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7月9日,麦科医药(02335.HK)自主研发的全球首个抗凝抗板双功能抗栓多肽药MT1002,用于血液透析患者抗凝的II期临床试验成功完成首例患者入组。这是继MT1002针对急性缺血性卒中Ib/II期完成首例入组后,该产品在另一重大适应症上的快速推进。短期内两大适应症相继完成入组里程碑,展现了麦科医药管线协同发力的研发效率。
透析抗凝:370万患者的“出血-缺血”平衡难题
对于终末期肾病患者而言,血液透析是维持生命的主要方式。中国接受血液透析的患者已从2020年的70万人增至2025年的110万人,复合年增长率超过10%,预计到2035年将达280万人;全球范围则从2020年的330万人增至2025年的370万人,预计2035年将达550万人。
然而,透析患者长期面临一个棘手难题:体外循环管路容易激活凝血系统,导致透析器堵塞,必须使用抗凝剂;但抗凝过度又会引发出血风险。
目前最常用的抗凝剂是普通肝素,但其存在剂量个体差异大、出血风险高、可诱发肝素诱导的血小板减少症(HIT)等严重问题。据统计,初次接触肝素后II型血小板减少症发病率约3%-5%,是一种可能危及生命的并发症。市场急需更安全、更可控的抗凝方案。
MT1002:全球首个抗凝抗板双功能抗栓多肽药
MT1002是目前全球首个进入临床阶段兼具抗凝和抗血小板聚集双重作用的抗栓多肽药物,同时靶向凝血因子II和血小板糖蛋白IIb/IIIa受体。
通俗理解,传统肝素是“单靶点”作战,难以精准平衡“防堵”与“出血”的矛盾。MT1002则通过“一药双靶”协同设计,在抑制血栓形成的同时尽量降低出血风险。其临床优势包括:起效早、给药方便、无需频繁监测凝血指标、肝肾功能损害患者无需调整剂量、停药后凝血功能迅速恢复。
图片来自麦科医药招股书
II期临床两阶段设计:先探索最佳剂量,再验证优效性
本次MT1002-II-C05研究为一项在中国开展的两阶段、多中心II期临床试验。第一阶段为单臂剂量探索阶段,目的是找到MT1002在血液透析患者中的最佳有效剂量;第二阶段为随机、阳性对照(普通肝素)验证阶段,验证MT1002与肝素相比是否具有抗凝优效性。
此次完成的首例入组,属于第一阶段的里程碑事件,标志着该研究正式迈入实质性受试者给药阶段。
管线梯队有序:七款临床管线分层推进
MT1002的快速推进并非孤例,而是麦科医药“晚期兑现、中期成长、早期储备”完整管线梯队的缩影。公司目前拥有7款临床阶段管线,其中6款实现中美双申报,是国内多肽创新药领域临床管线数量最多且技术领先的企业。
在临近商业化的后期管线中,核心产品MT1013治疗慢性肾病继发性甲旁亢,已完成III期患者全部入组,预计2027年初提交上市申请。该产品已于2026年与云顶新耀达成商业化合作,首付款加里程碑金额最高达12.4亿元,其中2亿元首付款已到账。
在II期临床阶段,MT1002正同步推进血液透析抗凝、急性缺血性卒中、ACS-PCI三大适应症的II期临床开发。另一款脑卒中管线MT200605(神经保护剂)已完成II期360例患者全部入组。同时,获批适应症药物性肝损伤、代谢功能障碍相关脂肪性肝病及胆汁淤积性肝病的MT2004也处在II期临床试验阶段。
在I期临床阶段,XTL6001是全球首个在中美均获批临床的GLP-1R/GCGR/MasR三重激动剂,其创新引入了MasR靶点,带来独特的肾脏保护优势,从而将适应症从减重自然延伸至慢性肾脏病合并蛋白尿等疾病,补足了GLP-1单靶药物在肾病获益上的疗效短板。
此外,公司还拥有MT1009(骨质疏松)、MT1011(抗凝逆转剂)等已进入临床阶段的在研药物管线,及多条尚未进入临床试验阶段的早期管线,形成了丰富且具有梯度的差异化产品布局。
四大自研平台支撑,差异化管线持续兑现
麦科医药的高效多肽研发优势根植于其自主搭建的四大技术平台——双/多特异性肽及其大分子技术平台、计算器辅助肽设计平台、成药性评价平台及口服肽递送平台,形成了从靶点发现到产业化的全链条能力。依托这一平台体系,公司在肾病、代谢、心脑血管等多个慢病领域构建起差异化的管线矩阵。
此次MT1002透析抗凝适应症II期完成首例入组,是公司登陆港交所后管线推进的又一关键信号。一周内两大适应症相继完成临床首例入组里程碑,连同MT200605处于II期收尾阶段、MT1013Ⅲ期临床稳步推进并提前兑现商业化,麦科医药在未被满足的临床需求市场布局中不断验证“科学经营与自我造血能力并重”的差异化路径。
未来,麦科医药将持续践行“创新制药,守护健康,满足未被满足的临床需求”的企业使命,加快推进MT1002透析抗凝临床研究,力争早日为全球终末期肾病患者提供更安全、更有效的抗凝治疗方案。
MICOT
On July 9, Micot Pharma (02335.HK) announced that the Phase II clinical trial of MT1002, the world's first dual-function antithrombotic peptide with both anticoagulant and antiplatelet activities independently developed by the Company for anticoagulation during hemodialysis, successfully enrolled its first patient. This milestone followed the first patient enrollment in the Phase Ib/II clinical trial of MT1002 for acute ischemic stroke , marking the rapid advancement of MT1002 in another major therapeutic indication. With first-patient enrollment milestones achieved in two major indications, Micot Pharma further demonstrated the efficient execution of its clinical development strategy and the strong momentum of its innovative pipeline.
