黄果指出，国家药监局高度重视集采药品的质量监管，在各方持续努力下，生产供应质量整体稳定可 控。黄果强调，要充分认识保障集采中选药品质量安全的重要性，中选企业要严格落实主体责任，加强 质量控制、药物警戒和信息化追溯等工作，持续合规生产；监管部门将继续实行中选药品生产检查和产 品抽检两个"全覆盖"，并不断优化工作机制，探索开展风险监测等工作，前移监管触角，防范化解风 险，坚决查处违法违规生产经营行为。 这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 黄果在北京调研集采中选药品质量监管工作 11月18日，国家药监局党组成员、副局长黄果在北京市调研集采中选药品质量监管工作，实地走访华润 双鹤药业股份有限公司，调研企业质量管理及地方药品监管部门监管情况。 汇宇制药：多个产品获得境外上市许可 11月19日，汇宇制药公告称，公司子公司Seacross Pharmaceuticals Ltd.于近期分别收到巴基斯坦药品监 督管理局、英国药品和健康产品管理局和北马其顿药品和医疗设备管理局核准签发的公司产品普乐沙福 注射液、注射用塞替派、注射用阿扎胞苷、注射用唑来膦酸浓溶液 ...

Core Viewpoint - The Chinese Vaccine Industry Association has issued an initiative to combat "involution" competition in the vaccine sector, aiming to promote high-quality development and establish a healthy competitive environment in the industry [1][2]. Group 1: Initiative Details - The initiative mandates all members of the Chinese Vaccine Industry Association to adhere to the Vaccine Administration Law and the Price Law of the People's Republic of China, ensuring fair and legal pricing based on production costs and market demand [1]. - Members are required to resist disorderly low-price competition and are prohibited from participating in bidding with prices below cost, thereby ensuring product and service quality standards [1][2]. Group 2: Industry Context - The association currently has over 330 member units and 35 branches, encompassing major vaccine and biological product companies, as well as upstream and downstream service providers in the biopharmaceutical industry [4]. - A price war has emerged in the public market, with significant price drops observed. For instance, the bid price for a trivalent flu vaccine from Shanghai Biological Products Research Institute was set at 5.5 yuan per dose in September, marking a new low in the public flu vaccine market [4]. - The price of a bivalent HPV vaccine from Watson Bio was reduced to 27.5 yuan per dose in a procurement project, humorously compared to the cost of a cup of milk tea [4]. Group 3: Financial Impact - The price war reflects a phenomenon of homogenized competition within the industry, leading to financial pressure on vaccine companies. In the first three quarters of this year, 10 out of 14 listed vaccine companies reported a year-on-year decline in net profit [5]. - Notably, five companies, including Zhifei Biological Products and Kanglaite, reported significant losses, totaling over 12 billion yuan for Zhifei alone [5]. - Industry insiders have expressed concerns that some companies are engaging in price wars to survive or capture market share, hoping for further national measures to address the issue of "involution" [5].

Key Points - 合富中国's stock will resume trading on November 20 after completing an investigation into unusual trading fluctuations, confirming normal business operations and no undisclosed significant matters [1] - 中金公司 plans to merge with 东兴证券 and 信达证券, leading to a suspension of its A-shares starting November 20 due to uncertainties surrounding the merger [1] - 大为股份 is progressing with the transition from exploration to mining rights for its lithium battery project in Hunan, having received necessary approvals [1] - 燕东微's major shareholders plan to reduce their stakes by up to 2.5% through block trades or centralized bidding from December 11, 2025, to March 11, 2026 [2] - 中水渔业's major shareholder reduced its stake to 5% after selling 258.88 million shares [3] - 韵达股份 reported a slight decline in express service revenue for October 2025, totaling 4.495 billion yuan, a year-on-year decrease of 0.88% [4] - 倍杰特 intends to acquire a 55% stake in 大豪矿业 for 224.8 million yuan [4] - 辰奕智能 plans to acquire a 55% stake in 华泽电子 through cash [4] - 赣粤高速's actual controller will change from the provincial transportation department to the provincial state-owned assets supervision and administration commission [5] - 东软集团 received a notification for a 4.2 billion yuan contract for intelligent cockpit controllers from a major domestic automotive manufacturer [5] - 海正药业's subsidiary plans to invest in a pet prescription food project [5] - 龙利得's controlling shareholder plans to increase its stake by at least 56 million yuan [6] - 新兴装备's shareholders plan to reduce their stakes by up to 3.13% [6] - 普洛药业 plans to repurchase shares worth between 180 million and 360 million yuan [6]

【导读】中国疫苗行业协会：严禁以低于成本的报价参与竞标 中国基金报记者 卢鸰 倡议提出，中国疫苗行业协会全体会员须严格遵循《中华人民共和国疫苗管理法》《中华人民共和国价格法》，以生产经营成本与市场供求状况为定价基 本依据，依法自主合理定价，自觉维护市场价格稳定，共同营造公平有序的竞争环境。坚决抵制无序低价竞争，在招投标全流程中，严禁以低于成本的报 价参与竞标，切实保障产品与服务的质量标准。 受此影响，智飞生物、沃森生物等疫苗上市公司的盈利持续大幅下滑，其股价也持续暴跌。 智飞生物(300122) < G 闭市 11-19 15:30:54 通 融 20.84 额 3.05亿 股本23.94亿 市盈 -37.3 万得 盘口 -0.20 -0.95% 换 1.03% 市值 499亿 市净 1.70 分时 五日 日K 周K 月K 更多 [0] 叠加 设均线 MA 5:21.76↑ 10:21.57↓ 20:24.96↓ 前复权 159.98 <146.21 83.83 2019-02 2021-05 2023-08 2025-11 016-11 - 编辑：杜妍 倡议要求，全体会员应坚持创新驱动发展，推动关键核心技术 ...

