Shionogi partners with Indian companies for Ensitrelvir sublicense, expanding access to Covid-19 antiviral in LMICs

Japanese pharmaceutical company Shionogi & Co and the Medicines Patent Pool (MPP) announced the signing of seven agreements, including with two drugmakers from India, for Shionogi’s ensitrelvir fumaric acid, a Covid-19 antiviral currently approved in Japan and being evaluated in clinical trials outside of Japan.

The sublicence agreements were signed with two generic manufacturing companies from India, Hetero and Laurus Labs Limited; three from China, Zhejiang Charioteer Pharmaceutical, Zhejiang Lepu Pharmaceutical, and Fosun International Limited; and a Ukrainian company Joint Stock Company Lekhim and Vietnamese company Stellapharm J.V. Co. Ltd.

Under the licence agreement, the seven generic manufacturers can manufacture and supply ensitrelvir in 117 low- and middle-income countries (LMICs), pending regulatory authorisation or approval in those countries. 

MPP is a United Nations-backed international public health organisation, and the announcement was made on the sidelines of a business briefing in Tokyo by MPP and Unitaid.

Known as Xocova in Japan, ensitrelvir received emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) to treat SARS-CoV-2 infection in November 2022. In April 2023, ensitrelvir was granted Fast Track designation by the United States Food and Drug Administration. The head licence agreement between MPP and Shionogi was signed in October 2022, a first for MPP with a Japanese pharmaceutical company, the note said.

Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease, the MPP note explained.

Charles Gore, Executive Director of MPP, said: “Even though Covid-19 is no longer classified as a Public Health Emergency of International Concern, we see numbers ebb and flow across continents as we learn to live with the disease. So having quality effective treatments readily available in LMICs is still so important.” Gore pointed to Lekhim JSC from Ukraine and Zhejiang Charioteer and Lepu Pharma from China on their first sublicence agreements signed with MPP. 

Isao Teshirogi, Representative Director, President and CEO of Shionogi, said, “What has been important for Shionogi is to work upstream with MPP, as we believe that the public health-oriented licensing agreement we signed with MPP has the potential to increase affordable Covid-19 treatment options for people living in LMICs.”

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