Key Points - Tibet Tourism may apply for suspension of trading if significant abnormalities occur in stock transactions [1] - Southern Road Machinery's stock price has deviated from its fundamental situation [1] - Industrial Fulian's major customers and products have not undergone significant changes [1] - Yingweike has established a relatively complete liquid cooling technology and product solution capability [1] - Victory Energy's operational situation remains normal with no significant changes in the internal and external business environment [1] - Qizheng Tibetan Medicine's operational situation is normal with no significant changes in the internal and external business environment [1] - Dongxin Co. states that its investment in Shanghai Lishuan's chip products is not applicable for large model computing clusters [1] - Guosheng Co. has obtained project filing related to PEEK from its wholly-owned subsidiary [1] - Action Education's actual controller proposed a mid-term dividend of 10 yuan per 10 shares [1] Mergers and Acquisitions - Darui Electronics plans to acquire 80% of Weiste's equity through capital increase and share acquisition [1] - Dashengda intends to acquire 30% equity of Thailand's Far East [1] Financing - Aoshikang plans to issue convertible bonds not exceeding 1 billion yuan for high-end printed circuit board projects [1] - Sixuan New Materials intends to raise no more than 466 million yuan through a private placement [1] - Changhua Chemical plans to raise no more than 230 million yuan for a carbon dioxide polyether project [1] Share Buybacks and Reductions - Fuanna plans to repurchase shares worth between 55.85 million and 104 million yuan [1] - Jiangnan Yifan's board member intends to increase his stake in the company [1] - Jieya Co. and its concerted parties plan to reduce their holdings by no more than 4.95% [1] - Other companies including Tongda Co., Haohan Deep, and Wanhu Chemical also plan to reduce their holdings [1] Operational Data - Sinopec expects a net profit decline of 39.5% to 43.7% year-on-year for the first half of the year [1] - Qingdao Bank reported a net profit of 3.065 billion yuan for the first half, up 16.05% year-on-year [1] - Daodaquan's net profit increased by 563.15% year-on-year, proposing a dividend of 1.76 yuan per 10 shares [1] - Zhengdan Co. reported a net profit increase of 120.35% year-on-year, proposing a dividend of 3 yuan per 10 shares [1] - Other companies reported varying profit changes, including losses and significant increases [1] Contracts and Major Investments - Sanhui Electric signed a framework contract for robot equipment sales [1] - Zhejiang University Network New's subsidiary won a smart engineering project worth 94.2712 million yuan [1] - New Aluminum Times plans to invest no less than 500 million yuan in a project for lightweight, high-strength auto parts [1] - Zhishang Technology will use part of its raised funds for a smart manufacturing production base in Vietnam [1]

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]