GUANGZHOU, China --- Bio-Thera Solutions (688177:SH), a
commercial-stage biopharmaceutical company developing a pipeline of innovative
therapies and biosimilars, today announced the company has reached a licensing agreement with Mega Lifesciences PCL for BAT1706, its bevacizumab biosimilar, under which Mega will have
exclusive rights to distribute and market the drug in Indonesia.
been approved in Indonesia for metastatic colorectal cancer, locally recurrent
or metastatic triple negative breast cancer, advanced, metastatic, or recurrent
non-small cell lung cancer, epithelial ovarian, fallopian tube, and primary
peritoneal cancer, and cervical cancer.
successfully completed a global Phase III comparative clinical study which was
a multicenter, randomized, double blind study evaluating the efficacy, safety,
pharmaco-kinetics and immunogenicity of BAT1706 versus EU-Avastin® plus chemotherapy in patients with advanced non
squamous non-small cell lung cancer.
approved for sale by the China National Medical Products Administration (NMPA)
in November 2021 and is marketed in China under the brand name Pobevcy®. Bio-Thera has
also filed commercial license applications with the European Medicines Agency
(EMA) and the United States Food and Drug Administration (FDA). Mega will be responsible for filing the
dossier in Indonesia.
will leverage Mega’s strong local presence, and sales and marketing
capabilities in Indonesia. Bio-Thera will be responsible for commercial supply
of BAT1706 out of its manufacturing facilities in Guangzhou,
pleased to partner with Mega to commercialize our bevazcizumab biosimilar in Indonesia”, said Dr. Shengfeng Li, CEO of Bio-Thera. “We look forward to bringing an important
product to patients in Indonesia in collaboration with Mega.”
Solutions, Ltd., a leading global biotechnology company in Guangzhou, China, is
dedicated to researching and developing novel therapeutics for the treatment of
cancer, autoimmune, cardiovascular diseases, and other serious unmet medical
needs, as well as biosimilars for existing, branded biologics to treat a range
of cancer and autoimmune diseases. A leader in next generation antibody
discovery and engineering, the company has advanced six candidates into
late-stage clinical trials and has three approved products, QLETLI®2, POBEVCY®3 and 施瑞立®4 (BAT1806) in China. In addition, the company has
multiple promising candidates in early clinical trials and IND-enabling
studies, focusing on immuno-oncology, ADC targeted therapies, autoimmune
diseases, and other severe and emerging unmet medical needs. For more
information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol)
and WeChat (Bio-Thera).
Note Regarding Forward-Looking Statements
release contains certain forward-looking statements relating to BAT1706 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, for example, the development processes
could be lengthy and high in vitro affinity may not translate to desired
results in vivo or successful 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
Avastin® is a registered trademark of Genentech, Inc.
QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.
POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.
4. 施瑞立® is
a registered trademark of Bio-Thera Solutions, Ltd.