Hemodialysis Anticoagulation: Balancing Bleeding and Thrombosis in 3.7 Million Patients Worldwide
Hemodialysis is the primary life-sustaining therapy for patients with end-stage kidney disease (ESKD). In China, the number of patients receiving hemodialysis has increased from approximately 700,000 in 2020 to 1.1 million in 2025, representing a compound annual growth rate (CAGR) of more than 10%, and is projected to reach 2.8 million by 2035. Globally, the hemodialysis population has grown from approximately 3.3 million in 2020 to 3.7 million in 2025 and is expected to reach 5.5 million by 2035.
Despite advances in dialysis therapy, anticoagulation during hemodialysis remains a longstanding clinical challenge. Contact between blood and the extracorporeal circuit activates the coagulation cascade, increasing the risk of dialyzer clotting and necessitating the use of anticoagulants. However, excessive anticoagulation may substantially increase the risk of bleeding.
Unfractionated heparin (UFH) remains the most widely used anticoagulant in clinical practice. However, its use is associated with considerable interpatient variability in dose response, an increased risk of bleeding, and the potential to induce heparin-induced thrombocytopenia (HIT). The incidence of Type II HIT following initial exposure to heparin has been reported to be approximately 3%–5%, representing a potentially life-threatening complication. Consequently, there remains a significant unmet clinical need for safer and more controllable anticoagulation strategies.
MT1002: The World's First Dual-Function Antithrombotic Peptide with Both Anticoagulant and Antiplatelet Activities
MT1002 is the world's first clinical-stage antithrombotic peptide to combine both anticoagulant and antiplatelet activities in a single molecule. It simultaneously targets coagulation factor II* and the platelet glycoprotein IIb/IIIa (GPIIb/IIIa) receptor.
Unlike conventional heparin, which acts primarily through a single therapeutic target, MT1002 is designed with a dual-target mechanism to achieve a more balanced antithrombotic effect. By coordinately inhibiting both the coagulation cascade and platelet aggregation, MT1002 is designed to reduce thrombus formation while minimizing the risk of bleeding.
The potential clinical advantages of MT1002 include rapid onset of action, convenient administration, no requirement for routine coagulation parameter monitoring, no dose adjustment in patients with hepatic or renal impairment, and rapid recovery of coagulation function following treatment discontinuation.
