GUANGZHOU, China--(BUSINESS WIRE)--Bio-Thera
Solutions, a commercial-stage biopharmaceutical company, today
announced that the Phase III clinical trial comparing the safety and
efficacy of BAT1706 versus Avastin®1 (bevacizumab) met its
primary endpoint. BAT1706 is being developed by Bio-Thera Solutions as a
proposed biosimilar to Avastin®. The trial demonstrated equivalence in
overall response rate (ORR) for the first-line treatment of patients
with non-squamous non-small cell lung cancer.
“We are pleased to report on our second proposed biosimilar with
positive study results. These results demonstrate the potential of our
proposed bevacizumab biosimilar to be a safe and effective treatment
option for cancer patients,” said Shengfeng Li, Ph.D., CEO of Bio-Thera
Solutions. “Bio-Thera is committed to increasing patient access to
innovative medicines through the development of high-quality
biosimilars.”
The BAT1706 Phase III clinical study is a multicenter, randomized,
double blind, study evaluating the efficacy, safety, pharmacokinetics
and immunogenicity of BAT1706 versus EU Avastin® plus chemotherapy in
patients with advanced non squamous non-small cell lung cancer. The
primary endpoint measures ORR. Results of the study will be presented in
full at a future medical meeting or summarized in publication.
More information regarding the BAT1706 Phase III clinical trial,
including inclusion and exclusion criteria and primary and secondary
outcome measures, can be found here: http://clinicaltrials.gov/ct2/show/NCT03329911
BAT1706 is Bio-Thera Solutions’ second proposed biosimilar with positive
Phase III study results. The company’s first biosimilar product,
QLETLI® (格乐立®), a biosimilar to Humira® (adalimumab), has received
marketing authorization and is available in China. Bio-Thera Solutions
is developing several additional proposed biosimilars, including
ustekinumab, secukinumab and golimumab, among others.
About BAT1706
BAT1706 is a monoclonal antibody (mAb) that is in development as a
potential biosimilar to Avastin®. BAT1706 works by binding the vascular
endothelial growth factor (VEGF) protein. In the U.S., Avastin® is
indicated for the treatment of patients with metastatic colorectal
cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma,
metastatic renal cell carcinoma, persistent, recurrent, or metastatic
cervical cancer, and epithelial ovarian, fallopian tube, or primary
peritoneal cancer. BAT1706 is an investigational compound and has not
received regulatory approval in any country. Biosimilarity has not yet
been established by regulatory authorities.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical
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. As a leader in the next generation
antibody discovery and engineering, the company has advanced five
candidates into late stage clinical trials and one of which, QLETLI®
(格乐立®), a biosimilar to Humira® (adalimumab), is available to patients
with rheumatoid arthritis, ankylosing spondylitis, or plaque psoriasis
in China. In addition, the company has multiple candidates in early
clinical trials and IND-enabling studies, focusing on innovative targets
in immuno-oncology and autoimmune diseases. For more information,
please visit www.hkbulova.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
1 Avastin® is a registered trademark of Genentech, Inc.