YS Biopharma Co., Ltd. announced that its YS-HBV-002 immunotherapeutic vaccine, designed to treat patients suffering from chronic Hepatitis B virus ("HBV") infection, has been granted clinical trial approval by the Philippine Food and Drug Administration ("PFDA"). In light of the approval, the Company is preparing to initiate a Phase I clinical trial for YS-HBV-001 in the Philippines, which is expected to begin in June 2024. Chronic HBV infection is a major global health concern, with an estimated 254 million people suffering from the condition, with 1.2 million new infections each year, according to the World Health Organization (WHO).

Those infections are at higher risk for cirrhosis, liver failure, and liver cancer, with between 15%-40% of chronic HBV patients afflicted with one or more of these conditions. At present, the efficacy of existing anti-viral treatment paradigms is limited, and no cure for chronic HBV has yet been developed. Despite the availability of preventive vaccines for hepatitis B infection, there remains an urgent need for effective therapies for individuals who are already infected and have progressed to chronic stages of infection.

The Phase I clinical trial for Y S-HBV-002 will mark an important milestone in addressing this unmet medical need. This trial will employ a double-blind, randomized, placebo-controlled, dose-escalation approach, and aims to evaluate the safety, immunogenicity, and efficacy of YS-HBV-000 among adult patients diagnosed with chronic HBV infection. By targeting both humoral and cellular immune responses, YS-HBV-003 has the potential to disrupt immune tolerance mechanisms and facilitate the treatment of chronic HBV infection in patients.

YS-HBV-004 is a new generation of therapeutic HBV vaccine based on the proprietary technology and clinical results of YS- HBV-001, the first generation of HBV vaccine in the pipeline of YS Biopharma. YS- HBV-002 is formulated with several key components, including recombinant core and surface hepatitis B antigens, and YS Biopharma's proprietary PIKA adjuvant. This carefully designed set of components has the potential to activate both innate and adaptive immune responses in patients, thereby generating a more robust and targeted response to the virus.