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Development Pharmaceutical Co.
, Ltd.
announced on May 18 that the U.
S.
FDA has approved a Phase III pivotal clinical trial of Prokalamide for the treatment of male and female patients with COVID-19 in hospital
.
At the same time, the FDA agreed to expand the inclusion of female patients in the phase III pivotal clinical trial of Prokalamide for mild and moderate new crowns
Dr.
Tong Youzhi, founder, chairman and CEO of Pioneer Pharmaceuticals, said: “The company plans to carry out a key global multi-center phase III clinical trial of Prokalamide for the treatment of hospitalized patients with new crown in nearly 10 countries around the world.
The US FDA first agreed The implementation of this phase III clinical trial program will help advance the entire clinical process
.
At the same time, the FDA agreed to include female subjects in the previously approved phase III clinical trial of mild and moderate new coronary disease, which means that Prokalamide is expected Benefit more patients