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科普|儿童肾病40%与遗传相关,细胞疗法后基因治疗曙光初现
Di Yi Cai Jing· 2025-05-23 14:22
沈茜告诉第一财经记者,除了细胞治疗之外,在复旦儿科医院肾脏科和风湿科学科带头人徐虹教授的带 领下,一种目前用于法布雷病的基因疗法未来也有望用于肾病治疗。目前该疗法已经进入IIT(研究者 发起研究)阶段。 除了细胞治疗之外,在复旦儿科医院肾脏科和风湿科学科带头人徐虹教授的带领下,一种目前用于法布 雷病的基因疗法未来也有望用于肾病治疗。目前该疗法已经进入IIT阶段。 近日,浙江大学医学院附属儿童医院肾脏内科公布消息称,一名多药耐药型肾病综合征患儿接受了一种 靶向BCMA/CD70自体CAR-T细胞治疗后,在回输的第3个月,尿蛋白11年来首次转阴。 这一病例的救治成功意味着CAR-T细胞治疗在治疗儿童肾病方面迈出重要的一步,有望帮助更多疑难疾 病患儿实现治愈。 此前,细胞治疗已经用于儿童系统性红斑狼疮以及难治性幼年皮肌炎等疾病。 5月22日,在复旦大学附属儿科医院肾脏科的一场儿童肾病公益项目中,复旦大学附属儿科医院肾脏科 主任沈茜教授对第一财经记者表示:"系统性红斑狼疮会导致狼疮性肾炎,肾炎会影响肾功能,如果不 及时治疗就会发展成为尿毒症。" "法布雷病是一种基因遗传性疾病,会导致包括肾衰竭在内的多种脏器的功能损伤 ...
全球无血清细胞冻存培养基市场前10强生产商排名及市场占有率
QYResearch· 2025-05-22 08:38
Core Viewpoint - The article discusses the advantages and market potential of serum-free cell freezing media, highlighting its growing importance in cell therapy, regenerative medicine, and biopharmaceuticals, while also addressing the challenges faced in its market adoption [1][2][3]. Group 1: Advantages of Serum-Free Cell Freezing Media - Serum-free cell freezing media offers clear composition, better batch stability, reduced immunogenicity, and lower contamination risks compared to traditional serum-containing freezing solutions [1]. - The media typically contains appropriate cryoprotectants (like DMSO), carbon sources, buffering agents, and cell-protective factors, effectively maintaining cell viability during freezing and thawing processes [1]. - The rapid market growth is driven by the increasing demand for high-value cell products such as stem cells, immune cells, and CAR-T therapies, which require high-quality freezing media [1][3]. Group 2: Market Challenges - The development of serum-free formulations has a high technical barrier, requiring extensive experimentation to optimize cell survival and functionality, leading to long development cycles and high costs [2]. - There is a lack of universal products due to the varying dependence of different cell types on freezing environments, which limits large-scale adoption [2]. - Cost sensitivity among users leads some to still prefer traditional serum-containing freezing solutions, and the absence of standardized product evaluation criteria creates information asymmetry for users [2]. Group 3: Future Market Trends - The serum-free cell freezing media market is expected to evolve towards customization, high performance, and compliance, with advancements in AI and high-throughput screening enabling more precise formulation development [3]. - Increasing regulatory scrutiny on cell-based therapies is pushing companies to expedite the registration and certification processes for serum-free products [3]. - The Asia-Pacific region, particularly China, is projected to be one of the fastest-growing markets due to supportive policies, biopharmaceutical investments, and technological advancements [3]. - According to QYResearch, the global serum-free cell freezing media market is expected to reach USD 410 million by 2031, with a compound annual growth rate (CAGR) of 8.3% in the coming years [3]. Group 4: Market Share and Key Players - Major manufacturers in the global serum-free cell freezing media market include Thermo Fisher, Merck, Zenoaq, Cytiva, and STEMCELL, with the top five companies holding approximately 70% of the market share as of 2024 [8]. - DMSO-containing products dominate the market, accounting for about 84.6% of the total share [10]. - Biopharmaceutical companies represent the largest downstream market, capturing around 53.9% of the demand for serum-free cell freezing media [12].
