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On December 26, the National Health Commission issued the overall plan on the implementation of "Class B and B tubes" for new coronavirus infection, requiring the improvement of the preparation of drugs and testing reagents related to the treatment of
new coronavirus infection.
In the face of the rising number of new crown infections, domestic pharmaceutical companies have promoted research and development to meet the growing demand
for new crown oral drugs in the market.
On December 28, Grand Pharma announced that the company's self-developed innovative oral small molecule drug GS221 against new coronavirus infection
Several clinical trials
have been conducted.
The available clinical results show that the drug is safe and well tolerated, and the treatment effect of clinical improvement, shortening of nucleic acid conversion time and rapid reduction of viral load has been shown after administration
.
GP's preclinical studies have shown that GS221 has shown effective inhibitory effects against the novel coronavirus and its various variants.
Animal studies and phase I clinical trials have shown good product safety; GS221 shows better metabolic stability and bioavailability compared to other similar oral anti-coronavirus infection products
.
An industry insider explained: "This means that the safety and effectiveness of this product are comparable to similar products around the world, and some indicators are even better than similar products
.
" ”
In response to the sales matters that the market is concerned about, industry insiders analyzed that if GS221 is successfully approved for marketing, compared with imported new crown oral drugs, or even existing domestic oral drugs, it will be an affordable, highly accessible and clinically targeted oral new crown drug
.
This drug will greatly reduce the economic pressure on the public to purchase drugs and benefit more and wider people
.
The market demand for new crown treatment is large
Drug development should continue to advance
The new crown virus will exist in nature for a long time, which means that the new crown treatment drugs will face a large demand for a long time, and the research and development of new crown treatment drugs still needs to continue to advance
.
3CLprotease (3CLpro), a proteolytic enzyme encoded by the SARS-CoV-2 genome, is a key enzyme in the viral replication process, and has high clinical value
in the development of new crown therapeutics due to its highly conserved sequence and the absence of human homologs.
At present, many pharmaceutical companies are focusing on the research and development of small molecule oral drugs such as 3CL protease as the main antiviral target, among which Pfizer's Paxlovid (nematevir) is the world's first oral 3CL protease inhibitor
against the new coronavirus.
GS221 developed by Grand Pharma is also an oral small molecule 3CL protease inhibitor
against the new coronavirus.
It is reported that Grand Pharma has completed 31 patent layouts (including 4 overseas patent applications) of GS221, of which 6 patents have been officially authorized
by the State Intellectual Property Office.
At the same time, the company is also continuing to develop the second generation of small molecule 3CLpro inhibitors to achieve product iteration.
At present, Grand Pharma's ongoing clinical research to evaluate the effectiveness of GS221 in the treatment of mild to moderate COVID-19 is divided into two phases, the first phase of the trial intends to enroll 70 asymptomatic/mild/ordinary patients with positive COVID-19 nucleic acid test, and the second phase trial intends to enroll 312 patients with mild disease/ordinary type with positive COVID-19 nucleic acid test, all using randomized, double-blind, placebo-controlled to explore the time of nucleic acid conversion negative after medication, Improvement in associated symptoms and safety
of the drug.
GP introduced that the first phase of the trial has completed the enrollment and follow-up of all patients, the safety is good, no serious or adverse events leading to drug discontinuation have been observed, and the clinical symptoms of patients have improved, the nucleic acid negative time has been shortened and the viral load has decreased rapidly after administration, suggesting that GS221 has potential clinical benefits for patients.
Phase II trials have been initiated and enrollment of participants has begun
.
This means that in the future, GP will further provide drug support
for the treatment of new coronavirus infection after the launch of this product.
Excellent safety and effectiveness
The price after listing is close to the people
"New crown pneumonia" bid farewell to the historical stage, but the new crown virus infection has not ended, and the prevention and control work has entered a new stage
.
According to the overall plan of "On the Implementation of "Class B and B Tube" for Novel Coronavirus Infection" issued by the National Health Commission, it is necessary to prepare
for the treatment of traditional Chinese medicines, symptomatic treatment drugs, anti-new coronavirus small molecule drugs, and antigen detection reagents 。 Medical institutions at or above the county level dynamically prepare traditional Chinese medicines, anti-new coronavirus small molecule drugs, antipyretic and cough drugs and other symptomatic treatment drugs according to the daily usage of three months; Primary medical and health institutions dynamically prepare traditional Chinese medicines, symptomatic treatment drugs and antigen detection reagents related to novel coronavirus infection according to 15%-20% of the population served, and increase
in densely populated areas as appropriate.
As new crown infections peak in various places, the price and supply capacity of new crown oral drugs have attracted much attention
.
At present, Pfizer's new crown oral drug nematevir/ritonavir tablets (Paxlovid) is priced at 2300 yuan / box, while the domestic new crown oral drug azvudine tablets medical insurance listing price is 270 yuan / bottle
.
However, due to the current large demand, the price of nematevir/ritonavir tablets on the market has risen to more than 3,000 yuan / box, and the price of azvudine tablets has also reached 330 yuan / box, which has increased significantly compared with the price of medical insurance
.
Analysts believe that the market expects domestic anti-new crown treatment drugs with better safety and efficacy to benefit the people at price
.
In recent days, many places have been promoting the marketing process
of related new crown oral drugs.
Grand Pharma also said that the company will continue to go all out to promote relevant research and communication with NMPA, and strive to obtain the approval of the product for marketing
as soon as possible.
In addition, the company has achieved pilot scale-up of the new crown oral drug GS221 and established a corresponding production line, and currently has an annual production capacity of 40 million servings to meet the treatment needs
.
According to Grand Pharma's announcement, based on the results of the current positive clinical trial research, GS221 is expected to become a broad-spectrum anti-new coronavirus drug with good economic benefits, excellent therapeutic effect, safety and compliance after successful marketing approval, which is expected to greatly improve drug accessibility and reduce the economic pressure
on the public to purchase drugs.