GUANGZHOU, China, July 25,
2024 /PRNewswire/ -- Bio-Thera Solutions Inc.
(688177: SH), a commercial-stage biopharmaceutical company
developing a pipeline of innovative therapies and biosimilars,
today announced that dosing has recently begun in an integrated
Phase I / Phase III clinical study for BAT3306, a proposed
biosimilar of Keytruda® (pembrolizumab). The clinical
study is a randomized, double-blind, parallel group, active control
study to compare the pharmacokinetics, efficacy and safety of
BAT3306 to Keytruda® in non-squamous non-small cell lung
cancer (nsNSCLC) patients. The study is expected to enroll
approximately 676 patients.
"Keytruda is the most important innovative cancer therapy
currently in use," said Shengfeng
Li, CEO at Bio-Thera. "Bio-Thera is committed to expanding
access to this important cancer therapy with the development of
BAT3306."
Bio-Thera Solutions is developing a large pipeline of
biosimilars that include BAT1806, a tocilizumab has been approved
by FDA, EMA and NMPA, BAT1706, a bevacizumab has been approved by
FDA and NMPA. BAT2206, a ustekinumab has been filed with FDA, EMA
and NMPA. Bio-Thera Solutions is also pursuing biosimilar versions
of golimumab, secukinumab, and mepolizumab.
About Bio-Thera Solutions
Bio-Thera Solutions,
Ltd., a leading innovative, global biopharmaceutical company
in Guangzhou,
China, is dedicated to researching
and developing novel therapeutics for the treatment of
cancer, autoimmune, cardiovascular, eye diseases, and
other severe unmet medical needs, as well as biosimilars for
existing, branded biologics to treat a range of cancer and
autoimmune diseases. As a leader in next generation antibody
discovery and engineering, the company has advanced multiple
candidates into late-stage development, including three approved
products: QLETLI® (BAT1406) in
China, TOFIDENCE™/
BAT1806 in the US, EU and China and Avzivi®
/ Pobevcy® (BAT1706) in the
US and China. In addition,
the company has more than 20 promising candidates in clinical
trials, focusing on immuno-oncology in the post-PD-1
era and targeted therapies such as ADCs. For more
information, please visit www.bio-thera.com/en/ or
follow us on Twitter (@bio_thera_sol) and
WeChat (Bio-Thera).
Cautionary Note Regarding Forward-Looking
Statements
This news release contains certain
forward-looking statements relating to BAT3306 or the product
pipelines in general of Bio-Thera Solutions. Readers
are strongly cautioned that reliance on any forward-looking
statements involves known and unknown risks and uncertainties. The
forward-looking statements include, among others, those
containing "could," "may," "should," "will," "would," "anticipate,"
"believe," "plan," "promising," "potentially," or similar
expressions. They reflect the company's current views with respect
to future events that are based on what the company believes are
reasonable assumptions in view of information currently available
to Bio-Thera Solutions, and are not a guarantee of
future performance or developments. Actual results and events may
differ materially from information contained in the forward-looking
statements as a result of a number of factors, including, but not
limited to, risks and uncertainties inherent in pharmaceutical
research and development, such as the uncertainties of pre-clinical
and clinical studies. Other risks and uncertainties include
challenges in obtaining regulatory approvals, manufacturing,
marketing, competition, intellectual property, product efficacy or
safety, changes in global healthcare situation, changes in the
company's financial conditions, and changes to applicable laws and
regulations, etc. Forward-looking statements contained herein are
made only as of the date of their initial publication. Unless
required by laws or regulations, Bio-Thera Solutions
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events,
changes in the company's views or otherwise.
1. Keytruda® is a registered trademark of Merck Sharp
& Dohme
2. QLETLI® is a registered trademark
of Bio-Thera Solutions, Ltd.
3.
TOFIDENCE™ is a trademark of Biogen
4. Avzivi® is a registered trademark
of Sandoz AG
5.
POBEVCY® is a registered trademark of
Bio-Thera Solutions, Ltd.
Contact
Bio-Thera Solutions,
Ltd.:
Bert E. Thomas IV
+1.410.627.1734
bethomas@bio-thera.com
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SOURCE Bio-Thera Solutions, Ltd