生物医药ETF(512290)当日上涨1.40%,创新药出海与治疗技术突破驱动行业复苏
Mei Ri Jing Ji Xin Wen· 2025-05-20 04:23
Core Viewpoint - The biopharmaceutical sector is experiencing growth driven by innovation and increasing domestic demand, with significant developments in various therapeutic areas and technologies [1][2][3]. Group 1: Market Performance - The Biopharmaceutical ETF (512290) opened with a gain of 1.40% [1]. - The CS Biomedicine Index (930726), which the ETF tracks, reflects the overall performance of listed companies in the biopharmaceutical, medical device, and healthcare service sectors in China [1]. Group 2: Industry Developments - The biopharmaceutical sector is witnessing a recovery in exports, with Q1 2025 pharmaceutical exports reaching $26.632 billion, a year-on-year increase of 4.39%, and exports to the U.S. growing by 9.6% [2]. - Companies like Maiwei Biotech are advancing differentiated innovation in R&D, with key clinical studies underway for core products [1][2]. - New products in the biopharmaceutical space, such as the C-reactive protein testing kit by New Industry Biotech, are enhancing the company's product line [1]. Group 3: Innovation and Growth Potential - The global market for gout treatment is projected to reach 1.42 billion patients by 2030, with significant opportunities for new drugs targeting URAT1 [2]. - The cell therapy sector is making strides with universal CAR-T technologies showing breakthroughs in efficacy and cost-effectiveness [2]. - The medical device sector is transitioning from manufacturing to intelligent manufacturing, with new technologies like pulsed field ablation (PFA) improving surgical safety and efficiency [3].
商业秘密|医疗企业利润承压,转型大健康能否让企业迅速“回血”?
Di Yi Cai Jing· 2025-05-17 13:46
一些人去海南打干细胞,去一次疗养的花费甚至高达百万元。提供这种服务的企业赚了很多钱。 近期,75岁"输液大王"刘革新"赤膊上阵"卖保健品的消息在网上疯传。刘革新是科伦药业董事长,他在今年5月的业绩电话会上高调回应:"科伦已决定挺进 大健康赛道。" "企业要生存,严肃医疗赛道的竞争非常内卷,传统产品的创新乏力,权衡利弊之下,搞大健康副业是最佳的选择了。"再生医学领域专家韩厉对第一财经记 者表示。他还称,最近经常接到一些医药公司的邀请,请他做一些关于再生医学的科普。 一位专家对第一财经记者表示,在国内,干细胞治疗的需求正在快速增长。"据我了解,一些人去海南打干细胞,去一次疗养的花费甚至高达百万元。"他告 诉第一财经记者,"提供这种服务的企业赚了很多钱。" 发力消费医疗已成行业趋势 以近期引发网络热议的"高潮针"为例,这种富血小板血浆(PRP)的注射仅获批作为骨折手术的辅助治疗,是被严格监管的三类医疗器械。然而,无论是在 大量的美容机构,PRP不仅用于皮肤注射,甚至被违规用于阴道内注射。注射一针的费用往往高达万元。 而来自多家上市公司的财报显示,在主营业务利润下滑的背景下,医美相关业务已经开始产生收入,尽管各家企业 ...
研判2025!中国再生医学行业产业链图谱、政策、市场规模及未来趋势:先进医疗技术需求不断增长,全球再生医学市场规模加速扩容[图]
Chan Ye Xin Xi Wang· 2025-05-15 01:20
Industry Overview - Regenerative medicine (RM) utilizes biological and engineering theories to promote self-repair and regeneration of the body, or to construct new tissues and organs for repairing, regenerating, and replacing damaged tissues and organs [1][4] - The global regenerative medicine market is expanding, with the market size projected to grow from $20.04 billion in 2021 to $35.82 billion in 2024 [1][12] Market Status - Regenerative medicine is considered the "third medical revolution" following drug and surgical treatments, becoming a core component of life science strategies globally [6][12] - The industry includes upstream raw materials and equipment supply, midstream product R&D and production, and downstream application through medical institutions and aesthetic organizations [4][12] Policy and Regulatory Environment - Various countries have implemented policies to promote the development of regenerative medicine, such as the U.S. "21st Century Cures Act" and the EU's regulations on biotechnology [7][9] - In China, policies have been established to support the clinical application of regenerative medicine technologies, including the management of stem cell therapies and the promotion of innovative medical technologies [9][23] Market Competition - The regenerative medicine sector has attracted numerous companies, with major players including Johnson & Johnson, Bard, Geistlich, and domestic firms like Zhenghai Biological, Guanhou Biological, and Maipu Medical [16][18] - The market is characterized by a diverse range of products and applications, with companies focusing on specific therapeutic areas such as cancer treatment, tissue repair, and organ transplantation [18][20] Development Trends - The industry is witnessing technological integration and innovation, with advancements in 3D bioprinting, gene editing, and artificial intelligence enhancing treatment efficacy [22][24] - The dual drive of policy support and capital investment is accelerating the commercialization of regenerative medicine, with increasing coverage of medical insurance for regenerative products [23][24]
