获国际顶尖学术认可！继Ⅱ期临床突破MT200605再入选世界卒中大会口头报告

点击蓝字 关注我们

近日，麦科医药（2335.HK）拥有全球自主知识产权的注射用神经保护候选药物MT200605的非临床及I期研究结果，成功入选第18届世界卒中大会（18th World Stroke Congress，WSC 2026）口头报告。
 

本届大会将于2026年10月21日至23日在韩国首尔举行。
 

世界卒中大会由世界卒中组织（World Stroke Organization，WSO）主办，是全球卒中领域重要的国际学术交流平台，本届大会将汇聚全球卒中研究与临床实践领域的顶尖专家，集中展示卒中前沿研究、临床试验与创新治疗策略。

世界卒中组织WSO成立于2006年，是全球唯一专注于卒中的权威国际组织。
 

世界卒中大会的口头报告（Oral Presentation）的遴选竞争十分激烈。WSC 2026共收到1618篇摘要投稿。口头报告席位仅授予具有源头创新、拥有重要临床转化潜力的研究。成功入选，代表该研究在科学创新性、方法学质量和临床价值三个维度上均通过了国际同行专家的严格评审。
 

MT200605相关研究入选大会“FC01 – 基础科学、转化研究与生物标志物”专场，这是大会最核心的前沿学术板块之一。该结果充分说明：MT200605的上游—中游—下游三重协同作用机制设计，已经获得国际卒中领域的关注和认可。
 

与非临床、I 期研究登上WSC国际口头报告相呼应，MT200605 治疗急性缺血性脑卒中的 II 期临床试验也取得关键突破，研究顺利达到主要终点，结果兼具统计学显著性与临床意义。从早期基础转化成果登上国际顶级学术舞台，到 II 期临床拿到阳性循证证据，MT200605 逐步构建起完整证据链，为脑卒中神经保护提供了一条区别于传统思路的全新研发方向。

本次II期临床研究共纳入360例急性缺血性脑卒中（脑梗）患者，采用多中心、随机、双盲、安慰剂对照设计。主要疗效终点为治疗后第90天改良Rankin量表（mRS）评分达到0—1分的患者比例。
 

为什么mRS 0—1分如此重要？
 

mRS是卒中临床研究中全球公认的功能结局评价工具，也是美国FDA、欧洲EMA等监管机构认可的关键疗效指标。0—1分意味着患者在卒中90天后无明显功能障碍，或虽有症状但基本不影响日常活动。以“患者能否恢复相对独立的生活”作为疗效判定标准，比单纯看“血管通了没有”或“影像上梗死面积缩小了多少”，更能回答患者和家属最关心的问题。

顶线结果显示，中剂量组和高剂量组达到mRS 0—1分的患者比例均高于安慰剂组。其中，高剂量组患者获得良好功能结局的优势较安慰剂组提高100%以上，且组间差异具有统计学意义；各项次要疗效终点也呈现一致的积极趋势。

MT200605在II期阶段即显示出改善患者90天功能结局的积极信号。研究期间未发生与试验药物相关的严重不良事件，整体安全性和耐受性良好。

急性缺血性脑卒中始于脑血管闭塞，但患者能否恢复，并不只取决于血管是否重新开通。
 

缺血发生后，氧化应激、炎症反应及神经元损伤等系列病理损伤仍可能持续进展。即便大血管实现血流再通，部分患者仍会出现血管通了，但功能却没有同步恢复的现象。因此，神经保护药物并非替代溶栓或血管内治疗，而是在现有标准治疗基础上进一步发挥脑组织保护作用。
 

但这条研发道路极其艰难。
 

2006年发表于《Annals of Neurology》的一项系统梳理共纳入1,026种急性卒中实验性治疗，其中仅114种曾进入临床研究，另有912种停留在动物实验阶段。2008年的综述进一步指出，截至当时，全球已开发超过1,000种神经保护候选化合物、开展超过100项临床试验，却尚无一种在患者中证实疗效。
 

