Events. The Geneva pharmaceutical patent pool (MPP) announced that it had signed agreements with 27 generic pharmaceutical enterprises to produce Merck’s oral covid-19 antiviral drug molnupiravir and supply it to 105 low-income and middle-income countries. Among Chinese pharmaceutical enterprises, Brightgene Bio-Medical Technology Co.Ltd(688166) , Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Desano, Longze pharmaceutical and Langhua Pharmaceutical (via Biology) were selected.
Viewpoint:
The population of 105 countries authorized by MPP to supply molnupiravir generic drugs accounts for 52.9% of the world. The countries authorized to obtain the supply of molnupiravir generic drugs are low-income and middle-income countries. Based on the data released by the United Nations Population Division, the authorized supply covers 4.127 billion people, accounting for 52.9% of the world’s total population. This move will greatly improve the global accessibility of covid-19 oral small molecule drugs, effectively increase the treatment rate of covid-19 infected people, reduce the risk of epidemic spread, and play a positive role in global epidemic prevention and control.
MPP creates a balance between the commercial demands of the original research pharmaceutical enterprises to pursue return on investment and the government’s responsibility to protect citizens’ right to life and health. MPP negotiated with the original pharmaceutical enterprises on the voluntary license of drug patents. The original pharmaceutical enterprises put their drug patents into the patent pool, and the generic pharmaceutical enterprises applied to MPP for the patent implementation license in the patent pool to produce and supply generic drugs to low – and middle-income countries, which alleviated the supply shortage caused by the compulsory license of drug patents to a certain extent. In the past 2010-2020 years, nearly 20 drugs have been able to cover more patients in the world through this way, mainly for the treatment of AIDS, hepatitis C and tuberculosis. At present, MPP has reached 23 product or technology licensing agreements with 13 patent holding enterprises, including 2 covid-19 oral drugs and 1 covid-19 serological antibody diagnostic reagent.
MPP application needs to go through the process of application, authorization, technical handover, PQ application, etc. Pharmaceutical enterprises can fill in the EOI online, provide specific information about production capacity, production records of drugs with guaranteed quality, R & D capacity and regulatory compliance, and hope to obtain authorized product development, production, supervision and distribution plans and specific investment plans, and authorize the implementation license after MPP screening; After signing the agreement, the authorized enterprise shall carry out technical handover with the original research enterprise, complete the research and development of API and preparation according to the technical path provided by the original research enterprise, submit PQ application to who, and carry out the production, supply and sales of imitation drugs to the countries to be covered with or without on-site verification.
It is expected that the MPP currently applying for Pfizer has also been submitted and Sichuan Kelun Pharmaceutical Co.Ltd(002422) has applied for admission. The information submitted by other enterprises cannot be determined for the time being. Applying for and obtaining MPP authorization reflects the ability of each company in Global Compliance production and helps to establish its brand influence in the field of global API supply and cdmo services.
The corresponding market space of molnupiravir and paxlovid imitation products in the future is US $1.225 billion and US $3.675 billion respectively. Based on the rough calculation of the supply of molnupiravir and paxlovid’s original products to Europe and the United States in 2022, one dose of covid-19 small molecule drug can be used for every 6.64 people; Assuming that the global actual average infection rate is the same as the statistical infection rate in Europe and the United States, and the treatment rate is 60% in Europe and the United States, the MPP authorized supplier countries will obtain a total of 373 million doses of covid-19 small molecules in 2022; Refer to Dr. Reddy’s laboratories, India Ltd has disclosed the cost of a single course of treatment of molflo generic drug (USD 18.77). Assuming that the average price of covid-19 small molecule generic drug is USD 13.14 after extensive supply in the future, and the market share of molnupiravir and paxlovid generic products are 25% and 75% respectively, the corresponding market space of molnupiravir and paxlovid generic drugs is USD 1.225 and 3.675 billion respectively.
Risk warning: the risk that the R & D progress is less than expected; Risk of epidemic development and change; Risk of regulatory policy changes.
