- PhaseBio Pharmaceuticals (NASDAQ:PHAS) announces that the Investigational New Drug (IND) application for bentracimab has been approved by China National Medical Products Administration (NMPA).
- Bentracimab is a novel, human monoclonal antibody fragment that in earlier trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta/Brilique (ticagrelor).
- With approval of the IND, PhaseBio and development partner SFJ Pharmaceuticals are authorized to begin enrolling patients in China into the ongoing late-stage trial of the drug.
- The companies anticipate enrolling the first patients at sites in China later in 2021, after the trial has reached its interim enrollment milestone expected in mid-2021.
- Shares up more than 1% premarket.
- PhaseBio had entered into an exclusive licensing agreement with Alfasigma S.p.A for the commercialization of bentracimab, in June.