细胞治疗

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从“再生医学明星”到增长几近停滞,冠昊生物到底怎么了?|创新药观察
Hua Xia Shi Bao· 2025-10-09 11:56
作为营收支柱的硬脑膜补片业务,正面临多重压力。集采政策冲击下的价格体系松动、国产竞品的技术 追赶,叠加自身产品迭代缓慢,共同构成了增长瓶颈。单一产品依赖的商业模式,在市场竞争加剧的背 景下更显脆弱。 研发投入的持续收缩与技术转化的低效,使得第二增长曲线迟迟未现。人工肝、CAR-T等前沿布局与核 心业务缺乏协同,而核心产品创新"断档"的隐患,正让公司在行业变革中逐渐失去主动权,未来发展的 不确定性进一步放大。 业绩增长的背后 本报(chinatimes.net.cn)记者张斯文 于娜 北京报道 冠昊生物的半年报数据看似显现出回暖迹象,营收与利润的双增长为这家曾被视为"再生医学明星"的企 业带来短暂的市场关注。但拉长周期观察,核心业务的增长停滞与结构性矛盾已逐渐显现。这家曾以再 生医学技术为标签的企业,正陷入"短期数据回暖"与"长期发展乏力"的张力之中。 2025年半年报显示,公司营收2.01亿元,同比微增5.89%;归母净利润2040万元,增速仅1.27%。 若将时间轴拉长至五年,这份"平淡无奇"的中报,不过是公司漫长估值消化周期的最新注脚。 Wind数据显示,2020—2024年,公司营收从4.37亿元降至3 ...
药明巨诺-B:国家药监局正式受理倍诺达 使用国产病毒载体的上市后补充申请
Zhi Tong Cai Jing· 2025-10-09 09:11
药明巨诺-B(02126)发布公告,中国国家药品监督管理局(NMPA)已正式受理其倍诺达新增使用国产病毒 载体的上市后补充申请。 慢病毒载体作为目的基因递送工具,在细胞治疗产品中起着重要的作用,可以实现嵌合抗原受体基因的 转导和整合。慢病毒载体是瑞基奥仑赛注射液的重要的生产原材料之一,当前生产中所使用的慢病毒载 体由国外生产商供货,价格贵且供货存在不稳定性,较大地限制了瑞基奥仑赛的商业化生产及临床开 发。药明巨诺研发并新增了自主生产的慢病毒载体(JWLV011),旨在实现病毒生产工艺优化、品质控制 加强的前提下,确保瑞基奥仑赛注射液的稳定持续供应以及降低成本。 本次申请是基于一项II期单臂研究,目的是评估和论证使用新工艺病毒载体(JWLV011)生产的瑞基奥仑 赛注射液,与使用现有病毒载体生产的瑞基奥仑赛注射液产品可比。目前本研究已完成至少3个月随 访:观察到的3个月最佳客观缓解率(ORR)为66.67%,疾病完全缓解率(CR)为41.67%。最常见的严重不 良事件为血细胞减少;CAR-T相关毒性如细胞因子释放综合征(CRS),多为1级,无≥3级CRS发生,无任 何级别免疫效应细胞相关神经毒性综合征(ICAN ...
建设世界一流脐带血干细胞公共资源实体库:北京市脐带血库二十三年的光荣与梦想
Sou Hu Wang· 2025-10-09 02:22
【筚路蓝缕二十三载,今天,我国首家脐带血库——北京市脐带血造血干细胞库迎来23岁生日。这不仅 是佳宸弘生物(北京市脐带血库运营方)的重要里程碑,更是脐带血生命科学和医疗事业发展的一个缩 影。 二十三载春秋,作为北京地区唯一具有法定开展脐带血采集、制备、检测、冻存、选择、运输和发放等 资质的国家特殊血站,北京市脐带血库坚持走中国特色卫生与健康发展道路,从零起步,将守护精神从 概念变为现实,努力建设世界一流脐带血干细胞公共资源实体库,在公共卫生应急管理体系中持续发挥 作用,向着更具使命的未来加速奔跑。】 北京一家医院的诊室里,王芳盯着眼前的确诊单,不敢相信地问医生:"大夫,嘉嘉真得了这种病?"医 生点点头,让她再次确认孩子得的就是可怕的"白血病"。王芳的眼泪夺眶而出。 当医生得知王芳的大宝欢欢的脐带血保存在北京市脐带血库后,结合孩子的病情,为他制定了用哥哥脐 带血辅助其父亲单倍体异基因造血干细胞移植的方案。哥哥这份沉睡了16年的脐带血就像一位"穿越时 空"的使者,顺利植入弟弟体内并使之恢复了正常的造血。王芳感叹:"真没想到,16年前一个并不经意 的决定,竟成为如今挽救孩子的关键!" 阿源是一个聪明活泼的男孩儿,不 ...
