Nigerian Firm Codix Bio Secures First WHO-Backed License to Manufacture Rapid Diagnostic Tests in Africa
核心洞察
Codix Bio (搜索) has become the first company to receive a sublicense under WHO's Health Technology Access Programme, allowing it to produce rapid diagnostic tests using South Korean SD Biosensor (搜索)'s technology.
The landmark agreement initially focuses on HIV (搜索) testing with potential expansion to malaria (搜索) and syphilis (搜索) diagnostics, addressing Africa's critical dependence on imported medical products highlighted during the COVID-19 (搜索) pandemic.
The rapid diagnostic tests can deliver results within 20 minutes without sophisticated equipment, supporting WHO's 2023 World Health Assembly commitments to promote equitable access to diagnostics as a cornerstone of universal health coverage.
Nigerian health technology company Codix Bio (搜索) has secured a groundbreaking sublicensing agreement with the Medicines Patent Pool (搜索) (MPP) to develop and manufacture rapid diagnostic tests (RDTs) using technology from South Korean company SD Biosensor (搜索), marking a significant advancement for local healthcare manufacturing in Africa.
The agreement, announced jointly by MPP and the World Health Organization (WHO), represents the first sublicense granted under WHO's Health Technology Access Programme (HTAP), which aims to expand manufacturing capacity in underserved regions and reduce dependence on imported medical products.
Strategic Importance for African Healthcare Manufacturing
The sublicensing agreement addresses a critical gap in Africa's healthcare infrastructure, as most low- and middle-income countries currently rely heavily on imported diagnostics. This vulnerability became particularly evident during the COVID-19 (搜索) pandemic, when supply chain disruptions severely impacted access to essential medical products across the continent.
"This landmark agreement is a defining moment in our journey of health-tech innovation and a breakthrough for local healthcare manufacturing in Africa," said Sammy Ogunjimi, Group Managing Director of Codix Group. "Being selected as the first sublicensee under this global initiative underscores our commitment to contribute meaningfully to pandemic preparedness and regional health security."
The Nigerian firm will initially focus on producing RDTs for HIV (搜索) detection, with plans to potentially expand to malaria (搜索) and syphilis (搜索) diagnostics. The technology is particularly valuable for its adaptability to other diseases, which could prove crucial during future health emergencies.
Technical Capabilities and Clinical Applications
The rapid diagnostic tests developed under this agreement offer significant advantages for healthcare delivery in resource-limited settings. The tests can generate results within 20 minutes and do not require sophisticated laboratory equipment, making them ideal for use in primary healthcare facilities throughout Africa.
According to WHO officials, the tests are highly sensitive and can be easily administered in various healthcare settings. This accessibility is particularly important in regions where laboratory infrastructure is limited or non-existent.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized the broader implications: "Sublicensing SDB's RDT technology marks a major milestone in strengthening manufacturing capabilities in regions where they are needed most. It can help advance global commitments made at the 2023 World Health Assembly to promote equitable access to diagnostics as a cornerstone of universal health coverage and pandemic preparedness."
Evolution of WHO's Technology Access Initiatives
This agreement emerges from WHO's evolving approach to technology access. The Health Technology Access Programme (HTAP) developed from the earlier COVID-19 (搜索) Technology Access Pool (C-TAP) initiative, broadening its scope to address a wider range of health technologies beyond the pandemic response.
Charles Gore, Executive Director of the Medicines Patent Pool (搜索), highlighted the significance of this development: "Today marks a major step forward in diversifying diagnostic production and ensuring access where it is needed most. It shows how voluntary licensing and coordinated technology transfer can empower manufacturers in LMICs, ultimately helping reshape global supply chains to become more equitable and resilient."
The non-exclusive, transparent license between SD Biosensor (搜索) and MPP was initially agreed upon in December 2023. Following an open call for applications from manufacturers based in low- and middle-income countries, Codix Bio (搜索) emerged as the first selected sublicensee.
Comprehensive Support Framework
Beyond the technology transfer itself, HTAP will coordinate support across multiple domains to ensure successful implementation. This includes workforce development, regulatory compliance assistance, and strategies for product uptake in local and regional markets.
"By coupling the technology transfer with coordinated support, this initiative not only helps Codix Bio (搜索) respond to health priorities in Nigeria and the region – it also demonstrates a collaborative model for building sustainable and self-reliant local manufacturing capacity," said Hyo-Keun Lee, Vice Chairman of SD Biosensor (搜索), Inc.
The initiative aligns with broader continental efforts to strengthen health security and reduce import dependence, supported by institutions such as the Africa Centres for Disease Control and Prevention (Africa CDC (搜索)), the Global Fund (搜索), and Unitaid (搜索).
As Codix Bio (搜索) begins developing its manufacturing capabilities, WHO and MPP are continuing evaluations for potential additional sublicensees, suggesting this first agreement may represent the beginning of a more extensive effort to transform diagnostic manufacturing across underserved regions.