Pharma Focus Europe

Phase 3 Clinical Trial Approval for YS Biopharma's PIKA Rabies Vaccine Granted by Philippines FDA

Friday, June 02, 2023

YS Biopharma Co., Ltd. (NASDAQ: YS) has announced that its PIKA Rabies Vaccine has received Phase 3 clinical trial approval from the Food and Drug Administration of the Philippines. The vaccine is being developed by YS Biopharma, a global biopharmaceutical company focused on discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer.

The Phase 3 clinical trial, scheduled to begin later this year, will be a multi-center, multi-country study evaluating the safety and immunogenicity of the PIKA Rabies Vaccine. It will involve approximately 4,500 subjects in the Philippines, Singapore, and Pakistan. Upon successful completion of the Phase 3 trials, YS Biopharma plans to submit New Drug Applications or Biologics License Applications to relevant regulatory authorities for the commercialization of the vaccine. The company intends to launch the sales and marketing of the PIKA Rabies Vaccine in North America, as well as in countries across Asia, Africa, Europe, the Middle East, and Central and South America.

The PIKA Rabies Vaccine is a novel vaccine powered by YS Biopharma's proprietary PIKA adjuvant technology, which aims to induce accelerated immunity and generate a higher immune response. It has received orphan-drug designation (ODD) from the US FDA for the prevention of rabies infection, including post-exposure prophylaxis (PEP) for rabies. The vaccine has the potential to offer an accelerated three-visit one-week regimen, surpassing the current available vaccine options with longer regimens. YS Biopharma has already completed Phase 1 and Phase 2 clinical trials of the PIKA Rabies Vaccine in Singapore, and an additional Phase 1 trial was conducted in China to determine the optimal dosage and regimen. All three trials have demonstrated the vaccine's safety, tolerability, and immunogenicity. The company has also gained approval to conduct Phase 3 clinical trials of the vaccine in Singapore and Pakistan.

Rabies is a vaccine-preventable viral disease that affects the central nervous system. It has a nearly 100% fatality rate, making it one of the deadliest known infectious diseases with no current cure. According to the World Health Organization, rabies causes an estimated 59,000 deaths annually in over 150 countries, with the majority of cases occurring in Asia and Africa. Children account for over 30% of rabies victims, highlighting the urgency to develop more effective and accelerated immune protection through advanced vaccines.

Dr. Zenaida Mojares, Chief Medical Officer of YS Biopharma, emphasized the significance of obtaining Phase 3 clinical trial approval in the Philippines as a crucial step in advancing the development of the PIKA Rabies Vaccine. The company's focus remains on generating robust clinical data to demonstrate the vaccine's clinical advantages and benefits as a new standard of care. YS Biopharma is committed to using its innovation and expertise to contribute to the fight against rabies, a preventable tragedy that continues to pose a significant challenge to global public health.

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