] - The company has undergone changes in its share capital, including share buybacks and convertible bonds conversion [1] - **Regulatory Approval** - The issuance has received approval from the China Securities Regulatory Commission, and the sponsoring institution has no objections to the listing of these restricted shares [1]

Group 1 - Shudao Equipment's subsidiary signed a construction contract worth 24.68 million yuan for a hydrogen fuel cell manufacturing base project [1] - Zhongliang Technology received a land acquisition compensation of 30 million yuan from the government [2] - Palm Holdings won a bid for a high-standard farmland construction project in Lankao County, with a contract value of 433 million yuan, accounting for 14.12% of the company's audited revenue for 2024 [3] Group 2 - Changchun Yidong's subsidiary received a government subsidy of 2.85 million yuan, which is 122.78% of the company's audited net profit for the last fiscal year [4] - Wuzhou Transportation successfully issued 200 million yuan in medium-term notes with an interest rate of 2.10% [5][6] - Tiandi Source's subsidiary plans to apply for a trust loan of up to 500 million yuan from related parties [8] Group 3 - Tiandi Source's subsidiary acquired a residential land use right in Xi'an for 2.015 billion yuan [9] - Opcon Vision received a medical device registration certificate for its ultrasonic nebulizer [11] - Jingjiawei announced the resignation of its vice president due to personal reasons [13] Group 4 - Fulinh Precision's subsidiary received a prepayment of 1.5 billion yuan from CATL for securing lithium iron phosphate material supply [15] - Yunzhu Technology's subsidiary received a government subsidy of 20.12 million yuan [16] - Kehua Bio's ferritin test kit received a medical device registration certificate [17] Group 5 - Jinghua Pharmaceutical's medical sodium alginate wound dressing received a medical device registration certificate [18] - Lingwei Technology established a wholly-owned subsidiary with a registered capital of 1 million yuan [19] - Sanwei Co. won a bid for concrete sleeper procurement projects worth 158 million yuan [20] Group 6 - Shanghai Pharmaceuticals' Nicardipine tablets passed the consistency evaluation for generic drugs [21] - Lushan New Materials increased its idle fund management limit to 750 million yuan [24] - Huayi Technology announced the retirement of a core technical staff member [25] Group 7 - Yingli Environment plans to use up to 300 million yuan of idle raised funds for cash management [30] - Yong'an Forestry plans to develop a national reserve forest project in Putian, Fujian, with an estimated investment of 154 million yuan [32] - Xinyuan Technology's shareholders plan to reduce their holdings by up to 3.18% of the company's shares [60]

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]

华海药业9月16日晚间公告，公司近日收到国家药品监督管理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》。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，本品适用于单用坎地沙坦酯或氢氯噻嗪不能有效控制血压的成年 人原发性高血压，或两药联合用药同剂量的替代治疗。注射用盐酸罗沙替丁醋酸酯用于上消化道出血 （由消化性溃疡、急性应激性溃疡、出血性胃炎等引起）的低危患者。根据国家相关政策，公司坎地沙 坦酯氢氯噻嗪片（Ⅱ）和注射用盐酸罗沙替丁醋酸酯按化学药品3类批准生产可视同通过一致性评价。 ...