抗凝逆转的“通用解药”：麦科奥特MT1011完成I期临床，剑指临床痛点

MICOT

全球约4.23亿心血管疾病患者中，约1500万人使用新型口服抗凝药（NOACs）。然而，每种NOACs均有

颅内及胃肠道出血风险，按严重出血年发生率1%-3%计算，全球每年新增15-45万严重出血患者。

当前临床困境在于：唯一针对Xa因子抑制剂的逆转剂Andexanet alfa因30天血栓发生率约9.7%，已于2025年12月撤市；而Praxbind仅对达比加群酯有效，且为生物制剂、需冷藏、价格昂贵。临床亟需一款广谱、快速、安全的逆转剂——这正是麦科奥特MT1011瞄准的临床价值缺口。

MT1011是麦科奥特研发的一款新型合成的、作用机制独特的小分子药物。由于其独特作用机制，可以拮抗抗凝药使其失去抗凝活性，从而快速重建正常凝血。

2026年4月17日，MT1011的I期临床研究完成数据库锁定。该项目在首都医科大学附属北京世纪坛医院（单中心）开展，顺利完成了方案拟定的5个剂量组的递增试验。安全性揭盲结果（试验药物组）未出现与药物相关的SAE。这一安全性轮廓为后续II期临床奠定了良好基础。

麦科奥特将携手研究团队，尽早推进II期临床。抗凝逆转领域仍存在巨大未被满足的需求，MT1011的I期成功给患者和医者带来新希望。这款“中国智造”能否成为紧急时刻的“通用解药”？我们期待II期临床给出答案。

Among approximately 423 million cardiovascular disease patients worldwide, around 15 million are treated with novel oral anticoagulants (NOACs). However, all NOACs carry bleeding risks. Based on a 1%-3% annual incidence of severe bleeding, there are 150,000 to 450,000 new severe bleeding cases globally each year.

The clinical dilemma: Andexanet alfa, the only reversal agent for factor Xa inhibitors, was withdrawn in December 2025 due to a 9.7% 30-day thrombosis rate. Praxbind only targets dabigatran and is a costly biological agent requiring refrigeration. There is an urgent need for a broad-spectrum, rapid, and safe reversal agent—precisely the unmet need MT1011 aims to address.

MT1011 is a newly synthesized small-molecule drug with a unique mechanism of action developed by M. Thanks to its distinctive mechanism, it can antagonize anticoagulants to inactivate them and rapidly restore normal blood coagulation.

On April 17, 2026, the Phase I clinical study of MT1011 completed database lock. This study was conducted at Beijing Shijitan Hospital, Capital Medical University (single center), and successfully completed the dose-escalation trial of five dose groups as specified in the protocol. According to the unblinded safety results of the investigational drug group, with no drug-related serious adverse events (SAEs) reported. This favorable safety profile lays a solid foundation for the subsequent Phase II clinical trial.

Micot will collaborate with the research team to advance the Phase II clinical study as soon as possible. Significant unmet needs remain in the anticoagulation reversal field. The successful Phase I completion of MT1011 brings new hope to patients and clinicians. Can this domestically innovated product truly serve as a universal antidote in emergency situations? Phase II will provide the answer.