Mesoblast global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, and label extension for Ryoncil® (remestemcel-L-rknd) in adults with steroid refractory acute graft versus host disease (SR-aGvHD)..

Mesoblast是炎症性疾病同种异体细胞药物的全球领导者，今天提供了关于与美国食品药品监督管理局（FDA）持续进展的最新信息，涉及Revascor®（rexlemestrocel-L）在治疗射血分数降低（HFrEF）和炎症的缺血性慢性心力衰竭患者中的加速审批通道，以及Ryoncil®（remestemcel-L-rknd）在类固醇难治性急性移植物抗宿主病（SR-aGvHD）成人患者中的标签扩展。

In the first week of June, Mesoblast held a Type B meeting with FDA under its Regenerative Medicines Advanced Therapy (RMAT) designation for REVASCOR to discuss components of a potential filing for a Biologics License Application (BLA). There was general alignment on items regarding chemistry, manufacturing & controls (CMC), potency assays for commercial product release, and proposed design and primary endpoint for the confirmatory trial post-approval.

6月的第一周，Mesoblast 在其再生医学先进疗法（RMAT） designation 下与 FDA 举行了一次 B 型会议，讨论了 REVASCOR 的生物制品许可申请（BLA）潜在提交的组成部分。在化学、制造和控制（CMC）、商业产品放行的效力测定以及批准后确证试验的拟议设计和主要终点等方面达成了大致一致。

The Company will await the final minutes from FDA in order to provide detailed feedback and timelines for potential filing..

公司将会等待FDA的最终会议记录，以便提供详细的反馈和潜在备案的时间表。

In early July, Mesoblast has an upcoming meeting with FDA to discuss a pivotal trial of Ryoncil® in adults with SR-aGvHD. This trial will be conducted with the NIH-funded Bone Marrow Transplant Clinical Trials Network (BMT-CTN), the objective being to extend the product’s label from children to adults with SR- aGvHD.

七月上旬，Mesoblast将与FDA举行会议，讨论Ryoncil®在SR-aGvHD成人患者中的关键试验。该试验将在NIH资助的骨髓移植临床试验网络（BMT-CTN）进行，目标是将该产品的适应症从儿童扩展到SR-aGvHD成人患者。

Ryoncil® is the first and only mesenchymal stromal cell product approved by the FDA for any indication..

Ryoncil® 是首个也是唯一一个获得 FDA 批准的用于任何适应症的间充质基质细胞产品。

Ryoncil® became commercially available for purchase in the United States on March 28, 2025, within one quarter of receiving FDA approval to treat children with SR-aGvHD. More than 20 transplant centers will have been onboarded by the end of the quarter, exceeding the company’s expectations at product launch.

Ryoncil® 在获得 FDA 批准治疗患有 SR-aGvHD 的儿童后一个季度内，于 2025 年 3 月 28 日在美国上市销售。在本季度末之前，将有超过 20 家移植中心被纳入使用，超出了公司产品发布时的预期。

Mesoblast has continued to expand coverage for Ryoncil® to over 220 million US lives insured by commercial and government payers. To date, 37 of the 51 States provide fee-for-service Medicaid coverage for Ryoncil® through Orphan Drug Lists or medical exception / prior authorization (PA) process. The remainder will come online July 1, 2025, with mandatory coverage for all 24 million lives..

Mesoblast继续扩大Ryoncil®的覆盖范围，目前已覆盖超过2.2亿美国商业保险和政府支付方保障的生命。截至目前，51个州中有37个州通过孤儿药清单或医疗例外/事先授权（PA）流程为Ryoncil®提供按服务付费的医疗补助覆盖。其余州将于2025年7月1日上线，届时将强制覆盖所有2400万生命。

“We are very pleased with the momentum of interactions with FDA on both our cardiac and GvHD programs,” said Mesoblast Chief Executive Dr. Silviu Itescu. “We are also encouraged by the strength of the of the Ryoncil® commercial launch, the rate of hospital onboarding, physician adoption, and payor coverage exceeding our expectations in the ten weeks since commercial launch.

