New York, 24 September 2026 / Kampala, 25 September 2026
Quality Chemical Industries Limited (Qcil), a Ugandan pharmaceutical manufacturer, today announced that it has signed a sublicence agreement with the Medicines Patent Pool (MPP) to develop, manufacture and supply a generic version of baloxavir marboxil, a single-dose oral antiviral medicine for influenza, for countries covered by the licence. The sublicensing agreement was announced in New York, during a side event at the United Nations General Assembly, organised by the Medicines Patent Pool (MPP), supported by Roche.
The sublicence follows the voluntary licence agreement MPP and Roche signed in May 2026. That agreement allows selected generic manufacturers to develop, produce and supply baloxavir marboxil in 129 low- and middle-income countries, creating additional supply pathways for seasonal influenza treatment and pandemic preparedness.
Baloxavir marboxil works by blocking influenza viruses from multiplying early in an infection. The World Health Organisation clinical practice guidelines for influenza recommend it, and the European Medicines Agency and the United States Food and Drug Administration have approved it. Approved indications and eligible age groups vary by country.
Evidence published in the New England Journal of Medicine from the phase III CENTERSTONE trial showed that treating an infected person with a single oral dose of baloxavir reduced the odds of influenza transmission to household contacts by 32% compared with placebo. The medicine is also active against influenza strains resistant to some other classes of antiviral medicines.
Under the MPP-Roche licence, Roche will support sublicensees through MPP by providing a foundational data package, reference products for bioequivalence studies and necessary regulatory waivers. Qcil will independently undertake the product development, manufacturing and regulatory work required for a generic version. Supply will begin only after the applicable development, quality and regulatory requirements have been met.
For more than two decades, Qcil has manufactured quality-assured, WHO-prequalified treatments for HIV and malaria. The baloxavir sublicence extends that experience into influenza and supports more geographically diverse manufacturing for seasonal outbreaks and future pandemics.
“This sublicence gives Qcil an opportunity to apply its manufacturing and regulatory experience to an important influenza treatment for low- and middle-income countries. Working with MPP, and with support from Roche under the voluntary licence, we will now begin the development work required for a quality-assured generic version. This partnership can widen access to treatment while strengthening manufacturing capacity in Africa and preparedness for future influenza outbreaks.” Ajay Kumar Pal, Chief Executive Officer of Qcil, said.
Qcil thanked MPP and Roche for using voluntary licensing to support wider access to baloxavir marboxil and to strengthen the supply of influenza antivirals in low- and middle-income countries.
