South Africa has shortlisted three local manufacturers to potentially produce the six-monthly HIV prevention jab lenacapavir (LEN). The country wants to make LEN on home soil, but it is essential to determine whether it can do so quickly and cheaply enough to improve access to the jab.
South Africa’s health authorities launched the lenacapavir (LEN) injection in June and are now evaluating domestic firms for voluntary licensing to produce generic versions. However, simply wanting to manufacture the drug locally does not guarantee that companies can produce it efficiently, at the right quality, or at a competitive price.
Local Manufacturing Challenges
A production licence for LEN in South Africa would likely differ from the six generic licences already issued to manufacturers in Egypt, India, and Pakistan. Those agreements require full production, including synthesizing the active pharmaceutical ingredient (API). In contrast, South Africa’s licence would focus on development, permitting companies to import the API instead of producing it domestically.
Local manufacturing would likely begin with the fastest achievable steps, such as assembling the final product, preparing sterile injections, packaging, or quality control. While this approach still offers benefits, it’s key to clarify what ‘local production’ truly means—what it entails in terms of production processes.
South Africa’s hurdles for local LEN production
Before a local injection is ready, several steps need to be taken. A manufacturer needs a licence with clear terms, access to technical knowledge, reliable supplies of ingredients and materials, and strict quality systems. It also needs to meet production and registration requirements, adapt a production line, test and validate the manufacturing process, and train staff.
South Africa has the regulatory expertise, clinical trial experience, and pharmaceutical manufacturing infrastructure needed. Yet the primary concern is whether a manufacturer could invest in LEN production only to find the local market too small or unpredictable to sustain affordable costs. If production is limited to South Africa’s domestic needs, it may struggle to compete with large-scale generic suppliers serving multiple countries.
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Demand is the missing piece in the equation. The issue is not only whether South Africa can make LEN but also whether enough of it will be bought at a price that allows local production to survive. South Africa’s HIV prevention needs are large, with around 134,000 new infections per year. However, government budgets are under pressure, and prevention programs already have to pay for various services, including daily HIV prevention pills, condoms, and HIV testing.
Securing guaranteed demand is essential, and Unitaid has signaled willingness to assist. Governments can provide manufacturers with clearer demand forecasts through national rollout plans and purchasing commitments.
Demand and timing decide LEN’s future
Without reliable demand, a local licence could become a symbolic achievement rather than a practical solution for expanding access. Timing is also critical, as existing generic producers are expected to supply lower-cost LEN from 2027. If those products arrive quickly, South Africa will have to ask where a locally made product fits.
The answer should not be defensive, and the fastest route to access may be to import affordable generics while local production is being developed. Access and manufacturing are related goals, but they are not the same goal. People at risk of HIV should not have to wait for local production if safe, affordable products are available sooner. Local manufacturing is worth pursuing because learning to make LEN could help South Africa make other important medicines locally in the future.
Three firms shortlisted for voluntary licensing
These names were sent to Gilead Sciences, the drug’s developer, for evaluation and potential voluntary licensing, a process expected to take three to six months.
Building a Reliable Supply Chain
This would not only support local manufacturing but also ensure a reliable supply of the medicine to those who need it.
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