（编辑 姚尧） 证券日报网讯 11月26日晚间，西高院发布公告称，西安高压电器研究院股份有限公司（以下简称"公 司"）于近日收到保荐机构中国国际金融股份有限公司（以下简称"中金公司"）出具的《关于变更西安 高压电器研究院股份有限公司首次公开发行A股股票项目持续督导保荐代表人的说明》。中金公司系公 司首次公开发行股票并在科创板上市的保荐机构，原委派持续督导的保荐代表人为佟妍女士、贾义真先 生。现因佟妍女士工作变动，不再继续担任公司持续督导的保荐代表人，为保证持续督导工作的有序进 行，中金公司委派湛政杰先生接替佟妍女士担任公司的持续督导保荐代表人，继续履行持续督导职责。 ...

据悉，HP518片与海创药业已成功实现商业化落地的第二代AR抑制剂氘恩扎鲁胺(海纳安)形成差异化组 合矩阵，前者聚焦AR降解，后者专注AR信号阻断。 与传统AR抑制剂仅能抑制受体活性的作用模式不同，HP518片可更高效地阻断AR通路，为前列腺癌患 者提供了下一代治疗方案的核心解决路径。公告显示，HP518已完成在澳大利亚和中国的Ⅰ期临床研 究，另中国Ⅱ期临床试验已完成全部参与者入组。 作为国内首款获批上市治疗该适应症的国产创新药物，氘恩扎鲁胺软胶囊相较于其他新型内分泌药物， 在安全性方面表现优异，可显著降低中枢神经系统不良事件(如癫痫、跌倒等)发生率，且无皮疹相关不 良反应，同时减少老年患者常见并发症风险该药品有望在进入医保后，惠及更多前列腺癌患者。据沙利 文预测，2030年中国前列腺癌市场规模将达500亿元。 本报讯(记者蒙婷婷)11月24日晚间，海创药业股份有限公司(简称"海创药业")发布公告称，公司自主研 发的新一代AR(雄激素受体)靶向蛋白降解剂HP518片联合抗肿瘤药物开展用于治疗晚期前列腺癌的Ⅰb/ Ⅱ期临床试验获中国国家药品监督管理局药品审评中心批准。 ...

公告显示，截至目前，HP518片已分别于中国、澳大利亚和美国三个国家获批开展用于晚期前列腺癌的 临床试验。目前国内外暂无同类产品获批上市。 北京商报讯（记者 丁宁）11月24日晚间，海创药业（688302）发布公告称，公司收到中国国家药品监 督管理局药品审评中心核准签发的《药物临床试验批准通知书》，同意HP518片联合抗肿瘤药物开展用 于治疗晚期前列腺癌的Ⅰb/Ⅱ期临床试验。 ...

Group 1 - Huafeng Co., Ltd. announced a stock suspension due to a potential change in control after signing a share transfer intention agreement [1] - Keshida plans to reduce its shareholding by up to 424,000 shares, representing 0.07% of its total share capital [1] - Jinqilin intends to distribute a cash dividend of 0.10 yuan per share, totaling 19.61 million yuan [1] Group 2 - Rejingshi Biotech has repurchased 904,100 shares, accounting for 0.98% of its total share capital, with a total expenditure of 150 million yuan [2] - Yishitong has repurchased 1,236,500 shares, representing 0.619% of its total share capital, with a total expenditure of approximately 33.49 million yuan [2] Group 3 - Hanjia Design announced the release of a detention on its subsidiary's chairman, allowing him to resume duties [4] - Qingmu Technology plans to acquire 65.83% of Vitalis Pharma AS for 300 million Norwegian Krone (approximately 212 million yuan) [4] - Anda Intelligent's shareholder plans to reduce its stake by up to 2.74% [4] Group 4 - Wansheng Intelligent is a candidate for a project with a pre-bid amount of approximately 42.99 million yuan, representing 4.56% of its audited revenue for 2024 [4] - Yipin Hong received a drug registration certificate for a medication used to treat Alzheimer's symptoms [4] Group 5 - *ST Sansheng received a total of 254 million yuan from restructuring investors [4] - Haichuang Pharmaceutical received approval for clinical trials of HP518 tablets for advanced prostate cancer treatment [4] Group 6 - Ningbo Huaxiang's subsidiary plans to invest 5 million yuan in a venture capital fund focusing on intelligent industries [4] - Petty Co. plans to repurchase shares worth 50 to 70 million yuan [4] Group 7 - Tongji Technology's subsidiary won a construction project with a bid price of 866 million yuan [4] - Prolo Pharmaceutical received a drug registration certificate for a generic drug [4] Group 8 - Jingyan Technology plans to use up to 1.6 billion yuan of idle funds for financial management [4] - Furan De received government subsidies totaling 34.65 million yuan [4] Group 9 - David Medical's subsidiary's medical device registration has been accepted [4] - Jusaylong plans to increase its subsidiary's capital by 170 million yuan through debt-to-equity conversion [4] Group 10 - Heng Rui Pharmaceutical's application for a drug license has been accepted by the National Medical Products Administration [4] - Lege Co. plans to increase its stake in the company by 40 to 80 million yuan [4] Group 11 - New Beiyang's subsidiary won a project with the Bank of Communications [4] - Jiangxi Changyun plans to publicly transfer land use rights and buildings with a starting price of 7.79 million yuan [4] Group 12 - Shenqi Pharmaceutical's subsidiary has paid approximately 16.67 million yuan in tax and penalties [4] - Panjiang Co. plans to invest 1.334 billion yuan in a power plant project [4] Group 13 - Fashilong's vice president resigned for personal reasons [4] - Chunxue Food received government subsidies of 3.79 million yuan [4] Group 14 - China Galaxy completed the repayment of a short-term financing bond totaling 3.025 billion yuan [4] - Jiuzhou Pharmaceutical received approval for a chemical raw material drug [4] Group 15 - Longqi Technology's subsidiary plans to invest 30 million yuan in a venture capital fund [4]

证券代码：688302 证券简称：海创药业 公告编号：2025-050 海创药业股份有限公司 自愿披露关于口服 PROTAC 药物 HP518 片联合抗肿瘤药物 治疗晚期前列腺癌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。 重要内容提示： 近日，海创药业股份有限公司（以下简称"公司"）收到中国国家药品监督管 理局药品审评中心核准签发的《药物临床试验批准通知书》，同意 HP518 片联合抗肿 瘤药物开展用于治疗晚期前列腺癌的Ⅰb/Ⅱ期临床试验。截至目前，HP518 片已分 别于中国、澳大利亚和美国三个国家获批开展用于晚期前列腺癌的临床试验。目前 国内外暂无同类产品获批上市。 现将相关情况公告如下： | 药品名称 | HP518 片 | | --- | --- | | 剂型 | 片剂 | | 申请事项 | 境内生产药品注册临床试验 | | 申请人 | 海创药业股份有限公司 | 一、 药品基本情况 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 9 月 4 日受理的 ...

HP518由靶蛋白配体、E3连接酶配体及连接子构成，通过诱导AR泛素化并依赖蛋白酶体降解AR蛋白， 从而实现对AR信号通路的深度抑制，达到抗肿瘤的目的。其具有PROTAC类药物的典型优势，包括催 化性、高选择性及良好安全性。HP518片作为新型PROTAC口服药物，已有临床前研究结果显示， HP518片对耐药的AR突变体及野生型AR蛋白均具有高降解活性，并对AR依赖的前列腺癌细胞具有优异 的抑癌活性，有望克服前列腺癌治疗中由突变引起的耐药问题，可为该群体患者提供新的治疗手段。 海创药业(688302.SH)发布公告，近日，公司收到中国国家药品监督管理局药品审评中心核准签发的 《药物临床试验批准通知书》，同意HP518片联合抗肿瘤药物开展用于治疗晚期前列腺癌的Ⅰb/Ⅱ期临 床试验。截至目前，HP518片已分别于中国、澳大利亚和美国三个国家获批开展用于晚期前列腺癌的临 床试验。目前国内外暂无同类产品获批上市。 ...

HP518由靶蛋白配体、E3连接酶配体及连接子构成，通过诱导AR泛素化并依赖蛋白酶体降解AR蛋白， 从而实现对AR信号通路的深度抑制，达到抗肿瘤的目的。其具有PROTAC类药物的典型优势，包括催 化性、高选择性及良好安全性。HP518片作为新型PROTAC口服药物，已有临床前研究结果显示， HP518片对耐药的AR突变体及野生型AR蛋白均具有高降解活性，并对AR依赖的前列腺癌细胞具有优异 的抑癌活性，有望克服前列腺癌治疗中由突变引起的耐药问题，可为该群体患者提供新的治疗手段。 智通财经APP讯，海创药业(688302.SH)发布公告，近日，公司收到中国国家药品监督管理局药品审评 中心核准签发的《药物临床试验批准通知书》，同意HP518片联合抗肿瘤药物开展用于治疗晚期前列腺 癌的Ⅰb/Ⅱ期临床试验。截至目前，HP518片已分别于中国、澳大利亚和美国三个国家获批开展用于晚 期前列腺癌的临床试验。目前国内外暂无同类产品获批上市。 ...

证券代码：688302 证券简称：海创药业 公告编号：2025- 050 海创药业股份有限公司 自愿披露关于口服 PROTAC 药物 HP518 片联合抗肿瘤药物 治疗晚期前列腺癌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。 一、 药品基本情况 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 9 月 4 日受理的 HP518 片临床试验申请符合药品注册的有关要求，同意其联合抗肿 瘤药物开展用于治疗晚期前列腺癌的Ⅰb/Ⅱ期临床试验。 二、 药品其他情况 HP518 是公司基于蛋白降解靶向联合体（Proteolysis Targeting Chimera， PROTAC）核心技术平台自主研发的口服靶向降解雄激素受体（Androgen receptor, AR）的 PROTAC 药物，拟联合抗肿瘤药物治疗晚期前列腺癌。 HP518 由靶蛋白配体、E3 连接酶配体及连接子构成，通过诱导 AR 泛素化并依赖 蛋白酶体降解 AR 蛋白，从而实现对 AR 信号通路的深度抑制 ...

