MT1002完成Ib/II期首例患者入组 急性缺血性卒中临床研究迈入新阶段

根据2025年《急性缺血性卒中的治疗进展》综述，AIS占我国新发卒中的69.6%~72.8%，患者基数庞大。患者每延误治疗1分钟，约有190万个脑细胞死亡。当前临床治疗以溶栓、取栓为主，但存在时间窗窄、出血风险高、无法全面阻止血栓进展等局限，因此阻止血栓进展、减少神经功能恶化，促进神经功能恢复，从而改善临床预后等药物需求迫切。

据摩熵医药数据显示，国内缺血性脑卒中急性期治疗药物市场规模巨大，近几年均保持在百亿元人民币以上，2023年市场规模已达129亿元。根据 The Business Research Company 的研究，AIS全球治疗市场规模在 2025 年已达到 101.2 亿美元，预计到 2030 年将以 9.1% 的复合年增长率增长至 156.8 亿美元。
 

面对巨大的临床需求和市场空间，MT1002的研发承载着重要的社会价值与商业潜力。麦科奥特此次推进关键临床试验，不仅是其研发管线的重要进展，更是向百亿级卒中治疗市场迈出的坚实一步。

MT1002是一款凝血因子II与GPIIb/IIIa双靶点拮抗剂，兼具抗凝与抗血小板双重作用。通俗而言，传统抗栓药常面临“防血栓易引发出血”的两难，MT1002通过双靶点协同，有望在有效抗栓的同时降低出血风险。

本次完成首例入组的Ib/II期临床试验是一项设计严谨、分两部分进行的多中心研究:

首例患者的成功入组，正是该试验第一部分的关键一步，为后续的临床数据积累和药物开发奠定了坚实基础。

麦科奥特在脑卒中领域并非单兵作战。进度更快的MT200605是一款神经保护剂，通过激活神经营养通路并清除有害自由基，帮助缺血脑细胞“存活”而非“坏死”，目前已率先完成II期360例入组。
 

MT1002负责急性期抗栓“堵住上游”，MT200605负责脑保护与功能恢复“守住下游”，两者形成完整的治疗时间轴覆盖，临床协同意义明确。

作为港股18A首家多肽创新药企，麦科奥特始终坚守践行“创新制药，守护健康，满足未被满足的临床需求”的企业使命。公司拥有7条临床管线，6款实现中美双申报。核心产品MT1013在临床III期阶段，就已与云顶新耀达成2亿元首付款+最高10.4亿元里程碑的BD合作，其中2亿元首付款已到账，验证了市场对公司管线的认可。

本次MT1002临床Ib/II期完成首例入组，连同MT200605已处于II期收尾阶段，麦科奥特在百亿美金级卒中治疗市场的“双管线”兑现节奏正逐步清晰。麦科奥特将秉持科学严谨的态度，加快推进MT1002临床的受试者入组与研究数据积累，力争早日为全球急性缺血性卒中患者提供更安全、更有效的创新治疗方案。

According to Advances in the Treatment of Acute Ischemic Stroke (2025), AIS accounts for 69.6%–72.8% of new stroke cases in China, representing a large patient population. For every one-minute treatment delay, approximately 1.9 million neurons are lost. Current clinical treatment mainly relies on thrombolysis and thrombectomy, but these approaches are limited by narrow therapeutic time windows, high bleeding risk, and an inability to fully prevent thrombus progression. Therefore, drugs that can prevent thrombus progression, reduce neurological deterioration, promote neurological recovery, and improve clinical prognosis are urgently needed.
 

According to Pharnexcloud data, China’s acute-phase ischemic stroke drug market is substantial, remaining above RMB 10 billion in recent years and reached RMB 12.9 billion in 2023. According to The Business Research Company's research，global AIS Therapeutics market size has reached USD $10.12 billion in 2025 and is expected to grow to$15.68 billion in 2030 at a compound annual growth rate of 9.1%.
 

Given this clinical need and market potential, MT1002 carries important social value and commercial potential. Micot’s advancement of this key clinical trial is not only an important milestone for its R&D pipeline, but also a solid step toward the RMB 10 billion-level stroke treatment market.

MT1002 is a dual antagonist of coagulation factor II and the GP IIb/IIIa receptor, primarily targeting clinical needs in anticoagulation and anti-thrombosis. In plain terms, conventional anti-thrombotic drugs often face the dilemma of preventing thrombosis while increasing bleeding risk. Through dual-target synergy, MT1002 has the potential to achieve effective anti-thrombotic effects while reducing bleeding risk.

The Phase Ib/II clinical trial that enrolled its first patient is a rigorously designed, two-part, multi-center study:

Successful first-patient enrollment represents a key step in Part 1 of the trial, laying a solid foundation for subsequent clinical data accumulation and drug development.

Micot is not advancing in the stroke field with a single program alone. Its more advanced asset, MT200605, is a neuroprotectant  that activates neurotrophic signaling pathways and eliminates harmful free radicals, helping ischemic brain cells “survive” rather than undergo “necrosis.” It has already completed enrollment of 360 patients in its Phase II trial.

MT1002 addresses acute-phase anti-thrombosis by addressing upstream thrombotic events, while MT200605 focuses on brain protection and functional recovery by supporting downstream recovery. Together, they cover the full treatment timeline, with clear clinical synergy.

As the first peptide innovative drug company listed under Chapter 18A on the HKEX, Micot has consistently upheld its corporate mission of “Innovate Medicines, Guard Health, Address Unmet Clinical Needs.” The Company has seven drug candidates had entered clinical trials in China and/or the United States,and six of which had completed dual regulatory filings in both jurisdictions. Its Core Product MT1013, currently in Phase III development, has entered into a business development (BD) collaboration with Everest Medicines, including an RMB 200 million upfront payment and up to RMB 1.04 billion in milestone payments. The RMB 200 million upfront payment has been received, validating market recognition of the Company’s pipeline.

With MT1002 completing first-patient enrollment in its Phase Ib/II trial, and MT200605 entering the final stage of Phase II, the value-realization timeline of Micot’s dual-pipeline strategy in the USD 10 billion-level stroke treatment market is becoming increasingly clear. Micot will continue to uphold a scientifically rigorous approach, accelerate patient enrollment and study data accumulation for MT1002, and strive to provide safer and more effective innovative treatment options for patients with AIS worldwide as early as possible.