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New crown oral medicine
Oral medicationAfter the "Class B tube", ensuring the adequate supply of new crown oral drugs will become one of the key measures in the normalization of prevention and control, because new crown oral drugs may become the existence
of cold medicine.
To achieve this, affordable prices, good safety, stable supply, and easy availability are necessary conditions, and they are also key factors
in determining which new crown oral drug will stand out in the future.
Recently, the National Health Commission announced that from January 8, 2023, the Category A control of the new crown will be lifted and the "Category B and B Management" plan will be implemented instead; The new crown pneumonia, which has been called for three years, was officially renamed "new coronavirus infection"
.
In the first wave of the epidemic, although most people relied on antipyretic drugs such as ibuprofen and acetylaminophen to survive the course of yang to yin, the perception of the public and scientific evidence could not prove that these drugs could effectively reduce viral load and improve the five main symptoms of new crown infection: nasal congestion/runny nose, sore throat, cough, fever and tiredness, thereby shortening the time
for patients to "turn negative".
Behind the stockpiling of common cold medicine "one medicine is difficult to find", it is actually exposed the urgent need
of the people for the "symptomatic" drugs of the new crown.
The State Food and Drug Administration has repeatedly stated that it will "speed up the review and approval of drugs urgently needed for the clinical diagnosis and treatment of new coronary pneumonia"
.
According to industry insiders, a number of new crown specific drugs, including Shionogi Ensitrelvir and Simcere's SIM0417, are close to the approval stage
.
For investors in the secondary market, any update of the news of the new crown oral medicine will become the most nerve-pulling sector
.
01 Fewer side effects, better safety, Shionogi ensetvir or into a dark horse
With fewer side effects and better safety, Shionogi Ensetvir may become a dark horseIn addition to old drugs and new uses, according to statistics, as of the end of November, 5 new crown oral drugs have been approved for marketing
worldwide.
These new crown oral drugs that have been verified by clinical trials mainly have two mechanisms
: 3CL protease inhibitor and polymerase inhibitor (RdRp).
Pfizer's P drug (Paxlovid) and Merck's M drug (Molnupiravir) are representatives
of the two technology streams, respectively.
Among domestic new crown drugs, RdRp mechanism products have made the fastest progress, and 3CL protease product candidates are in large-scale clinical trials
.
At present, the new crown oral drugs that have been conditionally approved in China are Azvudine tablets (RdRp mechanism) and Pfizer's P drug (3CL protease mechanism).
In addition, the new drug Ensitrelvir (developed by Shionogi Yoshi) and the domestic 3CL new crown drug approved in Japan at the end of November are also close to the approval stage in China, which will effectively fill the market gap
.
So, which of these new crown drugs is better or worse?
Benefiting from the first-mover advantage, P drug is the most widely used new crown oral drug on the current market, but its "defects" are also obvious, including room for improvement in the coverage, safety and price of the indicated population
.
These limitations also leave room for imagination for latecomers of new crown oral drugs, such as ensetivir, which is recognized by experts as the best oral drug from the comprehensive consideration of efficacy and safety, which has become one of the dark horses
.
.
These limitations also leave room for imagination for latecomers of new crown oral drugs, such as ensetivir, which is recognized by experts as the best oral drug from the comprehensive consideration of efficacy and safety, which has become one of the dark horses
.
First of all, from the applicable population, P drug is conditionally approved for mild to moderate new crown infection with high risk factors for severe disease, while the indications approved by ensetvir in Japan do not have similar restrictions and can be used
at the early stage of the patient's confirmed infection.
This means that ensetvir will have a wider audience, especially in the context of Omicron's dominance, where mild to moderate disease is the majority
.
.
"Small indications for the population" is a major regret
of P drug new crown drugs.
Huachuang Research said that the current approved indications for Paxlovid are relatively small, and in larger indications, its phase III interim clinical analysis did not meet the primary endpoint
of symptom relief.
Therefore, under strict prescription conditions, P drug is really applicable to a limited
number of people.
Secondly, from the perspective of efficacy, "ensetivir is the first oral new crown drug
to show both symptom improvement and antiviral effects.
" Shionogi wrote in the submission
.
According to the phase III clinical results disclosed by Shionogi Yoshi, the 1821 patients with mild to moderate disease enrolled in ensetevir in Japan, South Korea and Vietnam, regardless of whether they were vaccinated or not, regardless of whether there were high-risk factors, five typical characteristic symptoms (nasal congestion/runny nose, sore throat, cough, fever and tiredness) were significantly improved, and the symptoms disappeared (167.
9 hours).
vs 192.
2 hours, p=0.
04), reached the primary endpoint
.
It also significantly outperformed placebo
in the secondary endpoint viral conversion rate.
to show both symptom improvement and antiviral effects.
" All five typical symptoms (nasal congestion/runny nose, sore throat, cough, fever, and tiredness) improved significantly and disappeared (167.
9 hours vs 192.
2 hours, p=0.
04), reached the primary endpoint
.
The primary endpoint of the approved indication selection for P was hospitalization, which reduced the risk of hospitalization or death by 89%
compared with placebo.
On a larger indication, Paxlovid also conducted a Phase II/III clinical trial (EPIC-SR trial) in unvaccinated adults and vaccinated adults with one or more risk factors for progression to severe disease, with symptom relief
selected for the primary endpoint.
Unfortunately, the trial failed in June because it failed
to achieve statistically significant symptom relief.
