Pfizer submitted an emergency authorization application for oral new crown drugs and agreed to other companies' production. CDMO will win Calaiying?

On November 16, Pfizer announced that it has submitted an emergency authorization application (EUA) for the new crown oral drug Paxlovid™ (PF-07321332+ritonavir) to the FDA, which is based on the mid-term phase II/III clinical EPIC-HR study announced recently Analyze the data
.

At the same time, Pfizer stated that it has already started rolling submission of listing applications to many countries including the United Kingdom, Australia, and South Korea

Paxlovid is a compound preparation of 3CL protease inhibitor PF-07321332 and low-dose Ritonavir.
Ritonavir helps to slow down the metabolism or decomposition of PF-07321332 and maintain its effective concentration in the body for a long time.
With its antiviral activity
.

If authorized or approved, Paxlovid will administer a combination of 300 mg (two 150 mg tablets) of PF-07321332 and a 100 mg ritonavir tablet for oral administration by patients with COVID-19
.

It is administered twice a day for 5 days

Authorized companies can supply to 95 countries/regions

Authorized companies can supply to 95 countries/regions

On the same day, Pfizer has reached an agreement with an organization called MPP (Medicines Patent Pool) supported by the United Nations to allow other manufacturers to produce its COVID-19 oral antiviral therapy candidate PF-07321332
.

Pfizer mentioned in the cooperation statement with MPP that the agreement will enable MPP to facilitate the additional production and distribution of research antiviral drugs by granting sublicenses to qualified generic drug manufacturers, pending regulatory authorization or approval, with the purpose of promoting More access to the global population
.

According to the terms of the license agreement signed between Pfizer and MPP, qualified generic drug companies licensed worldwide will be able to provide combination therapy of PF-07321332 and ritonavir to 95 countries/regions, covering approximately 53% of the global population.
Including all low-income and low-middle-income countries in sub-Saharan Africa and some high-middle-income countries, as well as countries that have transitioned from low-middle-income status to high-middle-income status in the past five years
.

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 charge an authorization fee for sales in low-income countries, and will further exempt all countries/regions covered by the agreement.
Sales authorization fee
.

"Pfizer is committed to developing scientific breakthrough therapies to help everyone end this epidemic
.

We believe that oral antiviral therapy can play an important role in reducing the severity of COVID-19 infection, reducing the pressure on the healthcare system, and saving lives.

"This authorization is very important.
If authorized or approved, this oral drug is particularly suitable for low-income and middle-income countries, and can play a key role in saving lives and contribute to the global fight against the new crown epidemic," MPP Executive Director Charles Gore (Charles Gore) added, "We will work with generic drug companies to make the combination therapy of PF-07321332 and the HIV drug ritonavir, which can provide patients with sufficient supply
.

"

Similar products have been approved for listing in the UK

Similar products have been approved for listing in the UK

On November 5th, Pfizer announced that Paxlovid (PF-07321332+ritonavir) was used in a randomized, double-blind II/ In the interim analysis of the Phase III EPIC-HR study, the risk of hospitalization and death was significantly reduced
.

A scheduled interim analysis showed that among patients treated within 3 days of the onset of symptoms, PAXLOVID can reduce the risk of hospitalization or death from any cause related to COVID-19 by 89% (primary endpoint) compared with placebo; after randomization 0.
8% of patients in the PAXLOVID group were hospitalized to day 28 (3/389 hospitalization, no deaths)
.

In the placebo group, 7.

Among patients treated within 5 days of the onset of symptoms, hospitalizations or deaths related to COVID-19 also experienced a similar decrease
.

After randomization, 1% of patients in the PAXLOVID group were hospitalized to the 28th day (6/607 hospitalization, no deaths)

It is worth mentioning that on November 14, Merck/Ridgeback announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing of molnupiravir (MK-4482, EIDD-2801) in the UK for the treatment of mild to moderate COVID- 19 adult patients
.

Molnupiravir is the world's first oral antiviral drug approved for the treatment of mild to moderate COVID-19 in adults.
These patients have tested positive for SARS-CoV-2 and have at least one risk factor for developing a serious disease
.

In October this year, Merck and MPP reached a similar deal, agreeing to other drugmakers to produce molnupiravir in 105 poorer countries

Pfizer's cooperation with MPP is partially questioned

Pfizer's cooperation with MPP is partially questioned

In response to Pfizer’s move, Doctors Without Borders stated that this cooperation did not provide the drug to the world as “disheartening” and accused the agreement that countries such as China, Argentina and Thailand should not be excluded
.

Dr.

Critics have also pointed out that less than 1% of Pfizer’s new crown vaccine goes to poorer countries
.

Robbie Silverman of Oxfam America expressed support for Pfizer’s agreement to allow other manufacturers to produce its new crown oral drug, and pointed out that billions of people still do not have access to it.
Therapies and vaccines developed by the company
.

"This cooperation has sparked another thought: If Pfizer is willing to share the intellectual property rights of its oral drugs, why have they so far refused to take the same measures on their new crown vaccine?" Robbie Silverman questioned
.

CDMO wins Gloria?

CDMO wins Gloria?

In addition, on the eve of Pfizer's announcement that it agreed to other companies to produce its new crown oral drugs, the leading domestic new drug service outsourcing company Kailai Ying issued an announcement stating that the company continued to provide contract customization for a small molecule chemical innovation drug of a large pharmaceutical company in the United States.
During the development and production (CDMO) service process, its wholly-owned subsidiary Asymchem, Inc.
and Jilin Kailaiying Pharmaceutical Chemical Co.
, Ltd.
signed a new batch of "supply contracts" with customers for related products
.

As of the signing date of the contract, the cumulative contract value of CDMO services for this product was US$481 million (approximately 3.
07 billion yuan), and the new supply contract has come into effect after being signed and sealed by both parties
.
Kailaiying stated that the transaction involved keeping trade secrets.
According to the relevant agreement signed between the company and the customer, it did not disclose the basic information of the counterparty and product-related information
.

Regarding this cooperation, the outside world has speculated that the cooperating party is Pfizer
.
But some people familiar with the matter said that Pfizer has a very strong small molecule drug production line, and Merck is more likely
.

Reference materials:

Reference materials:

Pfizer seeks emergency use authorization for novel COVID-19 oral antiviral candidate

Pfizer seeks emergency use authorization for novel COVID-19 oral antiviral candidate

Pfizer agrees to let other companies make its COVID-19 pill

Pfizer agrees to let other companies make its COVID-19 pill

Pfizer and The Medicines Patent Pool (MPP) Sign Licensing Agreement for COVID-19 Oral Antiviral Treatment Candidate to Expand Access in Low- and Middle-Income Countries

Pfizer and The Medicines Patent Pool (MPP) Sign Licensing Agreement for COVID-19 Oral Antiviral Treatment Candidate to Expand Access in Low- and Middle-Income Countries