2020年的一项系统比较显示，报告阳性主要结局的比例，从动物研究的约69%降至早期临床的32%，到III期仅为6%。截至目前，欧美仍无获批用于急性缺血性脑卒中的神经保护药物，亚洲部分已上市或使用的相关药物也仍缺乏国际公认的高等级循证支持。

也正因如此，MT200605在II期阶段以90天功能结局为主要终点，并在高剂量组取得统计学显著差异，在急性脑卒中神经保护领域相当难得。

凭借差异化的多重作用机制，MT200605有望打破神经保护药物长期转化失败魔咒，真正实现从基础药理保护到患者长期功能获益的跨越。

MT200605并非只干预缺血性脑损伤的某一个环节，而是围绕进入脑组织、覆盖复杂损伤链条并支持后续修复进行系统性设计。

2026年，麦科奥特与首都医科大学附属北京天坛医院共同参与“心脑血管栓塞性疾病防治创新药物研发及临床试验”创新药物研发国家科技重大专项。在该专项中，麦科奥特重点负责MT200605治疗急性缺血性脑卒中的临床开发及试验验证工作。
 

国家科技重大专项看重药物的源头创新与亟待满足的重大临床需求；II期临床试验回答的是创新机制能否真正转化为患者实实在在的临床获益；而入选WSC口头报告，则让MT200605的研究成果获得与全球卒中领域顶尖专家开展专业对话交流的机会。
 

从获得国家级战略项目支持，到随机对照临床试验的数据验证，再到国际权威学术平台，MT200605一步步夯实从源头创新到临床转化的全套研发证据。

根据大会安排，MT200605相关研究将于2026年10月21日在“基础科学、转化研究与生物标志物”专场进行口头报告。

报告题目：
MT200605: A Novel Bifunctional Neuroprotectant for Ischemic Stroke

专场名称：
FC01 – Basic Science, Translational Research & Biomarkers
报告时间：2026年10月21日 08:00—09:30
报告地点：韩国首尔COEX会议中心，Conference Room 201

期待2026年10月首尔，MT200605在世界卒中大会舞台上，向全球卒中领域专家展现中国原创的神经保护研究成果。

Recently, the nonclinical and Phase I results of MT200605, a proprietary injectable neuroprotective candidate developed by Shaanxi Micot Pharmaceutical Technology Co., Ltd. (2335.HK; “Micot”), were accepted for an Oral Presentation at the 18th World Stroke Congress (WSC 2026).
 

The Congress will take place October 21–23, 2026, in Seoul, Republic of Korea.
 

Organized by the World Stroke Organization (WSO), the World Stroke Congress is a major international stroke forum. WSC 2026 will bring together leading stroke researchers and clinicians worldwide to present cutting-edge research, clinical trials, and innovative therapies.

Founded in 2006, the World Stroke Organization (WSO) is the only global organization solely focused on stroke and an international authority in the field.
 

Selection for a WSC Oral Presentation is highly competitive. WSC 2026 received 1,618 abstracts, with oral slots reserved for studies showing original innovation and strong translational potential. Acceptance signifies that the research passed rigorous international peer review for scientific innovation, methodological quality, and clinical value.
 

The MT200605 research was selected for “FC01 – Basic Science, Translational Research & Biomarkers,” one of the Congress’s core scientific sessions. This recognition shows that MT200605’s tripartite synergistic mechanism spanning upstream, midstream, and downstream processes has gained international attention and recognition.
 

Alongside its nonclinical and Phase I research being accepted for a WSC oral presentation, the Phase II trial of MT200605 in acute ischemic stroke also achieved a key breakthrough, meeting its primary endpoint with both statistical significance and clinical relevance. From early translational findings reaching a leading international scientific stage to positive Phase II clinical evidence, MT200605 is building a comprehensive evidence chain and offering a new direction for stroke neuroprotection distinct from conventional approaches.

The Phase II trial enrolled 360 patients with acute ischemic stroke in a multicenter, randomized, double-blind, placebo-controlled design. The primary efficacy endpoint was the proportion of patients achieving a modified Rankin Scale (mRS) score of 0–1 at Day 90.
 

Why is an mRS score of 0–1 so important?
 

