South Africa’s Push for Local Lenacapavir Production to Enhance HIV Prevention
South Africa has launched a bold bid to enable local lenacapavir production, targeting the twice-yearly injectable long-acting HIV prevention drug from Gilead Sciences, which shows near-complete effectiveness in preventing infections. On March 5, 2026, the South African government, via the South African National AIDS Council (SANAC), announced efforts for a voluntary licensing agreement with Gilead, backed by Unitaid and the United States Pharmacopeia (USP). This includes calls for expressions of interest from local manufacturers to produce quality-assured lenacapavir, extending Gilead’s October 2024 royalty-free licenses to six generic makers in Egypt, India, and Pakistan for 120 low- and middle-income countries.
Diversifying Supply in HIV Epicenter
Local lenacapavir production could secure a seventh license for a South Africa-based manufacturer, diversifying global supply chains and rooting manufacturing in sub-Saharan Africa—the region hardest hit by HIV. This strategy counters international supply risks by producing closer to users, speeding access, stabilizing supply, and aiding shifts to domestic funding. Plans cover both active pharmaceutical ingredients and finished products, boosting regional capacity and disruption resilience.
Rigorous Manufacturer Selection Process
The expression of interest assesses technical skills, regulatory adherence, and equitable access commitment, under SANAC’s Adhoc Committee on Lenacapavir Licensing. This intergovernmental group partners with Unitaid’s USP-led program, plus Africa CDC, Africa Medicines Agency (AMA), Medicines Patent Pool, WHO, and financiers. Unitaid and USP provide technical aid for development, quality standards, approvals, and WHO prequalification, ensuring top-tier results.
Cost Savings and Equity Gains
Local lenacapavir production promises wins by slashing import and chain costs, enhancing affordability in high-burden areas. It supports competitive pricing via voluntary licenses for low- and middle-income nations, plus sustainable domestic reimbursement. Leaders like SANAC’s Deputy President Paul Mashatile, Kenya’s President William Ruto (AU manufacturing champion), Africa CDC’s Dr. Jean Kaseya, and AMA’s Dr. Delese Mimi Darko highlight trends in manufacturing independence, jobs, regulatory harmony—strengthening health security, access, and Africa’s HIV response control.