恒瑞医药涨2.11%,成交额18.46亿元,主力资金净流入1.69亿元
Xin Lang Cai Jing· 2025-09-30 03:23
Company Overview - Jiangsu Hengrui Medicine Co., Ltd. is primarily engaged in the research, production, and sales of pharmaceuticals, focusing on oncology and covering various research areas including kinase inhibitors, antibody-drug conjugates (ADC), tumor immunology, hormone receptor regulation, DNA repair, and supportive therapies [2] - The company's product portfolio includes anti-tumor drugs, analgesics, and contrast agents, applicable in various fields such as autoimmune diseases, metabolic diseases, cardiovascular diseases, infectious diseases, respiratory diseases, hematological diseases, pain management, neurological diseases, ophthalmology, and nephrology [2] - The main revenue composition is as follows: oncology 52.12%, neuroscience 15.33%, others (supplementary) 10.63%, contrast agents 9.82%, metabolic and cardiovascular 6.25%, others 3.07%, immunology and respiratory system 2.78% [2] Financial Performance - As of June 30, 2025, Hengrui Medicine achieved a revenue of 15.76 billion yuan, representing a year-on-year growth of 15.88%, and a net profit attributable to shareholders of 4.45 billion yuan, with a year-on-year increase of 29.67% [3] - The company has distributed a total of 9.30 billion yuan in dividends since its A-share listing, with 3.57 billion yuan distributed over the past three years [3] Stock Performance - On September 30, Hengrui Medicine's stock price increased by 2.11%, reaching 70.66 yuan per share, with a trading volume of 1.846 billion yuan and a turnover rate of 0.41%, resulting in a total market capitalization of 468.985 billion yuan [1] - Year-to-date, the stock price has risen by 54.62%, with a 1.38% increase over the last five trading days, a 2.60% increase over the last twenty days, and a 32.32% increase over the last sixty days [1] - The net inflow of main funds was 169 million yuan, with significant buying and selling activities recorded [1]
药明康德涨2.09%,成交额5.44亿元,主力资金净流入1295.46万元
Xin Lang Zheng Quan· 2025-09-30 01:45
9月30日,药明康德盘中上涨2.09%,截至09:40,报107.47元/股,成交5.44亿元,换手率0.21%,总市值 3171.98亿元。 责任编辑:小浪快报 资金流向方面,主力资金净流入1295.46万元,特大单买入5498.92万元,占比10.11%,卖出5298.69万 元,占比9.74%;大单买入1.42亿元,占比26.06%,卖出1.31亿元,占比24.05%。 药明康德今年以来股价涨101.41%,近5个交易日涨2.91%,近20日跌3.74%,近60日涨53.42%。 资料显示,无锡药明康德新药开发股份有限公司位于上海浦东新区外高桥保税区富特中路288号,香港铜 锣湾希慎道33号利园1期19楼1910室,成立日期2000年12月1日,上市日期2018年5月8日,公司主营业务 涉及小分子化学药的发现、研发及生产全方位、一体化平台服务,以全产业链平台的形式面向全球制药 企业提供各类新药的研发、生产及配套服务。主营业务收入构成为:化学业务78.37%,测试业务 12.93%,生物学业务6.02%,其他(补充)1.90%,其他业务0.79%。 药明康德所属申万行业为:医药生物-医疗服务-医疗研发外包 ...
