GUANGZHOU, China --- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced the company has reached a licensing agreement with Macter International Ltd. for BAT1706, its bevacizumab biosimilar, under which Macter will have exclusive rights to distribute and market the drug in Pakistan and Afghanistan.

BAT1706 has successfully completed a global Phase III comparative clinical study which was a multicenter, randomized, double blind study evaluating 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?².  BAT1706 was recently approved by the United States Food and Drug Administration (FDA) on December 7, 2023, and will be marketed in the United States under the brand name Avzivi?⁴.  Bio-Thera has also filed commercial license applications with the European Medicines Agency (EMA).  Macter will be responsible for filing the dossier in Pakistan and Afghanistan.

This partnership will leverage Macter’s strong local presence, and sales and marketing capabilities in Pakistan and Afghanistan. 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 Macter to commercialize our bevacizumab biosimilar in Pakistan and Afghanistan”, said Dr. Shengfeng Li, CEO of Bio-Thera.  “We look forward to bringing an important product to patients in Pakistan and Afghanistan in collaboration with Macter.”

About Macter International

Macter International Limited is public limited company and has a successful 40 years track record. Macter is one of the leading pharmaceutical and biopharmaceutical company in Pakistan that pioneers in science and pursues innovations. Macter is committed to provide high quality affordable biosimilar and branded generic products for the millions of Patients across Pakistan and neighboring countries in niche therapeutic segments such as Oncology, Autoimmune Disease, Cardio-Metabolic, Nephrology, Rheumatology and Respiratory. Macter provide single platform for developing, registering, manufacturing and distributing products. With passion, and enduring dedication, Macter have been contributing to the improvement of patient welfare and access to healthcare by offering innovative treatment options.

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?⁴ in China, and TOFIDENCE?⁵/ BAT1806 and Avzivi?³/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 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.     POBEVCY? is a registered trademark of Bio-Thera Solutions, Ltd.

3.     Avzivi? is a registered trademark of Novartis, Inc.

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

5.     TOFIDENCE? is a trademark of Biogen, Inc.