Minovia Therapeutics has received Fast Track Designation from the US Food and Drug Administration (FDA) for its lead investigational therapy, MNV-201, in Myelodysplastic Syndrome (MDS).

米诺维亚治疗公司（Minovia Therapeutics）已获得美国食品药品监督管理局（FDA）对其主要研究性疗法MNV-201在骨髓增生异常综合征（MDS）中的快速通道资格。

MDS is an age-related blood disorder caused by ineffective blood cell production and genetic instability, which may progress to Acute Myeloid Leukaemia (AML). Patients often face a high symptom burden and an increased risk of complications. Minovia’s research suggests MDS may be linked to mitochondrial dysfunction, further supporting the company’s approach..

MDS是一种与年龄相关的血液疾病，由无效的血细胞生成和基因不稳定性引起，可能会进展为急性髓系白血病（AML）。患者通常面临较高的症状负担和并发症风险。Minovia的研究表明，MDS可能与线粒体功能障碍有关，进一步支持了该公司的研究方向。

MNV-201 is a first-in-class cell therapy based on Minovia’s Mitochondrial Augmentation Technology (MAT). The treatment involves introducing healthy mitochondria into a patient’s own stem cells to restore energy production, organ function, and overall health. Early clinical studies in Pearson Syndrome have indicated safety and potential multi-system benefits..

MNV-201 是一种基于 Minovia 的线粒体增强技术 (MAT) 的首创细胞疗法。该治疗涉及将健康的线粒体引入患者自身的干细胞中，以恢复能量生产、器官功能和整体健康。在 Pearson 综合征的早期临床研究中已显示出安全性和潜在的多系统益处。

This is the second FDA Fast Track recognition for MNV-201, which already holds Fast Track and Rare Paediatric Disease Designations for the treatment of Pearson Syndrome, a rare and life-threatening mitochondrial disorder affecting children. The therapy is currently under investigation in a Phase 2 clinical trial for Pearson Syndrome and a Phase Ib trial in low-risk MDS patients.

这是MNV-201获得的第二个FDA快速通道认定，该药物已拥有治疗Pearson综合征的快速通道和罕见儿科疾病认定。Pearson综合征是一种罕见且危及生命的儿童线粒体疾病。目前，该疗法正在针对Pearson综合征的二期临床试验和针对低风险MDS患者的Ib期试验中进行研究。

Six of the nine planned patients in the MDS study have already been treated..

MDS研究中计划的九名患者已有六名接受治疗。

Fast Track Designation is intended to speed up the development and review of medicines for serious conditions with unmet medical needs. It provides opportunities for closer interaction with the FDA, eligibility for priority review, and the option of rolling submission for a future Biologics License Application..

快速通道资格旨在加快针对未满足医疗需求的严重疾病的药物的研发和审查进程。它提供了与FDA更密切互动的机会，优先审查的资格，以及未来生物制品许可申请的滚动提交选项。

The company has also announced a definitive business combination agreement with Launch One Acquisition Corp., a special purpose acquisition company.

公司还宣布了与特殊目的收购公司Launch One Acquisition Corp.的最终业务合并协议。

Upon completion, expected in late 2025, the combined entity will continue as Minovia Therapeutics and list on Nasdaq under a new ticker symbol.

预计在 2025 年底完成合并后，合并后的实体将继续以 Minovia Therapeutics 的名义存在，并在纳斯达克上市，使用新的股票代码。