Group 1: Index and Market Trends - The Hang Seng Hong Kong Stock Connect Innovative Drug Index will be revised to exclude CXO companies, focusing solely on innovative drug firms, achieving a 100% purity in its index composition [1] - This adjustment is expected to increase the weight of Hong Kong innovative drug companies in the index, better reflecting the core trends and valuation logic of the innovative drug industry [1] Group 2: Company Developments - Heng Rui Medicine received approval from the National Medical Products Administration for its innovative drug SHR0302 for treating severe alopecia areata, marking a significant advancement in domestic JAK1 inhibitors [2] - The approval addresses a substantial patient population in China, with approximately 3.49 million alopecia areata patients reported in 2021, highlighting the unmet medical need in this area [2] - Huiyu Pharmaceutical's TCE tri-antibody drug HY05350 has received clinical trial approval for treating advanced solid tumors, showcasing the company's capabilities in innovative drug development [3] - Han Yu Pharmaceutical expects a net profit of 142 to 162 million yuan for the first half of 2025, driven by strong global market demand and successful product approvals, indicating a recovery from previous losses [4] - The company's performance is significantly influenced by a few products in overseas markets, raising questions about future sustainability [4]

证券代码：688553 证券简称：汇宇制药 公告编号：2025-051 四川汇宇制药股份有限公司 关于自愿披露公司产品获得境外上市许可的公告 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、准确性和完整性依法承担法律责任。 四川汇宇制药股份有限公司（以下简称"公司"）子公司 Seacross Pharma (Europe) Ltd.近期收到意大利国家药品和保健品安全局和荷兰健康产品监管局分 别核准签发的公司产品注射用替考拉宁的上市许可。现将相关情况公告如下： 二、药品的其他相关情况 注射用替考拉宁主要用于治疗成人及儿童的肠外感染，例如复杂的皮肤和软 组织感染、骨骼和关节感染、获得性肺炎、尿路感染并发症、感染性心内膜炎、 持续性流动腹膜透析相关的腹膜炎，以及与上述症状相关的菌血症。该产品亦可 用于治疗梭状芽胞杆菌相关的腹泻以及结肠炎。 公司注射用替考拉宁研发成功后已进行了多国注册申报，分别已在中国、英 国、法国、爱尔兰、葡萄牙、意大利、荷兰 7 个国家获得上市许可。截至目前， 公司已分别在德国、西班牙 2 个国家提交注册申请。 三、对公司的影响及风险提示 公 ...

一、药品基本情况 证券代码：688553 证券简称：汇宇制药 公告编号：2025-050 四川汇宇制药股份有限公司 关于自愿披露注射用 HY05350 获得药物临床试验批准 通知书的公告 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、准确性和完整性依法承担法律责任。 近日，四川汇宇制药股份有限公司（以下简称"公司"）全资子公司四川汇 宇海玥医药科技有限公司（以下简称"汇宇海玥"）收到国家药品监督管理局核 准签发的《药物临床试验批准通知书》，注射用 HY05350（项目研发代号为 "HY-0005"）用于治疗晚期实体瘤的临床试验获得批准。现将相关情况公告如 下： 注射用 HY05350 为全资子公司汇宇海玥自主研发的一种三特异抗体 TCE（T cell engager）产品，其以 CD3、MSLN、PD-L1 为靶点，注册分类为 1 类创新型 治疗用生物制品。截至本公告披露日，国内外尚无同靶点产品获批上市。 研究表明，HY05350 可以通过 CD3 抗体识别并招募 T 细胞，通过 MSLN 抗 药品名称：注射用 HY05350 注册分类：1 类创新型治疗 ...

Core Viewpoint - Huiyu Pharmaceutical's wholly-owned subsidiary, Huiyu Haiyue, has received approval from the National Medical Products Administration for the clinical trial of injection HY05350, aimed at treating advanced solid tumors, marking a significant milestone in the company's development of innovative therapies [1] Group 1 - The clinical trial approval is for injection HY05350, which is a self-developed tri-specific antibody TCE product targeting CD3, MSLN, and PD-L1 [1] - HY05350 is classified as a Class 1 innovative therapeutic biological product, indicating its potential as a novel treatment option [1] - As of the announcement date, there are no approved products targeting the same antigens in both domestic and international markets, highlighting the uniqueness of HY05350 [1]

汇宇制药公告，子公司Seacross Pharma(Europe)Ltd.近期收到意大利国家药品和保健品安全局和荷兰健康 产品监管局分别核准签发的公司产品注射用替考拉宁的上市许可。注射用替考拉宁主要用于治疗成人及 儿童的肠外感染，例如复杂的皮肤和软组织感染、骨骼和关节感染、获得性肺炎、尿路感染并发症、感 染性心内膜炎、持续性流动腹膜透析相关的腹膜炎，以及与上述症状相关的菌血症。该产品亦可用于治 疗梭状芽胞杆菌相关的腹泻以及结肠炎。 ...

