证券代码：688553 证券简称：汇宇制药 公告编号：2025-091 四川汇宇制药股份有限公司 自愿披露 HYP-6589 片联合用药获得药物临床试验申请 受理通知书的公告 受理号：CXHL2501288；CXHL2501289； 适应症：拟用于与奥希替尼联合治疗靶点驱动基因阳性的晚期非小细胞肺癌。 申请人：四川汇宇海玥医药科技有限公司 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 二、本次药品新增联合用药的情况 HYP-6589 片是公司全资子公司汇宇海玥开发的高选择性 SOS1 小分子抑制 剂，其注册分类为化学药 1 类创新药。根据国家药品监督管理局发布的《化学药 品注册分类及申报资料要求》（2020 年第 44 号），HYP-6589 为新的结构明确 的，具有药理作用的化合物，公司已获批并正在中国开展单药治疗晚期实体瘤的 临床研究。具体详见公司于 2024 年 11 月 8 日刊登在上海证券交易所网站 （www.sse.com.cn）上的《关于自愿披露 HYP-6589 片获得药物临床试验批准通 知书的公告》（公告编号：2024-105）。 本公司董事会及全体董 ...

Core Viewpoint - Huiyu Pharmaceutical (688553) announced that its wholly-owned subsidiary, Huiyu Haiyue, received a notice of acceptance from the National Medical Products Administration for the clinical trial application of HYP-6589 tablets in combination with Osimertinib for the treatment of advanced non-small cell lung cancer with target-driven gene positivity, marking a significant step in the development of this innovative drug [1] Company Summary - Huiyu Pharmaceutical's HYP-6589 is classified as a Category 1 innovative chemical drug, indicating its novel nature in the pharmaceutical market [1] - There are currently no similar products approved for sale domestically or internationally, highlighting the potential market opportunity for HYP-6589 [1]

Core Insights - HYP-6589, a selective SOS1 small molecule inhibitor developed by the company's subsidiary, has received acceptance for clinical trial application in combination with Osimertinib for treating advanced non-small cell lung cancer with target-driven gene positivity [1][2] - The drug is classified as a Class 1 innovative chemical drug and is currently undergoing clinical research for monotherapy in advanced solid tumors in China [1] - There are no similar products approved for market in both domestic and international markets as of the announcement date [1] Group 1 - HYP-6589 has received the acceptance notice from the National Medical Products Administration for clinical trials [1] - The drug is designed to enhance the efficacy of Osimertinib and potentially overcome resistance mechanisms associated with it [2] - Preclinical studies indicate that the combination of SOS1 inhibitors and Osimertinib can achieve deeper and more sustained inhibition of MAPK and PI3K signaling pathways [2] Group 2 - SOS1 is a crucial regulator in the RTK-RAS signaling pathway, which is activated by receptor tyrosine kinases [2] - The activation of SOS1 leads to the formation of RAS-GTP, which is essential for downstream signaling pathways [2] - Inhibition of SOS1 has shown potential to address unmet clinical needs in the context of Osimertinib resistance [2]

Core Viewpoint - The company Huayu Pharmaceutical (688553.SH) announced that its wholly-owned subsidiary Sichuan Huayu Haiyue Pharmaceutical Technology Co., Ltd. received a notice from the National Medical Products Administration for the clinical trial application of HYP-6589 tablets in combination with Osimertinib for the treatment of advanced non-small cell lung cancer with target-driven gene positivity [1] Group 1 - HYP-6589 tablets are a highly selective SOS1 small molecule inhibitor developed by the company's subsidiary, classified as a Class 1 innovative chemical drug [1] - The drug has been approved for clinical research in China for monotherapy in advanced solid tumors [1] - The new application for clinical trials in combination with Osimertinib for advanced non-small cell lung cancer has been accepted, with no similar products approved for marketing domestically or internationally as of the announcement date [1]

Core Viewpoint - The announcement indicates that Huiyu Pharmaceutical's wholly-owned subsidiary, Huiyu Haiyue, has received approval from the National Medical Products Administration for a clinical trial application involving HYP-6589 tablets in combination with Osimertinib for treating advanced non-small cell lung cancer with target-driven gene positivity [1] Group 1 - Huiyu Haiyue received the acceptance notice for the clinical trial application on November 21, 2025 [1] - The drug HYP-6589, also known by its research and development code "HY-0006," is intended for use in conjunction with Osimertinib [1] - The focus of the clinical trial is on advanced non-small cell lung cancer that is positive for target-driven genes [1]

