- BioDlink’s bevacizumab injection secures marketing authorization in Colombia and Pakistan following its recent approval in Nigeria, marking key regulatory milestones in high-need emerging markets.

- GMP certification in Brazil, Colombia, and Argentina spans the top three most populous countries in South America, collectively representing 71.4% of the continent’s population

- Backed by a globally recognized quality system and a strong track record in monoclonal antibody, ADC/XDC, biosimilar development and manufacturing, BioDlink, in partnership with Kexing BioPharm is fast-tracking access to high-quality oncology biosimilars in underserved regions.

Suzhou, China– Aug 13, 2025 — BioDlink announced that its self-developed bevacizumab injection biosimilar has received marketing approval from Colombia’s National Institute for Surveillance of Medicines and Foods (INVIMA) and Pakistan’s Drug Regulatory Authority of Pakistan (DRAP). This development underscores its mission to improve access to critical cancer therapies worldwide.

Following GMP certification in China, Colombia, Brazil, Argentina, Egypt, Indonesia and Pakistan, Kexing BioPharm, the global licensee for bevacizumab injection in emerging markets, has initiated regulatory filings in 35 countries in close collaboration with BioDlink. GMP certification in Brazil, Colombia and Argentina covers the top three most populous countries in South America, representing 71.4% of the continent’s population ^[1].

BioDlink's manufacturing facilities span 50,000 square meters and have passed antibody drug and ADC EU-QP inspection (including zero-defect) five times in the past four years. BioDlink's global-quality system is robust, delivering over 100 clinical projects with development, clinical filings, and manufacturing services worldwide, including Europe and the U.S.

Meeting unmet needs in public health

Colombia and Pakistan are key pharmaceutical markets in South America and South Asia respectively. Both nations see a trend toward an increase in the incidence of colorectal cancer . The launch of bevacizumab injection seeks to lower the cost of treatment for both public health systems and patients, while maintaining rigorous global quality standards.

Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF), is widely used in the treatment of various cancers, including metastatic colorectal cancer (mCRC) and metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC). According to industry estimates, bevacizumab injection achieved global sales of USD 8.5 billion in 2023^[2]. 

“Cancer incidence is rising sharply, especially colorectal cancer^[3], which has seen a global increase in early-onset cases in middle- and low‑income countries,” said Dr. Jun Liu, CEO and Executive Director of BioDlink. “With our partnership with Kexing Biopharm, we are committed to serving South American and other emerging markets and combat colorectal and lung cancers, the top two leading causes of cancer-related deaths worldwide ^[4].”

Since BioDlink signed an international commercialization agreement with Kexing BioPharm in early 2022, both parties have achieved an efficient closed-loop “R&D-manufacturing-access” model. BioDlink focuses on ensuring international manufacturing and supply chain robustness, while Kexing BioPharm leverages its global channels to drive localized market access efficiently.

BioDlink and Kexing BioPharm share an operational philosophy of “leading with quality and building on compliance” to focus on emerging markets such as South America, South Asia, Southeast Asia and Africa. Both companies look forward to deepening their global collaboration to fulfill a shared mission of advancing global healthcare.

Reference:

[1] Top three most populous countries in South America. 

https://en.wikipedia.org/wiki/List_of_South_American_countries_by_population

[2] Bevacizumab injection achieved global sales of USD 8.5 billion in 2023.

https://dataintelo.com/report/global-bevacizumab-injection-market

[3] Cancer incidence is rising sharply, especially colorectal cancer

https://www.sciencedirect.com/science/article/pii/S1936523321001662

[4] Combat colorectal and lung cancers, the top two leading causes of cancer-related deaths worldwide

https://www.who.int/news-room/fact-sheets/detail/lung-cancer

https://www.who.int/news-room/fact-sheets/detail/colorectal-cancer