Shaanxi Micot Pharmaceutical Technology Co., Ltd. (Micot Pharma) has officially commenced substantive execution of its Phase II clinical programme for MT1002, following the successful enrolment of the first hemodialysis (HD) patient in study MT1002-II-C05.

The multicentre trial is divided into two segments. Part 1 is a single-arm, dose-finding stage designed to establish the optimal MT1002 dosage for HD-related anticoagulation. Part 2 will randomise patients to receive either MT1002 or unfractionated heparin to compare anticoagulant efficacy, with superiority over heparin set as the primary endpoint.

MT1002 is described as the world’s first dual-functional antithrombotic peptide in clinical development, simultaneously antagonising coagulation factor II and platelet receptor GPIIb/IIIa. The candidate is intended to deliver rapid onset anticoagulation without routine monitoring, require no dose adjustment for hepatic or renal impairment, and allow swift reversal of effects after discontinuation.

Market data cited from Frost & Sullivan highlight a growing HD population: global patient numbers are projected to rise from 3.30 million in 2020 to 3.70 million by 2025, 4.60 million by 2030 and 5.50 million by 2035. In China, the HD population expanded from 0.70 million in 2020 to 1.10 million in 2025, reflecting a 10.10% CAGR, and is forecast to reach 1.80 million by 2030 and 2.80 million by 2035. This expanding market underpins the clinical and commercial rationale for MT1002’s development.

The Board, led by Chairman and CEO Dr. Wang Bing, noted that the initial patient enrolment marks a key milestone in advancing MT1002 through mid-stage clinical evaluation and provides momentum for the ongoing assessment of its safety and efficacy profile in the HD setting.