GUANGZHOU, China–(BUSINESS WIRE)–Bio-Thera Solutions, Ltd., a fully-integrated pharmaceutical company, today announced that QLETLI® (格乐立®), a biosimilar to Humira® (adalimumab), is now available in China. QLETLI® (格乐立®), the first adalimumab biosimilar 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 biosimilar to receive regulatory approval and is the second biosimilar 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 biosimilar 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 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.
Bio-Thera Solutions is developing several additional proposed biosimilars, including biosimilars to Avastin® and to Actemra®/RoActemra®, which are both currently being evaluated in global Phase III clinical trials. Bio-Thera is also pursuing biosimilars to Simponi® and to Stelara®.
The active ingredient of QLETLI® (格乐立®) is an anti-TNF-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 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 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 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.bio-thera.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.