LENACAPAVIR, a long-acting HIV prevention drug, could soon be produced in South Africa as part of a major effort to strengthen regional manufacturing and expand access to one of the most promising new tools in HIV prevention.
HIV remains a major public health challenge globally, particularly in sub-Saharan Africa, which carries the highest burden of infection. Lenacapavir, originally developed by Gilead Sciences, is a twice-yearly injectable medicine that has demonstrated near-complete effectiveness in preventing HIV infection, making it a potentially transformative option for populations at high risk.
South Africa Moves Toward Local Lenacapavir Production
The South African government has announced plans to pursue an agreement with Gilead Sciences that could enable local production of lenacapavir. As part of this process, authorities have issued a call for expressions of interest to identify pharmaceutical manufacturers within the country capable of producing the drug to international quality standards.
If successful, a South African manufacturer could become the seventh global licensee for generic lenacapavir. In October 2024, Gilead granted voluntary licences to six manufacturers in Egypt, India, and Pakistan, allowing them to produce the medicine for distribution across 120 low- and middle-income countries.
Establishing an additional manufacturing site in South Africa could diversify global supply and bring production closer to regions with the highest HIV burden.
Strengthening Regional Medicine Supply Chains
The initiative is being coordinated by the South African National AIDS Council as part of a broader effort to build domestic pharmaceutical manufacturing capacity. The goal is to produce both the active pharmaceutical ingredient and the finished lenacapavir product locally.
Partners including Unitaid and the United States Pharmacopeia will provide technical and market support through the MedSuRe Africa regional manufacturing programme. This collaboration aims to strengthen product development, ensure regulatory compliance, and support international quality standards, including potential World Health Organization (WHO) prequalification.
Expanding local production could also improve supply resilience, helping countries in the region secure reliable access to HIV prevention medicines as they increasingly move towards domestic financing of health programmes.
A Step Toward Greater Health Sovereignty
Regional health leaders have emphasised that local manufacturing of medicines such as lenacapavir could play a critical role in addressing long-standing inequities in access to life-saving treatments. By producing innovative HIV prevention tools within Africa, countries may be better positioned to respond to regional health priorities while strengthening pharmaceutical capacity.
If the initiative succeeds, it could represent an important milestone in efforts to improve access to next-generation HIV prevention technologies and support broader ambitions to end HIV as a public health threat.
Reference
Unitaid. South Africa launches bid to enable local production of long-acting HIV prevention drug, lenacapavir. 5 March 2026. Available at: https://unitaid.org/news-blog/south-africa-launches-bid-to-enable-local-production-of-long-acting-hiv-prevention-drug-lenacapavir/. Last accessed: 11 March 2026.
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