Group 1 - The core point of the news is that Huang Qianyi, a shareholder holding over 5% of Huayu Pharmaceutical, has had 27.22 million shares frozen due to a private lending dispute with Jin Zuping, which represents 6.426% of the company's total share capital [1] - The court has not yet heard the case regarding the asset preservation application filed by Jin Zuping [1] - On March 31, Huayu Pharmaceutical announced that Huang Qianyi intended to reduce his holdings by up to 12.7 million shares, not exceeding 3% of the total shares, due to personal funding needs [3] Group 2 - Huayu Pharmaceutical, established in 2010 and located in Sichuan Neijiang, is a research-driven comprehensive pharmaceutical company focused on the R&D, production, and sales of anti-tumor drugs and injectables [3] - The company was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on September 29, 2021, with Ding Zhaowei as the actual controller [3] - For the period from January to March 2025, Huayu Pharmaceutical reported revenue of 239 million yuan, a year-on-year decrease of 1.46%, and a net loss attributable to shareholders of 25.63 million yuan, a year-on-year decrease of 155.19% [3] - As of the close on the 25th, Huayu Pharmaceutical's stock price was 16.51 yuan per share, down 3.05%, with a total market capitalization of 6.994 billion yuan [3]

Core Viewpoint - The announcement details the freezing of 27,219,439 shares held by shareholder Huang Qianyi, which accounts for 6.426% of the total share capital of Sichuan Huiyu Pharmaceutical Co., Ltd. The freezing is due to a civil loan dispute with Jin Zuping, and it will not affect the company's control or operations [1][2]. Summary by Sections Shareholder Information - Huang Qianyi is not a controlling shareholder or actual controller of the company, and the frozen shares will not lead to a change in control [1][2]. - The frozen shares represent 100% of Huang Qianyi's holdings in the company [1]. Frozen Shares Details - The shares were frozen by the Hangzhou Binjiang District People's Court starting from June 20, 2025, until June 20, 2028 [1]. - The total number of shares frozen is 27,219,439, which is 6.426% of the company's total share capital [1]. Reason for Freezing - The freezing of shares is a result of a property preservation application made by Jin Zuping due to a civil loan dispute with Huang Qianyi [1]. - As of the announcement date, the case has not yet been heard in court [1].

证券代码：688553 证券简称：汇宇制药 公告编号：2025-049 四川汇宇制药股份有限公司 持股 5%以上股东股份被冻结的公告 | | | 二、股东股份累计被冻结情况 截至公告披露日，上述股东及其一致行动人累计被冻结股份情况如下： | 股东名称 | 持 | 股 | 数 | 量 | 持股比例 | 累计被冻结 | 占其所持股 | 占公司总股 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | （股） | | | | | 数量（股） | 份比例 | 本比例 | | 黄乾益 | 27,219,439 | | | | 6.426% | 27,219,439 | 100% | 6.426% | 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、准确性和完整性依法承担法律责任。 重要内容提示： 公司于 2025 年 6 月 20 日收到股东黄乾益先生的《关于股份被冻结的告知函》， 获悉股东黄乾益先生持有公司的 27,219,439 股股份被浙江省杭州市滨江区人民 法院司法冻结，具体情况如下： 股 ...

证券代码：688553 证券简称：汇宇制药 公告编号：2025-048 四川汇宇制药股份有限公司 关于自愿披露注射用 HY0001a 获得药物临床试验批准 通知书的公告 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、准确性和完整性依法承担法律责任。 近日，四川汇宇制药股份有限公司（以下简称"公司"）全资子公司四川汇 宇海玥医药科技有限公司（以下简称"汇宇海玥"）收到国家药品监督管理局核 准签发的《药物临床试验批准通知书》，生物创新药注射用 HY0001a（项目研 发代号为"HY-0001"）用于治疗晚期实体瘤的临床试验获得批准。现将相关情 况公告如下： 一、药品基本情况 药品名称：注射用 HY0001a 注册分类：1 类创新型治疗用生物制品 申请事项：境内生产药品注册临床试验 受理号：CXSL2500294 适应症：用于治疗晚期实体瘤。 申请人：四川汇宇海玥医药科技有限公司 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，2025 年 4 月 11 日受理的注射用 HY0001a 临床试验申请符合药品注册的有关要求，同 意本品开展晚期实体瘤 ...

Core Viewpoint - Huiyu Pharmaceutical's subsidiary Huiyu Haiyue has received approval from the National Medical Products Administration for clinical trials of its innovative drug HY0001a, aimed at treating advanced solid tumors, marking a significant milestone in the company's research and development efforts [1] Group 1 - The clinical trial approval is for the injectable HY0001a, which is an antibody-drug conjugate developed independently by the company [1] - HY0001a is classified as a Class 1 innovative therapeutic biological product [1] - As of the announcement date, there are no approved products targeting the same site in both domestic and international markets, making this the first drug globally to enter clinical trials for this target [1]