- BAT1706 is Bio-Thera Solutions' second EMA approved
product
- BAT1706 is Bio-Thera Solutions' second product receiving
marketing authorization from NMPA, FDA and EMA
GUANGZHOU, China, July 30,
2024 /PRNewswire/ -- Bio-Thera
Solutions Inc. (688177:SH), a commercial-stage
biopharmaceutical company developing a pipeline of innovative
therapies and biosimilars, today announced that the EMA has
approved BAT1706 (bevacizumab), a biosimilar referencing
Avastin®. Sandoz AG and its affiliates have rights
to market BAT1706 in Europe under
the brand name Avzivi®. BAT1706 is
Bio-Thera's second EMA approved product and Bio-Thera's second
product to receive marketing authorization from NMPA, US FDA and
EMA.
"The EMA approval of BAT1706 is another significant
accomplishment for Bio-Thera as it marks Bio-Thera's second EMA
approved product," said Shengfeng Li, CEO at Bio-Thera. "As
our biosimilar pipeline continues to mature, we intend to seek more
biosimilar approvals, expanding patient access to important
therapies."
Bio-Thera and Sandoz AG entered into a license and
commercialization agreement for BAT1706 (Avzivi®) in
September 2021. Under the terms of
the agreement, Bio-Thera is responsible for the development and
manufacturing of the product. Sandoz is responsible for the
commercialization of Avzivi® in the European Union,
the United States and other
countries around the world.
About BAT1706 (Avzivi®, bevacizumab)
BAT1706 (Avzivi®, bevacizumab) is a humanized
monoclonal antibody that targets VEGF. It specifically binds to
VEGF and blocks the binding of VEGF to its receptor, thereby
reducing neovascularization, inducing the degradation of existing
blood vessels, and thereby inhibiting tumor growth. The brand name
for BAT1706 in the EU and the United
States is Avzivi®. In the Europe, Avzivi® is indicated
for the treatment of 1) Metastatic carcinoma of the colon or
rectum, in combination with fluoropyrimidine-based chemo-therapy is
indicated for treatment of adult patients, 2) Metastatic breast
cancer, in combination with paclitaxel is indicated for first-line
treatment of adult patients, 3) Metastatic breast cancer, in
combination with capecitabine is indicated for first-line treatment
of adult patients in whom treatment with other chemotherapy options
including taxanes or anthracyclines is not considered appropriate.
Patients who have received taxane and anthracycline-containing
regimens in the adjuvant setting within the last 12 months should
be excluded from treatment with Avzivi in combination with
capecitabine. 4) Unresectable advanced, metastatic or recurrent
non-small cell lung cancer other than predominantly squamous cell
histology, in addition to platinum-based chemotherapy is indicated
for first-line treatment of adult patients, 5) Unresectable
advanced, metastatic or recurrent non-squamous non-small cell lung
cancer with Epidermal Growth Factor Receptor (EGFR) activating
mutations, in combination with erlotinib, is indicated for
first-line treatment of adult patients, 6) Advanced and/or
metastatic renal cell cancer, in combination with interferon
alfa-2a is indicated for first line treatment of adult
patients, 7) Advanced (International Federation of Gynecology
and Obstetrics (FIGO) stages III B, III C and IV) epithelial
ovarian, fallopian tube, or primary peritoneal cancer, in
combination with carboplatin and paclitaxel is indicated for the
front-line treatment of adult patients, 8) Platinum-sensitive
epithelial ovarian, fallopian tube or primary peritoneal cancer, in
combination with carboplatin and gemcitabine or in combination with
carboplatin and paclitaxel in adult patients with first recurrence
who have not received prior therapy with bevacizumab or other VEGF
inhibitors or VEGF receptor–targeted agents, 9) Platinum-resistant
recurrent epithelial ovarian, fallopian tube, or primary peritoneal
cancer, in combination with paclitaxel, topotecan, or pegylated
liposomal doxorubicin in adult patients who received no more than
two prior chemotherapy regimens and who have not received prior
therapy with bevacizumab or other VEGF inhibitors or VEGF
receptor–targeted agents, 10) Persistent, recurrent, or metastatic
carcinoma of the cervix, in combination with paclitaxel and
cisplatin or, alternatively, paclitaxel and topotecan in adult
patients who cannot receive platinum therapy.
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, and TOFIDENCE™/ BAT1806 and
Avzivi® / Pobevcy® (BAT1706) in the US,
EU 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),
WeChat (Bio-Thera), and Linked-In.
Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking
statements relating to BAT1706 (Avzivi®) 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. Avzivi® is a registered trademark of Sandoz AG
2. Avastin® is a registered trademark of Genentech,
Inc.
3. QLETLI® is a registered trademark of Bio-Thera
Solutions, Ltd.
4. TOFIDENCE™ is a trademark of Biogen
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