MICOT PHARMA-B (02335) received the first project funding under the National Science and Technology Major Project and obtained ethics approval from the lead site for the Phase III clinical trial of MT200605.
MICOT PHARMA-B (02335) announced that the Company, together with Beijing Tiantan Hospital, Capital Medical University (Beijing Tiantan Hospital), jointly undertakes a research project under the National Science and Technology Major Project "Major New Drug Creation" involving the Company's key product MT200605, and has recently received the first tranche of central government special funding for this project. The Company has also obtained ethics approval from the lead site for the Phase III clinical trial of MT200605.
MICOT PHARMA-B (02335) announced that the Company and Beijing Tiantan Hospital, Capital Medical University (Beijing Tiantan Hospital) are jointly undertaking a research project under the National Science and Technology Major Project "Major New Drug Creation" involving the Company's key product MT200605, and have recently received the first tranche of central government special funding for the project. The Company has also obtained ethics approval from the lead site for the Phase III clinical trial of MT200605.
This project is a sub-project under the National Science and Technology Major Project "Major New Drug Creation" (the Project), jointly undertaken by the Company and Beijing Tiantan Hospital.
The "Major New Drug Creation" National Science and Technology Major Project focuses on major diseases that seriously endanger the health of the Chinese people, including malignant tumors, cardiovascular and cerebrovascular diseases, neurodegenerative diseases, diabetes, and autoimmune diseases. It centers on major scientific and technological issues in the new drug R&D and industrialization process, develops innovative drugs with significant clinical value, and enhances China's pharmaceutical innovation capabilities.
Beijing Tiantan Hospital is the host institution of the National Clinical Research Center for Neurological Diseases and a core leading institution for national cerebrovascular disease clinical research. The hospital's neurology team has long led multiple international multicenter clinical studies in the field of acute ischemic stroke, with representative studies including TASTE-2, TRACE III, and EMPHASIS, whose findings have been published in international academic journals such as the New England Journal of Medicine and The Lancet. The hospital is one of the leading institutions in the field of stroke clinical research in China.
Pursuant to the project task statement and the cooperation agreement between the parties, the Group is responsible for the R&D, manufacturing, and clinical trial supply of MT200605. The Group will also cooperate in the execution of the clinical research protocol, undertake quality control of investigational products and pharmacovigilance related to the clinical research, and ensure compliant use of project funds and submission of periodic reports.
Beijing Tiantan Hospital is responsible for the academic leadership and design of the clinical research protocol, leading the organization of the multicenter clinical research network, coordinating the research execution of sub-centers, as well as clinical data collection, statistical analysis, and clinical research quality control. It will also leverage the Clinical Research Methodology Department, Project Management Department, and Clinical Data and Biobank Platform of the National Clinical Research Center for Neurological Diseases to provide methodological and platform support for the Project.
Intellectual property rights arising from the Project shall be governed by the relevant provisions on intellectual property management of the National Science and Technology Major Project and the cooperation agreement between the parties.
The Company has recently received the first tranche of central government special funding for the Project of RMB960,000. As stipulated in the project task statement, the remaining funds will be disbursed in stages based on the acceptance of project milestones. The first tranche of special funding will be used to support clinical R&D investment in MT200605.
The Board believes that this cooperation and the receipt of the first tranche of special funding are of strategic significance to the Group, as specifically reflected in the following aspects.
1. Advancing the clinical R&D process of MT200605
Building on the positive results of the Phase II clinical trial of MT200605, this cooperation will fully leverage Beijing Tiantan Hospital's professional advantages in stroke research and multicenter clinical trials to support the subsequent clinical development of MT200605. At the same time, the project funding will provide additional financial support for related R&D activities, facilitating the continued advancement of the product's clinical R&D work.
2. Enhancing clinical R&D capabilities and deepening research cooperation
The Group's participation in the National Science and Technology Major Project reflects the high degree of alignment between the Company's R&D direction and the national innovative drug development strategy. This cooperation is expected to further enhance the Group's capabilities in clinical trial management and clinical research, providing support for the continued development of its innovative drug pipeline in the cardiovascular and cerebrovascular disease field.
Following the completion of the Phase II clinical trial of MT200605, the Company has received the first tranche of central government special funding for the Project and is advancing the clinical development of MT200605 toward Phase III. The Company has recently obtained approval from the ethics committee of the lead site (Beijing Tiantan Hospital) for the Phase III clinical trial (Phase III Clinical Trial) of MT200605 for the treatment of patients with acute ischemic stroke. The Phase III clinical trial covered by such approval is titled "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Verify the Efficacy and Safety of MT200605 in Patients with Acute Ischemic Stroke," with protocol number MT200605-AIS-3041.
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