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 committed to developing 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 today announced that it recently received notification from the European Medicines Agency (EMA) that Avzivi® (BAT1706), a biosimilar developed with reference to Anvitin® (bevacizumab), has received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP), which recommended to the European Commission (EC) that it grant marketing authorization for Avzivi® for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, metastatic renal cell carcinoma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and metastatic cervical cancer.

The CHMP's opinion on Avzivi® is based on the results of comprehensive analyses, supported by preclinical and clinical data: Avzivi® has been extensively characterized and analyzed for structural, physicochemical, and biological characteristics that demonstrate similarity to the originator; the Phase I clinical study of Avzivi® has been conducted in healthy subjects comparing Avzivi® with the the pharmacokinetic profile, safety and immunogenicity of Avzivi® with that of commercially available originator drugs in the U.S. and Europe, and the results demonstrated its concordance with the originator drug; the Phase III clinical study of Avzivi® has further demonstrated a high degree of similarity to the originator drug in terms of safety, efficacy and immunogenicity.

In September 2021, BIO-THERA signed a commercialization and licensing agreement with Sandoz for Avzivi® (BAT1706). 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® (BAT1706) in the United States, Europe and most of the other international markets not covered by the BAT1706 collaboration.

Dr. Shengfeng Li, Founder and Managing Director of BIO-THERA, commented, "We are very pleased to receive a positive CHMP opinion for Avzivi®. This is BIO-THERA's second product to receive a positive CHMP opinion, and it is an important signal prior to the EMA's formal approval of the product for marketing. the issuance of a positive opinion by the CHMP is expected to allow us to more quickly provide new cancer patients in Europe with new treatment options for those in need. The positive opinion issued by the CHMP is expected to allow us to provide new treatment options to European cancer patients in need more quickly. We will also continue our efforts to develop and advance safe, effective and affordable biologics to benefit patients worldwide."

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