GAITHERSBURG, Md., May 16, 2023
/PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma"
or the "Company"), a global biopharmaceutical company dedicated to
discovering, developing, manufacturing, and commercializing new
generations of vaccines and therapeutic biologics for infectious
diseases and cancer, today announced its PIKA Rabies Vaccine has
received Phase 3 clinical trial approval from the Drug Regulatory
Authority of Pakistan ("DRAP").
The Phase 3 clinical trial will evaluate the safety and
immunogenicity of the Company's PIKA Rabies Vaccine in preventing
rabies infection.
The PIKA Rabies Vaccine is a novel vaccine powered by YS
Biopharma's proprietary PIKA adjuvant technology to induce
accelerated immunity and produce a higher immune response. The PIKA
Rabies Vaccine has the potential to become the first accelerated
three-visit one-week regimen, superior to the currently available
vaccine with a five-visit one-month or three-visit three-week
regimen. The Company has completed Phase 1 and Phase 2 clinical
trials of its PIKA Rabies Vaccine in Singapore. Another Phase 1 trial was also
conducted in China to confirm the
optimum dose and regimen to be used. All three clinical trials have
shown that the PIKA rabies vaccine is safe, tolerable, and
immunogenic. YS Biopharma has also obtained approval to conduct
Phase 3 clinical trials of the PIKA Rabies vaccine in Singapore.
The Phase 3 study is a multi-center, multi-country study set to
be conducted in Singapore,
the Philippines, and Pakistan in 2023. YS Biopharma anticipates
conducting Phase 3 clinical trials in healthy volunteers without
exposure to animal bites, with an estimated 4,500 subjects in
total. The Company is also planning to conduct more advanced
clinical trials in China. Pending
the successful completion of Phase 3 trials, the Company intends to
submit the New Drug Application or Biologics License Application
for the PIKA Rabies Vaccine to regulatory authorities in
China and countries in
Asia and other continents.
Dr. Zenaida Mojares, Chief
Medical Officer of YS Biopharma, commented, "We are delighted to
receive approval from DRAP to conduct the PIKA Rabies Vaccine Phase
3 clinical trial in Pakistan. This
approval marks a significant milestone in the development of our
PIKA Rabies Vaccine as we continue to expand our clinical trial
program globally. Our progress enables us to advance towards our
mission of providing innovative and efficacious vaccines in the
fight against a vaccine-preventable rabies disease, with an almost
100% case fatality rate."
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
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
or not 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 under the heading "Risk Factors" in the final prospectus
filed with the SEC on February 8,
2023, as supplemented on February 21,
2023, 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
Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com
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SOURCE YS Biopharma Co., Ltd.