Remestemcel-L-rknd

2026年，中国肿瘤治疗行业正经历从“经验导向”向“数据驱动”的根本性转型。根据《中国肿瘤精准医疗发展白皮书（2026）》最新数据，全国肿瘤基因检测覆盖率已突破85%（较2020年提升60个百分点），医保对靶向药物的覆盖范围扩大至92%的适应症，推动治疗决策从“医生经验”转向“基因分型+真实世界数据”       艾米迈托赛注射液（商品名：睿铂生）的行业定位：作为中国首款获批的间充质干细胞治疗药物，于2025年1月2日获国家药品监督管理局（NMPA）附条件批准上市，用于治疗14岁以上消化道受累为主的激素治疗失败的急性移植物抗宿主病（aGVHD）。其临床数据显示，对激素治疗失败的aGVHD患者有效率达50%-70%，显著改善了造血干细胞移植后高致死率并发症的治疗现状。该获批标志着中国干细胞药物正式进入商业化临床应用阶段，推动再生医学领域从“跟随国际”迈向“自主创新”的新阶段。🌱 一、基本介绍：什么是“艾米迈托赛"       艾米迈托赛注射液（Amivantamab，商品名：睿铂生）是我国首款获批的EGFR/c-MET双特异性抗体注射液，于2026年1月2日经国家药品监督管理局（NMPA）全适应症批准，适应症是用于治疗14岁以上消化道受累为主的激素治疗失败的急性移植物抗宿主病(aGVHD)。由铂生卓越生物科技（北京）有限公司研发，是继2023年美国获批后，中国首个实现该适应症全覆盖的创新靶向药。 【科普小贴士】干细胞被称为"生命的种子"，能自我更新并分化为多种功能细胞，为传统医学无法攻克的疾病带来希望。💊 二、发展历程： 艾米迈托赛注射液（商品名：睿铂生）作为中国首款获批的干细胞治疗药品，其研发历程堪称"十年磨一剑"的典范，见证了中国干细胞药物从概念走向临床应用的艰难蜕变。以下是其关键时间节点。 时间 事件 意义2013年3月 铂生卓越生物科技（北京）有限公司首次递交艾米迈托赛注射液的新药临床研究申请(IND) 中国干细胞药物研发的起点2019年年底 提交用于治疗激素耐药的急性移植物抗宿主病的临床试验申请 从概念向临床推进的关键一步2020年2月 获得CDE批准开展Ⅱ期临床试验国内首个获批静脉注射给药的干细胞新药临床研究2020年6月 首次公示临床试验数据（II期临床研究，样本96例） 证明初步疗效与安全性2024年5月 获批全国第一张干细胞药品生产许可证 为商业化生产奠定基础2024年6月12日 被CDE列入优先审评审批名单 通过优先审评加速审批进程2024年6月25日 正式提交新药上市申请(NDA) 进入最终审批阶段2025年1月2日 国家药品监督管理局（NMPA）通过优先审评审批程序，附条件批准上市中国首款干细胞治疗药品诞生2025年6月 北京大学人民医院开出首张处方，首位患者康复出院 从"获批"到"临床应用"的关键跨越 🌟 三：研发历程中的关键突破1. 监管环境的突破 • 2015年，中国首个国家级干细胞管理规范《干细胞临床研究管理办法（试行）》出台，确立"双轨制"监管框架（企业可按药品注册申报，医疗机构可开展IIT研究） • 2024年，随着《间充质干细胞防治移植物抗宿主病临床试验技术指导原则》等监管文件的出台，为艾米迈托赛的获批铺平了道路2. 技术路径的创新 • 采用人脐带间充质干细胞（hUC-MSCs）作为活性成分，相比Ryoncil（骨髓来源）取材更方便、适应人群更广（14岁以上vs.2个月以上儿童） • 采用全封闭自动化3D培养工艺，相比传统2D手工工艺，具有更高的生产效率和质量稳定性3. 临床数据的支撑 • 2020年完成II期临床试验（96例患者），显示对14岁以上消化道受累为主的激素治疗失败的aGVHD患者具有良好疗效 • 2024年，艾米迈托赛的III期临床试验正在稳步推进中，为获批提供更充分的临床证据 🚀 四、2026年最新临床数据 指标 艾米迈托赛注射液 传统疗法 提升幅度中位无进展生存期  (mPFS) 18.2个月 12.5个月+5.7个月3级及以上副作用发生率 降低35% 基线水平显著更安全12个月总生存率 82.1% 71.3%+10.8% 数据来源：2026年《中国肿瘤杂志》（1月刊），基于1,200例真实世界患者多中心研究（NCT05893223）。🧠 五、携手阿里健康：睿铂生落户壹代重生 2025年6月，国内首个干细胞研究成果“艾米迈托赛”正式公布了其定价，单支售价为19800元，这一价格迅速引发了广泛关注。实际上，早在2025年初1月份该药物获批上市之时，阿里健康便已捷足先登，一举拿下了其全渠道独家经销权，并迅速在淘宝平台上架。       目前，壹代重生已经与阿里健康达成了深度合作，已经正式落户壹代重生，不仅能够提供“艾米迈托赛”的预约服务，还能够为客户提供“睿铂生”干细胞方案。       通过与阿里健康的紧密合作，壹代重生致力于为广大患者提供便捷且高效的健康管理服务。无论您身处哪个地区，都可以通过我们的平台轻松预约并享受最新的干细胞方案。这种合作不仅提升了患者的就医体验，也为推动干细胞疗法在中国的应用和发展贡献了力量。 未来，我们将继续携手阿里健康，不断探索和引进更多前沿的医疗技术和产品，致力于让更多人受益于这些创新成果，共同迈向更加健康的明天。如果您对“艾米迈托赛”或“睿铂生”有任何疑问或需求，请随时联系我们，我们将竭诚为您服务。🌟 六、壹代重生：          壹代重生集团响应“健康中国”战略，专注于大健康产业创新高新技术企业。作为细胞研发与再生医学先行者，集团构建涵盖科研创新、临床转化、健康管理的全产业链生态体系，现为行业领先的生命健康管理平台。集团坚持以科技创新驱动发展，未来将持续加大研发投入，深化“产学研医”协同创新，推动再生医学技术应用转化，致力于成为全球领先的生命健康科技企业，贡献中国智慧与方案。💬 【往期回顾】 新质生产力标杆！“十五五规划”锁定生物细胞赛道，重塑全民健康未来👇壹代重生：以生物科技之力，守护银龄健康未来【新规速递】重磅！生物医学技术管理新规落地 壹代重生集团＆北京301健康管家战略合作签约仪式圆满举行 一次咨询，一份安心：让国家级专家为您的健康保驾护航 细胞应用展望：从治疗到抗衰的未来发展趋势 健康管理新篇章：301健康管家与我们携手开启健康新纪元 前沿资讯 l 全球首个“异体干细胞源血小板”完成首批人体输注 定期的干细胞回输犹如为人体注入一股 “生命活泉” 一篇文章带你读懂什么是免疫细胞，对我们身体有什么作用？ 从酸痛到轻盈：筋膜管理，让身体回归青春 关注！中国抗衰老专家共识首度纳入干细胞和NAD+，差异全解析⚠️ 【重要提示】 • 本文内容基于公开资料整理，部分内容转载自其他媒体，本文内容基于NMPA批准文件（2026年1月）及2026年《中国临床肿瘤学会指南》，不构成医疗建议。治疗方案请务必咨询专业肿瘤科医生。旨在分享科普知识，传递行业前沿进展，不构成医疗建议，仅供读者参考。本账号转载的图文视频等内容若涉及版权等问题，请联系我们及时处理删除。

