New drug gma301 of Hongyun Huaning pulmonary hypertension antibody is approved by FDA

Recently, gma301, the original monoclonal antibody new drug of Hongyun Huaning biomedical Co., Ltd., has been approved by the US FDA for clinical trials This is another milestone in the globalization of Hongyun Huaning new drug research and development, which is approved by the authoritative drug regulatory agency after the drug review center of China National Drug Administration Gma301 is the world's first new antibody drug targeting endothelin receptor A, which is independently developed by Hongyun Huaning (Hangzhou) biomedical Co., Ltd., a local Chinese enterprise, using the independently constructed G protein coupled receptor antibody technology platform It is intended to be used in the treatment of pulmonary hypertension, breaking through the treatment pattern of no biological antibody drugs in this field The results of cynomolgus monkey experiments show that gma301 is expected to transform pulmonary hypertension, an incurable disease in cardiovascular field with an average survival period of no more than 3 years, into a chronic disease with controllable growth period, and bring "life" hope for pulmonary hypertension patients all over the world In the early stage, Hongyun Huaning has completed phase ia clinical trial of the drug in Australia Based on the good results of phase ia clinical trials, China and the United States drug regulatory agency agreed to omit the clinical trials of healthy people and directly carry out phase IB clinical trials for patients with pulmonary hypertension.