Group 1 - Kanglongda's shareholder plans to reduce holdings by up to 3% of the company's shares, totaling no more than 4.83 million shares [1] - The company specializes in the research, production, and sales of special and ordinary labor protection gloves [1] Group 2 - Haizheng Pharmaceutical's subsidiary plans to collaborate with East China Institute on a biological method for synthesizing heparin, with a project contract amount not exceeding 120 million yuan [2] - The company focuses on the research, production, and sales of chemical raw materials and formulations [3] Group 3 - Tianyin Holdings received approval from the China Securities Regulatory Commission for a stock issuance to specific investors [4] - The company is engaged in the sales of smart terminals, e-commerce, lottery, mobile resale, and mobile internet businesses [4] Group 4 - Shanghai Yashi plans to use up to 200 million yuan of temporarily idle raised funds for cash management in high-security, liquid deposit products [5] - The company specializes in supply chain logistics and execution trade [6] Group 5 - Parker New Materials intends to use 130 million yuan of idle raised funds to purchase structured deposits with expected annual yields between 0.59% and 2.9001% [7] - The company focuses on the research, production, and sales of various types of ring forgings, free forgings, and die forgings [7] Group 6 - Huayang New Materials appointed Jing Hongsheng as the new general manager [8] Group 7 - Liyuan Technology's shareholder plans to reduce holdings by up to 2.03% of the company's shares, totaling no more than 3.04 million shares [9] - The company specializes in the research, design, and integration of environmental water treatment systems and hydrogen fuel cell engine systems [9] Group 8 - Shengnuo Biopharmaceutical's subsidiary received approval for the listing application of Visepegenatide raw materials, a GLP-1 receptor agonist for treating type 2 diabetes and obesity [10][11] - The company focuses on the research, production, and sales of peptide raw materials and formulations [10] Group 9 - Puluo Pharmaceutical plans to repurchase shares worth between 180 million and 360 million yuan, with a maximum price of 23 yuan per share [12] - The company specializes in the research, production, and sales of raw material intermediates and innovative drugs [12] Group 10 - Dongfang Electric's subsidiary plans to establish a joint venture with Anhui Waneng Energy, with a registered capital of approximately 1.857 billion yuan [13] - The company is involved in the development, design, manufacturing, and sales of advanced power generation equipment [13] Group 11 - Hefei China announced that its stock will resume trading on November 20 after completing a review of abnormal trading fluctuations [14] - The company focuses on international trade and after-sales services related to in vitro diagnostic medical devices [14] Group 12 - Dafeng Industrial won a bid for the stage equipment project of the Shenzhen International Performing Arts Center, with a contract amount of 165 million yuan [15] - The company specializes in cultural sports equipment, digital art technology, and operation services [15] Group 13 - Baiyunshan's subsidiary received a drug registration certificate for An Gong Niu Huang Wan in Vietnam [16] - The company is engaged in the research, manufacturing, and sales of traditional Chinese and Western medicines [16] Group 14 - Neusoft Group received a notification to supply intelligent cockpit domain controllers for multiple models from a well-known domestic automobile manufacturer, with an estimated total amount of about 4.2 billion yuan [17] - The company focuses on providing industry solutions and software products [17] Group 15 - Huayu Pharmaceutical's product received overseas marketing approval [18] - The company specializes in the research, production, and sales of innovative and high-quality generic drugs in the oncology field [18] Group 16 - Yao Pi Glass received approval from the CSRC for its stock issuance to specific investors [19] - The company specializes in the production and sales of float glass and processed glass [19] Group 17 - Guangyu Yuan's vice president Wang Junbo resigned due to work adjustments [20] - The company focuses on the production and sales of traditional Chinese medicine products [20] Group 18 - Biyi Co. received approval from the CSRC for its stock issuance to specific investors [21] - The company specializes in the design, manufacturing, and sales of smart small household appliances [21] Group 19 - Sunshine Nuohe's application for acquiring 100% equity of Jiangsu Langyan Life Science Technology Co., Ltd. through share issuance and convertible bonds has been accepted by the Shanghai Stock Exchange [22] - The company provides comprehensive drug research and development services for domestic pharmaceutical enterprises and research institutions [22] Group 20 - Longxin General plans to increase capital in its wholly-owned subsidiary by no more than 1.65 billion yuan [23] - The company specializes in the research, production, and sales of motorcycles and engines [23] Group 21 - Jiekang Equipment received a corrective order from the Tianjin Securities Regulatory Bureau due to internal control deficiencies [24] - The company specializes in the research, production, and sales of nuclear biochemical safety equipment [24] Group 22 - Wantong Technology plans to raise no more than 920 million yuan through a private placement to supplement working capital [25] - The company focuses on information technology services for highways and ports [25] Group 23 - Dongshan Precision has submitted an application for H-share listing to the Hong Kong Stock Exchange [26] - The company specializes in the research, production, and sales of electronic circuit products and precision components [26] Group 24 - Yonghe Intelligent Control plans to publicly transfer 100% equity of its wholly-owned subsidiary Kunming Medical Oncology Hospital [27] - The company specializes in water and heating valve fittings, tumor precision radiation therapy, and photovoltaic battery businesses [27] Group 25 - Aok Shares signed a strategic cooperation framework agreement with Suzhou Qitian New Materials Co., Ltd. [28] - The company focuses on the research and production of high-end new materials derived from ethylene oxide and ethylene [28] Group 26 - Hongquan Technology's shareholder plans to reduce holdings by up to 3% of the company's shares, totaling no more than 299,440 shares [29] - The company specializes in the research, production, and sales of intelligent connected products and software platform development [29] Group 27 - Shilong Industrial's controlling shareholder plans to reduce holdings by up to 3% of the company's shares, totaling no more than 7.2 million shares [30] - The company specializes in the research, production, and sales of chemical products [30] Group 28 - Tangrenshen decided to terminate the investment in the "Dongchong Phase III Pig Breeding Base Construction Project," reallocating the remaining funds of 78.9587 million yuan to supplement working capital [31] - The company specializes in the research, production, and sales of feed, pigs, meat products, and animal health products [31] Group 29 - Gaode Infrared's actual controller plans to reduce holdings by up to 3% of the company's shares, totaling no more than 12.8 million shares [32] - The company specializes in infrared focal plane detector chips and infrared thermal imaging systems [32] Group 30 - Kangyuan Pharmaceutical's actual controller recently increased holdings by 20,000 shares [33] - The company specializes in the research, production, and sales of pharmaceuticals [33] Group 31 - Haida Group plans to repurchase shares worth between 1 billion and 1.6 billion yuan, with a maximum price of 62.00 yuan per share [34] - The company provides overall solutions for animal husbandry [34] Group 32 - Qizhong Technology's 850 million yuan convertible bonds have been approved for listing [35] - The company specializes in advanced packaging and testing of integrated circuits [35] Group 33 - Dingyang Technology launched the new SNA5000B series vector network analyzer [36] - The company specializes in the research, production, and sales of general electronic testing and measuring instruments [36] Group 34 - Airo Energy plans to distribute a cash dividend of 0.9375 yuan per share to all shareholders [37] - The company specializes in photovoltaic energy storage systems and products [37] Group 35 - Hechuan Technology's actual controller and some directors plan to reduce holdings by up to 6% of the company's shares [38] - The company specializes in the research, production, and sales of industrial automation products [38] Group 36 - China First Heavy Industries' chairman was arrested for suspected bribery [39] - The company specializes in heavy machinery manufacturing for various industries [39] Group 37 - Lianhuan Pharmaceutical plans to invest 15 million yuan in joint research with Nanjing University for anti-thrombotic small nucleic acid drugs [40] - The company specializes in the manufacturing and sales of chemical raw materials [40] Group 38 - Anxu Biotech's shareholder plans to reduce holdings by up to 0.94% of the company's shares, totaling no more than 120,000 shares [41] - The company specializes in the research, production, and sales of POCT reagents and instruments [41] Group 39 - Yaxiang Integration's shareholder reduced holdings by 130,000 shares [42] - The company specializes in providing cleanroom engineering and related services for high-tech electronic industries [42] Group 40 - Zhongwen Media plans to use up to 9.5 billion yuan of idle funds to purchase financial products [43] - The company specializes in traditional publishing and various new media businesses [43]

