YS Biopharma Co., Ltd. (Nasdaq: YS), a China-based global biopharmaceutical company, announced on Thursday that it has received clinical trial approval from the Philippine Food and Drug Administration (PFDA) for its YS-HBV-002 immunotherapeutic vaccine intended for the treatment of patients suffering from chronic hepatitis B virus (HBV) infection.

The company is now preparing to commence a Phase one clinical trial for YS-HBV-002 in the Philippines that is expected to begin in June 2024.

The trial is to employ a double-blind, randomised, placebo-controlled, dose-escalation approach, and aims to assess the safety, immunogenicity, and efficacy of YS-HBV-002 in adult patients diagnosed with chronic HBV infection. The company says 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.

Dr David Shao, YS Biopharma director, president, and CEO, said, '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. As always, we plan to conduct the clinical trial to the highest safety and ethical standards, and we are eager to take the next step towards delivering these much-needed treatment options to chronic HBV patients.'