YS Biopharma Secures Phase 3 Clinical Trial Approval From Philippines FDA for Rabies Vaccine

YS Biopharma (Nasdaq: YS) has been granted approval to proceed with a Phase 3 clinical trial for a rabies vaccine by the Philippines Food and Drug Administration. The trial evaluating the company’s PIKA rabies vaccine is expected to commence later in 2023.

The vaccine candidate has been granted orphan drug designation by the US FDA for prevention of rabies infection including post-exposure prophylaxis for rabies.

Highlights

YS Biopharma’s study is a multi-center, multi-country study designed to evaluate the safety and immunogenicity of the Company’s PIKA Rabies Vaccine.

The study will include approximately 4,500 subjects in the Philippines, Singapore, and Pakistan.

Following the submission of New Drug Applications or Biologics License Applications, the Company plans to launch the sales and marketing of the Vaccine in North America, as well as in countries throughout Asia, Africa, Europe, the Middle East, and Central and South America.

Rabies is a vaccine-preventable viral disease affecting the central nervous system. It has a case-fatality rate of almost 100%, the highest among known infectious diseases, and there is currently no cure for rabies infection. 

About YS Biopharma

YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. YS Biopharma operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry.