Boan Biotech Obtains ANVISA GMP Certification

Boan Biotech announced today that it has received GMP certification from the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) for its biological product, Boyuno^® (Bevacizumab Injection), covering the drug substance and the drug product.

Boyuno is a recombinant anti-VEGF humanized monoclonal antibody injection, developed by Boan Biotech as a bevacizumab biosimilar. 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 accepted the marketing authorization application for the product in Brazil.

ANVISA, a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), conducted a comprehensive five-day GMP inspection with two Brazilian inspectors and an observer from the China National Medical Products Administration (NMPA). The inspection covered various aspects, including production workshops, quality systems, QC laboratories, utilities, and training systems, with no observations from ANVISA. The ANVISA GMP certification represents a pivotal step for the subsequent marketing authorization approval of Boyuno and establishes a robust foundation for the global commercialization of Boan Biotech's future innovative biologics and biosimilar products.

The Brazilian pharmaceutical market is a major emerging market with significant growth potential. IQVIA data indicates that the pharmaceutical market in Brazil was valued at approximately USD 30.2 billion in 2022, constituting about half of the entire pharmaceutical market in Latin America. It is expected to maintain an annual growth rate of 7-10% from 2023 to 2027. In terms of the needs of local patients, data from the World Health Organization's International Agency for Research on Cancer shows that, in 2020, breast cancer, lung cancer, colorectal cancer and cervical cancer ranked among the top ten cancers in terms of new cases in Brazil¹, indicating huge unmet treatment needs in the country. Bevacizumab as a preferred anti-angiogenic therapy is widely used to treat malignancies including those mentioned above. Making Boyuno available in Brazil will increase the accessibility of bevacizumab to local patients, contributing to an extension of their high-quality life expectancy.

Envisioned as a “leading global biopharmaceutical company”, Boan Biotech develops biologics for both Chinese and international markets. The company has established a management system in line with Chinese, American, EU and Japanese standards, to ensure the quality of Boyuno and more products yet to come.

Reference:

1.The website of the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO). URL: https://gco.iarc.fr/today/data/factsheets/populations/76-brazil-fact-sheets.pdf