GUANGZHOU, China, Dec. 7, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced that the United States Food and Drug Administration (FDA) has approved Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®. Avzivi® is Bio-Thera's second USFDA approved product and is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States.

The FDA approval of Avzivi® was based on a comprehensive analytical, non-clinical and clinical data package submitted by Bio-Thera to the FDA. Extensive analytical characterization between BAT1706 and US and EU Avastin® was conducted on structural, physicochemical, and biological properties to support biosimilarity of BAT1706. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of BAT1706 with both the US and EU Avastin® in healthy volunteers. A randomized, double-blind, three-arm parallel phase III study compared BAT1706 with Avastin® for efficacy, safety, and immunogenicity in subjects with advanced non-squamous non-small cell lung cancer. The totality of the evidence demonstrated that BAT1706 has similar efficacy, safety, immunogenicity and quality as the reference product bevacizumab.

"Bevacizumab has been widely used in the treatment for lung and colorectal cancers and many other cancers around the world," commented professor Li Zhang, leading investigator for global phase III study of Avzivi®. "The global phase III clinical trial has confirmed that Avzivi® is highly similar to Avastin® in terms of efficacy, safety and immunogenicity. The approval of Avzivi® by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option. We hope Bio-Thera continues to make more high-quality biosimilars available to patients around the world."

"The approval of Avzivi® is another landmark accomplishment for Bio-Thera as it marks Bio-Thera's second FDA approved product in the United States," said Shengfeng Li, CEO at Bio-Thera. "As our biosimilar pipeline continues to mature, we intend to seek more approvals of biosimilars, expanding patient access to important therapies."

Bio-Thera and Sandoz entered into a license and commercialization agreement for Avzivi® (BAT1706) in September 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Sandoz is responsible for the commercialization of Avzivi® in the United States and other countries around the world.

About Avzivi® (bevacizumab-tnjn)

Avzivi® (bevacizumab-tnjn) is a humanized monoclonal antibody that targets VEGF. It specifically binds to VEGF and blocks the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. The original company name for Avzivi® is BAT1706. In the United States, Avzivi® is indicated for the treatment of 1) Metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment, 2) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (Limitation of Use: not indicated for adjuvant treatment of colon cancer), 3) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment, 4) Recurrent glioblastoma in adults, 5) Metastatic renal cell carcinoma in combination with interferon alfa, 6) Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan, 7) Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as 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 multiple candidates into late-stage development, including three approved products: QLETLI® in China, and TOFIDENCE™/ BAT1806 and Avzivi® /Pobevcy® in the US and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit www.bio-thera.com/en/or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to Avzivi®/BAT1706 or the product pipelines in general of Bio-Thera Solutions. 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 "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions 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 and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include those associated with regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, 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. Unless required by laws or regulations, 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. Avzivi® is a registered trademark of Novartis AG
2. Avastin® is a registered trademark of Genentech, Inc.
3. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.
4. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.
5. TOFIDENCE™ is a trademark of Biogen, Inc.

SOURCE Bio-Thera Solutions, Ltd.

Posted: December 2023