Reporter |
Editor |Xie Xin
Recently, according to The Paper, Anna Tian, President of MSD China, stated in an interview that the company has rolling submitted the application materials for its COVID-19 oral drug Molnupiravir to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The company looks forward to receiving feedback as soon as possible and achieving the launch of Molnupiravir in China.
This is also the case with Pfizer's COVID-19 oral medication Paxlovid (Nirmatrelvir Tablets/Ritonavir) Another COVID-19 oral drug submitted for marketing approval in China after receiving approval.
As of now, the only drug available in China is Pfizer's Paxlovid.An Oral COVID-19 Drug Approved for Marketing. The difference is,PaxlovidBelongs to3CL protease inhibitors, while Molnupiravir belongs to RNA polymerase inhibitors, which can bind to the RNA polymerase of the novel coronavirus, introducing incorrect nucleotides into newly synthesized RNA molecules, thereby exerting an inhibitory or antiviral effect.
In fact, overseas, Molnupiravir was approved earlier than Paxlovid.。It is the world's first approved oral COVID-19 medication for treating mild to moderate adult patients, receiving approval for market launch in the UK on November 4, 2021, and emergency authorization from the U.S. Food and Drug Administration on December 23 of the same year.
Currently, Molnupiravir has been granted marketing authorization or emergency use authorization in more than twenty countries and regions worldwide, including the United States, the European Union, the United Kingdom, Australia, Japan, and South Korea.
In terms of efficacy and safety, at the end of 2021, MSD announced the Phase III clinical research report of Molnupiravir, which showed that it could reduce the risk of hospitalization/death by 30% (6.8% vs 9.7%). This study, named MOVe-OUT (MK-4482-002) (NCT04575597), was a global multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial. The participants were non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19 who had not been vaccinated against COVID-19 before enrollment and had at least one risk factor associated with poor disease prognosis (elderly (>60 years), active cancer, chronic kidney disease, chronic obstructive pulmonary disease, obesity, severe heart disease, or diabetes), and had symptoms appearing within five days prior to randomization.
The primary efficacy endpoint of MOVe-OUT was to evaluate the efficacy of Molnupiravir (800mg, twice daily) by comparing the percentage of participants hospitalized and/or deceased from randomization through Day 29 between the Molnupiravir group and the placebo group. In the interim analysis report, the risk of hospitalization or death in the Molnupiravir group was reduced by approximately 50%. In the full analysis of all randomized participants (n=1433), as of Day 29, the Molnupiravir group had a lower risk of hospitalization or death. The absolute risk reduction was 3.0% (95% confidence interval: 0.1, 5.9), with 9.7% (68/699) of patients in the placebo group compared to 6.8% (48/709) in the Molnupiravir group, representing a 30% relative risk reduction.
In terms of safety, consistent with earlier clinical trials, no safety issues were identified with molnupiravir, and there was no evidence of clinically significant abnormalities in laboratory test results. The incidence of all adverse events (AEs) was comparable between the molnupiravir and placebo groups (30.4% vs. 33.0%, respectively). The incidence of drug-related adverse events was also similar (8.0% vs. 8.4%, respectively), with a lower proportion of patients in the molnupiravir group discontinuing treatment due to adverse events compared to the placebo group (1.4% vs. 2.9%, respectively). As of Day 29, no deaths were reported in the molnupiravir group, while there were 9 deaths reported in the placebo group. After Day 29, an additional 3 deaths due to adverse events were reported in the placebo group, and 1 death was reported in the molnupiravir group.
In addition, there is currently a study named MOVE-AHEAD evaluating the post-exposure prophylactic effect of Molnupiravir. This is a global, multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial aimed at assessing the efficacy and safety of Molnupiravir in preventing household transmission of COVID-19.
As an antiviral drug against COVID-19, Molnupiravir has also achieved strong commercial returns. In its 2021 earnings report, MSD projected Molnupiravir’s revenue for 2022 to be between $5 billion and $6 billion. In the latest Q1 2022 earnings report, Molnupiravir sales reached $3.2 billion. This figure positions Molnupiravir as MSD's second-strongest product after Keytruda (K-drug). During the quarter,PembrolizumabThe sales revenue was $4.809 billion.
In terms of production and supply, on January 20, 2022, the Medicines Patent Pool (MPP) announced that it had signed agreements with 27 generic drug manufacturers to produce Molnupiravir and supply it to 105 low- and middle-income countries as stipulated in the agreement. This is also the result of the voluntary licensing agreement signed between Merck & Co., Inc. and the Medicines Patent Pool in October 2021.