YS Biopharma Granted Phase I Clinical Trial License of Therapeutic Chronic Hepatitis B Virus Vaccine
- YS Biopharma receives approval for Phase I clinical trial of YS-HBV-002 vaccine for chronic hepatitis B virus infection.
- Chronic HBV infection affects an estimated 254 million people globally, with 1.2 million new infections each year.
- Existing anti-viral treatments have efficacy, and no cure for chronic HBV has been developed.
- YS-HBV-002 aims to disrupt immune tolerance mechanisms and provide a safe and effective solution for chronic HBV patients.
- The Phase I trial will evaluate safety, immunogenicity, and efficacy of YS-HBV-002 among adult patients with chronic HBV infection.
- None.
Insights
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 infected are at higher risk for cirrhosis, liver failure, and liver cancer, with between
Dr. David Shao, Director, President, and CEO of YS Biopharma, commented, "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."
The Phase I clinical trial for YS-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-002 among adult patients diagnosed with chronic HBV infection. 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-HBV-002
YS-HBV-002 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. The re-establishment of a desirable and comprehensive immune response is the first step towards the eradication of chronic HBV infection from the body.
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
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements'' within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of YS Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, YS Biopharma's ability to source and retain talent, and the cash position of YS Biopharma. Forward-looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma's management and are not predictions of actual performance.
YS Biopharma cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading "Risk Factors" in the Post-effective Amendment No. 2 to the Company's Registration Statement on Form F-1 filed with the SEC on January 23, 2024, and other filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements.
Investor Relations Contact
Alyssa Li
Director of Investor Relations
Email: ir@yishengbio.com
Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/ys-biopharma-granted-phase-i-clinical-trial-license-of-therapeutic-chronic-hepatitis-b-virus-vaccine-302120805.html
SOURCE YS Biopharma Co., Ltd.
FAQ
What is the purpose of the Phase I clinical trial granted to YS Biopharma by the Philippine FDA?
How many people globally are estimated to be affected by chronic HBV infection?
What are the potential risks for individuals with chronic HBV infection?
When is the Phase I clinical trial for YS-HBV-002 expected to begin?