New York, April 22, 2024 - PRISM MarketView - Global biopharmaceutical company, YS Biopharma (Nasdaq: YS) has been granted clinical trial approval in the Philippines for its YS-HBV-002 immunotherapeutic vaccine for chronic hepatitis B virus (HBV) infection. YS expects to initiate a Phase 1 clinical trial in the Philippines in June 2024.
Chronic HBV infection is a significant unaddressed public health threat, with 1.2 million new infections each year, and causing 1.1 million deaths each year, according to the World Health Organization (WHO). There is no cure for HBV and the efficacy of existing anti-viral treatment is limited.
“The approval of YS-HBV-002 by the Philippines FDA and Ethics Committee represents a significant milestone in our efforts to develop innovative therapies for chronic hepatitis B infection. At present, there is no effective vaccine treatment option for patients suffering from chronic HBV, leaving them at higher risk for other conditions affecting the liver and significantly hampering their quality of life. With our recent approval and upcoming clinical study, we hope to provide these patients with a safe and effective solution to combat this significant unaddressed public health threat.”
Dr. David Shao, Director, President, and CEO of YS Biopharma
YS Biopharma’s trial will be a double-blind, randomized, placebo-controlled, dose-escalation study to evaluate the safety, immunogenicity, and efficacy of YS-HBV-002 in adults with chronic HBV infection. The company believes that by targeting both humoral and cellular immune responses, YS-HBV-002 has the potential to disrupt immune tolerance mechanisms and facilitate the treatment of chronic HBV infection in patients.
About YS Biopharma
YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, 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 www.ysbiopharma.com.
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