Investment Rating - The report maintains an investment rating of "Outperform" with a rating of A [7] Core Insights - The report highlights significant advancements in small nucleic acid drugs for the treatment of hepatitis B, particularly the promising data from the drug AHB-137 presented at the AASLD 2025 conference, indicating its potential as the best small nucleic acid drug for hepatitis B [3][22] Summary by Sections Weekly New Drug Market Review - From November 17 to November 23, 2025, the top five gainers in the new drug sector were: - LaiKai Pharmaceutical (+13.34%) - Beihai Kangcheng (+2.67%) - Jiahe Biotech (+2.19%) - Yongtai Biotech (+1.94%) - Youzhi You (+1.14%) - The top five losers were: - WuXi AppTec (-15.75%) - Adi Pharma (-14.56%) - Mengke Pharma (-14.34%) - Yiming Oncology (-13.40%) - Kain Technology (-13.04%) [1][16] Weekly Focused Investment Targets - The report suggests focusing on several promising targets due to upcoming catalysts, including: 1. Products with high certainty for overseas expansion certified by MNCs: Sanofi, Federated Pharmaceuticals, and Kelun-Botai 2. Products with overseas data catalysts: Betta Pharmaceuticals, Hutchison China MediTech, and Yiming Biotech 3. Potential blockbuster products for overseas licensing by MNCs: Fuhong Hanlin, CSPC Pharmaceutical Group, and Yifang Biotech 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat reduction and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][20] Weekly New Drug Industry Analysis - The report emphasizes the breakthrough data for small nucleic acid drugs in treating hepatitis B, particularly the two-phase follow-up data for AHB-137, which shows a high potential for becoming the leading small nucleic acid drug in this field [3][22] Weekly New Drug Approval & Acceptance Status - No new drug or new indication approvals were reported this week, but six new drug or new indication applications were accepted [4][24] Weekly New Drug Clinical Application Approval & Acceptance Status - This week, 42 new drug clinical applications were approved, and 44 new drug clinical applications were accepted [5][26] Domestic Market Key Events TOP3 - Key events included: 1. Zean Biopharma's strategic collaboration with GSK to develop up to four "first-in-class" candidates in oncology [11] 2. Innovent Biologics announcing successful Phase III clinical study results for a drug in moderate to severe obesity [11] 3. Fuhong Hanlin's FDA approval for a biosimilar product [11] Overseas Market Key Events TOP3 - Key events included: 1. Merck's presentation of key Phase III trial results at the AHA Scientific Sessions [12] 2. Johnson & Johnson's acquisition of Halda Therapeutics for $3.05 billion [12] 3. The EMA's recommendation for the approval of a gene therapy product [12]

Core Insights - In 2024, China approved 48 innovative drugs for market entry, ranking second globally, just behind the United States with 50 approvals. In the first half of this year, the National Medical Products Administration approved 43 innovative drugs, marking a 59% year-on-year increase [1] Policy Guidance - Beijing has implemented a series of pioneering reforms in the pharmaceutical and health sector, including the establishment of green channels for rare disease drug approvals and optimizing clinical trial reviews. These measures aim to create a favorable environment for high-quality industry development [2] - The Beijing Municipal Science and Technology Commission has introduced 32 new measures to support the high-quality development of innovative pharmaceuticals and medical devices [2] - Chengdu has also rolled out specific policies to support the biopharmaceutical industry, focusing on drug and device R&D innovation and enhancing clinical research quality [2] Innovation Ecosystem - Chengdu's Tianfu International Biotech City is a key hub for the biopharmaceutical industry, housing 108 clinical research drugs, including 63 in clinical stages. The "Wutong Plan" launched by Chengdu High-tech Zone offers a comprehensive service list for the pharmaceutical health industry [3] - Jiangsu province has established a robust innovation ecosystem, exemplified by the production of the world's first dual-target weight-loss drug, which was approved in just 16 months [4] Comprehensive Innovation Efforts - Jiangsu has concentrated resources in policy, funding, and talent to strengthen its innovative platforms and tackle key technological challenges in the biopharmaceutical sector [5][6] - The National Biopharmaceutical Technology Innovation Center is focusing on critical technology R&D and public platform construction, with 66 projects already initiated [6] Capital Support - The capital market is increasingly supporting innovative drug development, with Beijing's Changping District establishing a multi-faceted investment framework, including a 200 billion yuan pharmaceutical investment fund [7] - The Zhongguancun Life Science Park in Changping has become a hub for cell and gene therapy, with over 20 companies advancing their products into clinical research [7] - Jiangsu's Shengsheng Biopharmaceutical Co. has committed to significant R&D investments, increasing its budget from 20 billion yuan in the first five years to nearly 80 billion yuan in the subsequent five years [7] Industry Layout - Under the dual support of policies and funding, various regions are accelerating their focus on cutting-edge fields, enhancing both the innovation and industrial chains [8] - The Suzhou Biopharmaceutical Industrial Park has gathered over 620 innovative pharmaceutical companies and more than 35,000 R&D talents, establishing a strong foundation for drug development and high-end medical devices [8]