R & D process and future prospect of covid-19 oral drugs: Omicron spread all over the world, and two oral covid-19 drugs were approved

Omicron is spreading all over the world and is gradually replacing Delta. On November 9, 2021, a covid-19 virus B.1 was detected in case samples for the first time in South Africa 1.529 mutant. In just two weeks, the mutant became the absolute dominant mutant of covid-19 infection in Gauteng Province, South Africa, with rapid growth. On November 26, who defined it as the fifth “variant of concern” (VOC). According to the weekly report of who, as of December 21, 106 countries have monitored the input of this variant. In the current detection of virus types, the proportion of Omicron in global virus types has increased rapidly.

Neutralizing antibodies and vaccines have decreased, and small molecule oral drugs are expected to become game changer. Since the current small molecule antiviral drugs do not act on S protein, it is expected that the mutant will have a limited impact on the effectiveness. Compared with neutralizing antibodies, small molecule oral drugs have many advantages: 1) neutralizing antibodies may fail in the case of virus variation, and the high cost and intravenous injection reduce the accessibility of drugs. 2) Oral drugs have small capacity constraints, low cost and more convenient distribution. They can be administered quickly after infection or covid-19 symptoms. At present, two small molecule oral drugs, Mosha domopivir and Pfizer paxlovid, have obtained the U.S. EUA, and the domestic small molecule covid-19 drug prochloramide is undergoing a global phase III clinical trial.

Overseas:

1) Pfizer’s paxlovid data is amazing, the risk of hospitalization and death is reduced by 89%, the United States EUA is approved, and it plans to produce 80 million courses of treatment in 2022;

2) Moshadong molnupiravir was approved by the US EUA. The latest updated data show that it can reduce the risk of hospitalization and death by 30%, and produce at least 20 million courses of treatment in 2022;

3) Roche / atea at-527: phase II test failed to reach the main end point, Roche terminated cooperation with atea, and atea modified phase III scheme continued to be developed

Domestic:

1) The development of pharmaceutical ar antagonist prochloramide is currently in phase III clinical progress in the world, and Paraguay has been approved as EUA

2) The real biological antiviral drug azvudine is under phase III study of covid-19, and the preliminary data are good;

3) Several small molecule drugs in early clinical stage are under research, Shanghai Junshi Biosciences Co.Ltd(688180) vv116 has been approved overseas, and Frontier Biotechnologies Inc(688221) phase I clinical in the United States is in progress.

Investment suggestions: it is suggested to pay attention to the relevant development enterprises of advanced therapies and drugs, including Shanghai Junshi Biosciences Co.Ltd(688180) , development of pharmaceutical-b, tengshengbo pharmaceutical-b, etc; At the same time, pay attention to the cdmo industrial chain of drugs related to large pharmaceutical enterprises in the world.

Risk tips: covid-19 virus mutation risk, significant risk of epidemic prevention and control, risk that the clinical progress is less than expected, and risk that the research report information is not updated in time

 

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