高效入组，里程碑达成！麦科奥特MT200605 II期临床研究完成全部360例受试者入组

急性缺血性卒中是由于脑内血管突然闭塞导致的一系列神经功能损伤症状，具有高发病率、高致残率和高死亡率的特点。据2021年全球疾病负担（GBD）研究显示，全球新发卒中事件约1190万例，卒中患病人数达9380万例，卒中已成为全球第三大死亡原因（占总死亡的10.7%）和第四大致残原因（占总残疾调整生命年的5.6%）。

中国是全球卒中负担最重的国家之一。2021年，中国新发卒中事件约780万例，占全球新发卒中的74.7%；卒中患病人数约2633.5万例，占全球的28.1%；卒中死亡人数约259.2万例，占全球的35.5%。缺血性卒中后，脑内发生一系列病理生理变化，包括脑血流减少引发的神经元凋亡、炎症反应、氧化应激及血脑屏障破坏等，最终导致神经功能缺损。

目前，中国国家药品监督管理局（NMPA）在《急性缺血性脑卒中治疗药物临床试验技术指导原则》中指出，除溶栓类药物外，神经保护剂的疗效尚缺乏充分临床证据支持。《中国急性缺血性卒中诊治指南2023》虽推荐部分神经保护剂（如依达拉奉右莰醇、银杏内酯等），但仅为II级推荐/B级证据。因此，缺血性卒中患者的神经保护治疗仍存在巨大未满足需求，亟需探索新机制与新靶点。

MT200605是陕西麦科奥特医药科技股份有限公司自主设计、合成的单体小分子化合物，是一种受体酪氨酸激酶B（TrkB）激动剂，具有脑源性神经营养因子（BDNF）样作用。其通过激活TrkB，调节下游信号通路，保护脑神经组织结构和功能；同时可增强线粒体ATP合成，发挥抗氧化和清除氧自由基的作用，有望在急性缺血性卒中等多种神经系统疾病中提供治疗新选择。

高效入组：关键里程碑

组长单位立项审查：2025年8月6日，项目顺利完成组长单位——首都医科大学附属北京天坛医院的立项审查。

首例入组：2025年9月30日

末例入组：2026年3月20日

总入组例数：360例 / 360 subjects

入组时长：约5.5个月（173天）

从首例入组到全部入组完成，项目团队仅用时173天，入组速度远超预期。这一高效推进，得益于组长单位及全国各参研中心研究团队的鼎力支持，以及我司在运营管理、监查及供应链保障上的高效协同。

Acute ischemic stroke is a condition characterized by a series of neurological deficits caused by sudden occlusion of cerebral blood vessels. It is associated with high incidence, high disability, and high mortality rates. According to the 2021 Global Burden of Disease (GBD) study, there were approximately 11.9 million new stroke events and 93.8 million prevalent stroke cases globally. Stroke has become the third leading cause of death (accounting for 10.7% of total deaths) and the fourth leading cause of disability (accounting for 5.6% of total disability-adjusted life years) worldwide.

China is one of the countries with the highest stroke burden globally. In 2021, there were approximately 7.8 million new stroke events in China, accounting for 74.7% of new strokes worldwide; the number of prevalent stroke cases was about 26.335 million, representing 28.1% of the global total; and stroke-related deaths numbered approximately 2.592 million, accounting for 35.5% of the global total. After ischemic stroke, a series of pathophysiological changes occur in the brain, including neuronal apoptosis, inflammatory responses, oxidative stress, and disruption of the blood–brain barrier due to reduced cerebral blood flow, ultimately leading to neurological deficits.

Currently, the National Medical Products Administration (NMPA) of China, in its “Technical Guidelines for Clinical Trials of Drugs for Acute Ischemic Stroke,” notes that apart from thrombolytic agents, the efficacy of neuroprotective agents lacks sufficient clinical evidence. Although the “Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023” recommends some neuroprotective agents (such as edaravone dexborneol and ginkgolides), these are only Level II recommendations with Grade B evidence. Therefore, there remains a significant unmet need for neuroprotective therapies in patients with acute ischemic stroke, and exploration of new mechanisms and new targets is urgently needed.

MT200605 is a small molecule compound independently designed and synthesized by Shaanxi Micot Medical Technology Co., Ltd. It acts as a tropomyosin receptor kinase B (TrkB) agonist with brain-derived neurotrophic factor (BDNF)-like effects. By activating TrkB, it modulates downstream signaling pathways to protect the structure and function of brain neural tissues. Additionally, it enhances mitochondrial ATP synthesis and exerts antioxidant effects by scavenging oxygen free radicals. MT200605 holds promise as a novel therapeutic option for acute ischemic stroke and other neurological disorders.

Efficient Enrollment: Key Milestones

Lead Site Initiation Review：On August 6, 2025, the study successfully completed the initiation review at the lead site, Beijing Tiantan Hospital, Capital Medical University.

First Subject In：September 30, 2025

Last Subject In：March 20, 2026

Total Enrolled Subjects：360 subjects

Enrollment Duration：Approximately 5.5 months (173 days)

From the first subject enrolled to the completion of full enrollment, the project team achieved this in just 173 days—a pace far exceeding expectations. This efficient execution was made possible by the strong support from the lead site and all participating clinical centers, as well as the effective coordination of our company in operational management, monitoring, and supply chain support.