Shaanxi Micot Advances First-in-Class Dual-Target Anticoagulant MT1002 into Phase II Hemodialysis Trial
核心洞察
Shaanxi Micot has enrolled the first patient in a Phase II multicenter trial in China for MT1002, a first-in-class dual-functional antithrombotic peptide for hemodialysis patients.
MT1002 uniquely combines anticoagulant and antiplatelet effects by simultaneously targeting coagulation factor II and GPIIb/IIIa (搜索), with potential advantages including rapid onset and no need for frequent monitoring.
The trial will first determine optimal dosing and then compare MT1002's efficacy against unfractionated heparin, aiming to demonstrate superior anticoagulant performance.
Shaanxi Micot Pharmaceutical Technology Co., Ltd. (搜索) has enrolled the first patient in a Phase II multicentre clinical trial in China for its independently developed anticoagulant candidate MT1002, moving the novel antithrombotic peptide into substantive clinical execution for hemodialysis patients. The milestone marks a significant step forward for what the company describes as the first dual-functional antithrombotic peptide in clinical development.
The Phase II study is designed to first establish the optimal dose of MT1002 before proceeding to a head-to-head comparison against unfractionated heparin, the current standard of care for anticoagulation during hemodialysis. The trial aims to demonstrate superior anticoagulant performance, potentially addressing long-standing limitations of existing therapies.
A Novel Dual-Target Mechanism
MT1002 is a coagulation factor II and GPIIb/IIIa (搜索) dual-target peptide antagonist. By simultaneously targeting both pathways with a single molecule, MT1002 combines anticoagulant and antiplatelet effects in one agent. This dual functionality is designed to address the persistent clinical challenge of balancing bleeding and ischemia risks inherent in multi-drug combination regimens currently used in antithrombotic management.
The company highlights several potential advantages of MT1002, including rapid onset of action, simplified administration, and the elimination of the need for frequent monitoring—features that could meaningfully improve the patient experience and clinical workflow in dialysis settings.
Growing Market Need
The trial advances Micot's position in a rapidly expanding hemodialysis market, both in China and globally. Rising numbers of patients with chronic kidney disease (搜索) (CKD) and end-stage renal disease (搜索) (ESRD) underscore the commercial and clinical significance of effective, convenient anticoagulation solutions for dialysis. The global CKD patient population is projected to reach 188 million by 2030, according to company disclosures.
Micot's Broader Pipeline
MT1002 is one component of Micot Pharma's broader peptide drug portfolio, which spans kidney, metabolic, cardiovascular, and cerebrovascular diseases. The company, which listed on the Hong Kong Stock Exchange under ticker 2335.HK, has built a pipeline consisting of one core product and six key candidates, all of which have entered clinical stages, with six filing simultaneously in both China and the United States.
MT1002 is currently in Phase II clinical trials in both the U.S. and China, with the company reporting good efficacy and safety across different patient populations and dose levels. The candidate is positioned alongside MT200605, another cardiovascular asset targeting acute ischemic stroke through dual mechanisms of promoting nerve regeneration and scavenging oxygen-free radicals.
Micot Pharma's core product, MT1013, a dual-target receptor agonist for chronic kidney disease (搜索)-secondary hyperparathyroidism (CKD-SHPT), has completed Phase III patient enrolment, with an NDA submission expected in early 2027. The company also has XTL6001, described as the world's first and only GLP-1R/GCGR/MasR tri-target agonist with IND approvals in both China and the U.S., which has completed Phase I clinical trials.