Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of its drug HB0043, which targets pyogenic hidradenitis and represents a significant advancement in the treatment of autoimmune diseases [1][2]. Group 1: Drug Information - The drug HB0043 is a recombinant humanized IgG1 bispecific antibody that targets both IL-17A and IL-36R, demonstrating high binding and blocking activity [2]. - HB0043 has shown superior efficacy compared to monoclonal antibodies in various animal disease models, including atopic dermatitis, idiopathic pulmonary fibrosis, diabetic nephropathy, and neutrophilic asthma [2]. - The drug is expected to provide new therapeutic strategies for immune-mediated inflammatory skin diseases and fibrotic diseases, addressing the limitations of single-factor blocking therapies [2][3]. Group 2: Clinical Trial Approval - The drug has received approval for clinical trials, with the first phase set to take place in New Zealand, as approved by the Ethics Committee [1]. - The company has invested approximately RMB 69.09 million in the research and development of HB0043 to date [2]. Group 3: Competitive Advantage - HB0043 is the first bispecific antibody globally targeting both IL-17A and IL-36R, potentially overcoming the limitations of existing single-target therapies [3]. - The drug is positioned to be widely applicable in various Th17/IL-36 related immune-mediated diseases, showcasing a first-in-class advantage in its mechanism and potential [3].

（文章来源：证券日报） 证券日报网讯 7月31日晚间，华海药业发布公告称，近日，公司的下属子公司上海华奥泰生物药业股份 有限公司和华博生物医药技术（上海）有限公司收到国家药品监督管理局核准签发的注射用HB0043的 《药物临床试验批准通知书》。 ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 号 | 2025-086 | | --- | --- | --- | --- | --- | | 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。 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"）和华博生物医药技 术（上海）有限公司（以下简称"华博生物"）收到国家药品监督管理局（以下简称 "国家药监局"）核准签发的注射用 HB0043 的《药物临床试验批准通知书》。现将相 关情况公告如下： 适应症：化脓性汗腺炎 剂型：注射用无菌粉末 申请事项：临床试验 申请人：上海华奥泰生物药业股份有限公司；华博生物医药技术（上海）有限公 司 结论：同意开展临床试验 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 ...

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] Group 2: Market Potential - As the first bispecific drug targeting IL-17A and IL-36R globally, 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 is anticipated to have broad applications in various Th17/IL-36 related immune-mediated diseases, showcasing a first-in-class advantage [2]

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]