“我们对与FDA在心脏和GvHD项目上的互动进展感到非常满意，”Mesoblast首席执行官Silviu Itescu博士表示。“自Ryoncil®商业上市以来的十周内，其商业推出的力度、医院的加入速度、医生的采用率以及支付方的覆盖范围都超出了我们的预期，这也让我们备受鼓舞。”

We will be providing an update on sales of Ryoncil® in our quarterly activities report at the end of next month.”.

我们将在下个月底的季度活动报告中提供Ryoncil®销售情况的更新。

About Mesoblast

关于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（公司）是开发用于治疗严重和危及生命的炎症性疾病的同种异体（现成）细胞药物的世界领导者。公司专有的间充质谱系细胞治疗技术平台的疗法通过释放抗炎因子来应对严重炎症，这些因子能够对抗并调节免疫系统的多个效应分支，从而显著减轻破坏性的炎症过程。

Mesoblast’s RYONCIL® (remestemcel-L) 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 www.ryoncil.com.

Mesoblast公司的RYONCIL®（remestemcel-L）用于治疗两个月及以上的儿童类固醇难治性急性移植物抗宿主病（SR-aGvHD），是首个获得FDA批准的间充质基质细胞（MSC）疗法。请访问www.ryoncil.com查看完整的处方信息。

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

Mesoblast致力于基于其remestemcel-L和rexlemestrocel-L同种异体基质细胞技术平台，开发用于不同适应症的其他细胞疗法。RYONCIL正被开发用于其他炎症性疾病，包括成人SR-aGvHD和对生物制剂耐药的情况。

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.

炎症性肠病。Rexlemestrocel-L 正在开发用于心力衰竭和慢性腰痛。该公司已在日本、欧洲和中国建立了商业合作伙伴关系。

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 are expected to provide commercial protection extending through to at least 2041 in major markets..

关于Mesoblast的知识产权：Mesoblast拥有强大而广泛的全球知识产权组合，已获得超过1,000项专利或专利申请，涵盖间充质基质细胞成分、制造方法和适应症。这些已授予的专利和专利申请预计将在主要市场提供至少到2041年的商业保护。

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.

关于Mesoblast的生产：公司专有的生产流程产出工业化规模、冷冻保存、可立即使用的细胞药物。这些细胞疗法具有明确的药物释放标准，计划在全球范围内让患者随时可用。

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 www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast

Mesoblast 在澳大利亚、美国和新加坡设有分支机构，并在澳大利亚证券交易所 (MSB) 和纳斯达克 (MESO) 上市。欲了解更多信息，请访问 www.mesoblast.com、LinkedIn: Mesoblast Limited 和 X: @Mesoblast。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含与未来事件或我们未来财务表现相关的前瞻性陈述，这些陈述涉及已知和未知的风险、不确定性以及其他可能导致我们的实际结果、活动水平、表现或成就与这些前瞻性陈述中明示或暗示的任何未来结果、活动水平、表现或成就存在重大差异的因素。

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.

我们根据《1995年私人证券诉讼改革法案》及其他联邦证券法的安全港条款作出这些前瞻性陈述。前瞻性陈述不应被解读为对未来业绩或结果的保证，实际结果可能与这些前瞻性陈述中预期的结果不同，且差异可能重大且不利。

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 c.

前瞻性声明包括但不限于以下方面的声明：Mesoblast公司临床前和临床研究的启动、时间、进展和结果，以及Mesoblast的研发计划；Mesoblast将候选产品推进至临床研究、招募患者并成功完成临床研究（包括多国临床试验）的能力；Mesoblast提升其生产能力的能力；监管文件和批准、生产活动及产品营销活动的时间或可能性（如有）；Mesoblast的RYONCIL用于儿科SR-aGVHD的商业化以及其他任何获批准的候选产品；围绕干细胞疗法使用的监管或公众认知及市场接受度；如果Mesoblast的任何候选产品获批，可能因患者不良事件或死亡而被撤市的风险；战略合作的潜在益处等。

Corporate Communications / Investors

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Source: mesoblast.com

来源：mesoblast.com