Core Insights - Huahai Pharmaceutical's subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HB0043, a bispecific antibody targeting IL-17A and IL-36R, aimed at treating various autoimmune diseases [1][2] Group 1: Product Development - HB0043 is a recombinant humanized IgG1 bispecific antibody that targets both IL-17A and IL-36R, demonstrating high binding and blocking activity [1] - The drug has shown superior efficacy compared to monoclonal antibodies in various animal disease models, including atopic dermatitis, idiopathic pulmonary fibrosis, diabetic nephropathy, and neutrophilic asthma [1] - HB0043 offers a new approach to targeted therapy for immune-mediated inflammatory skin diseases and fibrotic diseases, addressing the limitations of single-factor blocking therapies [1] Group 2: Market Potential - As the first bispecific drug globally targeting both IL-17A and IL-36R, HB0043 is expected to overcome the limitations of existing single-target therapies [2] - Current treatments, such as IL-17A inhibitors and IL-36R monoclonal antibodies, have shown positive effects in multiple indications but may still fall short in addressing inflammation in some patients [2] - The innovative dual-target mechanism of HB0043 positions it as a first-in-class (FIC) therapy with broad potential applications in various Th17/IL-36 related immune-mediated diseases [2]

Core Viewpoint - Huahai Pharmaceutical's subsidiary has received approval for clinical trials of HB0043, a bispecific antibody targeting IL-17A and IL-36R, which aims to treat various difficult autoimmune diseases [1][2] Group 1: Product Development - HB0043 is a recombinant humanized IgG1 bispecific antibody that targets both IL-17A and IL-36R, demonstrating high binding and blocking activity [1] - The drug has shown superior efficacy compared to monoclonal antibodies in various animal disease models, including atopic dermatitis, idiopathic pulmonary fibrosis, diabetic nephropathy, and neutrophilic asthma [1] Group 2: Market Potential - As the world's first bispecific antibody targeting IL-17A and IL-36R, HB0043 is expected to overcome the limitations of existing single-target therapies [2] - Current therapies targeting IL-17A and IL-36R have shown positive effects in multiple indications, but there are still shortcomings in addressing inflammation in some patients [2] - HB0043's innovative dual-target approach may lead to broad applications in various Th17/IL-36 related immune-mediated diseases, showcasing its first-in-class (FIC) advantages [2]

Core Viewpoint - Huahai Pharmaceutical (600521.SH) announced that its subsidiaries Huao Tai and Huabo Biotech received approval from the National Medical Products Administration for the clinical trial of injectable HB0043, a bispecific antibody targeting IL-17A and IL-36R, aimed at treating various autoimmune diseases [1] Summary by Relevant Categories Product Development - HB0043 is a recombinant humanized IgG1 bispecific antibody with high binding and blocking activity [1] - The company has invested approximately 69.09 million yuan in the research and development of this project [1] Market and Competition - The development cycle for pharmaceutical products is long and carries uncertainties [1] - Future competitive dynamics in the market are expected to change [1]

Group 1 - The stock price of Huahai Pharmaceutical closed at 22.72 yuan on July 30, down 1.43% from the previous trading day [1] - The stock reached a high of 24.24 yuan and a low of 22.55 yuan during the day, with a volatility of 7.33% [1] - The trading volume was 606,356 hands, with a total transaction amount of 1.406 billion yuan [1] Group 2 - Huahai Pharmaceutical operates in the chemical pharmaceutical industry, covering the research, production, and sales of active pharmaceutical ingredients and formulations [1] - The company is based in Zhejiang and its products are involved in cardiovascular, psychiatric, and antiviral fields [1] - During the early trading session on July 30, the stock experienced a rapid rebound, with price fluctuations exceeding 2% within five minutes [1] Group 3 - The main funds showed a slight net inflow on that day [1]

