Industry update
From December 22 to 23, FDA successively approved the emergency authorization application (EUA) of Pfizer’s covid-19 oral drug paxlovid and the emergency authorization application (EUA) of mosadon covid-19 oral drug molnupiravir for the treatment of non hospitalized adult covid-19 infected patients with high risk of developing into severe diseases.
Paxlovid is an oral specific drug developed by Pfizer for the treatment of covid-19. It is a compound preparation composed of 300mg of 3CL protease inhibitor nirmatrelvir (pf-07321332) and 100mg ritonavir. The patient is orally administered twice a day for 5 days.
The FDA’s emergency use authorization is based on the previously completed epic-hr clinical trial. In this study for non hospitalized high-risk patients, the data of all 2246 enrolled patients show that, Paxlovid reduced the risk of hospitalization / death by 89% (0.7% vs 6.5%, patients treated within three days after symptom onset) and 88% (0.8% vs 6.3%, patients treated within five days after symptom onset) compared with placebo. There were no deaths in the treatment group and 12 deaths (1.2%) in the control group. The virological secondary endpoint of epic-hr showed that paxlovid reduced the viral load by about 10 times compared with placebo (reduced by 0.93log10 copies / ml, n = 499), indicating strong activity against SARS cov-2. In addition, in another epic-sr clinical trial for non hospitalized general risk patients, interim data showed that paxlovid reduced the hospitalization rate by 70% (0.6% vs 2.4%, P = 0.051) and the viral load by about 10 times (reduced by 1log10 copies / ml). In vitro test data showed that nirmatrelvir, the main antiviral component of paxlovid, was effective against Omicron mutant.
Pfizer will supply 10 million courses of paxlovid to the U.S. government from 2021 to 2022. Pfizer is expected to produce 120 million courses of paxlovid in 2022.
Molnupiravir is an oral specific drug developed by mosadon for the treatment of covid-19. It is a nucleoside analogue that can interfere with virus replication. The FDA’s emergency use authorization is based on the previously completed moveout clinical trial. In this study for moderate and mild non hospitalized patients, molnupiravir reduced the risk of hospitalization / death by 30% compared with placebo (6.8% vs 9.7%), there were no deaths in the treatment group and 9 deaths in the control group (1.3%).
At present, the US government has purchased 3.1 million courses of molnupiravir and the UK government has purchased 2.23 million courses of molnupiravir.
Based on the therapeutic mechanism, accessibility and economy of oral drugs, we continue to be optimistic about the application prospect of oral small molecule covid-19 drugs.
Investment advice
It is suggested to pay attention to four main epidemic lines: ① small molecule cdmo industrial chain and its upstream of fine chemicals; ② Other upstream supply chains related to covid-19, including suppliers of antigens, antibodies, enzymes, plasmids, etc; ③ Epidemic related innovative drug R & D enterprises; ④ Other epidemic related, such as vaccine R & D enterprises, covid-19 test kit suppliers and other anti epidemic equipment / consumables suppliers.
It is suggested to focus on: Asymchem Laboratories (Tianjin) Co.Ltd(002821) , Wuxi Apptec Co.Ltd(603259) , Zhejiang Jiuzhou Pharmaceutical Co.Ltd(603456) , Zhejiang Ausun Pharmaceutical Co.Ltd(603229) , Kingsley biotechnology, etc.
Risk statement
Covid-19 epidemic development and change risk, product R & D data and progress are less than expected risk, product capacity and sales are less than expected risk, government orders are less than expected risk, policy risk, etc.
