On January 20, the pharmaceutical patent pool Organization (MPP) announced that it had signed agreements with 27 enterprises to produce and supply molnupiravir generic drugs, an oral anti-covid-19 virus drug, for 105 low – and middle-income countries or regions around the world. Five Chinese pharmaceutical enterprises have signed agreements, namely Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (600196. SH / 02196. HK), Brightgene Bio-Medical Technology Co.Ltd(688166) (688166. SH), Langhua pharmaceutical, Shijiazhuang Longze pharmaceutical and Shanghai desaino under Weiya biology. Among them, except Langhua pharmaceutical is authorized to produce APIs, the other four Chinese pharmaceutical enterprises can produce APIs and finished drugs at the same time.
MPP is a public health organization supported by the United Nations. It is committed to increasing access to life-saving drugs in low – and middle-income countries and regions through innovative business models and promoting the development of such drugs. MPP said that this authorization is to promote the affordability and accessibility of oral anti-covid-19 drugs in low – and middle-income countries and help local epidemic prevention and control.
Molnupiravir is an oral ribonucleoside analogue that can inhibit the replication of sars-cov-2 (covid-19 virus). It was jointly developed by mosadon and Ridgeback.
This drug is also the first approved oral anti-covid-19 virus drug in the world. It was conditionally approved by the British drug and Health Products Administration (MHRA) in November 2021. In December 2021, it was successively authorized by the US Food and Drug Administration (FDA) for emergency use and the emergency special approval of the Ministry of health, labor and welfare of Japan.
In December 2021, the results of move-out, a phase 3 clinical trial of the drug, showed that early treatment and administration of molnupiravir could significantly reduce the risk of hospitalization or death in high-risk adult patients with unvaccinated covid-19 pneumonia.
In October 2021, before the approval, MSD signed the license agreement of molnupiravir with MPP. According to the terms of the agreement, the pharmaceutical patent pool organization can grant a license through MSD, and then grant a non exclusive sublicense (“MPP license”) to the manufacturer, so as to increase more production bases and supply molnupiravir with quality assurance or who pre certification for the countries / regions covered by MPP license (subject to the approval of local regulatory authorities).
According to the agreement, as long as covid-19 pneumonia is still listed as a public health emergency of international concern by the World Health Organization, MSD will not charge royalties from molnupiravir sales.
MPP said that through MPP’s independent review, the licensed enterprises have proved that they have the ability to meet MPP’s requirements for production capacity and regulatory compliance, and can produce drugs that meet international quality standards.
During the signing of this agreement, a total of 13 pharmaceutical enterprises in the world were licensed to produce molnupiravir API and finished drug at the same time, another 5 pharmaceutical enterprises were authorized to produce API and 9 pharmaceutical enterprises were authorized to produce finished drug.