方大集团东北制药持续发力新药研发
Liao Ning Ri Bao· 2025-05-12 22:01
Core Insights - Liaoning Fangda Group Northeast Pharmaceutical's Q1 2025 report shows a significant increase in R&D investment by 88% year-on-year, indicating a strategic shift towards R&D-driven growth and quality enhancement over mere revenue increase [2][4] Group 1: Quality Improvement and Financial Health - Despite a slight revenue increase of 0.36% in Q1 2025, the company achieved steady improvement in operational quality through refined management and structural optimization [2] - Sales expenses decreased by 20.5% year-on-year, while management expenses also reduced, and R&D expenses rose strategically to 32 million yuan, reflecting precise resource allocation [2] - The company's debt-to-asset ratio fell to 58.82%, a decrease of 2.63 percentage points from the beginning of the year, indicating enhanced financial health and reduced short-term repayment risks [2] Group 2: Innovation and Product Development - Northeast Pharmaceutical is implementing a dual-driven strategy of "innovative drugs + generic drugs," creating a product matrix covering various therapeutic areas including neurology, digestion, endocrinology, oncology, and autoimmune diseases [3] - The company is accelerating its strategic layout in cutting-edge fields, particularly in tumor immunotherapy, with over 10 immune therapy products targeting diseases like pancreatic cancer and colorectal cancer [4] - A notable product in development is a TCR-T cell drug targeting KRASG12D, which is expected to be the first of its kind in China to enter Phase I clinical trials [4] Group 3: Global Market Expansion - The company is leveraging its international presence to enhance its global sales network, with its main products exported to over 100 countries and regions [5] - The global sales strategy has effectively diversified market risks and established sustainable revenue capabilities [5] - Although there may be short-term profit fluctuations due to increased R&D investments, the strategic transformation is showing initial positive results, positioning the company for future growth cycles as innovative therapies are commercialized [5]
中源协和: 中源协和细胞基因工程股份有限公司2024年年度股东大会会议资料
Zheng Quan Zhi Xing· 2025-05-09 09:12
Core Points - The company is holding a shareholder meeting on May 20, 2025, to discuss various agenda items including the independent director's report for 2024 and voting on resolutions [1][2] - The company reported a revenue of 1.585 billion yuan for 2024, a slight decrease of 0.27% compared to the previous year, with a net profit of 100 million yuan, down 5.73% [10][11] - The company has made significant progress in stem cell drug development, with multiple clinical trials approved and ongoing for new treatments [12][22] - The company is focusing on enhancing its governance structure and compliance, having received various quality management certifications [17][18] Company Operations - The board of directors has operated in compliance with relevant laws and regulations, approving 32 resolutions with a 100% approval rate [5][6] - The company has established a governance structure involving the shareholder meeting, board of directors, and supervisory board, ensuring clear responsibilities and effective operation [10] - The company has implemented a comprehensive quality management system, achieving ISO certifications in quality, environmental management, and occupational health and safety [17][18] Financial Performance - The company reported a total asset value of 5.249 billion yuan as of December 31, 2024, a decrease of 3% from the previous year [30] - The company’s cash flow from operating activities was negative 64 million yuan, indicating challenges in cash generation [30] - The company has initiated a share buyback program, repurchasing shares worth 200 million yuan, which is 199.32% of its net profit for the year [31] Future Plans - The company aims to deepen its research and development in stem cell therapies and expand its market presence both domestically and internationally [22][24] - The company plans to enhance its automated production capabilities and improve the efficiency of its cell therapy products [23] - The company is committed to building a comprehensive health management ecosystem for families, integrating various health services and insurance collaborations [25]