Core Viewpoint - Huyou Pharmaceutical (688553.SH) has experienced a significant decline in stock price, closing at 20.60 yuan with a drop of 5.24%, indicating a state of breaking down [1]. Group 1: Company Overview - Huyou Pharmaceutical was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on October 26, 2021, with an initial public offering of 63.6 million shares at a price of 38.87 yuan per share [1]. - On the first day of trading, the stock reached a peak price of 42.59 yuan, marking the highest point since its listing [2]. Group 2: Fundraising and Financials - The total amount raised from the IPO was 2.472 billion yuan, with a net amount of 2.361 billion yuan after deducting issuance costs, which was 453 million yuan more than the original plan [2]. - The funds are intended for the construction of the Huyou EU Standard Injectable Drug Industrialization Base (Phase II), the Huyou Innovative Drug Research Institute, and to supplement working capital [2]. - The total issuance costs amounted to 111 million yuan, with underwriting fees to CITIC Securities and Guodu Securities totaling 98.875 million yuan [3].

格隆汇11月19日｜有投资者在互动平台向汇宇制药提问：相关媒体报道，公司在前段时间的进博会上， 与阿斯利康签订了战略合作框架协议。但公司在业绩说明会上表示，公司尚未与阿斯利康达成任何药物 研究合作。公司能具体说说双方之间的关系吗？ 汇宇制药回复称，公司与阿斯利康已签署战略合作框 架协议，该协议不涉及具体药物研究合作内容，不会对公司经营产生重大影响，该事项未达披露标准， 因此公司未进行披露。未来，公司期待与阿斯利康进行药物研究等更多合作，如后续合作预计将对公司 经营产生重大影响，公司将严格按照监管规定，及时履行信息披露义务并发布公告。 ...

中国经济网北京11月19日讯汇宇制药(688553.SH)今日收报20.60元，跌幅5.24%。目前该股处于破发状 态。 2021年10月26日，汇宇制药在上交所科创板上市，公开发行股票6360.00万股，发行价格为38.87元/股， 保荐机构、主承销商为中信建投（601066）证券，保荐代表人为杨泉、田斌，联席主承销商为国都证 券。 汇宇制药发行募集资金总额为24.72亿元，扣除发行费用后，募集资金净额为23.61亿元。汇宇制药最终 募集资金净额比原计划多4.53亿元。汇宇制药于2021年10月18日披露的招股书显示，公司拟募集资金 19.07亿元，分别用于汇宇欧盟标准注射剂产业化基地(二期)项目、汇宇创新药物研究院建设项目、补充 流动资金。 汇宇制药发行费用合计1.11亿元，其中中信建投证券、国都证券获得承销费9887.48万元。 上市当日，汇宇制药盘中最高报42.59元，创上市以来股价最高点。 ...

Market Overview - The chemical pharmaceutical sector experienced a decline of 1.44% on November 19, with Hainan Haiyao leading the drop [1] - The Shanghai Composite Index closed at 3946.74, up 0.18%, while the Shenzhen Component Index closed at 13080.09, unchanged [1] Stock Performance - Notable gainers in the chemical pharmaceutical sector included: - Shanhe Pharmaceutical (300452) with a closing price of 15.07, up 9.04% and a trading volume of 390,200 shares, totaling 586 million yuan [1] - ST Suhao (600200) closed at 1.02, up 5.15% with a trading volume of 429,200 shares [1] - ST Jingfeng (000908) closed at 66.8, up 5.02% with a trading volume of 354,800 shares [1] - Major decliners included: - Muan Nanhai (000566) with a closing price of 7.20, down 10.00% and a trading volume of 2,192,500 shares, totaling 1.625 billion yuan [2] - Sitaili (603520) closed at 10.66, down 6.74% with a trading volume of 315,600 shares [2] - Yatai Pharmaceutical (002370) closed at 7.79, down 6.59% with a trading volume of 1,044,700 shares [2] Capital Flow - The chemical pharmaceutical sector saw a net outflow of 2.278 billion yuan from institutional investors, while retail investors contributed a net inflow of 2.139 billion yuan [2] - The top stocks by net inflow from institutional investors included: - Changshan Pharmaceutical (300255) with a net inflow of 71.90 million yuan, accounting for 6.20% of total inflow [3] - Xingqi Eye Medicine (300573) with a net inflow of 70.33 million yuan, representing 12.29% [3] - Shanhe Pharmaceutical (300452) with a net inflow of 68.13 million yuan, making up 11.62% [3]