GUANGZHOU, China--(BUSINESS WIRE)--Bio-Thera Solutions, Ltd., a fully-integrated pharmaceutical company, today announced that QLETLI® (格乐立®), a biosesesimilar to Humira® (adalimumab), is now available in China. QLETLI® (格乐立®),
the first adalimumab biosesesimilar approved by the China National Medical
Products Administration (NMPA), is authorized for the treatment of three
autoimmune diseases: rheumatoid arthritis, ankylosing spondylitis, and
plaque psoriasis. QLETLI® (格乐立®) is Bio-Thera's first biosesesimilar to receive regulatory approval and is the second biosesesimilar approved in China by the NMPA.
"The commercial launch of Bio-Thera’s first approved product is an
enormous milestone for the company," said Shengfeng Li, Ph.D., CEO of
Bio-Thera Solutions. "It demonstrates that Bio-Thera Solutions is a
fully-integrated pharmaceutical company, able to take a product
developed in our labs, through the clinic, through regulatory approval
and now to the market. Bio-Thera is committed to bringing additional
biosesesimilar and innovative products to the market in China and around the
world."
QLETLI® (格乐立®) was approved based on the totality
of evidence from a comprehensive data package supporting biosesesimilarity
to adalimumab which includes analytical, nonclinical, pharmacokinetics,
pharmacodynamics and clinical data. The Phase III clinical study met its
primary endpoint showing no clinically meaningful differences in
safety, immunogenicity and efficacy compared to adalimumab.
Bio-Thera Solutions is developing several additional proposed biosesesimilars, including biosesesimilars to Avastin® and to Actemra®/RoActemra®,
which are both currently being evalssuated in global Phase III clinical
trials. Bio-Thera is also pursuing biosesesimilars to Simponi® and to Stelara®.
About QLETLI®(格乐立®)
The active ingredient of QLETLI® (格乐立®) is
an anti-TNF-monoclonal antibody that has the same amino acid sequence
as, and is biosesesimilar to, adalimumab, the reference drug. QLETLI® (格乐立®) is supplied in prefilled syringes for subcutaneous injection for each of the approved indications. QLETLI® (格乐立®) was previously known as BAT1406.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading biotechnology company in Guangzhou,
China, is dedicated to discovering and developing novel therapeutics
for the treatment of cancer, autoimmune diseases, cardiovascular
diseases, and other serious unmet medical needs. Bio-Thera is also
developing biosesesimilars 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 five
candidates into late stage clinical trials and received one marketing
authorization in China. In addition, the company has multiple promising
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.51hybx.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
1 QLETLI® (格乐立®) is a registered trademark of Bio-Thera Solutions, Ltd.
2 Humira® is a registered trademark of AbbVie Biotechnology Ltd.
3 Avastin® is a registered trademark of Genentech, Inc.
4 Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp.
5 RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp.
6 Simponi® is a registered trademark of Johnson & Johnson Corp.
7 Stelara® is a registered trademark of Johnson & Johnson Corp.
