BioDlink Biopharm Co., Ltd. has achieved a major milestone with the approval of its Bevacizumab Injection (Pusintin®) by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC). This approval opens the gateway to the African market, aligning with BioDlink’s broader strategy to expand globally and provide affordable, high-quality biosimilar therapies to underserved regions.
Expanding Global Footprint Through Strategic Collaborations
Following successful GMP certifications in Brazil, Colombia, Egypt, Indonesia, and Argentina—countries with rigorous regulatory frameworks—BioDlink has further cemented its global reputation. This approval in Nigeria signals its first major step into Africa, a continent with growing healthcare demands and limited access to cost-effective cancer treatments.
With Kexing Biopharm acting as the global licensee for Pusintin® in emerging markets, BioDlink has initiated regulatory filings in 35 countries. This collaborative momentum supports its mission to accelerate approvals and market launches across Southeast Asia, Latin America, and now, Africa.
Addressing Nigeria’s Urgent Cancer Care Challenges
Nigeria, Africa’s most populous nation with over 220 million citizens, faces a mounting cancer crisis. The World Health Organization (WHO) reports over 120,000 new cancer cases annually in Nigeria, growing at an estimated 5% each year. Limited access to advanced oncology therapies has made affordable and effective options like Pusintin® critically important.
Pusintin®’s entry into Nigeria provides a timely and essential solution, offering a cost-effective, high-quality biologic therapy for patients in need. This development also sets a precedent for future biosimilar expansion across the continent.
Commitment to Global Standards in Manufacturing and Quality
BioDlink’s biologics manufacturing facilities are GMP-compliant and globally accredited, having passed stringent inspections in China, Japan, Brazil, Egypt, Colombia, Indonesia, and Argentina. Its track record includes four successful EU Qualified Person (QP) audits for antibody and ADC production in the past two years.
Operating from a large-scale manufacturing hub, BioDlink runs four commercial lines and five drug substance production centers, including specialized facilities for non-toxic conjugated substances. These resources support a robust pipeline of monoclonal antibodies, bispecific antibodies, and XDCs, maintaining consistent global supply.
The company has supported over 100 clinical development projects worldwide within the past three years, including filings in the U.S. and Europe, reinforcing its capacity to deliver at scale with uncompromising quality.
Sustaining Global Expansion
The Nigeria approval marks the beginning of BioDlink’s international commercial rollout, helping diversify its revenue streams and positioning it as a key player in biosimilar commercialization. By continuing its partnership with Kexing BioPharm, the company is accelerating efforts to expand in Southeast Asia and Latin America, reinforcing its dedication to global healthcare impact.
About BioDlink Biopharm Co., Ltd.
Founded in 2010, BioDlink is a biotechnology company specializing in biosimilars and bioconjugates. With over 20,000 liters of production capacity, the company has developed an integrated platform for R&D, scale-up, and quality analytics. Its advanced manufacturing lines include OEB-5 facilities for high-potency antibody-drug conjugates.
Recognized for its rigorous quality assurance, BioDlink has passed nearly 100 GMP audits and maintains compliance with regulatory standards in China, the U.S., the EU, and Japan.
With its mission to “Empower Innovation with Quality to Grow Together,” BioDlink continues to drive innovation in biosimilars and expand access to life-saving therapies around the world.
