• CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing Avzivi? to the reference product Avastin?

Guangzhou, China– June 3, 2024 –Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency  adopted a positive opinion for Avzivi? (bevacizumab), a biosimilar monoclonal antibody referencing AVASTIN?. The CHMP’s positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for Avzivi?.

“Bio-Thera is committed to developing high-quality biosimilars to expand patient access to important therapeutics like bevacizumab,” said Shengfeng Li, CEO of Bio-Thera Solutions. “The positive CHMP recommendation for Avzivi? demonstrates that commitment to patients, healthcare providers, and healthcare systems in Europe.”

This positive CHMP opinion on Avzivi? was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of Avzivi? was conducted and supports biosimilarity with the reference biologic product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of Avzivi? with both the EU and US reference product in healthy volunteers. In addition, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared Avzivi? with the reference product to confirm equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Advanced Non-Squamous Non-Small Cell Lung Cancer. The totality of evidence demonstrated Avzivi? is a biosimilar of the reference biologic.

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 will have the right to commercialize the medicine upon approval and successful Marketing Authorization Holder Transfer in the US, Europe*, Canada and selected other countries.

*Includes the European Economic Area (EEA), United Kingdom, Switzerland, the Balkan States and selected countries in Eastern Europe.

About Avzivi? (bevacizumab)

Avzivi? (bevacizumab) 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 product code for Avzivi? is BAT1706.  In Europe, Avzivi? is under review for marketing authorization 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.

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 woaishijie63.cn/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. Other risks and uncertainties include challenges in obtaining 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 Sandoz AG

2. Avastin? is a registered trademark of Genentech, Inc.

3. QLETLI? is a registered trademark of Bio-Thera Solutions, Ltd.

4. TOFIDENCE? is a registered trademark of Biogen MA Inc.

5. POBEVCY? is a registered trademark of Bio-Thera Solutions, Ltd.