Bio-Thera Solutions Announces Positive Top-Line Results for BAT1706, A Proposed Biosimilar to Avastin®

Results from the Comparative Phase III Clinical Study Demonstrate Equivalence in Patients with Non-squamous Non-small Cell Lung Cancer

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: https://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.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).

1 Avastin^® is a registered trademark of Genentech, Inc.

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