TOT BIOPHARM International Company Limited (“TOT BIOPHARM” or the “Company”; stock code: 1875.HK) is pleased to announce that the Company has received notice of Project Topics of 2019 Implementation Plan of Major Special Technology Projects for “Significant New Drug Creation” (Hygiene and Technology Project Document No. (2019)764) from the Development Center for Medical Science & Technology (“DCMST”) under the National Health Commission, giving approval to its application for “clinical research and industrialization of category 1 biological drug ‘monoclonal antibody anti-VEGF’ (item no.: TAB014) for treating wet macular degeneration”, and the project has been included among the National Major Scientific and Technological Special Projects for “Significant New Drug Development”, reflective of national endorsement, thus will receive central government funding.
Major Scientific and Technological Special Projects for “Significant New Drug Development” is among the 16 special projects in the National Outlines for Medium and Long-term Planning for Scientific and Technological Development (2006-2020). Those projects are of utmost importance to the technological development of China as they involve technological breakthroughs and use of integrated resources to complete within certain timeframes major strategic products, critical generic technologies and major engineering efforts, to help the nation realize her goals. The 16 major special projects included significant new drug development, large aircrafts, manned space and lunar exploration projects.
TOT BIOPHARM places great emphasis on technological innovation and has actively increased investment in the R&D in recent years. The Company’s new drug – TAB014 monoclonal antibody products – R&D project making it on the list of national major science and technology projects is not only proof of the country’s recognition for the Company’s technological innovation and related products, but is also conducive to speeding up the development and commercialization of the drug to more quickly benefit patients.
The Company’s drug candidate anti-VEGF monoclonal antibodies (project code: TAB014) for treating wet macular degeneration is a kind of bevacizumab based eye injection product for addressing retinal neovascularization. The project is progressing well and is currently in Phase I clinical research. The Company expects to complete Phase III clinical research for TAB014 before 2022, with the product launch to follow in 2023.
