GAITHERSBURG, Md., April 9,
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 positive
interim results from the ongoing Phase 3 clinical trial (the "Phase
3 Trial" or the "Trial") of its next-generation PIKA Rabies
Vaccine. The interim results indicate that the PIKA Rabies Vaccine
has successfully met the primary endpoints of the Trial and has the
potential to achieve best-in-class accelerated protection and meet
the WHO's goal of a one-week rabies vaccine regimen to replace the
conventional three- or four-week regimens.
The PIKA Rabies Vaccine, which utilizes YS Biopharma's
proprietary PIKA adjuvant technology, is designed to produce a more
robust immune response in an accelerated timespan compared to
existing rabies vaccines. It was granted orphan drug designation by
the US FDA for prevention of rabies virus infection including
post-exposure prophylaxis (PEP) for rabies.
The pivotal registration Phase 3 Trial is a randomized,
comparator-controlled, double-blind, multicenter trial which
includes 4,500 participants from the
Philippines and Pakistan.
It is designed to assess the immunogenicity, safety, and lot-to-lot
consistency of three lots of the PIKA Rabies Vaccine in healthy
adults using a 7-day vaccine schedule, versus a globally marketed
comparator following the standard 28-day regimen. The primary
immunogenicity endpoints of the study were geometric mean titers
(GMTs) of rabies virus neutralizing antibodies (RVNA) and RVNA
seroconversion rate at Day 14 in the first 900 participants. The
secondary immunogenicity endpoints were RVNA seroconversion rate
and GMTs of RVNA at Day 28, Day 42, Day 90, and Day 180 in the
first 900 participants, and RVNA seroconversion rate at Day 7 and
Day 365 in all participants.
Based on the interim data analysis, the PIKA Rabies Vaccine
demonstrates non-inferior immunogenicity to a globally marketed
comparator, while also helping patients achieve immunity in a
shorter timeframe of 7 days. The data, which comes from the first
900 participants enrolled in the Trial, revealed that the RVNA
seroconversion rate of the PIKA Rabies Vaccine was twice that of
the comparator by Day 7, showing the superiority of PIKA rabies
vaccine to offer quick onset of protection against virus infection.
This accelerated and higher seroconversion rate came at no cost to
safety, with the safety profile of the PIKA Rabies Vaccine
remaining highly tolerable.
Dr. Zenaida Mojares, Chief
Medical Officer of YS Biopharma, commented, "The interim results of
the pivotal Phase 3 Trial provide compelling evidence of the robust
immunogenicity and favorable safety profile of the PIKA Rabies
Vaccine. By providing a shortened treatment regimen without
sacrificing safety or quality, the PIKA Rabies Vaccine has the
potential to improve rabies treatment and compliance. At present,
the long and inconvenient regimen length for existing rabies
vaccines represents a major barrier to treatment completion, and we
are eager to see how the enhanced speed of the PIKA Rabies Vaccine
might have a positive impact on patients. We are proud of our team
for the hard work and dedication which got us to this point, and we
are excited to see how our advances will contribute to the ongoing
global fight against rabies."
Dr. David Shao, Director,
President, and CEO of YS Biopharma, added, "We would like to extend
our sincere gratitude to all the investigators and participants who
participated in the clinical trial. Thanks to their dedication and
efforts, animal bite patients are expected to have access to a new
rabies vaccine, thereby reducing the rate of immune failure. We
remain committed to working closely with drug regulatory agencies
in various countries including the
Philippines, Pakistan,
Singapore, China, and other jurisdictions regarding the
product registration and marketing application. We eagerly
anticipate the early approval of this innovative therapy for the
benefit of patients worldwide."
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 the Company, the development progress of all product
candidates, the progress and results of all clinical trials, the
Company's ability to source and retain talent, and the cash
position of the Company. 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 Company's most recent annual report on Form 20-F,
as well as discussions of potential risks, uncertainties and other
important factors in the Company's subsequent 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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