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Bio-Thera Solutions Submits Marketing Authorization Application (MAA) for BAT1706, a Proposed Biosimilar to Avastin®, to European Medicines Agency (EMA)

2020年11月25日 PM10:08
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GUANGZHOU, China

Bio-Thera Solutions (SHA: 688177), a commercial-stage biopharmaceutical company, today announced that it has submitted the MAA for BAT1706, a proposed biosimilar to Avastin® (bevacizumab), to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the European Union (EU) Member States, Iceland, Norway and Liechtenstein.

“The submission of the MAA for BAT1706 marks a milestone for Bio-Thera as the first ex-China MAA or BLA submission,” said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. “Bio-Thera intends to bring its pipeline of biosimilars and innovative therapies to patients around the world and this submission is an important step for extending the global reach of BAT1706”.

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 Europe for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, non–small cell lung cancer, advanced or metastatic renal cell cancer, epithelial ovarian, fallopian tube and primary peritoneal cancer, and cervical cancer.

A Biologics License Application seeking approval for BAT1706 for the treatment of metastatic carcinoma of the colon or rectum and non–small cell lung cancer is under review by the China National Medicinal Product Administration (NMPA). Bio-Thera intends to submit a BLA for BAT1706 to the U.S. Food and Drug Administration (FDA) before the end of 2020.

BAT1706 is Bio-Thera Solutions’ second proposed biosimilar submitted for regulatory approval. 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 golimumab, ustekinumab and secukinumab, and mepolizumab among others.

About BAT1706

BAT1706 is a monoclonal antibody that is in development as a potential biosimilar to Avastin®. BAT1706 works by binding the vascular endothelial growth factor (VEGF) protein. In the EU, 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.

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, plaque psoriasis, Crohn’s disease and uveitis indications 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).

Bio-Thera’s Notes Regarding Forward-Looking Statements

This press release contains certain forward-looking statements relating to BAT1706 or Bio-Thera Solutions and its product pipeline in general. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing “will,” “would,” “could,” “may,” “potential,” “promising,” “plans,” “expected,” or similar expressions. They reflect Bio-Thera Solutions’ current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information available to Bio-Thera Solutions as of the date of this press release and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research, development and commercialization, such as the risks and uncertainties of pre-clinical and clinical studies, and in obtaining regulatory approvals. Other risk factors include risks and uncertainties in manufacturing, distribution, marketing, competition, intellectual property, product efficacy or safety, changes in national and global financial and healthcare situations, changes in the company’s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company’s views or otherwise.

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

2 QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.

3 Humira® is a registered trademark of Abbvie, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201125005461/en/

CONTACT

Bio-Thera Solutions, Ltd.:

Bert E. Thomas IV +1.410.627.1734

bethomas@bio-thera.com

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