27 pharmaceutical companies were approved to imitate Merck's COVID-19 oral drugs, and 5 were Chinese pharmaceutical companies

Medicines PatentPool (MPP) announced that it has signed agreements with 27 generic drug manufacturing companies to produce and supply high-quality and affordable Merck oral anti-coronavirus drug Moldupiravir generic drugs for 105 countries or regions around the world to promote the affordability and accessibility of oral anti-coronavirus drugs and help prevent and control the epidemic.

Merck gave the green light early to other companies producing its oral anti-coronavirus drug, Molnupiravir, during the pandemic, a rare example in the pharmaceutical industry, which typically has a longer term of protection for its patented treatments.

The new agreement allows 27 generic drug manufacturers from India, China and other countries in Africa, Asia and the Middle East to produce APIs and finished drugs. Among them, a total of 5 Chinese pharmaceutical companies were shortlisted for the agreement list, Fosun Pharma, Brilliant Pharma, Shijiazhuang Longze Pharmaceutical and Shanghai Diesel were licensed to produce MORNUPIRAVIR APIs and finished drugs at the same time, and Langhua Pharmaceutical, a subsidiary of Via Biotech, was allowed to produce MORNUPIRAVIR APIs. According to CICC's calculations, if 50 million therapeutic drugs are produced globally in 2022, the corresponding API demand will be more than 400 tons, which will bring about an increase in demand for D-ribose of more than 300 tons.

Neither Merck nor its partner Ridgeback Biotherapeutics nor Emory University in the United States, where the drug was invented, will not collect sublicensed royalties from the MMOLUPIRAVIR sales of MPP sublicense holders.

According to Reuters, an MPP official involved in the negotiation of the agreement cited the drugmaker's initial estimate that a five-day, 40-tablet Molnuupiravir treatment would sell for about $20 in poorer countries. That's far less than the U.S. initial $1.2 billion deal with Merck (purchasing 1.7 million sessions, with an average cost of about $700 a course), but double the initial estimate of the World Health Organization's (WHO)-backed Global Procurement of COVID-19 Drugs and Vaccines Program.

Molnupiravir is an oral potent ribonucleoside analogue that inhibits replication of multiple RNA viruses, including the novel coronavirus. Molnupiravir was conditionally approved for marketing by the UK Medicines and Health Products Authority (MHRA) in November 2021, and was approved by the US Food and Drug Administration (FDA) for emergency use in December 2021 and the Japanese Ministry of Health, Labor and Welfare for emergency exceptions.

Molnupiravir is the first oral antiviral drug approved for the treatment of COVID-19. According to clinical trials, in adult patients with mild to moderate COVID-19, at risk of developing severe COVID-19 and/or hospitalization, Molnupiravir treatment significantly reduced the risk of hospitalization or death by 50%.

However, there are some problems with Molnupiravir, which has shown low efficacy in trials, its side effects have raised concerns, and in many poorer countries, lengthy application procedures can delay supply for months.

Molnupiravir has also not been approved by the World Health Organization, which makes it currently impossible for it to be marketed in most developing countries with limited regulatory resources mandated by the state.

It should be noted that Molnupiravir is not recommended for pregnant patients. According to the results of animal reproduction studies, Molnupiravir may cause harm to the fetus when given to pregnant animals.

The MPP group, which works to increase access to life-saving medicines in poor countries, has an agreement with Pfizer to sublicense its COVID-19 tablets paxlovid to generic drug manufacturers, in addition to an agreement with Merck.