The number of patients with covid-19 continues to grow worldwide. As of November 19, 256 million cases had been confirmed worldwide, and the current growth rate remains between 1% and 1.5%. There were 5.1378 million deaths worldwide, with a mortality rate of 2.01%. Vaccines and injectable covid-19 drugs have become powerful tools for epidemic control, and covid-19 patients have increased at a low speed. The listing of oral covid-19 drugs is expected to make the treatment of covid-19 as convenient as the treatment of influenza, and the popularity of oral covid-19 drugs will be significantly higher than that of injectable drugs.
Six injectable covid-19 drug therapies and three oral covid-19 drugs are on the market all over the world. At present, 7 covid-19 therapeutic drug therapies have been listed in the world, and 2 drugs have been submitted to NDA. The only covid-19 indication treatment drug listed in the United States is redcivir of Gilead, and the immune disease of baretinib is also listed in the United States, but its covid-19 indication is only listed in Japan. The drugs that have obtained the US emergency use authorization (EUA) include three neutralizing antibodies and three oral drugs. In the first three quarters of 2021, the listed covid-19 therapeutic drugs generated a total sales of US $10.5 billion.
Neutralizing antibody:
Overview of covid-19 neutralizing antibody of overseas enterprises: at present, five covid-19 neutralizing antibody therapies have been listed all over the world, among which sotrovimab, kasilizumab + idzumab and etsveimab + banivir mAb have been approved by the US EUA. At present, there are 12 projects in phase III clinical and phase II / III clinical. In the first three quarters of 2021, covid-19 neutralizing antibody generated a total sales of US $5.6 billion. The United States quickly pushed effective neutralizing antibodies to the market through EUA. At present, it is also the country with the largest amount of neutralizing antibodies in the world. At present, about 100000 neutralizing antibodies are distributed every week in the United States. From mid September to late December, a total of 1.665 million neutralizing antibodies were distributed. Among the three markets shared by Zaiyuan / Roche, Lilly / Junshi and GSK / vir, the sales volume of Zaiyuan / Roche is the largest, accounting for nearly 60% of the overall market, followed by Lilly / Junshi.
Research and development of covid-19 neutralizing antibody by Chinese Enterprises: Shanghai Junshi Biosciences Co.Ltd(688180) etacivir lisenceout to Lilly, which has contributed revenue in 2020. The neutralizing antibody cocktail therapy of tengshengbo medicine was approved to be listed in China on December 8, 2021. It is the first covid-19 neutralizing antibody therapy to be listed in China. The covid-19 neutralizing antibody of Maiwei biology and Sinocelltech Group Limited(688520) is in phase II / III clinical stage. In addition, bgb-dxp593 of Baiji Shenzhou and danxu biology is in international multicenter phase II clinical, and dxp-604 is in phase I clinical. Nearly 30 covid-19 neutralizing antibodies in China are still in the early research stage before phase II clinical, of which 3 are in phase II and phase I / II clinical, 4 are in phase I clinical, and others are in preclinical. In terms of antibody technology, most of them are monoclonal antibodies, and two are double antibodies, namely 89c8-ace2 (anti-sars-cov-2sprotein / ACE2 bispecific antibody) of pumis and bat2022 (anti-sars-cov-2 bispecific antibody) of Bio-Thera Solutions Ltd(688177) .
Covid-19 neutralizing antibodies of GSK / vir and tengshengbo were released through the company's official channels. In vitro pseudovirus test showed that they were effective against Omicron virus strain. By analyzing the mutation site and neutralizing antibody sequence of RBD segment of Omicron strain, it is found that there is only one overlap between sotrovimab and Omicron strain, which may explain why sotrovimab is less affected by Omicron strain mutation.
Oral preparations:
Oral RdRp inhibitor: represented by moneravir of methadone. There are 9 oral RdRp inhibitors for covid-19 in Research & market, of which 1 has been listed and 3 are in phase III clinical stage. Azvudine of real organism is in phase III clinical stage, and vv116 of Shanghai Junshi Biosciences Co.Ltd(688180) has been declared for clinical application.
Oral sars-cov-2mpro inhibitor: represented by paxlovid of Pfizer, there are 7 oral drugs in clinical stage in the world. Pfizer's paxlovid phase III interim data show outstanding efficacy. It has submitted EUA to FDA and submitted rolling listing applications in Britain, Australia and other countries. Ritonavir plus ritonavir announced that patients with New Coronavirus pneumonia who were hospitalized for mild to moderate patients could not benefit more from standard treatment. The safety data of s-217622 phase I of yanyeyi pharmaceutical is good.
Other mechanisms: prochloramide, which develops the pharmaceutical industry, has outstanding efficacy in preliminary clinical trials. At present, it has carried out a number of phase III clinical trials in Brazil and the United States.
The global oral covid-19 drug market is expected to be billions to tens of billions of dollars. In 2021, there will be about 140 million new patients with covid-19 in the world. Assuming that the unit price of oral drugs per course of treatment is US $500 / 300 / 100 respectively, the corresponding market space is US $12 / 72 / 2.4 billion respectively. At present, the global prevalence rate is 0.31%. If the prevalence rate decreases to 0.15% or increases to 0.45%, the corresponding market size is USD 6 / 36 / 1.2 billion and USD 171 / 103 / 3.4 billion respectively.
Relevant subject matter:
Covid-19 neutralizing antibody related targets: tengshengbo medicine, Shanghai Junshi Biosciences Co.Ltd(688180) , Baiji Shenzhou, Sinocelltech Group Limited(688520) , Maiwei biology, Fuhong Hanlin, jiminxin, Boan biology.
Covid-19 oral drug related targets: development of pharmaceutical industry, Shanghai Junshi Biosciences Co.Ltd(688180) , Xiansheng pharmaceutical industry, Wuxi Apptec Co.Ltd(603259) , Asymchem Laboratories (Tianjin) Co.Ltd(002821) , Porton Pharma Solutions Ltd(300363) .
Other covid-19 drug related targets: Frontier Biotechnologies Inc(688221) .
Risk tip: the R & D progress is less than expected, and the clinical results fail.
