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TOT BIOPHARM International Company Limited Provides Update to its Phase III Clinical Trial Application of TAB014 Authorized by United States Food and Drug Administration02/01/2021 | 05:03pm
The board of directors of the TOT BIOPHARM International Company Limited announced that, as notified to the Group by the United States Food and Drug Administration (FDA), the investigational new drug (IND) application in respect of the Phase III clinical trial of monoclonal antibody drug TAB014 (recombinant humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody) intravitreal injection for the treatment of wet (neovascular) age-related macular degeneration (wAMD) has recently been authorized by the FDA. Based on the data from the Phase I clinical trial of TAB014 conducted in the People's Republic of China ("China") and relevant clinical literature data, this IND application is a direct application for authorization to conduct Phase III clinical trial (being exempted from Phase II clinical trial). It is also the Group's first project with IND application submitted and authorized overseas, which is significant for the Group's entry into the international market. The clinical research and commercialization project in relation to TAB014 was listed by the Development Center for Medical Science & Technology of the National Health Commission of China as a special major project for technologies of innovative manufacturing of major new drugs at the end of 2019.
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