阿斯利康Gianluca Pirozzi博士:中国成全球罕见病研发“突破引擎” 高价值药物有望构建商业闭环
Mei Ri Jing Ji Xin Wen· 2025-09-29 14:08
"作为一名医生,同时也是罕见病患儿的父亲,我深知这个群体面临双重困境,既难以确诊,又无药可 治。"日前,阿斯利康全球高级副总裁Gianluca Pirozzi博士在接受《每日经济新闻》记者专访时如是袒 露心声。 统计数据显示,目前已知罕见病超1万种,但90%缺乏有效治疗手段,80%为遗传性疾病且多在儿童期 发病,平均诊断周期长达4.8年。这一严峻现状正在被全球医药巨头与中国市场深度绑定所改变。 首先是临床试验速度与质量领先。Gianluca Pirozzi告诉记者,在阿斯利康的大部分三期临床试验中,中 国都是首个参与方,且患者入组速度全球领先。"中国拥有规模庞大的临床研究中心,能将分散在各地 的患者有效聚集,这解决了罕见病临床试验最大的难题,患者招募。"更重要的是,中国中心提供的数 据质量与全球标准完全接轨,"速度与质量的双重优势,让中国成为药物开发的加速器"。 其次是前沿技术创新与转化领先。在Gianluca Pirozzi看来,中国在细胞治疗、基因治疗、IIT临床研究 (研究者发起的临床研究)等领域已走在全球前列。"这些技术突破不仅能加速本土研发,更能为全球 提供创新思路。"他解释道,技术创新与数据积累形 ...
药明康德涨2.01%,成交额32.53亿元,主力资金净流出8236.82万元
Xin Lang Zheng Quan· 2025-09-29 05:54
Group 1 - The core viewpoint of the articles highlights the performance and financial metrics of WuXi AppTec, indicating a significant increase in stock price and revenue growth [1][2]. - As of September 29, WuXi AppTec's stock price rose by 2.01% to 104.99 CNY per share, with a market capitalization of 309.87 billion CNY [1]. - The company has experienced a year-to-date stock price increase of 96.76%, while it has seen a decline of 3.40% over the last five trading days [1]. Group 2 - WuXi AppTec's revenue for the first half of 2025 reached 20.799 billion CNY, representing a year-on-year growth of 20.64%, while the net profit attributable to shareholders increased by 101.92% to 8.561 billion CNY [2]. - The company has distributed a total of 14.06 billion CNY in dividends since its A-share listing, with 10.406 billion CNY distributed in the last three years [3]. - As of June 30, 2025, the second-largest shareholder is Hong Kong Central Clearing Limited, holding 302 million shares, an increase of 56.02 million shares from the previous period [3].
2025年中国生物细胞资源产业链洞察报告(一):细胞存储技术
Tou Bao Yan Jiu Yuan· 2025-09-28 12:05
Investment Rating - The report does not explicitly provide an investment rating for the biological cell resource industry in China. Core Insights - The report aims to analyze the market development of the cell storage sector, focusing on technological advancements, policy environment, market size, and competitive landscape to provide decision-making references for related enterprises and investors [3]. Summary by Sections Overview of the Cell Storage Industry - The cell storage industry in China is evolving under supportive policies and regulatory frameworks, emphasizing product safety, quality control, and standardization [6]. - The aging population in China is increasing the demand for disease prevention, enhancing the value recognition of cell resource storage and regenerative medicine applications [6][26]. - Technological advancements have shifted cell storage from early low-temperature preservation to multi-mechanism collaborative strategies, addressing various challenges such as metabolic stability and oxidative stress [6]. Development Environment of the Cell Storage Industry - The continuous optimization of China's healthcare expenditure structure and the significant increase in government and social investment create a favorable environment for the biotechnology sector [21][25]. - The aging population and increasing life expectancy are driving the demand for preventive health investments, including cell storage [26][28]. Market Competition in the Cell Storage Industry - The Chinese cell storage market exhibits a multi-tiered competitive structure, with leading enterprises leveraging first-mover advantages and national layouts to drive automation and standardization [37]. - Local institutions benefit from regional policy support and local resources, forming strong regional influence [37]. - The third tier consists of numerous emerging and cross-industry companies with diverse business models, reflecting ongoing evolution and standardization within the industry [37].
