Guangzhou, China– July 30, 2024 – Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the EMA has approved BAT1706 (bevacizumab), a biosimilar referencing Avastin®.  Sandoz AG and its affiliates have rights to market BAT1706  in Europe under the brand name Avzivi®.  BAT1706 is Bio-Thera’s second EMA approved product and Bio-Thera’s second product to receive marketing authorization from NMPA, US FDA and EMA.

“The EMA approval of BAT1706 is another significant accomplishment for Bio-Thera as it marks Bio-Thera’s second EMA approved product” said Shengfeng Li, CEO at Bio-Thera. “As our biosimilar pipeline continues to mature, we intend to seek more biosimilar approvals, expanding patient access to important therapies.”

Bio-Thera and Sandoz AG entered into a license and commercialization agreement for BAT1706 (Avzivi®) 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 European Union, the United States and other countries around the world.

About BAT1706 (Avzivi®, bevacizumab)

BAT1706 (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 brand name for BAT1706 in the EU and the United States is Avzivi®. In the Europe, Avzivi® is indicated for the treatment of 1) Metastatic carcinoma of the colon or rectum, in combination with fluoropyrimidine-based chemo-therapy is indicated for treatment of adult patients, 2) Metastatic breast cancer, in combination with paclitaxel is indicated for first-line treatment of adult patients, 3) Metastatic breast cancer, in combination with capecitabine is indicated for first-line treatment of adult patients in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avzivi in combination with capecitabine. 4) Unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology, in addition to platinum-based chemotherapy is indicated for first-line treatment of adult patients, 5) Unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations, in combination with erlotinib, is indicated for first-line treatment of adult patients, 6) Advanced and/or metastatic renal cell cancer, in combination with interferon alfa-2a is indicated for first line treatment of adult patients,  7) Advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients, 8) Platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel in adult patients with first recurrence who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents, 9) Platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin in adult patients who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents, 10) Persistent, recurrent, or metastatic carcinoma of the cervix, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in adult patients who cannot receive platinum therapy.

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® (BAT1406) in China, and TOFIDENCE™/ BAT1806 and Avzivi® / Pobevcy® (BAT1706) in the US, EU 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.xjnhtz.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 BAT1706 (Avzivi®) 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 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 trademark of Biogen

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