BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as "BIO-THERA" or the "Company". The Company is dedicated to the development of a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology, and other major diseases that threaten human life or health. The Company recently received notification from the European Commission that Avzivi (BAT1706), a biosimilar developed by BIO-THERA with reference to Avastin® (bevacizumab), Intravenous Solution, has been granted marketing authorization by the European Commission for the treatment of metastatic colorectal, metastatic breast, non-small-cell lung, renal-cell, epithelial ovarian, fallopian tube or primary peritoneal, and cervical cancer. The decision was based on a positive review opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

In September 2021, BIO-THERA signed a commercialization and license agreement with Sandoz for Avzivi. Under the terms of the agreement, BIO-THERA is responsible for the development, manufacture and supply of the product, and Sandoz is responsible for the commercialization activities of Avzivi in the United States, Europe and most of the other international markets not covered by the BAT1706 collaboration. Of these, Avzivi has been approved for marketing in December 2023 in the United States.

Dr. Shengfeng Li, Founder and Chairman of BIO-THERA, commented, "We are very pleased to receive marketing approval from the European EMA for Avzivi, which is the second product of BIO-THERA to receive marketing approval from the European EMA, and the second product of BIO-THERA to achieve triple marketing in China, the U.S. and Europe. We will continue our efforts to actively promote the marketing of safe, effective and affordable biologics to benefit more patients in need."

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