YS Biopharma's PIKA Rabies Vaccine Receives Phase 3 Clinical Trial Approval in Pakistan
GAITHERSBURG,Md.,May 16,2023 -- YS Biopharma Co.,Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company"),a global biopharmaceutical company dedicated to discovering,developing,manufacturing,and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer,today announced its PIKA Rabies Vaccine has received Phase 3 clinical trial approval from the Drug Regulatory Authority of Pakistan ("DRAP"). The Phase 3 clinical trial will evaluate the safety and immunogenicity of the Company's PIKA Rabies Vaccine in preventing rabies infection.
The PIKA Rabies Vaccine is a novel vaccine powered by YS Biopharma's proprietary PIKA adjuvant technology to induce accelerated immunity and produce a higher immune response. The PIKA Rabies Vaccine has the potential to become the first accelerated three-visit one-week regimen,superior to the currently available vaccine with a five-visit one-month or three-visit three-week regimen. The Company has completed Phase 1 and Phase 2 clinical trials of its PIKA Rabies Vaccine in Singapore. Another Phase 1 trial was also conducted in China to confirm the optimum dose and regimen to be used. All three clinical trials have shown that the PIKA rabies vaccine is safe,tolerable,and immunogenic. YS Biopharma has also obtained approval to conduct Phase 3 clinical trials of the PIKA Rabies vaccine in Singapore.
The Phase 3 study is a multi-center,multi-country study set to be conducted in Singapore,the Philippines,and Pakistan in 2023. YS Biopharma anticipates conducting Phase 3 clinical trials in healthy volunteers without exposure to animal bites,with an estimated 4,500 subjects in total. The Company is also planning to conduct more advanced clinical trials in China. Pending the successful completion of Phase 3 trials,the Company intends to submit the New Drug Application or Biologics License Application for the PIKA Rabies Vaccine to regulatory authorities in China and countries in Asia and other continents.
Dr. Zenaida Mojares,Chief Medical Officer of YS Biopharma,commented,"We are delighted to receive approval from DRAP to conduct the PIKA Rabies Vaccine Phase 3 clinical trial in Pakistan. This approval marks a significant milestone in the development of our PIKA Rabies Vaccine as we continue to expand our clinical trial program globally. Our progress enables us to advance towards our mission of providing innovative and efficacious vaccines in the fight against a vaccine-preventable rabies disease,with an almost 100% case fatality rate."
About YS Biopharma
YS Biopharma is a global biopharmaceutical company dedicated to discovering,and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies,Coronavirus,Hepatitis B,Influenza,and Shingles vaccines. 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 bio-pharmaceutical industry. For more information,please visit investor.ysbiopharm.com.
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Investor Relations Contact
Robin Yang
Partner,ICR,LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com