According to the Zhitong Finance App, Maike Pharmaceutical-B (02335) announced that the company and Beijing Tiantan Hospital (Beijing Tiantan Hospital) affiliated to Capital Medical University jointly undertook research projects involving the company's key product MT200605 under the “Major New Drug Creation” national science and technology project, and has recently received the first special funding from the central financial administration for this project. The company has also obtained ethical approval from the MT200605 phase III clinical trial team leader unit.
This course is entitled “Major New Drug Creation”, a topic set up under the National Science and Technology Major Project (this topic), and is jointly undertaken by the Company and Beijing Tiantan Hospital.
The “Major New Drug Creation” major science and technology project focuses on major diseases that seriously endanger the health of our people, such as malignant tumors, cardiovascular diseases, neurological diseases, diabetes, and autoimmune diseases. It develops innovative drugs with significant clinical value around major scientific and technological issues in the development and industrialization of new drugs, and enhances China's pharmaceutical innovation capabilities.
Beijing Tiantan Hospital is a supporting unit of the National Clinical Medical Research Center for Neurological Diseases and is the core leading institution for clinical research on cerebrovascular diseases in the country. The hospital's neurology team has long led a number of international multi-center clinical studies in the field of acute ischemic stroke. Representative studies include TASTE-2, TRACEIII, and HYPERIS. The research results 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.
The Group is responsible for the R&D, production and clinical trial supply of MT200605 as agreed in the project task book and the cooperation agreement between the two parties. The Group will also cooperate with the implementation of clinical research plans, undertake quality control of test products and pharmacovigilance work related to clinical research, as well as the compliant use of project funds and the submission of phased reports.
Beijing Tiantan Hospital is responsible for academic leadership and research plan design of clinical research programs, leading the organization of multi-center clinical research networks, coordination of research execution, clinical data collection, statistical analysis and clinical research quality control, and relies on the clinical research methods department, project management department and clinical data and biological sample bank platform of the National Neurological Disease Clinical Research Center to provide methodological and platform support for this topic.
The intellectual property rights arising from this topic are implemented in accordance with the relevant regulations on the management of intellectual property rights for major national science and technology projects and cooperation agreements between the two parties.
The company has recently received the first special fund of RMB 960,000 from the central government for this project. As agreed in the project task book, the remaining funds will be disbursed in stages according to the project node's acceptance status. The first special funding will be used to support MT200605's clinical research and development investment.
The board of directors believes that this cooperation and the receipt of the first special fund are of strategic significance to the Group, as reflected in the following aspects.
1. Promote MT200605 clinical research and development process
Based on the positive results achieved in the MT200605 phase II clinical trial, this cooperation will give full play to the professional advantages of Beijing Tiantan Hospital in stroke research and multi-center clinical trials to support the subsequent clinical development of MT200605. At the same time, project funding will provide additional financial support for related R&D activities to help the continuous advancement of product clinical research and development work.
2. Enhance clinical research and development capabilities and deepen scientific research cooperation
The Group's participation in major national science and technology projects reflects the high degree of compatibility 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, and support the continuous development of innovative drug pipelines in the field of cardiovascular and cerebrovascular diseases.
After the completion of the MT200605 phase II clinical trial, the company has received the first special funding from the central government for this project and is promoting clinical development of MT200605 to phase III. The company recently obtained approval from the ethics committee of the MT200605 phase III clinical trial (phase III clinical trial) team leader unit (Beijing Tiantan Hospital) for treating patients with acute ischemic stroke. The name of the phase III clinical trial involved in this approval is “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”, and the protocol number is MT200605-AIS-3041.