South Africa Advances Plan to Produce Revolutionary HIV Prevention Drug
The Government of South Africa has launched a process to enable local production of Lenacapavir, a groundbreaking long-acting HIV prevention drug originally developed by Gilead Sciences.
The initiative seeks to secure a voluntary licensing agreement with Gilead that would allow a South African pharmaceutical manufacturer to produce the drug domestically. As part of the process, authorities have issued a call for expressions of interest to identify local companies capable of manufacturing quality-assured lenacapavir.
The effort is being coordinated by the South African National AIDS Council (SANAC) with technical and market support from Unitaid and the United States Pharmacopeia (USP), alongside other international partners.
Lenacapavir is administered as a twice-yearly injection and has demonstrated near-complete effectiveness in preventing HIV infection. Health experts regard it as one of the most promising new tools to reduce new infections, particularly in countries with a high HIV burden.
In October 2024, Gilead granted six voluntary licences to generic manufacturers in Egypt, India and Pakistan to produce and supply generic lenacapavir to 120 low- and middle-income countries. South Africa’s move to secure a seventh licence would bring production closer to the region most affected by HIV and help strengthen supply resilience.
Deputy President Paul Mashatile, who chairs SANAC, said the initiative builds on South Africa’s long-standing leadership in the fight against HIV.
“For decades, South Africa has shown that political will, scientific excellence and community leadership can change the course of an epidemic,” Mashatile said. “By enabling local production of the next generation of HIV prevention tools, we strengthen regional resilience and expand equitable access.”
The proposed manufacturing initiative aims to produce both the active pharmaceutical ingredient and the finished product in South Africa. If successful, it would significantly expand pharmaceutical manufacturing capacity in sub-Saharan Africa and help ensure a more predictable supply of the medicine.
The selected manufacturer will work with an ad hoc committee on lenacapavir licensing chaired by SANAC and supported through the MedSuRe Africa regional manufacturing programme, a Unitaid-funded initiative led by USP.
The programme collaborates with organisations including the Africa Centres for Disease Control and Prevention, the African Medicines Agency, the World Health Organization and the Medicines Patent Pool to strengthen regulatory systems, support product development and accelerate regulatory approval.
President William Ruto of Kenya, who serves as the African Union’s champion for local manufacturing of health commodities, welcomed the move, saying Africa must reduce reliance on imported medicines.
“Africa can no longer depend on medicines produced elsewhere for diseases that affect us most,” Ruto said, adding that manufacturing on the continent would strengthen supply chains, create skilled jobs and build scientific capacity.
Similarly, Jean Kaseya, Director-General of the Africa CDC, said expanding pharmaceutical manufacturing in Africa would improve access to essential medicines while strengthening health security across the continent.
Officials say local production of lenacapavir could accelerate access to the drug across southern Africa and support broader efforts to end HIV as a public health threat by 2030.
