MICOT PHARMA-B(02335): The Phase II clinical trial of MT1002 for anticoagulation in hemodialysis patients has completed the enrollment of the first patient.

MICOT PHARMA-B (02335) announced that the Phase II clinical study (MT1002-II-C05) of the candidate drug MT1002, developed independently by the group, for anticoagulation in hemodialysis patients has successfully completed the first patient enrollment, marking the official entry into the substantive execution phase of the clinical study. MT1002-II-C05 is a two-stage, multicenter Phase II clinical trial evaluating the effectiveness and safety of MT1002 in anticoagulation in hemodialysis patients in China. The first stage is a single-arm dose exploration stage to determine the optimal effective dose of MT1002; the second stage is a randomized, positive control (unfractionated heparin) verification stage to compare the anticoagulant effectiveness of MT1002 with heparin. The first subject enrolled in this announcement is the first subject enrolled in the first stage of this Phase II clinical trial. According to the company, MT1002 is the world's first anticoagulant antiplatelet dual-function antithrombotic peptide drug to enter clinical trials. It can simultaneously antagonize coagulation factors II and GPIIb/IIIa, providing dual anticoagulant and antiplatelet aggregation effects. It inhibits thrombus formation through a dual pathway and has clinical advantages including rapid onset, convenient dosing, no need for frequent monitoring, no need to adjust the dose in patients with liver and kidney function impairment, rapid recovery of indicators after discontinuation without affecting normal coagulation function and platelet function. Chronic kidney disease (CKD) is characterized by progressive loss of renal glomerular function caused by long-term renal parenchymal disease. End-stage renal disease (ESRD) is the final stage of CKD and has become an increasingly serious global public health issue, causing significant economic burden to families and society. The main treatment methods for patients with ESRD include hemodialysis, peritoneal dialysis (PD), and kidney transplantation (KT), with hemodialysis being the primary treatment method. Hemodialysis plays a role in clearing toxins, removing excess water, maintaining electrolytes and acid-base balance, and providing temporary renal replacement therapy through diffusion and convection, and its clinical application is becoming increasingly widespread. As stated in the company's prospectus, according to Frost & Sullivan data, the number of patients receiving hemodialysis globally is projected to increase from 3.3 million in 2020 to 3.7 million in 2025. It is estimated to reach 4.6 million by 2030 and 5.5 million by 2035. In China, the number of patients receiving hemodialysis is expected to increase from 700,000 in 2020 to 1.1 million in 2025, with a compound annual growth rate of 10.1%. It is projected to reach 1.8 million by 2030 and 2.8 million by 2035.