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- BioDlink’s Bevacizumab Injection has been granted marketing authorization by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), following GMP certifications in Brazil (a PIC/S member), Colombia, Egypt, Indonesia, and Argentina—further strengthening its global presence by opening access to the African market.
- Backed by a global recognized quality system and proven track record in antibody drug/XDC manufacturing and commercialization, BioDlink has strengthened its foothold in Latin America and beyond.
- BioDlink will accelerate the approval and market launch process of bevacizumab in emerging markets with Kexing Biopharm to fulfill the mission of safeguarding human health.
SUZHOU, China, June 16, 2025 /PRNewswire/ — BioDlink announced that its self-developed Bevacizumab Injection (Pusintin®) has received marketing approval from National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria. This significant milestone accelerates BioDlink’s global expansion efforts, and reaffirms its R&D and commercialization strength in biosimilar—offering a high-value, accessible treatment option for cancer patients worldwide.
Leveraging synergies with Kexing BioPharm, the global licensee for Pusintin® in emerging markets, Pusintin® has initiated regulatory filings in 35 countries. The approval in Nigeria not only marks the implementation of its global strategy but also signifies officially opening the door to the African market, bringing more affordable treatment alternatives to Nigerian patients.
ADDRESSING AFRICA‘S GROWING HEALTHCARE NEEDS
Africa, with a population exceeding 1.5 billion (World Bank, 2024), faces increasing medical demand. Nigeria, as the “most populous country in Africa” (~220 million people), possesses both massive healthcare challenge and a major growth opportunity. According to the World Health Organization (WHO), Nigeria reports over 120,000 new cancer cases annually, growing at a rate of 5% per year—amid limited access to high-quality therapies. Pusintin®‘s approval meets this urgent medical need while serves as a model for expansion into other emerging-market.
INTERNATIONALLY RECOGNIZED MANUFACTURING & QUALITY EXCELLENCE
The approval has validated Pusintin®‘s compliance complies with international standards for R&D, manufacturing, and quality system. BioDlink’s production facilities have already passed GMP inspections in China, Japan, Brazil, Colombia, Egypt, Indonesia, and Argentina and also passed antibody drug and ADC EU QP inspection 4 times in past two years. BioDlink’s global-quality system ensures robust commercial supply, delivering more than 100 clinical projects with development, clinical filings, and manufacturing services worldwide, including European and the U.S. in the past 3 years.
This millstone marks the beginning of BioDlink’s international commercial rollout, injecting new momentum into its revenue diversification strategy and reinforcing its capabilities in global biosimilar commercialization.
BioDlink operates a large-scale, GMP-compliant biologics manufacturing facility, featuring four commercial lines with five drug substance production centers (including non-toxic conjugated drug substance units) and four drug production centers. Its world-class facilities and stringent quality system deliver reliable global supply for monoclonal antibodies (mAbs), bispecific antibodies, XDCs, and other biologics at global standards.
SUSTAINING GLOBAL MOMENTUM
BioDlink will continue collaborating with Kexing BioPharm to accelerate Pusintin®‘s approval in Southeast Asia and Latin America. Driven by a committed to innovation, quality, and global compliance, BioDlink will continue accelerating its expansion in overseas and emerging markets—bringing life-changing therapies to more patients worldwide.
About BioDlink Biopharm Co., Ltd.
BioDlink was established in 2010, and has a large-scale commercial GMP production base for biological drugs, a total manufacturing capacity exceeding 20,000 liters. Guided by its “Empowering Innovation with Quality to Grow Together” mission, BioDlink is dedicated to advancing global healthcare through excellence in biosimilars.
The company has built integrated platforms for biosimilars and bioconjugates, offering process development, scale-up, and quality analytics solutions. Its scalable manufacturing lines include top-tier OEB-5 facilities for high-potency ADCs, with commercial antibody production already underway.
BioDlink’s quality management system complies with regulatory requirements in China, the U.S., the EU, and Japan. In addition, the company has already passed nearly 100 GMP audits, including a zero-defect EU QP audit, with its quality systems earning worldwide recognition.
Contact information
PR name: Fiona Wu
E-mail: pr@biodlink.com
