We received a reply from the US Food and Drug Administration (FDA) on the application for medical equipment clinical research (IDE) in the first/second stage of population expansion of human clinical trials of a new precursor chemotherapy drug OBI-3424, which can be used in the first/second stage of population expansion of human clinical trials without approval.
– OBI-866, an active immune anticancer drug, was approved by the Taiwan Food and Drug Administration of the Ministry of Health and Welfare for the first phase of human clinical trial.
– The new botulinum toxin preparation OBI-858 was approved by the Taiwan Food and Drug Administration of the Ministry of Health and Welfare for the first phase of human clinical trial.
– Convened annual general meeting, carried out reelection of directors comprehensively, and then Board of Directors Meeting was convened, in which directors elected and reappointed Michael N. Chang, legal representative of Yi Tai Investment Co., Ltd., as the Chairman.
– Passive immunity monoclonal antibody new drug OBI-888 had completed the assessment of major safety indicators for phase I human clinical trial, the safety and tolerance of OBI-888 were good, and there were no major safety concerns.
– Published in the journal of the national academy of sciences (PNAS) in cooperation with academia sinica, the paper proves that the Globo series is closely related to the survival of cancer cells, which provides an important theoretical basis for haoding Globo series to target new anti-cancer drugs.
– OBI-822 (Adagloxad Simolenin) was approved by Ministry of Health of Ukraine to carry out phase III human clinical trial.