milestone!

On December 22, U.
S.
local time, the FDA urgently approved Pfizer’s oral new crown drug Paxlovid for use in people over 12 years old and weighing at least 40 kg, making it the first oral new crown drug approved in the United States.
3CL protease inhibitor against SARS-CoV-2
.

This is a milestone event
.

However, the FDA emphasized that Paxlovid is not authorized for pre-exposure or post-exposure prevention of COVID-19 and is approved for the treatment of patients who require hospitalization due to severe or critical COVID-19

In early November, Pfizer announced the therapeutic effect data of its new crown oral specific drug
.

And Pfizer said that recent laboratory data show that Paxlovid is still effective against Omi Keron strain

Recent laboratory data indicate that Paxlovid is still effective against the Omi Keron strain

Reduce the risk of hospital death by 89%

PAXLOVID is an investigational SARS-CoV-2 protease inhibitor antiviral therapy, specifically designed for oral administration, so that it can be prescribed when there are signs of infection or the first awareness of exposure to help patients avoid possible causes Serious illness and death in hospital
.

PF-07321332 is designed to block the activity of SARS-CoV-2-3CL protease, which is an enzyme required for coronavirus replication

The main data supporting Paxlovid’s EUA comes from EPIC-HR, a randomized, double-blind, placebo-controlled clinical trial investigating the use of Paxlovid in the treatment of non-hospitalized, symptomatic adults with a laboratory-confirmed SARS-CoV-2 infection
.

The main data supporting Paxlovid’s EUA comes from EPIC-HR, a randomized, double-blind, placebo-controlled clinical trial investigating the use of Paxlovid in the treatment of non-hospitalized, symptomatic adults with a laboratory-confirmed SARS-CoV-2 infection
.

The data showed that compared with placebo, patients treated with PAXLOVID had a 89% lower risk of hospitalization or death from any cause related to COVID-19 within three days of the onset of symptoms, and there was no death in the treatment group
.

Similar results were observed within five days of the onset of symptoms

It is worth mentioning that, in addition to the US FDA approval for listing, Pfizer has begun rolling submissions in Paxlovid, including the United Kingdom, Australia, New Zealand, and South Korea, and plans to submit applications to other regulatory agencies around the world
.

Free authorized imitation

Free authorized imitation

In addition, it is worth noting that on November 16, Pfizer’s official website announced that it and the Pharmaceutical Patent Pool (MPP) have signed a license agreement for oral antiviral therapy candidates for COVID-19 to expand the availability in low- and middle-income countries.
And sex
.

According to the terms of the general license agreement between Pfizer and MPP, qualified generic drug manufacturers authorized by MPP will be able to provide the drug to 95 countries, covering approximately 53% of the world's population
.

Including all low-income and middle-income countries, as well as sub-Saharan middle- and high-income countries

It is worth noting that Pfizer stated that under the circumstance that COVID-19 is still listed as a public health emergency of international concern by the World Health Organization, Pfizer will not receive royalties for sales in low-income countries and will further Exemption of sales royalties in all countries/regions covered by the agreement
.

The agreement will enable MPP to promote the additional production and distribution of investigational antiviral drugs by granting sublicenses to qualified generic drug manufacturers, pending regulatory authorization or approval, with the aim of promoting greater access to the global population
.

The expected output in 2022 will reach 120 million treatment courses

The expected output in 2022 will reach 120 million treatment courses

Boosted by this news, Pfizer's stock price rose by nearly 3%.
Since the beginning of this year, the company's stock price has risen by 64%
.

SVBLeerink analyst GeoffreyPorges predicted in a report that Pfizer's revenue in 2022 is expected to reach 101.

Prior to this, Pfizer stated that Pfizer has started and will continue to invest up to approximately US$1 billion in its own funds to support the manufacturing and distribution of drug candidates for the research and treatment
.

It is reported that the US government purchased 10 million courses of Pfizer's new crown oral drug Paxlovid at a price of US$5 billion
.

However, US officials previously revealed that although the US government has ordered 10 million treatment courses from Pfizer, it is estimated that there are only 65,000 treatment courses at present, and it will reach 250,000 treatment courses by the end of January

Pfizer CEO Albert Bourla said that it is ready to start deliveries in the United States immediately
.
The company raised its 2022 production forecast from 80 million treatment courses to 120 million treatment courses
.

Pfizer CEO Albert Bourla said that it is ready to start deliveries in the United States immediately
.
The company raised its 2022 production forecast from 80 million treatment courses to 120 million treatment courses
.

Reference materials:

Reference materials:

[1]Coronavirus(COVID-19)Update:FDAAuthorizesFirstOralAntiviralforTreatmentofCOVID-19,RetrievedDecember22,2021,fromhttps:// -oral-antiviral-treatment-covid-19

[1]Coronavirus(COVID-19)Update:FDAAuthorizesFirstOralAntiviralforTreatmentofCOVID-19,RetrievedDecember22,2021,fromhttps:// -oral-antiviral-treatment-covid-19

[2] Pfizer official website and other public information

[2] Pfizer official website and other public information