GAITHERSBURG, Md., Sept. 15,
2023 /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 the United States Patent and Trademark Office has
issued it a patent covering the Company's PIKA YS-HBV-002, an
immunotherapeutic vaccine designed to treat patients suffering from
chronic hepatitis B virus ("HBV") infection. YS Biopharma expects
to submit an Investigational New Drug (IND) application and
commence the clinical development of PIKA YS-HBV-002 as a novel
immunotherapy for the treatment of chronic HBV infection in
2024.
According to the American Liver Foundation, it is estimated that
between 850,000 and 2.2 million people suffer from chronic HBV
infection in the United States.
Worldwide, nearly two billion people are hepatitis B carriers, and
about 400 million suffer from chronic HBV infection according to
the European Association for the Study of the Liver. 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. Chronic HBV infections occur in both
developing and developed countries, constituting a significant
unaddressed public health threat. At present, the efficacy of
existing treatment paradigms is limited, and no cure for chronic
HBV has yet been developed.
Unlike conventional prophylactic HBV vaccines that are
administered to healthy individuals, PIKA YS-HBV-002 is targeted at
patients who are already suffering from chronic HBV infection and
seeking effective treatment against the disease. PIKA YS-HBV-002
was developed based on YS Biopharma's proprietary PIKA
immunomodulating technology, coupled with multiple HBV antigens.
PIKA YS-HBV-002 has the potential to activate and re-establish a
desirable immune response in patients in order to eradicate HBV
infection. In clinical settings, PIKA technology has demonstrated
promising potential for activating both innate and adaptive immune
responses in humans. In recent years, immune-based intervention has
emerged as an important strategy in developing new therapeutics for
chronic HBV treatment, coming along with a better
understanding of the
underlying disease and the advancement of immunological
technologies.
Mr. Yi Zhang, the Project Leader
of the PIKA YS-HBV-002 program and the Chairman of the Board of
Directors of YS Biopharma, commented, "We are pleased to build on
our robust intellectual property franchise by adding another
important patent to our portfolio. This latest patent underscores
our dedication to innovation and our commitment to enhancing
treatment options for patients around the world. Our PIKA
YS-HBV-002 vaccine has the potential to advance the fight against
chronic HBV infection, a hugely significant unaddressed medical
need in the United States and
across the globe. This clinical candidate is based on the
advancement of multiple components from preclinical and clinical
studies, and we are now focused on progressing it to clinical
trials."
About YS Biopharma
YS Biopharma is a global biopharmaceutical company
dedicated to discovering, developing, manufacturing, and delivering
new generations of vaccines and therapeutic biologics for
infectious diseases and cancer. It has developed a proprietary
PIKA® immunomodulating technology platform and a
new generation of preventive and therapeutic biologics targeting
Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other
virus infections. 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 biopharmaceutical industry. For more information,
please visit investor.ysbiopharm.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 following the closing of the Business
Combination. 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.
These statements involve risks, uncertainties and other factors
that may cause actual results, levels of activity, performance, or
achievements to be materially different from those expressed or
implied by these forward-looking statements. Although YS Biopharma
believes that it has a reasonable basis for each forward-looking
statement contained in this press release, YS Biopharma cautions
you that these statements are based on a combination of facts and
factors currently known and projections of the future, which are
inherently uncertain. In addition, there are risks and
uncertainties described in the final prospectus relating to the
proposed Business Combination, and other documents filed by YS
Biopharma from time to time with the SEC. These filings may
identify and address other important risks and uncertainties that
could cause actual events and results to differ materially from
those contained in the forward-looking statements.
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, among others, the ability to recognize
the anticipated benefits of the Business Combination, costs related
to the transaction, the impact of the global COVID-19 pandemic, the
risk that the transaction disrupts current plans and operations as
a result of the consummation of the transaction, the outcome of any
potential litigation, government or regulatory proceedings, the
sales performance of the marketed vaccine product and the clinical
trial development results of the product candidates of YS
Biopharma, and other risks and uncertainties, including those
included in YS Biopharma's 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 Contacts
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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