The Government of South Africa has announced plans to engage with Gilead Sciences to pursue an agreement that would allow the local production of lenacapavir, a long-acting HIV prevention drug. As part of this effort, the government has issued a call for expressions of interest to identify domestic pharmaceutical manufacturers capable of producing high-quality lenacapavir. The initiative is being supported by Unitaid, the U.S. Pharmacopeia (USP), and other partners to strengthen regional manufacturing capacity and improve supply resilience.
Lenacapavir, originally developed by Gilead, is a twice-yearly injectable drug that has shown near-complete effectiveness in preventing HIV infection. It is considered one of the most promising innovations for reducing HIV transmission, particularly in countries with a high disease burden. In 2024, Gilead granted voluntary licenses to six generic manufacturers in Egypt, India, and Pakistan to supply the medicine to 120 low- and middle-income countries, helping expand global access.
South Africa is now seeking to add a seventh license for a local manufacturer, which would diversify global production and bring manufacturing closer to regions most affected by HIV. Producing the drug within Africa could speed up access, strengthen supply chains, and support the region’s capacity to address its own health priorities, particularly as countries shift toward greater domestic financing of healthcare systems.
The expression of interest forms part of a national initiative led by the South African National AIDS Council (SANAC) to produce both the active pharmaceutical ingredient and the finished lenacapavir product locally. Through this process, potential manufacturers will be assessed based on their technical expertise, regulatory compliance, and commitment to equitable access. The selected company will work closely with a multi-stakeholder committee supported by the MedSuRe Africa programme, which focuses on strengthening pharmaceutical manufacturing across the continent.
Partners including Africa CDC, the African Medicines Agency, WHO, development finance institutions, and other organizations will help ensure that production meets international quality standards and receives necessary regulatory approvals, including possible WHO prequalification. In addition, Unitaid, USP, and their partners will provide technical and market support to encourage sustainable, affordable supply and accelerate the adoption of lenacapavir once production begins.
Leaders and global health stakeholders have welcomed the initiative, highlighting its potential to strengthen Africa’s pharmaceutical independence and improve access to life-saving HIV prevention tools. By investing in local production and regional manufacturing capacity, South Africa aims to build stronger health systems, create jobs, and play a leading role in ending the HIV epidemic across the continent.
