#None #Nigeria #BioDlink #Bevacizumab

BioDlink's Bevacizumab Injection Receives Nigeria's Marketing Approval

In a significant move toward expanding its global presence, BioDlink has successfully secured marketing authorization from Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) for its self-developed Bevacizumab Injection, known as Pusintin®. This approval is a pivotal milestone as it signals BioDlink's entry into the African market, thereby offering a high-quality treatment option for cancer patients in the region.

Accelerating Global Expansion

This achievement is part of BioDlink's strategy to broaden its global footprint after receiving Good Manufacturing Practice (GMP) certifications from several countries across the globe, including Brazil, Colombia, Egypt, Indonesia, and Argentina. These certifications solidify the company's commitment to international standards, further enhancing its credibility in biosimilar market. The company’s ability to deliver high-quality biological drugs aligns with their mission to safeguard human health.

With a population of over 1.5 billion, Africa presents unique healthcare challenges and opportunities. Nigeria, the continent's most populous country, is faced with a growing number of cancer cases, exceeding 120,000 new patients annually, according to the World Health Organization (WHO). The need for accessible, high-quality therapies is critical as current medical infrastructure struggles to meet demand.

Meeting Healthcare Needs in Nigeria

The approval of Pusintin® represents a decisive effort to fulfill Nigeria's urgent healthcare requirements and serves as a model for future expansions into other emerging markets. BioDlink, through its collaborative efforts with Kexing Biopharm, aims to fast-track regulatory approvals across 35 different countries, showcasing its dedication to making affordable treatment alternatives available to patients in need.

By leveraging synergies with Kexing Biopharm, BioDlink is positioned to streamline the process of bringing Pusintin® to various regions, further enhancing patient access to essential cancer treatments. This collaboration emphasizes the importance of partnerships in overcoming the barriers to healthcare delivery in regions with significant medical needs.

Commitment to Quality and Excellence

BioDlink's commitment to quality is evident in its state-of-the-art production facilities, which have undergone rigorous inspections to ensure compliance with international standards. With GMP inspections completed successfully in multiple countries, BioDlink has established itself as a leader in production quality. This high standard of operation ensures the reliable supply of monoclonal antibodies (mAbs) and other biologics globally.

In the past three years, BioDlink’s global quality system has supported over 100 clinical projects, underscoring its capability in development, clinical filings, and manufacturing services worldwide. This robust commitment to quality not only meets the regulatory requirements of nations such as China, the U.S., the EU, and Japan but also positions BioDlink as a trusted entity in the biosimilars domain.

Sustaining Momentum for Future Growth

As BioDlink continues on its path of international expansion, the collaboration with Kexing BioPharm will facilitate similar initiatives across Southeast Asia and Latin America. Upholding a commitment to innovation and compliance, BioDlink remains focused on improving global healthcare by delivering transformative therapies to patients around the world. With the gateway now open to the African market, BioDlink is poised to make a lasting impact on cancer care in Nigeria and beyond.

About BioDlink Biopharm Co., Ltd.

Established in 2010, BioDlink boasts a large-scale commercial production base for biological drugs, with a manufacturing capability exceeding 20,000 liters. Its operational philosophy is centered on empowering innovation through quality, driving growth while advancing global healthcare. Their comprehensive platforms for biosimilars and bioconjugates combine process development, scale-up, and quality analytics, ensuring that they deliver top-tier healthcare solutions.

Through continued advancement and a deep commitment to quality, BioDlink aspires to be a beacon in the global biopharmaceutical landscape, focusing on serving the world's healthcare needs effectively.