Seven manufacturers sign sublicence agreements with the Medicines Patent Pool to produce generic versions of Shionogi’s COVID-19 oral antiviral ensitrelvir to increase access in low- and middle-income countries.

Japanese pharmaceutical company Shionogi & Co., Ltd and the Medicines Patent Pool (MPP), a United Nations-backed international public health organisation, have today announced that MPP has signed seven sublicence agreements for Shionogi’s ensitrelvir fumaric acid, a COVID antiviral currently approved in Japan and being evaluated in clinical trials outside of Japan. The announcement was made on the sidelines of a business briefing in Tokyo co-convened by MPP and global health partnership Unitaid. The sublicence agreements were signed with three generic manufacturing companies from China: Zhejiang Charioteer Pharmaceutical Co., Ltd., Zhejiang Lepu Pharmaceutical Co.,Ltd., and Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.,.; two from India: Hetero and Laurus Labs Limited; and with Ukrainian company Joint Stock Company Lekhim  and Vietnamese company Stellapharm J.V. Co., Ltd.

Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease. Known as Xocova® in Japan, ensitrelvir received emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the treatment of SARS-CoV-2 infection in November 2022. In April 2023, ensitrelvir was granted Fast Track designation by the U.S. 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. Under the terms of the licence agreement, the seven selected generic manufacturers will be able to manufacture and supply ensitrelvir in 117 low- and middle-income countries (LMICs), pending regulatory authorisation or approval in those countries.

Isao Teshirogi, Representative Director, President and CEO of Shionogi said: “Shionogi is excited that these seven manufacturers across four countries have signed sublicences agreements with MPP, showing their commitment to making generic versions of ensitrelvir for LMICs. 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. We consistently strive to supply the best possible medicines to protect the health and wellbeing of the patients we serve. It is another great example of what partnerships can achieve to advance global health.”

Charles Gore, Executive Director of MPP, said: “We look forward to working closely with all seven generic manufacturing partners on developing generic versions of ensitrelvir and making it available soonest. 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. I warmly welcome Lekhim JSC from Ukraine, and Zhejiang Charioteer and Lepu Pharma from China, as these are the first sublicence agreements that they have signed with MPP.”

Tenu Avafia, Deputy Executive Director of Unitaid, said: ” Unitaid’s vision is for new health technologies to be as quickly available and widely accessible in low-and middle-income countries as possible. This includes embedding access considerations into efforts to prevent, prepare for, and respond to pandemics, present and future. We commend Shionogi for reflecting G7 priorities to account for equity, efficiency, and affordability in the development of its treatment and for its early engagement with MPP on voluntary licensing. The signing of these seven sublicence agreements is an important milestone.”

Nombeko Mpongo, Community Liaison Administrator, Desmond Tutu HIV Centre, South Africa, said: “Through my work, I support two sisters who lost their parents to COVID-19 at the height of the pandemic. In our communities, such loss goes beyond the terrible grief as the young adolescents have been left to fend for themselves at a vulnerable age, curbing their future opportunities as they struggle to survive without the guidance of their parents. Access to treatment is so much more than a question of life and death, it is about the well-being of entire communities, so I welcome this announcement that will enable equitable access to COVID-19 treatments in my country and other LMICs.”