GUANGZHOU, China --- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosesimilars, today announced the company has reached a licensing agreement with Mega Lifesciences PCL for BAT1706, its bevacizumab biosesimilar, under which Mega will have exclusive rights to distribute and market the drug in Indonesia.

Bevacizumab has been approved in Indonesia for metastatic colorectal cancer, locally recurrent or metastatic triple negative breast cancer, advanced, metastatic, or recurrent non-small cell lung cancer, epithelial ovarian, fallopian tube, and primary peritoneal cancer, and cervical cancer.

BAT1706 has successfully completed a global Phase III comparative clinical study which was a multicenter, randomized, double blind study evalsuating the efficacy, safety, pharmaco-kinetics and immunogenicity of BAT1706 versus EU-Avastin® plus chemotherapy in patients with advanced non squamous non-small cell lung cancer.

BAT1706 was approved for sale by the China National Medical Products Administration (NMPA) in November 2021 and is marketed in China under the brand name Pobevcy®.  Bio-Thera has also filed commercial license applications with the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA).  Mega will be responsible for filing the dossier in Indonesia.

This partnership will leverage Mega’s strong local presence, and sales and marketing capabilities in Indonesia. Bio-Thera will be responsible for commercial supply of BAT1706 out of its manufacturing facilities in Guangzhou, China.

“Bio-Thera is pleased to partner with Mega to commercialize our bevazcizumab biosesimilar in Indonesia”, said Dr. Shengfeng Li, CEO of Bio-Thera.  “We look forward to bringing an important product to patients in Indonesia in collaboration with Mega.”

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading global biotechnology 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 biosesimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and has three approved products, QLETLI®2, POBEVCY®3 and 施瑞立®4 (BAT1806) in China. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on immuno-oncology, ADC targeted therapies, autoimmune diseases, and other severe and emerging unmet medical needs. For more information, please visit www.xianbanghuojia.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 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, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful 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. Avastin® is a registered trademark of Genentech, Inc.

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

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

4. 施瑞立® is a registered trademark of Bio-Thera Solutions, Ltd.