GAITHERSBURG, Md., Oct. 25,
2024 /PRNewswire/ -- LakeShore Biopharma Co., Ltd
(Nasdaq: LSB) ("LakeShore 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 it has been granted approval for a Phase III
clinical trial (the "Trial") by the National Medical Products
Administration (NMPA) in China to
explore the immunogenicity and safety of a simplified four-dose
regimen for its YSJA rabies vaccine which is the first generation
of the Company's rabies vaccine and has sold more than 100M doses since its market approval. This
simplified immunization schedule has the potential to provide
patients with more immunization options, reduce physician workload,
minimize hospital visits, improve patient adherence to vaccination
and also reduce the financial burden on patients under comparable
immunogenicity, boosting the vaccine's utility and aiding in the
prevention of rabies deaths.
The Trial, which is expected to begin in December 2024, will evaluate the immunogenicity
and safety of the YSJA rabies vaccine across two distinct four-dose
immunization schedules to determine their immunogenicity and safety
compared to the existing Essen
regimen (1-1-1-1-1). It will be a single center, randomized,
double-blind, controlled study. The two four-dose immunization
regimens which will be explored are the Zagreb Regimen (2-1-1),
which involves two shots in the first session and one shot each
across two subsequent sessions; and the Modified Essen Regimen
(1-1-1-1), which involves four sessions of a single shot each.
Compared to the conventional five-dose, Essen regimen (1-1-1-1-1), both options offer
greater flexibility for medical professionals and patients and
stand to improve the existing standard of rabies care.
Mr. Xu Wang, Chief Executive
Officer of LakeShore Biopharma, commented, "The approval of this
Phase III clinical trial for our YSJA rabies vaccine marks a
significant milestone in our efforts to expand the regimen profile
of our product. By evaluating simplified immunization schedules, we
aim to make our vaccine more competitive in the rapidly expanding
rabies vaccine market. We believe that this trial will validate the
clinical superiority of the YSJA rabies vaccine, and will help
attract increased recognition and support from researchers,
academics, and industry players around the world."
"The YSJA rabies vaccine is our flagship product and has already
proven to be a game-changer in preventing deaths and disabilities
related to rabies," Mr. Wang continued. "The potential impact of
this clinical trial, combined with our efforts to become a leading
rabies vaccine supplier, strengthens our confidence in continuing
expanding our market share in China. We are proud to be making another
critical contribution to the global fight against this disease, and
are eager to forge ahead as a leading innovator in rabies vaccine
development."
Rabies has an almost 100% fatality rate upon emergence of
clinical symptoms. Each year, it claims the lives of approximately
59,000 individuals in more than 150 countries. Transmission through
bites from infected dogs accounts for over 95% of rabies-related
fatalities, and 40% of these deaths occur in children under the age
of 15. Although rabies is typically lethal without treatment, the
administration of post-exposure prophylaxis can effectively prevent
fatalities when initiated following possible exposure.
About LakeShore Biopharma
LakeShore Biopharma,
previously known as 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. The Company 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.lakeshorebio.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 LakeShore Biopharma, the development progress of
all product candidates, the progress and results of all clinical
trials, LakeShore Biopharma's ability to source and retain talent,
and the cash position of LakeShore Biopharma. Forward-looking
statements may be identified by the use of words such as
"estimate," "plan," "project," "potential," "forecast," "intend,"
"will," "expect," "anticipate," "believe," "goal," "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 LakeShore
Biopharma's management and are not predictions of actual
performance.
LakeShore Biopharma cannot assure you the forward-looking
statements in this press release will 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 Annual Report on Form 20-F filed with the
Securities and Exchange Commission (the "SEC"), and other risks
described in documents subsequently filed or furnished by the
Company from time to time with the SEC. There may be additional
risks that LakeShore Biopharma does not presently know or that
LakeShore 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 LakeShore
Biopharma as of the date of this press release. Subsequent events
and developments may cause those views to change. However, while
LakeShore 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
LakeShore Biopharma as of any date subsequent to the date of this
press release. Except as may be required by law, LakeShore
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: LakeShoreBiopharma.IR@icrinc.com
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SOURCE LakeShore Biopharma Co., Ltd.
