Bio-Thera Solutions, Ltd., 

Bio-Thera Solutions Announces GMP Approval from ANVISA

Date: 2023-10-25Click:

GUANGZHOU, China, October 24, 2023 -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, announced that the National Health Surveillance Agency (“ANVISA”) published the approval of the certification of good manufacturing practices for the manufacture of the medicine bevacizumab by Bio-Thera Solutions through the General Management of Health Inspection and Surveillance, Resolution-RE no. 3,997 of October 19, 2023, in the Official Gazette of the Union.


The Certificate attests to the good manufacturing practices of Bio-Thera’s plant that manufactures the active ingredient and finished product for BAT1706, a biosimilar of bevacizumab, and is an important requirement for obtaining registration of the product with ANVISA. The import, commercialization, and distribution of the medicine in Brazil will be subject to obtaining registration with ANVISA and publication of the price by the Regulatory Chamber of Medicines Market (CMED).


BAT1706 will be distributed exclusively in Brazil by Bio-Thera’s partner Biomm.  Bio-Thera and Biomm entered into a partnership agreement for BAT1706 on December 17, 2020.


“Receiving the ANVISA GMP is another important step for Bio-Thera”, said Dr. Shengfeng Li, CEO of Bio-Thera.  “It demonstrates our commitment to good manufacturing practices and providing safe and effective products to patients.”


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®, POBEVCY® and BAT1806 in China and one FDA approved product, TOFIDENCE. 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 follow us on LinkedIn, X (@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. 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) QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.
POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.
TOFIDENCE™ is a trademark of Biogen, Inc.