The mRS is a globally accepted functional outcome measure in stroke trials and a key efficacy measure recognized by regulators including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). A score of 0–1 means that, 90 days after stroke, a patient has no significant disability, or symptoms that do not substantially affect daily activities. Assessing efficacy by whether patients can regain relatively independent lives addresses what matters most to patients and families more directly than whether a vessel has reopened or how much infarct volume has decreased on imaging.

Top-line results showed higher proportions of patients achieving mRS 0–1 in both the medium- and high-dose groups than in the placebo group. Notably, the benefit in achieving a favorable functional outcome in the high-dose group was more than 100% greater than with placebo, with a statistically significant between-group difference. Secondary efficacy endpoints also showed consistently favorable trends.
 

These findings indicate a positive signal for MT200605 in improving 90-day functional outcomes as early as Phase II. No study drug-related serious adverse events occurred, and overall safety and tolerability were favorable.

Acute ischemic stroke begins with cerebral vascular occlusion, but recovery does not depend solely on whether the vessel is reopened.

After ischemia, pathological injury—including oxidative stress, inflammation, and neuronal injury—may continue. Even after successful large-vessel recanalization, some patients experience “the vessel is open, but function does not recover accordingly.” Neuroprotective therapies therefore do not replace thrombolysis or endovascular treatment, but provide additional brain protection on top of standard care.
 

Yet this development path is exceptionally difficult.
 

A 2006 systematic analysis in Annals of Neurology identified 1,026 experimental treatments for acute stroke. Only 114 had entered clinical studies, while 912 remained in animal studies. A 2008 review further noted that, by then, more than 1,000 neuroprotective candidates had been developed worldwide and more than 100 clinical trials conducted, yet none had shown efficacy in patients.
 

A 2020 systematic comparison showed that the proportion of studies reporting a positive primary outcome fell from about 69% in animal studies to 32% in early clinical studies and only 6% in Phase III trials. To date, no neuroprotective drug has been approved in the U.S. or Europe for acute ischemic stroke, while some related drugs marketed or used in parts of Asia still lack internationally recognized high-level evidence.

Against this backdrop, MT200605’s use of 90-day functional outcome as the Phase II primary endpoint, with a statistically significant difference in the high-dose group, is particularly notable in acute stroke neuroprotection.

With its differentiated multi-mechanistic design, MT200605 has the potential to break the long-standing cycle of translational failure in neuroprotective drug development and bridge pharmacological neuroprotection to meaningful long-term functional benefit for patients.

MT200605 does not target a single step in ischemic brain injury. Instead, it was designed to reach brain tissue, cover the complex injury cascade, and support subsequent repair.
 

In 2026, Micot and Beijing Tiantan Hospital, Capital Medical University jointly participated in the National Science and Technology Major Project for Innovative Drug Development Project entitled “Development and Clinical Trials of Innovative Drugs for the Prevention and Treatment of Cardiovascular and Cerebrovascular Thromboembolic Diseases.” Under the project, Micot is primarily responsible for the clinical development and trial validation of MT200605 for acute ischemic stroke.
 

The National Science and Technology Major Project emphasizes original drug innovation and major unmet clinical needs. The Phase II trial addresses whether an innovative mechanism can translate into tangible patient benefit, while selection for a WSC oral presentation enables professional exchange on MT200605’s findings with leading stroke experts worldwide.
 

From national strategic project support, to randomized controlled trial validation, and then to an authoritative international scientific platform, MT200605 continues to strengthen the evidence supporting its path from original innovation to clinical translation.

According to the Congress program, the MT200605 research will be presented orally on October 21, 2026, during the “Basic Science, Translational Research & Biomarkers” session.

Presentation Title:
MT200605: A Novel Bifunctional Neuroprotectant for Ischemic Stroke
Session: FC01 – Basic Science, Translational Research & Biomarkers
Presentation Time: October 21, 2026, 08:00–09:30
Venue: Conference Room 201, COEX Convention & Exhibition Center, Seoul, Republic of Korea
 

We look forward to October 2026 in Seoul, when MT200605 will present China-originated advances in neuroprotection research to stroke experts worldwide at the World Stroke Congress.