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NMPA Accepts Bio-Thera Solutions’ Biologics License Application (BLA) for BAT1706, A Proposed Biosimilar to Avastin®

2020年06月20日 PM12:22
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GUANGZHOU, China

Bio-Thera Solutions (SHA: 688177), a commercial-stage biopharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin® (bevacizumab). Bio-Thera seeks commercial license for all approved indications of bevacizumab in China, advanced, metastatic or relapsed non-small cells lung cancer and metastatic colorectal cancer.

“BAT1706 is the company’s second application for marketing approval of a biosimilar in China, following the approval of Qletli® (adalimumab injection),” said Dr. Li Shengfeng, founder and CEO of Bio-Thera Solutions. “Lung cancer and colorectal cancer are high-risk cancers and patients need safe, effective, and affordable treatment drugs. BAT1706, developed in accordance with NMPA, FDA and EMA drug regulations, will provide a high-quality, low-cost treatment option for patients worldwide.”

BAT1706 is a proposed bevacizumab biosimilar developed by the company. Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF). It can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. Bevacizumab has been approved in China for two indications, namely advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal cancer. The indications approved in the United States and Europe also include certain types of renal cell carcinoma kidney cancer, ovarian cancer and cervical cancer and glioblastoma.

Through a series of preclinical comparison studies, clinical pharmacokinetic comparison studies, and international multi-center phase III clinical comparison studies, Bio-Thera Solutions has obtained data demonstrating that BAT1706 is highly similar to bevacizumab in clinical efficacy and safety.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200619005511/en/

CONTACT

Bio-Thera Solutions, Ltd.:

Bert E. Thomas IV +1.410.627.1734

bethomas@bio-thera.com

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