Image source: Micot Pharma Prospectus
Two-Part Phase II Study Design: Dose-Finding Followed by Superiority Evaluation
The MT1002-II-C05 study is a two-part, multicenter Phase II clinical trial being conducted in China. The first part is a single-arm dose-finding phase designed to identify the optimal therapeutic dose of MT1002 for anticoagulation during hemodialysis. The second part is a randomized, active-controlled study using unfractionated heparin (UFH) as the comparator to evaluate whether MT1002 demonstrates superior anticoagulant efficacy compared with UFH.
The successful enrollment of the first patient marked a key milestone in the initial dose-finding phase and signified the formal initiation of patient dosing in the study.
A Well-Balanced Clinical Pipeline: Seven Clinical-Stage Programs Advancing Across Development Stages
The rapid advancement of MT1002 is not an isolated achievement, but rather reflects the strength of Micot Pharma's well-balanced pipeline strategy, spanning late-stage value realization, mid-stage growth, and early-stage innovation. The Company currently has 7 clinical-stage pipeline assets, 6 of which are under clinical development in both China and the United States, representing one of the most extensive and technologically advanced clinical peptide innovation pipelines in China.
Among its late-stage programs approaching commercialization, MT1013, the Company's lead candidate for the treatment of secondary hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD), has completed patient enrollment in its Phase III clinical trial and is expected to submit a New Drug Application (NDA) to China's National Medical Products Administration (NMPA) in early 2027.
Earlier in 2026, MT1013 entered into a commercialization agreement with Everest Medicines, with a total deal value of up to RMB 1.24 billion, including an upfront payment of RMB 200 million, which has already been received.
At the Phase II stage, MT1002 is being developed in parallel across three major indications: anticoagulation during hemodialysis, acute ischemic stroke, and acute coronary syndrome in patients undergoing percutaneous coronary intervention (ACS-PCI). Another stroke program, MT200605, a neuroprotective agent, has completed enrollment of all 360 patients in its Phase II clinical trial.
At the Phase I stage, XTL6001 is the world's first triple agonist targeting GLP-1R, GCGR, and MasR to receive clinical trial authorization in both China and the United States. By incorporating the novel MasR target, XTL6001 is designed to confer differentiated renoprotective effects, extending its therapeutic potential beyond weight management to chronic kidney disease with proteinuria and other renal disorders, while addressing the limitations of single-target GLP-1 therapies in renal protection.
In addition, the Company is advancing several other clinical-stage pipeline candidates, including MT1009 for osteoporosis, and MT1011, an anticoagulant reversal agent. Together with multiple preclinical pipeline programs, these assets form a diversified and well-balanced portfolio of differentiated therapeutic candidates across multiple disease areas.
Four Proprietary Technology Platforms Drive Sustained Delivery of a Differentiated Pipeline
Micot Pharma's peptide drug discovery and development capabilities are built upon four proprietary technology platforms: a bispecific/multispecific peptide and peptide-based macromolecule technology platform, a computer-aided peptide design platform, a developability evaluation platform and an oral peptide delivery platform. Together, these platforms provide end-to-end capabilities spanning target discovery through commercialization, enabling the Company to build a differentiated pipeline portfolio across multiple chronic disease areas, including renal, metabolic, and cardiovascular diseases.
The successful enrollment of the first patient in the Phase II clinical trial of MT1002 for anticoagulation during hemodialysis represented another significant pipeline milestone following the Company's listing on the Hong Kong Stock Exchange (HKEX). Within a single week, MT1002 achieved first-patient enrollment milestones in two major indications. Together with MT200605 approaching completion of its Phase II clinical trial, the steady progress of the Phase III program for MT1013, and the early realization of commercial value through its strategic commercialization partnership, these achievements further validated Micot Pharma's differentiated development strategy of combining scientific innovation with sustainable value creation to address significant unmet medical needs.
Looking ahead, Micot Pharma will continue to uphold its mission of "Innovate Medicines, Guard Health, Address Unmet Clinical Needs." The Company will continue to advance the clinical development of MT1002 for anticoagulation during hemodialysis and strives to bring a safer and more effective anticoagulation therapy to patients with end-stage kidney disease worldwide as early as possible.
MICOT