The board of directors of Shandong Boan Biotechnology Co., Ltd. announced that its biological product, Boyuno®? (Bevacizumab Injection), received GMP certification from the Brazilian Agencia Nacional de Vigilancia Sanitaria ("ANVISA"). This GMP certification covers the drug substance and drug product of Boyuno®?.

Boyuno®? is a recombinant anti-VEGF humanized monoclonal antibody injection, independently developed by the Company as a biosimilar to bevacizumab. As the Company's first in-house developed commercial product, Boyuno®?

was launched in China in 2021 for the treatment of multiple types of cancer including advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), metastatic colorectal cancer, ovarian cancer and cervical cancer. Since its launch in China, Boyuno®? has been widely recognized by healthcare professionals and patients for its efficacy and safety.

In April 2023, ANVISA officially accepted the Biologics License Application (BLA) for Boyuno®? in Brazil. ANVISA is a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

The Company's comprehensive management system in research and development, production, and quality control, built to the highest international standards, ensured that this inspection was passed with no observations. Obtaining the GMP certification from ANVISA has advanced the marketing authorization approval of Boyuno®? in Brazil, and also established a solid quality foundation for the global commercial reach of the Company's future innovative biologics and biosimilar products.

The Company believes that the introduction of Boyuno®? in the Brazilian market will increase the accessibility of bevacizumab to more local patients, thus improving their survival and the quality of life.