Boan Biotech's Biologics License Application for Boyounuo® (Bevacizumab Injection) Accepted in Brazil

YANTAI,China,April 11,2023 -- Boan Biotech today announced that Brazil's Agência Nacional de Vigilância Sanitária (ANVISA) has accepted the company's Biologics License Application (BLA) for Boyounuo® (Bevacizumab Injection).

Envisioned to be "a leading global biopharmaceutical company",Boan Biotech develops biologics for both Chinese and international markets,including Europe and the U.S. As the company's first in-house developed commercial product,Boyounuo was launched in China in 2021 for treating multiple types of cancer including advanced,metastatic or recurrent non-small cell lung cancer (NSCLC) and metastatic colorectal cancer. Bevacizumab is a signature anti-angiogenic anticancer drug recommended by several global guidelines as a standard treatment for malignant cancers. After its launch in China,Boyounuo has been widely recognized by doctors and patients for its efficacy and safety. At the same time,Boan Biotech is also accelerating the commercial launch of this product overseas.

Boyounuo is a bevacizumab injection developed following international standards

Boyounuo is a recombinant anti-VEGF humanized monoclonal antibody injection,developed as a bevacizumab biosimilar in compliance with the regulations for biosimilars in China,the U.S.,and the EU. The drug has been compared head-to-head with the originator bevacizumab through pharmacological,non-clinical and clinical studies,showing that it's highly similar to the originator drug in terms of quality,safety,and efficacy.

Furthermore,the manufacturing and quality control of Boyounuoalso follow the highest international standards. Boan Biotech's manufacturing facility was built with a state-of-the-art design,and the production process is still under ongoing innovation and upgrade. The company has established a quality management system in line with Chinese,American and EU standards,to ensure the quality of Boyounuo and more products to come in overseas markets.

Boan Biotech is accelerating overseas expansion to serve global patients

The Brazilian pharmaceutical market is a major emerging market with huge growth potential. According to data from IQVIA,the country was the world's eighth-largest pharmaceutical market in 2021,and is expected to rise to the sixth-largest in 2026. Invoice spending on pharmaceutical products in Brazil is expected to reach USD 47-51 billion in 2026,with a compound annual growth rate (CAGR) of 7.5%-10.5% from 2022 to 2026,which is faster than the global average and the growth rate in developed markets1.

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,lung cancer and colorectal cancer were among the top five cancers in terms of new cases in Brazil2,indicating huge unmet treatment needs in the country. Bevacizumab as a preferred anti-angiogenic therapy is widely used to treat NSCLC,colorectal cancer,and other malignancies. Making Boyounuo available in Brazil will increase the accessibility of bevacizumab to local patients,extend their life expectancy,and improve the quality of life for them.

Dr. Dou Changlin,President of R&D and Chief Operating Officer of Boan Biotech,said: "At Boan Biotech,we're committed to serving patients around the world with high-quality biologics. Our products are developed to address worldwide clinical needs following international quality standards. Fast-growing emerging markets including Brazil are important parts of our international business. We are accelerating the overseas development and launch of our products aiming to build a leading Chinese biopharmaceutical brand in global markets."

About Boan Biotech

Boan Biotech (6955.HK) is a fully-integrated biopharmaceutical company developing,manufacturing,and marketing biologics,with a focus on oncology,autoimmune diseases,ophthalmology,and metabolic diseases. The company discovers antibodies on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform,Bispecific T-cell Engager Technology Platform,and ADC Technology Platform. Boan Biotech operates across the entire value chain of the industry from antibody discovery,cell line development,upstream and downstream process development,analytical and bio-analytical method development,and technology transfer to pilot and commercial production.

Boan Biotech's portfolio includes two commercial products. Its pipeline includes multiple innovative antibodies as drug candidates protected for their international intellectual property rights and a number of biosimilar candidates. In addition to China,the company is also developing biopharmaceutical products in overseas markets,including the U.S. and the EU. With a differentiated portfolio and well-established commercial capabilities,Boan Biotech operates across the industry's value chain from research and development to manufacturing and commercialization. This has laid a solid foundation for its long-term,high-quality growth.

References:

1. The Global Use of Medicines 2022. IQVIA Institute Report

2. Globocan 2020. International Agency for Research on Cancer. https://gco.iarc.fr/today/data/factsheets/populations/76-brazil-fact-sheets.pdf. Accessed in April 2023