Five Chinese Pharmaceutical Companies Authorized to Manufacture Merck's Molnupiravir for Low- and Middle-Income Countries
MSD
Pharmaceutical R&D and Manufacturer
Fosun Pharmaceutical
Healthcare Industry Group
Medicines Patent Pool
The Medicines Patent Pool (MPP) is a UN-backed public health organization dedicated to increasing access to life-saving medicines and fostering their development in low- and middle-income countries. It collaborates with international organizations, civil society, patient groups, industry, and other stakeholders to prioritize, forecast, and license needed medicines, while pooling intellectual property to encourage generic production and the development of new formulations. To date, the MPP has signed agreements with 10 patent holders covering 13 HIV medicines, one HIV technology platform, three direct-acting antivirals for hepatitis C, and one tuberculosis treatment. The organization was founded and continues to be funded by Unitaid. The mission of the Medicines Patent Pool is to accelerate the provision of affordable, high-quality treatment for patients with HIV, hepatitis C, and tuberculosis, as well as HIV-related comorbidities. Since 2018, the MPP has expanded its mandate to include other patented essential medicines on the World Health Organization (WHO) Model List of Essential Medicines (EML), as well as medicines highly likely to be added to the EML in the future. In 2020, we temporarily expanded the MPP’s mandate to include treatments for COVID-19.
On January 20, the Geneva-based Medicines Patent Pool (MPP) announced that it had signed agreements with 27 generic drug manufacturers to produce Merck's oral COVID-19 antiviral drug molnupiravir and supply it to 105 low- and middle-income countries. This sublicense agreement is a result of the voluntary licensing agreement signed between MPP and Merck in October 2021, thereby promoting global patient access to this COVID-19 oral drug co-developed by Merck and Ridgeback at an affordable cost.
Non-Exclusive Sub-License Agreement Allows Generic Drug Manufacturers to Produce Molnupiravir Active Pharmaceutical Ingredients and/or Formulations. Companies that have obtained sub-licenses have successfully demonstrated their ability to meet MPP's requirements for production capacity, regulatory compliance, and adherence to international quality assurance standards for pharmaceuticals. Among them, five companies will focus on producing active pharmaceutical ingredients, 13 companies will produce both active pharmaceutical ingredients and formulations, and nine companies will produce formulations. These companies are located across 11 countries worldwide, including Bangladesh, China, Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and Vietnam.
There are five companies in China qualified for generic production, including Fosun Pharmaceutical, Zhejiang Langhua Pharmaceutical Co., Ltd., Shijiazhuang Lonzeal Pharmaceuticals Co., Ltd., CQP, and Shanghai Desano Pharmaceutical Limited By Share Ltd.
Since COVID-19 is still categorized by the World Health Organization (WHO) as a Public Health Emergency of International Concern (PHEIC), Merck, Ridgeback, and Emory University, the inventor of this drug, will not receive royalties from the sales of molnupiravir by the sublicensees authorized through the MPP.
MPP Executive Director Charles Gore said: "We are encouraged by the swift action of many new and existing partners in obtaining sub-licenses for molnupiravir through the MPP. This is a crucial step in ensuring global access to urgently needed COVID-19 treatments. We believe that as manufacturers work closely with regulatory authorities, this drug will soon be available in middle- and low-income countries."
"From the outset, ensuring broader access to affordable molnupiravir has been a priority for MSD, which led us to sign a licensing agreement with MPP to expand the availability of quality-assured generic molnupiravir," said Paul Schaper, Executive Director of Global Public Policy at MSD. "We are pleased to see this vision come to fruition, with MPP-selected generic manufacturing sublicensees offering strong geographic diversity."