GUANGZHOU, China--(BUSINESS WIRE)--Bio-Thera
Solutions, Ltd., a clinical-stage pharmaceutical company, today
announced that the China National Medical Products Administration (NMPA)
has approved QLETLI® (格乐立®) for all eligible indications of the reference product, Humira® (adalimumab), in China. QLETLI® (格乐立®) is
the first adalimumab biosimilar approved by the NMPA and has been
approved for the treatment of three autoimmune diseases, including
rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.
QLETLI® (格乐立®) is Bio-Thera's first biosimilar to receive regulatory approval and only the second biosimilar approved by the NMPA.
"The NMPA approval of QLETLI® (格乐立®) is a
very important milestone for our biosimilar portfolio, providing an new
affordable treatment option for patients in China with several types of
autoimmune diseases," said Shengfeng Li, Ph.D., CEO of Bio-Thera
Solutions. "QLETLI® (格乐立®) is the first biosimilar from our portfolio to receive regulatory approval. We look forward to seeking approvals of QLETLI® (格乐立®) in other regulated markets around the world."
The approval of QLETLI® (格乐立®) was based on
the totality of evidence from a comprehensive data package supporting
biosimilarity 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.
"Approval of QLETLI® (格乐立®) is an exciting
accomplishment for Bio-Thera Solutions as it marks the first approval in
a regulated market from our biosimilar portfolio. This milestone
demonstrates Bio-Thera’s dedication to the development of high quality
biologic therapeutics." said Bert E. Thomas IV, Ph.D., M.B.A., Senior
Vice President of Business Development at Bio-Thera Solutions. "
Bio-Thera Solutions is committed to bring high quality biosimilar
products to patients around the world.”
Bio-Thera Solutions is developing several additional proposed biosimilars, including biosimilar versions of Avastin® and Actemra®/RoActemra®,
which are both currently being evaluated in global Phase III clinical
trials. Bio-Thera Solutions is also pursuing biosimilar versions of
Simponi® and Stelara®.
About QLETLI® (格乐立®)
The active ingredient of QLETLI® (格乐立®) is
an anti-TNF- α monoclonal antibody that has the same amino acid sequence
as, and is biosimilar 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 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 has received marketing authorization. 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.fulannite.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).
1 Humira® is a registered trademark of AbbVie Biotechnology Ltd.
2 Avastin® is a registered trademark of Genentech, Inc.
3 Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp.
4 RoActemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp.
5 Simponi® is a registered trademark of Johnson & Johnson Corp.
6 Stelara® is a registered trademark of Johnson & Johnson Corp.