On the occasion of the start of the year, a piece of news was sent back from the other side of the ocean that an original monoclonal antibody drug named GMA301 from GMAX has been approved by the US FDA for conducting clinical trials in the US. This is the second approval knowing that the drug having been firstly approved by China Drug Evaluation (CDE) center in October 2019. It is indeed a milestone of GMAX on its way to globalization for new drug research and development. 

GMA301 is the first antibody drug targeting endothelin receptor A for the treatment of Pulmonary Arterial Hypertension, independently developed by Gmax Biopharm LLC.  The drug is expected to turn pulmonary arterial hypertension which is a fatal cardiovascular disease with less than three years survival averagely into a manageable chronic disease, bringing hopes to the patients worldwide.

Earlier, GMAX has completed the phase Ia clinical trial of the drug in Australia. Based on the favorable results of the trial, the Chinese and U.S. regulatory authorities agreed the company further conducting the phase Ib clinical trial for the patients. 

The preparation work for the trial has been completed, and the trial will be carried out in multiple centers, in China and the United States simultaneously after the Chinese Spring Festival.

A Group photo of China and the US clinical development teams

A Group photo of a scientific symposium for the clinical trial