Mergers and Acquisitions - Chenyi Intelligent plans to acquire 55% of Huaze Electronics through cash payment [1] - Beijiete's wholly-owned subsidiary intends to acquire 55% of Dahao Mining for 225 million yuan [1] Share Buybacks and Equity Transfers - Chenzhan Optoelectronics' controlling shareholder is transferring 5.02% of shares [2] - Huamin Co., Ltd. plans to transfer 5.17% of shares by Jianxianghuihong [2] - Pro Pharmaceutical intends to repurchase shares worth between 180 million to 360 million yuan, with a maximum price of 23 yuan per share [2] - Ganyue Expressway's actual controller will change from the Provincial Department of Transportation to the Provincial State-owned Assets Supervision and Administration Commission [2] External Investments and Daily Operations - Hefei China has completed its suspension review and resumed trading [3] - Dwei Co., Ltd. is advancing the procedures for lithium battery new energy projects in Hunan Chenzhou [4] - Desay SV plans to launch an AI computing terminal for the robotics sector [4] - Neusoft Group received a notification from a major domestic automotive manufacturer to supply intelligent cockpit domain controllers, with a total expected supply amount of 4.2 billion yuan [4] - Junyi Digital plans to invest 120 million yuan in Guanghong Precision, acquiring 60% ownership post-investment [5] - Dongfang Electric intends to invest 910 million yuan to hold 49% in a joint venture [6] - Bailian Group's subsidiary plans to transfer 100% of its stake in Yangpu Century Bailian for 78.286 million yuan [6] - Ruisheng Intelligent's subsidiary won a bid for a China Mobile ICT project, focusing on computing server hardware and systems [6] - Zhifei Biological's clinical trial application for the ZFA01 adjuvant vaccine has been accepted [7] - Haizheng Pharmaceutical's subsidiary is collaborating with East China Institute on a biomanufacturing project for heparin [8] - Baiyang Pharmaceutical's Zap Therapeutic plans to invest 4.9 million USD in Baiyang Sap to expedite the clinical introduction of the ZAP-X Mars surgical robot [8] - Jinbei Automotive plans to invest 5.8 billion yuan and purchase equity in Changchun Zhongtuo Molding Technology [9] - Baili Tianheng has secured a commitment from Bank of China Sichuan Branch for a total of no less than 8 billion yuan in comprehensive credit support [10]

智飞生物表示，公司的重组带状疱疹ZFA01佐剂疫苗(CHO细胞)采用自主研制的新型佐剂，可同时激发 细胞免疫与体液免疫反应，免疫应答更为全面，有望增强疫苗的保护效果。该疫苗临床试验申请获得受 理，是公司新型佐剂技术平台应用，聚焦创新技术、增强核心攻关的成果。若本项目进展顺利，将进一 步丰富公司成人疫苗品种，完善公司产品布局，强化公司的市场地位。 北京商报讯(记者丁宁)11月19日晚间，智飞生物（300122）发布公告称，公司于近日获悉，由全资子公 司安徽智飞龙科马生物制药有限公司(以下简称"智飞龙科马")研发的重组带状疱疹ZFA01佐剂疫苗(CHO 细胞)获得国家药品监督管理局药物临床试验申请受理通知书。自受理之日起60日内，未收到药审中心 否定或质疑意见的，智飞龙科马可以按照提交的方案开展临床试验。 ...

北京商报讯（记者 王寅浩 宋雨盈）11月19日，智飞生物发布公告称，公司全资子公司安徽智飞龙科马 生物制药有限公司（以下简称"智飞龙科马"）研发的重组带状疱疹ZFA01佐剂疫苗（CHO细胞）获得国 家药品监督管理局药物临床试验申请受理通知书。根据公告，自受理之日起60日内，未收到药审中心否 定或质疑意见的，智飞龙科马可以按照提交的方案开展临床试验。 ...

格隆汇11月19日｜智飞生物公告，近日获悉，由全资子公司安徽智飞龙科马生物制药有限公司研发的重 组带状疱疹ZFA01佐剂疫苗（CHO细胞）获得国家药品监督管理局药物临床试验申请受理通知书（受理 号：CXSL2500978）。自受理之日起60日内，未收到药审中心否定或质疑意见的，智飞龙科马可以按 照提交的方案开展临床试验。 ...

每经AI快讯，11月19日，智飞生物（300122）(300122.SZ)公告称，公司全资子公司智飞龙科马研发的 重组带状疱疹ZFA01佐剂疫苗(CHO细胞)获得国家药品监督管理局药物临床试验申请受理通知书。该疫 苗采用自主研制的新型佐剂，可同时激发细胞免疫与体液免疫反应，有望增强疫苗的保护效果。智飞龙 科马研发的重组带状疱疹ZFA01佐剂疫苗(CHO细胞)用于预防由带状疱疹感染引起的疾病。 ...

人民财讯11月19日电，智飞生物（300122）11月19日公告，全资子公司智飞龙科马研发的重组带状疱疹 ZFA01佐剂疫苗(CHO细胞)获得国家药品监督管理局药物临床试验申请受理通知书。 ...