Core Points - The subsidiary of Fosun Pharma, Fuhong Hanlin, has received acceptance for the drug registration application of the biosimilar HLX14, a drug similar to Dexamethasone, by the National Medical Products Administration [1] - The application is classified as a Class 3.3 therapeutic biological product, with indications based on all approved indications of the reference drug Prolia in China [1] Product Information - HLX14 has been approved for marketing in the United States, European Union, and the United Kingdom, covering all indications of the original product [1] - The application for marketing registration was accepted by Health Canada in September 2024 [1] - Cumulative R&D investment is approximately 320 million yuan (unaudited) as of October 2025 [1] Market Outlook - According to IQVIA data, the global sales of Dexamethasone products are projected to be approximately 7.463 billion USD in 2024 [1]

Core Points - The Xi'an High Voltage Electrical Research Institute Co., Ltd. has received a notice from its sponsor, China International Capital Corporation (CICC), regarding a change in the representative responsible for ongoing supervision of its initial public offering (IPO) project [1] - The original supervising representatives were Ms. Tong Yan and Mr. Jia Yizhen, but due to Ms. Tong's job change, she will no longer serve in this role [1] - Mr. Zhan Zhengjie has been appointed to replace Ms. Tong and will continue to fulfill the duties of ongoing supervision [1]

Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration of China for its new generation androgen receptor (AR) targeted protein degrader HP518 tablets, which will be used in a Phase Ib/II clinical trial for advanced prostate cancer treatment [1] Group 1: Product Development - HP518 tablets offer a more efficient mechanism to block the AR pathway compared to traditional AR inhibitors, providing a core solution for next-generation treatment options for prostate cancer patients [1] - The Phase I clinical studies for HP518 have been completed in Australia and China, and the Phase II clinical trial in China has successfully enrolled all participants [1] Group 2: Market Positioning - HP518 tablets are positioned alongside Haichuang's commercially successful second-generation AR inhibitor, Dihydrotestosterone Enzalutamide (Hainan An), creating a differentiated combination matrix where HP518 focuses on AR degradation while Hainan An targets AR signal blockade [1] - Dihydrotestosterone Enzalutamide soft capsules are the first domestically approved innovative drug for this indication, demonstrating superior safety by significantly reducing the incidence of central nervous system adverse events and common complications in elderly patients [1] Group 3: Market Potential - The drug is expected to benefit more prostate cancer patients once it enters the medical insurance system, with projections indicating that the prostate cancer market in China could reach 50 billion yuan by 2030 [1]

Core Viewpoint - Haichuang Pharmaceutical has received approval from the National Medical Products Administration of China for clinical trials of HP518 tablets in combination with anti-tumor drugs for the treatment of advanced prostate cancer [1] Group 1: Company Developments - The company announced the approval of the clinical trial for HP518 tablets, which will be conducted in China, Australia, and the United States [1] - Currently, there are no similar products approved for market release in both domestic and international markets [1]

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 ...

Core Viewpoint - Haichuang Pharmaceutical (688302.SH) has received approval from the National Medical Products Administration of China for clinical trials of HP518 tablets in combination with anti-tumor drugs for the treatment of advanced prostate cancer, marking a significant step in the development of innovative cancer therapies [1] Group 1: Clinical Trial Approval - The company has been granted a Clinical Trial Approval Notice for HP518 tablets to conduct Phase Ib/II clinical trials for advanced prostate cancer [1] - HP518 has also received approval for clinical trials in China, Australia, and the United States, with no similar products currently approved for market [1] Group 2: Drug Mechanism and Advantages - HP518 is composed of a target protein ligand, an E3 ligase ligand, and a linker, which induces the ubiquitination of the androgen receptor (AR) and relies on proteasomal degradation to deeply inhibit the AR signaling pathway, achieving anti-tumor effects [1] - As a new oral PROTAC drug, HP518 exhibits typical advantages such as catalytic activity, high selectivity, and good safety profile [1] Group 3: Efficacy and Potential - Preclinical studies have shown that HP518 has high degradation activity against both resistant AR mutants and wild-type AR proteins, demonstrating excellent anti-cancer activity against AR-dependent prostate cancer cells [1] - The drug is expected to address resistance issues caused by mutations in prostate cancer treatment, providing new therapeutic options for this patient population [1]

Core Viewpoint - Haichuang Pharmaceutical (688302.SH) has received approval from the National Medical Products Administration of China for clinical trials of HP518 tablets in combination with anti-tumor drugs for the treatment of advanced prostate cancer, marking a significant step in the development of innovative cancer therapies [1] Company Summary - HP518 tablets have been approved for clinical trials in China, Australia, and the United States for advanced prostate cancer, with no similar products currently approved for market [1] - The drug is composed of a target protein ligand, an E3 ligase ligand, and a linker, which induces the ubiquitination of the androgen receptor (AR) and relies on proteasomal degradation to deeply inhibit the AR signaling pathway, achieving anti-tumor effects [1] - As a novel PROTAC oral drug, HP518 has shown high degradation activity against both resistant AR mutants and wild-type AR proteins in preclinical studies, demonstrating excellent anti-cancer activity against AR-dependent prostate cancer cells [1] Industry Summary - The approval of HP518 tablets represents a potential breakthrough in addressing treatment resistance caused by mutations in prostate cancer, providing new therapeutic options for patients [1]

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]