YS Biopharma, a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer, has announced that its PIKA Rabies Vaccine has received Phase 3 clinical trial approval from the Drug Regulatory Authority of Pakistan (“DRAP”).
This trial will evaluate the efficacy of YS Biopharma’s PIKA Rabies Vaccine in protecting people from rabies infection, by assessing the safety and immunogenicity of the vaccine. With this approval, YS Biopharma is one step closer to providing a much-needed solution to the global rabies problem.
YS Biopharma’s revolutionary PIKA Rabies Vaccine has the potential to revolutionize the way we vaccinate against rabies. By inducing accelerated immunity and producing a higher immune response, the PIKA Rabies Vaccine could become the first accelerated three-visit one-week regimen, superior to the currently available five-visit one-month or three-visit three-week regimens.
After successful Phase 1 and Phase 2 clinical trials in Singapore and a further Phase 1 trial in China to confirm the optimum dose and regimen, YS Biopharma has now been given the green light to conduct Phase 3 clinical trials in Singapore. All trials have shown that the PIKA rabies vaccine is safe, tolerable, and immunogenic. Could this innovative vaccine be the breakthrough we have been waiting for?
In 2023, YS Biopharma is initiating a multi-center, multi-country Phase 3 study of the PIKA Rabies Vaccine in healthy volunteers without exposure to animal bites. With an estimated 4,500 subjects in total, the study will take place in Singapore, the Philippines, and Pakistan.
If the trials are successful, the Company intends to submit a New Drug Application or Biologics License Application for the vaccine to regulatory authorities in China and countries in Asia and other continents. Additionally, YS Biopharma plans to conduct more advanced clinical trials in China.
We are thrilled to receive approval from DRAP for the Phase 3 clinical trial of our PIKA Rabies Vaccine in Pakistan! This milestone marks an important step in our mission to provide innovative and efficacious vaccines to combat the deadly rabies virus, which has an almost 100% case fatality rate. Our progress will help us move closer to our goal of controlling and preventing this disease worldwide.
About YS Biopharma
YS Biopharma is revolutionizing the biopharmaceutical industry with its groundbreaking PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics. Its products have the potential to improve Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines, and are available in China, the United States, Singapore and the Philippines.
With a management team that combines local expertise and global experience, YS Biopharma is leading the way in developing and manufacturing new generations of vaccines and therapeutic biologics for infectious diseases and cancer.