Chronic Hepatitis B immunotherapeutic Vaccine Given Approval to Begin Trials


The vaccine’s developer, YS Biopharma, will begin its phase 1 clinical trial in the Philippines this summer.

Image credit: pexels-karolina-grabowska

Image credit: pexels-karolina-grabowska

Global biopharmaceutical company YS Biopharma Co. announced last week that its investigational YS-HBV-002 immunotherapeutic vaccine, designed to treat patients suffering from chronic hepatitis B infection, was granted clinical trial approval by the Philippine Food and Drug Administration (PFDA). As such, the company is preparing to initiate a phase I clinical trial for the vaccine in that country, abd is expected to begin in June of this year.1

"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,” YS Biopharma CEO David Shao, PhD said in a statement. “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.”1

Trial Parameters and the Vaccine’s Makeup
The clinical trial for the vaccine is looking to address an unmet medical need. It will be a double-blind, randomized, placebo-controlled, dose-escalation study to evaluate the safety, immunogenicity, and efficacy of YS-HBV-002 among adult patients diagnosed with chronic HBV infection. By targeting both humoral and cellular immune responses, YS-HBV-002 is aiming to disrupt immune tolerance mechanisms and facilitate the treatment of chronic HBV infection in patients.1

YS-HBV-002 is a novel 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. Th vaccine has the potential to activate both innate and adaptive immune responses in patients, thereby generating a more robust and targeted response to the virus. The re-establishment of a desirable and comprehensive immune response is the first step towards the eradication of chronic HBV infection from the body.1

What You Need to Know

YS Biopharma's investigational vaccine, YS-HBV-002, received approval from the Philippine Food and Drug Administration (PFDA) for a phase I clinical trial.

YS-HBV-002 is a novel therapeutic HBV vaccine formulated with recombinant core and surface hepatitis B antigens, along with YS Biopharma's proprietary PIKA adjuvant.

Chronic hepatitis B is a significant public health concern worldwide, with an estimated 254 million people currently infected globally and 1.2 million new infections occurring annually.

Depth and Scope of Chronic Hepatitis B
According to the World Health Organization (WHO), an estimated prevalence of 254 million people who are currently infected with chronic HBV, and an incidence rate of 1.2 million new infections each year.2 Chronic HBV led to approximately 1.1 million deaths in 2022.2

Those infected 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.1

HBV Prevention
Two years ago, the US Centers for Disease Control and Prevention (CDC) has released new guidelines for HBV vaccination for prevention of the infection. Specifically, the federal agency now recommends universal vaccination for all adults aged 19-59 years in the US.3

In addition, the CDC recommend everyone get tested for hepatitis B, and offered more information on testing for specific populations including:

  • All adults 18 and older at least once in their lifetime using a triple panel test
  • Pregnant people during each pregnancy
  • People who are at ongoing risk for exposure should be tested periodically
  • Anyone who requests HBV testing should be tested.4

“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," Shao added.1


1. YS Biopharma Granted Phase I Clinical Trial License of Therapeutic Chronic Hepatitis B Virus Vaccine. YS Biopharma Press release. April 18, 2024. April 22.2024.
2. Abene S. Hepatitis B Virus (HBV) Bridges Gap Between Policy and Implementation in Vaccine Coverage. Contagion. April 12, 2024. Accessed April 22, 2024.
 3.Walter K. Universal Hepatitis B Vaccine Recommended by CDC. Contagion. March 31, 2022.
4. Viral Hepatitis. CDC. Last reviewed April 9, 2023. Accessed April 22, 2024.

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