专访阿斯利康全球高级副总裁Gianluca Pirozzi:中国正成为全球罕见病研发“突破引擎” 高价值药物有望构建商业闭环
Mei Ri Jing Ji Xin Wen· 2025-09-26 04:55
Core Insights - The article highlights the dual challenges faced by rare disease patients, including difficulties in diagnosis and lack of effective treatments, with over 90% of known rare diseases lacking any therapeutic options [2][3] - China is evolving from a participant in global rare disease research to a "breakthrough engine," leveraging its unique advantages in clinical trial efficiency, technological innovation, and disease data accumulation [2][4] Rare Disease Landscape - There are over 10,000 known rare diseases, with 90% lacking effective treatments and 80% being genetic, often manifesting in childhood, making pediatric rare disease drug development urgent yet complex [3][4] - The definition of rare diseases varies significantly across countries, complicating research and development efforts, particularly in China, where a clear regulatory list of rare diseases is still absent [3][4] China's Role in Rare Disease Research - China is recognized for its leading clinical trial speed and quality, with many Phase III trials involving Chinese participants, addressing the recruitment challenges faced in rare disease studies [4][5] - The country is at the forefront of technological innovations in cell and gene therapies, which not only accelerate local research but also provide innovative ideas for global applications [5][6] - China's healthcare system allows for efficient collection of disease registry data, crucial for understanding disease progression and setting treatment endpoints [5][6] AstraZeneca's Strategy in Rare Diseases - AstraZeneca has established partnerships with 14 Chinese biopharmaceutical companies to enhance its rare disease research, focusing on unmet clinical needs and differentiated project advantages [6][7] - The company emphasizes the importance of developing transformative therapies for rare diseases, which can create significant clinical value and support sustainable business models [7][8] Clinical Developments and Future Outlook - AstraZeneca has received approval for seven rare disease drugs globally and has ten ongoing Phase III clinical and regulatory review projects across various therapeutic areas [8][9] - The year 2025 is anticipated to be significant for AstraZeneca's rare disease research, with key Phase III study results expected to be released [9][10] - AstraZeneca is actively building a diagnostic and treatment ecosystem in China, having established 138 rare disease treatment centers to ensure standardized care [9][10] Patient Engagement and Accessibility - The company involves patients and caregivers early in the research process to ensure that clinical trials address the most critical disease improvement indicators [10] - AstraZeneca is advocating for the inclusion of rare disease drugs in national insurance programs to enhance accessibility for patients, while also calling for the establishment of special funds to alleviate patient financial burdens [10]
复星医药跌2.01%,成交额1.82亿元,主力资金净流出1462.99万元
Xin Lang Zheng Quan· 2025-09-26 01:47
Company Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. was established on May 31, 1995, and listed on August 7, 1998. The company is primarily engaged in drug manufacturing and research, covering medical devices, medical diagnostics, medical services, and pharmaceutical distribution and retail [1]. Financial Performance - For the first half of 2025, Fosun Pharma reported operating revenue of 19.514 billion yuan, a year-on-year decrease of 4.63%. However, the net profit attributable to shareholders increased by 38.96% to 1.702 billion yuan [2]. - The company has cumulatively distributed 12.593 billion yuan in dividends since its A-share listing, with 2.691 billion yuan distributed over the past three years [3]. Stock Performance - As of September 26, Fosun Pharma's stock price was 29.69 yuan per share, with a market capitalization of 79.285 billion yuan. The stock has increased by 21.02% year-to-date but has seen a decline of 4.01% over the past five trading days [1]. - The stock's trading volume on September 26 was 182 million yuan, with a turnover rate of 0.29% [1]. Shareholder Structure - As of June 30, 2025, Fosun Pharma had 230,000 shareholders, a decrease of 4.37% from the previous period. The average circulating shares per shareholder remained at 0 [2]. - The top circulating shareholder is Hong Kong Central Clearing Limited, holding 75.881 million shares, an increase of 11.194 million shares from the previous period [3].