Remestemcel-L-rknd

NEW YORK, Feb. 11, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided data presented at the February 2026 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR) in Salt Lake City, Utah. The study results showed that Ryoncil ® (remestemcel-L-rknd) achieved similarly high survival outcomes in steroid-refractory acute graft-versus-host disease (SR-aGvHD) irrespective whether used in children or adults, as second or third line, and in ruxolitinib naive or resistant patients. 1 Ryoncil ® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD). 2 Importantly, of the 53 patients with SR-aGvHD who received Ryoncil ® as ≥ third line treatment under the Emergency Investigational New Drug (EIND) program (89% grade III/IV disease), 15% died before being able to complete a full treatment course of Ryoncil ® compared with only 2% of patients who received Ryoncil ® as second-line in the Phase 3 trial MSB-GVHD001. These results emphasize the importance of using Ryoncil ® as early as possible after steroid resistance in acute GVHD in order to complete a full treatment course and maximize survival. Additionally, adult patients in the EIND program of Ryoncil ® had at least as favorable day 100 survival as children in the EIND program, providing strong support and rationale for the planned pivotal trial of early use of Ryoncil ® as part of the second-line treatment regimen in adults with severe SR-aGvHD. The trial is expected to commence enrollment this quarter after protocol approval by the trial's central Institutional Review Board (IRB). If successful, the trial will support label extension of Ryoncil ® for use in adults - a population approximately three times the size of the pediatric SR-aGvHD population. “Treatment initiation as early as possible is essential in order to give Ryoncil ® the best chance to save as many precious lives as possible,” said Mesoblast Chief Executive Dr. Silviu Itescu. "The Phase 3 trial in adults with SR-aGvHD will position Ryoncil ® as the earliest treatment regimen for severe disease after steroid resistance." 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 Twitter: @Mesoblast References / Footnotes Kurtzberg J, et al. Remestemcel-L-rknd (Ryoncil) Improves Survival After Failure of Second-Line Treatment for SR-aGVHD [Poster presentation]. 2026 Transplantation & Cellular Therapy Tandem Meetings Please see the full Prescribing Information at 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

故事要从一个简称说起：aGVHD（急性移植物抗宿主病）。这是造血干细胞移植后，免疫系统疯狂攻击患者自身的致命并发症。很长一段时间，对于激素治疗无效的患者，前方几乎是绝路。直到细胞药物出现。美国的Ryoncil在2024年获批，带来了希望，也带来了令人窒息的价格标签。几乎中国的“睿铂生”获批了。它带来了同样的希望，却附上了一张完全不同的账单。 价差的秘密，不在研发的取巧，而在产业的深处。是全产业链的贯通，将成本从悬崖边拉回地平线。想象一下：从一根捐赠的脐带开始，到一袋可以静脉输注的“活细胞药物”。这中间，是无数个精密环节的串联。上游的培养基、培养瓶、检测试剂，曾长期被国际巨头垄断，价格高昂且供应不稳。中游的生产，需要万级洁净车间、复杂的3D微载体培养系统、严苛的无菌操作。下游的质控、冷链运输、医院落地，每一个环节都关乎细胞的“活力”与患者的生死。 睿铂生的背后，是中国企业用十年时间，将这条链上的关键环节一一握在自己手中。原辅料，国产化了。生产成本因规模化与自动化下降逾60%。整个生产、质控、物流形成闭环，彻底规避了海外高昂的CDMO外包费用与供应链风险。这才有了定价的底气，也才有了进入“北京普惠健康保”特药目录，让患者最高报销65%的可能性。从“天价救命”到“普惠可及”，这不仅仅是商业的成功，更是产业能力对生命权的重新定义。 究竟是什么“细胞”，拥有如此魔力？ 细胞治疗，大体分为两大阵营：干细胞与免疫细胞。它们像人体自带的、两支性质不同的“特种部队”。干细胞的使命是“建设与调解”。它们可以分化成多种功能细胞，修补受损的组织；更厉害的是，它们能分泌各种因子，像智慧的“外交官”，调停过激的免疫风暴，为身体创造修复的环境。睿铂生就是这类“调解大师”的代表。 免疫细胞则是“防卫与攻击”。CAR-T疗法是其中的明星。医生从患者血液中提取出T细胞，在体外用基因工程给它装上能精准识别癌细胞的“导航头”（CAR），再大量扩增，回输到患者体内。这支经过武装的“特种部队”，便能精准追杀肿瘤细胞。自2017年首款产品上市以来，CAR-T已让许多濒临绝境的血液肿瘤患者重获新生。在中国，这一领域的发展堪称“狂飙”，短短四年已有超过8款产品上市，证明了中国产业化的惊人速度。 将活细胞变成标准化、可批量化生产的“药物”，是前所未有的挑战。这不仅仅是科学，更是复杂的工程学。细胞是活的，每一批都有细微差异。如何确保今天生产的第100袋细胞，和第一袋具有相同的治疗效力？生产工艺的丝毫变动，都可能改变细胞的特性。这就是细胞药生产的“黑箱”效应。因此，监管的门槛极高，药企必须提供海量数据，证明从供体筛选到最终产品的全流程，都稳健、可控、一致。 正是这种极高的壁垒，使得全产业链的布局不再是可选项，而是生存与竞争的必答题。我们看到，领先的企业正在向上游延伸，自主研发关键原辅料，打破“卡脖子”的瓶颈；在中游构建智能化、封闭式的生产线，用数据驱动来破解“黑箱”；在下游与顶级医院共建临床应用与研究中心，确保产品的价值能在临床被完美兑现。它们不再仅仅是药物研发公司，更是细胞治疗产业基础设施的提供者。 政策也在为这条贯通之路铺上最后的沥青。从国家层面清晰的药品监管路径，到天津、上海等地先行先试，出台精细化的地方支持条例，一个鼓励创新与严守安全底线并重的生态环境正在形成。资本的眼光更是雪亮的，它们正密集投向那些既拥有核心技术源头创新，又具备工艺放大与商业化落地能力的平台型企业。 未来已来。细胞治疗的战场，正从血液肿瘤扩展到实体瘤、自身免疫性疾病、神经退行性疾病等更广阔的领域。这意味着，一场更深刻的治疗革命正在酝酿。而决定这场革命最终能惠及多少人的，不再是单一的科研突破，而是从实验室到病房，那条漫长产业链上每一个环节的硬度、精度与协作效率。 当产业链完全贯通，成本曲线持续下降，我们今天仰望的“高科技疗法”，终将成为明天医院里可及的常规选项。这，或许才是细胞治疗商业化提速，带给人类最温暖的礼物。