Summary of Key Points from the Conference Call Industry Overview - The Chinese innovative pharmaceutical industry is experiencing a significant enhancement in strength, with its share of global first-in-class drugs increasing to 19% [7] - Multinational corporations (MNCs) are facing a severe patent cliff, with major companies like Merck, AbbVie, and BMS having over 60%, 58%, and 69% of their 2024 revenues coming from drugs facing patent expiration within the next five years [8][9] - MNCs are actively seeking business development (BD) transactions to address these challenges, with strong cash reserves available for such activities [10] Business Development Trends - The trend of Chinese innovative drugs going global is robust, driven by the strengthening capabilities of Chinese companies and the impending patent cliffs faced by MNCs [2] - MNCs are expected to engage in more BD transactions, particularly in the second half of 2025 and into 2026, as they seek to replenish their pipelines [2] Oncology Sector Insights - The oncology field is shifting from PD-1 combined with chemotherapy to next-generation immuno-oncology (IO) and antibody-drug conjugates (ADC) [3] - Potential MNC buyers in this space include AstraZeneca, Pfizer, and Merck, all of which are looking to enhance their portfolios with next-generation IO and ADC assets [3] Metabolic Disease Developments - The metabolic field is evolving from merely focusing on weight loss to comprehensive metabolic management, including fat reduction and muscle preservation [4][5] - Companies like Novo Nordisk and AstraZeneca are exploring oral medications and multi-target approaches in this area [4] Immune and Inflammatory Disease Innovations - New directions in the immune and inflammation sector include novel targets and engineering innovations, with significant investments from companies like AbbVie and Sanofi [6] - Emerging targets such as TL1a are attracting substantial investments, indicating a strong interest in this area [20] Market Position of Chinese Innovative Drugs - Chinese innovative drug companies have made significant strides in global markets, with improved clinical data quality and increased academic recognition [7] - The presence of Chinese companies in the oncology sector is growing, with several projects in advanced stages of development [14] MNC Strategies for BD Transactions - MNCs are focusing on four main strategies for BD transactions: consolidating core areas, entering new fields, exploring opportunities, and investigating new technologies [11] - The willingness of MNCs to invest in promising assets at the preclinical stage is evident, particularly in high-potential areas like TL1a [20] ADC and TCE Technology Developments - The ADC field is characterized by a tiered approach, with MNCs diversifying their portfolios across various targets [15] - T-cell engagers (TCE) are being developed for blood cancers and autoimmune diseases, with ongoing clinical trials showing promising results [16] Conclusion - The ongoing trends in the Chinese pharmaceutical industry, coupled with the challenges faced by MNCs, are creating a fertile ground for increased collaboration and investment opportunities in the global market [29]

Core Points - Zhejiang Huahai Pharmaceutical Co., Ltd. has announced a delay in the "Formulation Digital Intelligent Manufacturing Construction Project" to December 2026, as approved by the board of directors on July 24, 2025 [1][4] - The delay only involves adjustments to the project timeline and does not change the use of raised funds or negatively impact the company's normal operations or shareholder interests [1][4][5] - The total amount raised from the issuance of shares was approximately CNY 600 million, with a net amount of approximately CNY 582 million after deducting issuance costs [1][2] Fundraising Overview - The company raised CNY 599,999,994.54 by issuing 41,152,263 shares at a price of CNY 14.58 per share, with net proceeds of CNY 582,319,365.51 after deducting issuance costs [1][2] - The funds are allocated to two main projects: the "Formulation Digital Intelligent Manufacturing Construction Project" and working capital, with total planned investments of CNY 172,274.12 million [2] Project Delay Details - The original completion date for the "Formulation Digital Intelligent Manufacturing Construction Project" was set for July 2025, now postponed to December 2026 due to the project's large scale and external factors [3] - The project aims to integrate various information systems to create a fully automated production line with a designed capacity of 15 billion tablets per year [3] Impact of Delay - The delay is a strategic decision based on objective project conditions and will not materially affect the implementation of the project or the company's operations [4][5] - The company emphasizes that the delay does not involve changes to the investment content, purpose, total amount, or implementation entity of the project [4][5] Approval Process - The delay was approved through a series of meetings, including the board of directors and independent directors, and does not require shareholder approval [4][5][6]

