The South African National Aids Council (Sanac) has asked local drug companies to submit applications by April 7 to make generic versions of an anti-HIV jab that could end Aids by 2043 in the country — if 31-million HIV-negative people take it for at least a year each between now and then.
The original version of the once-every-six-months shot, known as lenacapavir (LEN), is produced by the US pharmaceutical company Gilead Sciences. The injection is almost foolproof in stopping people who don’t have the virus from getting it through sex. It was registered in South Africa in October.
Locally made shots could be available as early as next year — but only if Gilead awards a South African company, or companies, with a generic licence(s), which would require it to share its LEN recipe and technical secrets of how to make the medicine with a licensee or licensees.
The renewed effort — led by Sanac in collaboration with the health department; the department of trade, industry & competition; the science, technology & innovation department; and the National Treasury — comes after three South African companies (Aspen Pharmacare, Pharmacare and Cipla Medpro) failed to secure generic licences in 2024.
Instead, Gilead awarded licences to six generic companies in India, Pakistan and Egypt, which are expected to bring generics to the market in 2027.
How will the Sanac-led effort work?
Sanac will submit a shortlist of successful applicants that meet the requirements of the council’s expression of interest call to Gilead by July, CEO Thembisile Xulu told Bhekisisa. The applicants will be evaluated by a local manufacturing steering committee.
Gilead will then review Sanac’s list for potential licences granted directly to the companies (not the government) to make LEN from start to finish, including the production of the active pharmaceutical ingredient (API) that makes the medicine work.
The international health organisation Unitaid and scientific body US Pharmacopeia (USP) will help South African companies that Gilead issues with licences to master manufacturing processes and adhere to quality standards. Unitaid will also provide “market-shaping support”, including financial assistance in the form of volume guarantees to make LEN at a price equal to what the government pays for a daily HIV prevention pill (around $40 a year). The pill is already available for free in almost all government clinics.
Two of the six generic companies which already have licences — Hetero and Dr Reddy’s in India — have received grants from Unitaid and the Gates Foundation to help them make LEN at $40 for a year’s supply. Unitaid will provide South African companies with similar support to help them compete in these markets.
In two weeks, there will be a webinar for applicants to answer any questions, and the adjudication process will be one month, says Unitaid’s director of programmes, Robert Matiru.
Applicants will get a score out of 100; 60 points will be for their “technical capability”. Those that get a score of 45/60 or higher will progress to an assessment of their “access and implementation potential”, which will be scored out of 40. This will assess their ability to “expand access, improve affordability and promote continuous quality improvement”.
Xulu says Sanac is using “structured multisectoral engagements” with Gilead to make the process run smoothly. In its expression of interest, Sanac states: “The resulting shortlist will inform subsequent engagements with Gilead as part of efforts to secure a seventh voluntary licence agreement that supports regional manufacturing and equitable access.”
Can South Africa make LEN’s main ingredient?
Making LEN’s API is a complex 28-step process which requires specialised pharmaceutical processes and facilities — something many local drugmakers will struggle to manage.
When Gilead evaluated Aspen Pharmacare, Pharmacare and Cipla Medpro for generic licences in 2024, they didn’t make the cut because they couldn’t make the API.
But, says Xulu, Gilead’s new assessment, based on the applicants Sanac submits to them, will also look at their ability to produce LEN tablets that have to be taken alongside the first injection and how well they’re able to formulate the exact mixture and structure of ingredients so the medicine can be made into a safe tablet or injection that works properly.
When Africa produces the medicines its people need, we are not just improving access; we are building resilience, creating jobs and asserting our right to shape our own health future
— Jean Kaseya
Xulu says if Gilead’s assessment finds that no South African company is able to make the API, the multinational pharmaceutical group has agreed to allow successful licensees to import it during “the initial phase” of local production until they’re able to make it through technical transfer. This means Gilead, along with Unitaid and USP, will help train them to master the processes. The “initial phase”, Xulu says, could be anything between three months and a year, based on how long technology transfer with the six companies that already have licences takes.
The purpose of Sanac’s call is to “secure a licence from Gilead and help create an enabling environment for regional production”, Matiru told Bhekisisa. “In practice this could involve two or three manufacturers with complementary roles.
“For example, one company may produce oral loading tablets [the pills that have to be taken along with the first LEN jab], while another focuses on the injectable formulation. Or one may be selected which could manufacture both.”
Locally made LEN could be here within a year
Matiru said locally made LEN could be available as soon as next year — within 12 to 15 months after Gilead has awarded licences — if regulatory approvals are sped up by using regional bodies such as the African Medicines Agency. But such “expedited regulatory processes” will only allow the companies to supply South Africa and other Sub-Saharan African countries with the medicine.
For South African manufacturers to meet “global regulatory standards”, which will enable them to sell the medicine to donors such as the Global Fund to Fight Aids, TB & Malaria as well as countries beyond Sub-Saharan Africa (should the licences Gilead issues permit them to do that), it could take between two and three years, said Matiru.
He concluded: “The exact timelines will depend on the companies selected through the request for proposals and the level of technical and financial support required to produce at scale and meet the necessary quality standards.”
Why are the government and Unitaid helping drugmakers get LEN licences?
The health department will start to roll out LEN later this year with a two-year supply of stock paid for by the Global Fund. However, this is only enough to cover around 456,000 people in 2026 and 2027 and is only 3% of the doses the country needs to end Aids by 2043.
The country needs tens of millions more doses — and fast. If enough HIV-negative people take LEN, we could slow down the spread of the virus to the point where Aids would no longer be a public health problem, modelling scientists argue.
South Africa has around 170,000 new HIV infections a year. To end Aids as a public health threat, the country needs to bring down new infections to 65,000 a year so that the rate of new infections is reduced to 0.1% or below.
The six generic companies that already have licences from Gilead to make LEN will be able to sell their products to 120 countries, including South Africa. But none of them are based in Sub-Saharan Africa.
Ultimately, when — and if — South Africa becomes the first African country to make LEN, it will help the continent to respond to its own “health priorities”, says Unitaid, especially as countries move towards increasing their budgets to fund health problems within the context of funding cuts by the US and other Western governments.
“Africa carries the heaviest burden of HIV yet has historically had the least control over the medicines needed to fight it,” explains Jean Kaseya, director-general of the Africa Centres for Disease Control & Prevention.
“South Africa’s bold step to pursue local production of lenacapavir changes that narrative. When Africa produces the medicines its people need, we are not just improving access; we are building resilience, creating jobs and asserting our right to shape our own health future.”
The Gates Foundation is mentioned in this article. Bhekisisa receives funding from the foundation but operates editorially independently from it.
This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.
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