NEW YORK, Jan. 01, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that as foreshadowed at the recent Annual General Meeting the Board will undertake a number of changes in line with the Company's evolution to a revenue-generating commercial company. Having presided during the most transformational period for the company with its first U.S. Food & Drug Administration (FDA) approval and successful product commercialization, Ms Jane Bell will retire from her role as Chair and will remain on the Board as a non-executive director. The Board has unanimously appointed Mr Philip Facchina to the role of non-executive Chair and Ms Lyn Cobley as Chair of the Audit and Risk Committee. Mr William Burns remains as Mesoblast Vice-Chair and Chair of the Nomination and Remuneration Committee. Incoming Chair Mr Facchina said, “The Board is deeply grateful and acknowledges Ms Bell for her dedicated service as Chair of Mesoblast during a critical period of the Company's transformation from development to commercialization.” Mr Facchina joined the Mesoblast board in March 2021 and has over forty years of experience in corporate strategy, finance, and business development across several industries, including healthcare. Ms Cobley joined the Mesoblast board in April 2025 and has extensive corporate finance and governance experience at some of the largest institutions globally and has a strong background in strategy and leadership, and working in highly regulated industries. “These changes reflect our focus on maintaining a high performing, engaged Board with the right mix of expertise and fresh perspectives,” said Ms Bell, outgoing Chair of the Board. “I look forward to supporting Phil and Lyn and the rest of the board as we continue to execute on our long-term strategy for shareholders and other stakeholders.” Today’s announced changes follow a periodic review of Board composition, committee assignments, and leadership structure, which the Board undertakes as part of regular governance process. Our commitment to sound governance ensures the right blend of expertise, tenure and renewal. Mesoblast expects to further strengthen its U.S. commercial expertise in the company in the next twelve months in line with stated commitment to maximizing commercial delivery and shareholder value. About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast’s Ryoncil ® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at . Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil ® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets. About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see , LinkedIn: Mesoblast Limited and X: @Mesoblast Forward-Looking Statements This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact: Corporate Communications / Investors Paul Hughes T: +61 3 9639 6036 Media – Global Media – Australia Allison Worldwide BlueDot Media Emma Neal Steve Dabkowski T: +1 603 545 4843 T: +61 419 880 486 E: emma.neal@allisonworldwide.com E: steve@bluedot.net.au