Qcil, Medicines Patent Pool Sign Sublicence to Expand Access to Influenza Treatment

Ugandan pharmaceutical manufacturer Quality Chemical Industries Limited (Qcil) 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 treatment for influenza.

 

The agreement, announced in New York during a side event at the United Nations General Assembly, is expected to expand access to influenza treatment in countries covered by the licence while supporting efforts to strengthen regional pharmaceutical manufacturing and pandemic preparedness.

 

The sublicence follows a voluntary licence agreement signed between MPP and Roche in May 2026. 

 

Under the agreement, selected generic manufacturers can develop, produce and supply baloxavir marboxil in 129 low- and middle-income countries, creating additional supply pathways for seasonal influenza treatment and future pandemic response.

 

Baloxavir marboxil works by blocking influenza viruses from multiplying early during an infection. 

 

The medicine is recommended in the World Health Organization’s clinical practice guidelines for influenza and has been approved by both the European Medicines Agency and the United States Food and Drug Administration.  Approved uses and eligible age groups vary by country.

 

Evidence from the Phase III CENTERSTONE trial, published in the New England Journal of Medicine, found that treatment with a single oral dose of baloxavir reduced the odds of influenza transmission to household contacts by 32% compared with placebo. The medicine has also demonstrated activity 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 development, manufacturing and regulatory work required to produce a generic version of the medicine.

 

Commercial supply will begin only after the applicable development, quality and regulatory requirements have been met.

 

The new sublicence expands the company’s portfolio into influenza treatment and could contribute to more geographically diverse manufacturing capacity 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,” said Ajay Kumar Pal, Chief Executive Officer of Qcil.

“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.”

 

Pal added that the partnership could help widen access to influenza treatment while strengthening pharmaceutical manufacturing capacity in Africa.

 

The company said the next steps will focus on the development, quality, manufacturing and regulatory requirements needed before the generic product can be supplied in eligible countries.

 

By Christine Namatumbwe