Bio-Techne(TECH) - 2025 Q3 - Earnings Call Transcript
2025-05-07 14:02
Financial Performance - The company reported a 6% organic revenue growth for Q3, with adjusted operating margin at 34.9% [5][20][22] - Adjusted EPS increased to $0.56 from $0.48 year-over-year, while GAAP EPS decreased to $0.14 from $0.31 [20] - Q3 revenue reached $316.2 million, a 6% increase year-over-year on an organic basis [20][21] - Total adjusted gross margin was 71.6%, slightly down from 71.9% last year [22] Business Segment Performance - The Protein Sciences segment achieved 7% organic revenue growth, driven by large pharma customers [10][26] - The Diagnostics and Spatial Biology segment reported 2% organic revenue growth, with strong performance in automated spatial instruments [13][27] - The GMP reagents business saw a trailing twelve-month growth of over 13% [12] Market Performance - North America experienced low single-digit growth, while Europe saw mid single-digit growth, and China faced a mid single-digit decline [21] - The biopharma market increased mid single digits, while the academic market remained flat [21][22] Company Strategy and Industry Competition - The company is focusing on balancing investments for future growth while driving operational efficiencies [5][19] - The FDA's recent emphasis on reducing animal testing is seen as an opportunity for the company's organoid solutions [11] - The company is well-positioned to mitigate tariff impacts through its global operational footprint [17][18] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in navigating uncertainties related to NIH funding and tariffs, expecting to mitigate impacts by the start of fiscal year 2026 [28][32] - The company anticipates a temporary slowdown in growth momentum to low single digits in Q4 due to macro uncertainties [32] - Management believes that potential NIH funding cuts may not significantly impact long-term growth expectations [29][68] Other Important Information - The company generated $41.1 million in cash from operations and returned $12.6 million in dividends and $100 million through stock buybacks [25] - A new share repurchase program has been authorized for up to $500 million [25] Q&A Session Summary Question: Impact of NIH funding on guidance - Management indicated that while there is uncertainty, they believe severe cuts to NIH funding are unlikely and would have an immaterial impact on long-term growth [29][68] Question: Clarification on pharma growth rates - Management clarified that pharma experienced double-digit growth in Q3, but they expect a step down in Q4 due to order timing and tariff impacts [36][41] Question: Tariff exposure and local manufacturing - Management explained that they have pathways to mitigate tariff impacts and emphasized the importance of their local manufacturing footprint in China [48][50] Question: Academic market headwinds - Management acknowledged headwinds in the academic market due to NIH funding uncertainties but expressed confidence in their competitive positioning [70][72] Question: Growth expectations for GMP reagents - Management noted that the cell and gene therapy product line has shown a trailing twelve-month growth of over 30% [80]
南京新百2024年营收67亿元 大健康主业基本盘持续稳健
4月29日,南京新百(600682)发布2024年年度报告,公司报告期内实现营业收入67.00亿元,同比上涨 1.98%,归属于上市公司股东的净利润2.30亿元。公司同时发布的2025年一季报显示,1—3月实现营收 15.69亿元,归属于上市公司股东的净利润1.29亿元。南京新百大健康业务仍占主导地位,2024全年持续 稳健增长,并披露了2024年度ESG报告,坚持可持续高质量发展。 生物医疗方面,2024年,齐鲁干细胞继续实施多元化发展策略,在现有的脐血干细胞保存服务基础上持 续创新推出多室保存服务,以及包括免疫细胞储存和检测在内的多样化产品与服务;公司全资子公司济 南科阅医学检验实验室有限公司开展健康与衰老评估、AD检测等项目,并在深圳设立了深圳卓元干细 胞工程有限公司,扩大业务范围。2024年,齐鲁干细胞全力推进国际细胞治疗认证基金会FACT认证, 并已于2025年2月成为国内首家获得FACT国际认证的细胞机构。这一里程碑标志着齐鲁干细胞的技术实 力与质量管理体系跻身全球领先行列,也意味着我国细胞治疗领域迈入国际标准化新阶段。 2024年,丹瑞美国不断强化PROVENGE作为早期无症状或轻微症状的mCR ...
红杉中国医疗成员企业再创多项“首个”记录|Healthcare View
红杉汇· 2025-04-29 11:30
金仕生物 全球首款预装干瓣Prostyle A® 获批上市 4月9日,金仕生物宣布由公司自主研发的 Prostyle A®经导管人工主动脉瓣膜置换系统-干法预装可回收输送 系统 获得国家药品监督管理局 (NMPA) 批准上市 ( 国械注准20253130729) 。 作为全球首款预装干瓣,金仕生物推出的新一代介入主动脉瓣Prostyle A®集成了众多瓣膜领域的前沿技 术,拥有干瓣技术、巧妙便捷的预装系统、卓越的瓣膜血流动力学性能和耐久性,优秀的输送性和通过 性,平稳的释放和可靠的锚定等特点。金仕生物自主创新的干瓣技术,在国内、欧洲、美国、日本等国家 享有专利保护。这一产品的出现,迎来中国TAVR的新时代 ——干瓣时代。 艾柯医疗 全新血流导向密网支架系统"Lattice COUPLE"成功获批 近日,艾柯医疗全新血流导向密网支架系统"Lattice COUPLE",成功获得国家药监局批准注册 ( 注册证编 号:国械注准20253130668) 。至此, 艾柯医疗成为神经介入行业首家拥有三张密网注册证的企业 。 微光医疗 FDA 首次批准中国高端腔内介入影像设备 4月11日,微光医疗宣布其两款冠脉OCT设备及 ...