浙商证券股份有限公司 关于浙江华海药业股份有限公司 募投项目结项并将节余募集资金永久补充流动资金的 核查意见 浙商证券股份有限公司（以下简称"浙商证券"或"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"）公开发行可转换公 司债券的保荐机构，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》《上市公司募集资金监管规则》《上海证券交易所上市公司自律监 管指引第1号——规范运作》《上海证券交易所上市公司自律监管指引第11号—— 持续督导》等有关规定，对华海药业募投项目结项并将节余募集资金永久补充流 动资金事项进行了审慎核查，发表如下意见： 一、募集资金及募投项目基本情况 （一）募集资金基本情况 经中国证券监督管理委员会证监许可[2020]2261 号文《关于核准浙江华海药 业股份有限公司公开发行可转换公司债券的批复》的核准，华海药业已公开发行 1,842.60 万张可转换公司债券，每张面值 100 元。本次发行募集资金总额为 184,260.00 万元，扣除发行费用 2,089.55 万元（不含税），实际募集资金净额为 182,170.45 万元。 （二）募投项目基本情 ...

浙商证券股份有限公司 一、募集资金基本情况 经中国证券监督管理委员会《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）批准，浙江华海药业股份有 限公司（以下简称"公司"）向特定对象发行人民币普通股（A股）数量为 41,152,263股，发行价格为14.58元/股，募集资金总额为599,999,994.54元，扣除 发行费用17,680,629.03元（不含增值税）后，募集资金净额为582,319,365.51元。 上述募集资金已于2025年3月14日全部到位。天健会计师事务所（特殊普通合伙） （以下简称"天健所"）对上述募集资金到位情况进行了审验，并出具了《验资 报告》（天健验〔2025〕48号）。 募集资金到账后，公司对募集资金进行了专户存储，并与保荐机构、存放募 集资金的银行签署了募集资金专户存储三/四方监管协议。 二、募集资金使用计划及使用情况 （一）募集资金使用计划 关于浙江华海药业股份有限公司 部分募集资金投资项目延期的核查意见 浙商证券股份有限公司（以下简称"浙商证券"或"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 ...

| 证券代码：600521 | 证券简称：华海药业 | 公告编号：临 2025-085 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 关于募投项目结项并将节余募集资金永久补充流动资金的 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。 重要内容提示： ●本次结项的募投项目名称："浙江华海生物科技有限公司 ADC 产业化技改项 目"。 ●节余募集资金金额及用途：本次节余募集资金金额为 963.07 万元（实际金额 以资金转出当日募集资金专用账户余额为准），公司拟将上述节余募集资金永久补 充流动资金，用于公司日常经营及业务发展。 ●履行的审议程序：上述事项已经公司第九届董事会审计委员会第二次会议、 第九届董事会独立董事专门会议 2025 年第一次会议及第九届董事会第二次临时会 议审议通过，无需提交公司股东会审议，无需召开债券持有人会议。 一、募集资金及募投项目基本情况 （一）募集资金基本情况 经中国证券监督管理委员会证监许可[2020 ...

| 证券代码：600521 | 证券简称：华海药业 | 公告编号：临 | 2025-084 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 关于部分募集资金投资项目延期的公告 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。 重要内容提示： 浙江华海药业股份有限公司（以下简称"公司"）于 2025 年 7 月 24 日召 开第九届董事会第二次临时会议，审议通过了《关于部分募集资金投资项目延期的 议案》，一致同意将"制剂数字化智能制造建设项目"达到预定可使用状态的日期 延期至 2026 年 12 月。 本次募集资金投资项目延期仅涉及项目进度的调整，不存在改变或变相改 变募集资金用途的情况，不存在违规使用募集资金的情形，不会对公司的正常经营 产生重大不利影响，也不存在损害股东利益特别是中小股东利益的情形。 保荐机构已就本次部分募集资金投资项目延期事项发表了明确同意的意见。 该事项无需提交股东会审议。 一、募集资金基本情况 经中 ...