South Africa launches bid to enable local production of long-acting HIV prevention drug, lenacapavir

The Government of South Africa today announced that it is engaging with Gilead Sciences to pursue an agreement that would enable local production of lenacapavir, a revolutionary long-acting HIV prevention drug. As part of this effort, and in collaboration with Unitaid, USP and other partners, the government has published a call for expression of Interest that would assist in identifying South African pharmaceutical manufacturers capable of producing quality-assured lenacapavir.

Originally developed by Gilead, lenacapavir is a twice-yearly injection that has demonstrated near-complete effectiveness in preventing HIV. It is widely considered one of the most promising new tools to reduce infections, particularly in high-burden countries.

In October 2024, Gilead granted six voluntary licenses to generic manufacturers across Egypt, India, and Pakistan, allowing them to produce and supply generic lenacapavir to 120 low- and middle-income countries, an important step toward expanding access.

A seventh license for a South Africa-based manufacturer would further diversify global supply and align production more closely with the region that carries the highest HIV burden. Producing lenacapavir closer to where it is most needed could accelerate the pathway from innovation to access and help ensure more predictable, sustainable supply. It would also strengthen the region’s ability to respond to its own health priorities, especially as countries move toward longer-term domestic financing

The newly launched expression of interest forms part of a coordinated national effort led by the South African National AIDS Council (SANAC) that aspires to produce both the active pharmaceutical ingredient and the finished product in South Africa. If successful, this would expand regional manufacturing capacity in sub-Saharan Africa and strengthen long-term supply resilience.

Through this request for proposals, South Africa will assess manufacturers’ technical capabilities, regulatory compliance, and commitment to equitable access.

The selected manufacturer will work with the Adhoc Committee on Lenacapavir Licensing, a multi-stakeholder, intergovernmental body chaired by SANAC and supported by the Unitaid-established MedSuRe Africa regional manufacturing programme, which is led by USP in collaboration with partners including Africa CDC, Africa Medicines Agency, development financing institutions, the Medicines Patent Pool, WHO and funding agencies. Together, they will strengthen product development, ensure alignment with international quality standards, and support regulatory approval, including WHO prequalification where applicable.

Unitaid, USP and their partners will also provide market-shaping support to help accelerate uptake and ensure sustainable and affordable supply.

Deputy President Paul Mashatile, Chairperson of the South African National AIDS Council (SANAC):

For decades, South Africa has demonstrated that political will, scientific excellence, and community leadership can change the course of an epidemic,” said Deputy President Paul Mashatile, Chairperson of the South African National AIDS Council (SANAC). “Today, we build on that legacy by taking steps to ensure that the next generation of HIV prevention tools can be produced here at home—not only for South Africans but in partnership with, and for the benefit of, our region. In doing so, we strengthen regional resilience, expand equitable access, and advance our shared commitment to ending HIV.