On April 18th US Eastern Time, global biopharmaceutical company Lakeshore biopharma (Nasdaq: LSB) announced that its self-developed next-generation therapeutic vaccine “YS-HBV-002” has made significant breakthroughs in the field of chronic hepatitis B virus (HBV) infection treatment. It has obtained clinical trial approval from the Philippine Food and Drug Administration (PFDA) and is expected to launch Phase I clinical trials in the Philippines in June this year. This marks a crucial step for LakeShore Biopharma in overcoming the global challenge of chronic hepatitis B.

According to the World Health Organization (WHO), there are currently approximately 254 million people worldwide suffering from chronic hepatitis B, within an annual increase of 1.2 million new infections. According to statistics, there are about 86 million hepatitis B virus carriers in China, including 28 million hepatitis B patients. If left untreated, almost all chronic liver diseases can develop into cirrhosis. Chronic hepatitis B not only occurs in developing countries, but also in developed countries, which has constituted a major public health threat. 15~40% of chronic HBV infected individuals will suffer from diseases such as cirrhosis, liver failure, and liver cancer. HBV infection is expected to cause nearly 1.1 million deaths in 2022, with the majority dying from cirrhosis and hepatocellular carcinoma.

Although there are currently vaccines available to prevent chronic HBV infection, the existing antiviral treatments have limited efficacy for those who have already been infected and progressed to chronic hepatitis B, and treatments for curing chronic HBV have not yet been developed. There is an urgent need for more effective treatments.

In recent years, immune-activation therapy has become a new direction in the treatment of hepatitis B, and therapeutic vaccines are an important breakthrough in this direction. YS-HBV-002 is an innovative product developed by LakeShore Biopharma based on the first generation hepatitis B vaccine YS-HBV-001. Its research and development goal is to achieve a comprehensive attack on chronic hepatitis B virus by activating the immune response of patients. This vaccine combines the core antigen and surface antigen of recombinant hepatitis B virus, and introduces a LakeShore-Biopharma-specific PIKA adjuvant, aiming to activate the patient's innate and adaptive immune response, break the immune tolerance of chronic HBV infection, and achieve effective control of the virus. The preliminary preclinical security assessment has shown positive results with no serious adverse reactions, laying a solid foundation for the upcoming clinical trial.

Dr. Shao, Director, Co CEO, and CBO of LakeShore Biopharma, stated that the approval of YS-HBV-002 by the Philippine FDA and Ethics Committee is an important milestone in the development of innovative therapies for chronic HBV infection. At present, there is no effective vaccine treatment option for patients with chronic hepatitis B, which increases their risk of other liver diseases and seriously affects their quality of life. With the approval of clinical trials and upcoming clinical studies, LakeShore Biopharma hopes to provide safe and effective solutions for these patients to address this unresolved major public health threat.

As the Phase I clinical trial of YS-HBV-002 is about to start in the Philippines, the global hepatitis B treatment field will usher in new expectations. It is reported that the upcoming Phase I clinical trial of YS-HBV-002 will use a randomized, double-blind, placebo-controlled, and dose-increasing method to evaluate the security, immunogenicity, and efficacy of YS-HBV-002 in adult patients diagnosed with chronic HBV infection. As a big country of hepatitis B, China's patient groups are particularly urgent for this new treatment. In the future, with the deepening of research and the accumulation of clinical data, YS-HBV-002 is expected to bring a revolutionary breakthrough in the field of chronic hepatitis B treatment and a better quality of life for hepatitis B patients worldwide.