COVID-19: Japan’s vaccine development: AnGes, Shionogi, Sankyo, KM Bio
-Will it be supplied within 2021?-
Domestic vaccine development:
Domestic vaccine development for new coronavirus infections is progressing.
The Japanese government mentioned the possibility that a domestic vaccine would be approved by the end of the year.
Promoted by pharmaceutical manufacturers and bio-ventures.
Vaccine clinical trials:
At the final stage of vaccine clinical trials,
Large-scale inoculation was given to domestic and foreign subjects,
Safety and effectiveness must be confirmed.
Exceptionally, it is becoming more important to develop a system that can obtain early approval.
AnGes:
March 2021, about DNA (deoxyribonucleic acid) vaccine
Inoculation to 500 people was completed in a phase 2 clinical trial.
We are aiming for approval by the end of the year.
The timing and location of the transition to clinical phase 3 clinical trials are undecided.
The situation is waiting for “the issuance of guidelines by regulators”.
Shionogi:
A phase 3 clinical trial will be conducted for the transgenic protein vaccine.
UNIGEN manufactures the drug substance, and Api is in charge of manufacturing the formulation.
We are also developing a vaccine for mutant strains.
Daiichi Sankyo:
In March 2021, Daiichi Sankyo began a phase 1/2 clinical trial of the messenger ribonucleic acid (mRNA) vaccine.
KM Biologics:
KM Biologics has begun Phase 1/2 clinical trials for inactivated vaccines.
New switch