China NMPA Approves Bio-Thera Solutions’ QLETLI, A Biosimilar To Humira (Adalimumab)

Approval Based on Totality of Evidence Demonstrating That QLETLI®(格乐立®) Is Biosimilar to Humira®

First Approved Biosimilar From Bio-Thera's Biosimilar Portfolio

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 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.

Source: Bio-Thera Solutions, Ltd.

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