BioDlink Accelerates Global Expansion with Bevacizumab Launch in Colombia and Pakistan

- 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 /PRNewswire/ -- 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 tolower 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.

About BioDlink

BioDlink, a leading global Contract Development and Manufacturing Organization (CDMO) specializing in biologics, is committed to being the trusted partner of choice for biopharmaceutical innovators worldwide. Leveraging our advanced one-base integrated platform, BioDlink delivers end-to-end CDMO services for protein-based therapeutics (such as mAb, BsAb), biosimilar, and bioconjugated drugs (such as XDCs/ADCs) from early-stage research through to commercial-scale manufacturing.

BioDlink operates large-scale biopharmaceutical manufacturing facilities compliant with GMP standards and adheres to international quality management systems aligned with regulatory requirements in the US, the EU, and China. With our cutting-edge technology platforms and expert teams, BioDlink facilitates accelerated development timelines, with clients spanning Europe, the Americas, Asia, and several key emerging markets.

BioDlink operates with a clear service philosophy: "Quality-Driven, Innovation-Enabled, Growth-Shared," and has assembled an experienced and forward-thinking team. Committed to rigorous quality and compliance, the company nurtures a collaborative ecosystem that empowers its partners and delivers shared success. For more information, please visit: https://www.biodlink.com/

About Kexing Biopharm Co., Ltd.

Kexing Biopharm is an innovative biopharmaceutical enterprise mainly engaged in the integration of R&D, production and sales of recombinant protein drugs and microecological preparations. It focuses on antiviral, tumor and immune, blood, digestion, degenerative diseases and other therapeutic fields, builds cutting-edge biotechnology platforms such as new protein, new antibody, nucleic acid drugs, and adheres to the platform driven development model of "innovation+internationalization", At the same time, it explores the extensive application of biotechnology in the field of general health, actively cultivates and incubates new industries, the world's leading industrial platforms such as animal vaccines and synthetic organisms have been distributed, and is committed to becoming a leader in high-quality biopharmaceutics and serving global patients.

Reference:

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

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

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

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