The aforementioned research institutions believe that clinical trials with symptom relief as the primary endpoint are more difficult than reducing the risk of hospitalization
.
Once the endpoint of clinical remission can be reached, it means that the product is superior to Pfizer Paxlovid, and commercialization in the European and American markets is expected to be a great success
.
Therefore, symptom relief may become the best choice
for phase III clinical trials of new coronavirus drugs in the future.
Finally, from the perspective of safety, P drug needs to use ritonavir as an enhancer, or there is a risk of drug interaction, while ensetivir does not have the risk of enhancing ritonavir, and compliance will be better
.
Drug Fact Statement in the FDA
sheet), the warning content about P drugs also includes hepatotoxicity (patients taking ritonavir have symptoms such as elevated hepatic aminotransferases, hepatitis, jaundice, etc.
), and HIV-1 drug resistance (causing HIV-1 production against HIV).
Resistance to protease inhibitors) and so on
.
.
02The supply chain is rapidly localized to ensure the stability of supply
The supply chain is rapidly localized to ensure the stability of supplyAfter the "B tube", one of the key measures for prevention and control is to ensure the sufficient reserve
of new crown oral drugs.
For ordinary people, the current new crown oral medicine faces the double dilemma
of high price and difficult to obtain.
It is understood that P drug is prescribed by a doctor in the hospital for 2980 yuan / box, and it is 2300 yuan
after using medical insurance.
In some daigou channels, it was sold to more than 8,000 yuan / box
.
Despite such a high price, P drugs are still in a constant state of out-of-stock, whether it is a hospital or a daigou, it is not easy to buy P drugs
.
The price of domestic azvudine is relatively close to the people, but it is often in a state
of shortage of stock.
There is no doubt that more approvals of coronavirus oral drugs will fill these gaps, whether imported new drugs or domestic new drugs
.
People close to Shionogi said that because there is no need for enhancers, the cost and price of the independent oral drug ensetivir will be lower
.
On the other hand, in terms of supply chain, Shionogi expressed his willingness to localize the entire process from raw materials to production in China, which can not only maximize supply security and solve supply instability caused by supply chain, but also reduce costs and improve patient
accessibility.
.
On the other hand, in terms of supply chain, Shionogi expressed his willingness to localize the entire process from raw materials to production in China, which can not only maximize supply security and solve supply instability caused by supply chain, but also reduce costs and improve patient
accessibility.
There is also a voice behind the shortage - about the value of the new crown drug
.
Many respondents said that new crown drugs, especially small molecule drugs, inhibit the internal of virions
RdRp and 3CL protease play a role, are insensitive to virus mutations, and most of them still have inhibitory effects on various variants such as Omicron, which can become a powerful weapon
for normalized prevention and control.
Coupled with the convenience of oral administration of small molecule drugs, which can greatly alleviate the pressure on domestic medical resources, the industry still has high hopes for it, and believes that it is the last straw
on the main line of new crown investment.
A number of institutions, including Goldman Sachs, have predicted that under normal circumstances, the market size of new crown oral drugs is expected to reach $15 billion ~ $20 billion
.
The most optimistic estimation range is even as high as 180 billion yuan ~ 300 billion yuan, and the most cautious estimate of market space can reach 80 billion yuan
.
So who exactly can stand out and gain more market share? A number of respondents told E drug managers that the competition for new crown oral drugs in the future depends first and foremost on efficacy
.
In the case of similar efficacy, many factors
such as the population covered by the indication, commercialization, channel and the cost performance of the drug itself are compared.
Of course, the mutation of the new coronavirus will also affect sales expectations
.
With the evolution of the new crown virus, the mainstream strain has evolved from the original strain type of "highly virulent, relatively low contagious" to the "low virulence, but extremely contagious" Omicron
.
According to the theory of virus evolution, the long-term evolution direction of viruses is to reduce virulence and increase infectivity to ensure that the host can infect more people
.
"Omicron's mutation brings immune escape to the human body, so it is very contagious, and the latest strain R0 coefficient can reach 22, that is, one person can pass on 22 people
.
At present, BA.
4, BA.
5 and BF.
7, which are mainly popular in China, spread rapidly, and in this case, it is difficult to completely cut off their transmission chain
no matter how strong the prevention and control are.
Zhong Nanshan said
.
In summary, ensetivir, which can reduce infectivity more quickly and has better safety, may be expected to stand out and further become a "potential stock"
in domestic new crown oral drugs.
The next question is, who will be responsible for the commercialization of this potential new crown drug? Because this target will have a considerable impact on the market structure
of small molecule new crown drugs.
in domestic new crown oral drugs.
The next question is, who will be responsible for the commercialization of this potential new crown drug? Because this target will have a considerable impact on the market structure
of small molecule new crown drugs.
Looking back at the 100-year history of influenza, the real means to end influenza is actually the prevention and treatment combination
of "influenza vaccine + oral special drug".
In the three years of the new crown pandemic, we have experienced the process from "new crown pneumonia" to "new crown infection", and our new crown drug development has also experienced two stages from scratch and from there to excellent.
We thank all the medicine people for their efforts!
of "influenza vaccine + oral special drug".
In the three years of the new crown pandemic, we have experienced the process from "new crown pneumonia" to "new crown infection", and our new crown drug development has also experienced two stages from scratch and from there to excellent.
We thank all the medicine people for their efforts!
