GAITHERSBURG, Md., April 18,
2024 /PRNewswire/ -- YS Biopharma Co., Ltd. (Nasdaq:
YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical
company dedicated to discovering, developing, manufacturing, and
delivering new generations of vaccines and therapeutic biologics
for infectious diseases and cancer, today 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-002 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 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. In 2022, HBV infection resulted in an estimated
1.1 million deaths, mostly from cirrhosis and hepatocellular
carcinoma (primary liver cancer). Chronic HBV infections occur in
both developing and developed countries, constituting a significant
unaddressed public health threat. 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.
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 China, the United
States, Singapore and
the Philippines, and is led by a
management team that combines rich local expertise and global
experience in the bio-pharmaceutical industry. For more
information, please visit www.ysbiopharma.com.
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
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