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Recently, the epidemic situation in many places has faced a severe recovery, and the secondary market sentiment has also fluctuated
greatly.
The first to stir up fluctuations is an inhaled vaccine: Shanghai officially announced the official launch of inhaled new crown vaccination, and the secondary market with a keen sense of smell soon pushed CanSino directly to the 20cm limit
.
Subsequently, the new progress of the BioNTech vaccine talked about by the German chancellor during his visit to China, and the news that the company's CEO Wu Shaxin was accompanying him, caused another wave of fluctuations: Does Forbidden have another chance?
Coupled with a few rumors, the anti-epidemic concept stocks have entered a recovery-fall cycle
several times.
This reflects the market's huge concern and emotional fluctuations
about the epidemic.
In the future, this cycle will continue for a long time
.
.
Because stocks are a process of buying and selling, buying at low points and selling at high points makes real profits
.
So in this relay game, the truth of the news is no longer important, only a steady stream of people believe in this matter and participate, in the process of the continuous rise of related stocks, complete the withdrawal can make a wave
.
This is the operating logic
of the secondary market in this "feast of public opinion".
As for the fight against the epidemic itself, a central question is, can our current epidemic prevention toolkit – vaccines, drugs and medical infrastructure – cope with the impact of the new wave of the epidemic?
-01-
-01-Vaccines: How much room is there?
Vaccines: How much room is there?On November 4, 2022, German Chancellor Scholz officially visited China, and there were a large number of business leaders in the team, including the CEO of the vaccine company BioNtech, which was regarded by many as a signal
that mRNA vaccines are about to accelerate in China.
As early as March 2020, Fosun obtained the rights and interests of BioNtech in China, but both clinical progress and approval process have been slow
.
Until now, the fourth booster dose has begun to be widely vaccinated, and the mRNA vaccine introduced by Fosun has not yet been approved
in Chinese mainland.
However, taking a step back, even if it is approved, under the current many listed and unlisted domestic new crown vaccines, how much space can be vaccinated, there is still a question mark
.
The new crown vaccine has been administered several rounds, but the development of the new crown vaccine has not stopped
.
This is because in the current epidemic prevention and control, we still lack a revolutionary vaccine tool with clinical effects that can support the opening of the country, at least the existing vaccines, the data does not support this
.
However, the current research and development of the new crown vaccine faces several problems
.
First of all, although the domestic epidemic is still in the form of a point, it is difficult to predict, and second, for the local government, how to prevent the spread in the shortest time is the first priority, and other things need to give way
.
This also makes it difficult for even new crown vaccine companies to take the opportunity to complete large-scale randomized controlled experiments
.
If you leave this phase III clinical trial, relying only on antibody titers and safety data, it is difficult to convince the drug regulatory authorities to approve a new vaccine
in the current environment.
in the current environment based on antibody titer and safety data alone.
Secondly, there is a large time lag between vaccine companies from project approval to clinical practice, but the mutation rate of vaccines is getting faster and faster, which brings new problems
to the clinical and regulatory aspects of vaccine companies.
This requires a huge amount of clinical and regulatory resources to speed up efficiency, but how much energy pharmaceutical companies and drug regulators can share at the moment requires a game process, after all, no one can guarantee that a project must be the key to
changing the moment.
Image: Changes in the new coronavirus strain Source: Guotai Junan
Moreover, when the cost of phase III clinical subject enrollment is getting higher and higher, the cost of vaccine clinical development is getting higher and higher, but the competition of vaccines is becoming more and more fierce, and under the scissors difference, for the leaders of the new crown project of pharmaceutical companies, whether to stick to it is also a problem
that requires serious decision-making.
After all, this year, there have been several companies with mature commercialization of new crown vaccines, and there has been a sharp decline in revenue in this business: Zhifei, a recombinant protein vaccine, fell by 33% in the third quarter in the third quarter with a significant increase in non-new crown business this year; Kangtai Biologics, which later entered the inactivated new crown vaccine, recorded an impairment of 415 million new crown business assets in the middle of this year
.
During the global epidemic, foreign research teams have used active infection to test the preventive effect of vaccines, but this matter is difficult to land
in China.
First, it is difficult to pass ethically, and second, there are also challenges in clinical design and supervision
.
But as a once-in-a-century industry pain point, who can solve the various challenges brought by this virus on vaccines will definitely take this opportunity to complete a ladder leap.
There is a beautiful and hazy wish
in every vaccine company.
Image: Progress of domestic new crown vaccine research and development Source: Guosheng Pharmaceutical
Moreover, the brilliance of Sinovac's 90 billion net profit is too bright, adding a bit of thick certainty to this hazy expectation
.
Even if everyone knows in their hearts, half of Sinovac's performance comes from the first-mover first-come, grabbed the first dividend of the entire new crown vaccine market, and the other half comes from the national-led vaccine going abroad
.
Back to the public health level, the vaccine itself has data showing that it can reduce the rate of severe disease and mortality, and the molecular level can also cause a strong immune response, which is indeed one of
the powerful tools for epidemic prevention and control.
Even if vaccine companies are reluctant to do it due to revenue, all parties will push them forward
.
-02-
-02-Oral medicines: who is approved next?
Oral medicines: who is approved next?Another important anti-epidemic tool is therapeutic medicine
.
Among them, antiviral drugs are used in the early stage of infection, and their role is to slow down the replication of the virus and clear the virus after infection, thereby preventing its further harm to the human body, which can be described as "guarding the first gate"
.
Among them, oral drugs are particularly favored
for their ease of use.
Taking Pfizer's Paxlovid as an example, recent literature has shown that it has excellent efficacy in reducing hospitalization and mortality rates in people aged 65 and above, and can also significantly reduce the risk of
new crown sequelae.
At present, two new crown oral drugs have been launched in China: in addition to Pfizer's Paxlovid, there is also the real biological Azvudine
.
Merck Molnupiravir, which has been listed in several countries and regions, is currently not approved
.
However, Merck has granted Sinopharm the distribution and exclusive import rights of this drug, which may indicate that it is not far from being approved for marketing
.
Also completing Phase 3 trials is Junshi Biologics, whose VV116 has been approved in Uzbekistan for moderate to severe disease
.
Also at this stage is the pioneering pharmaceutical proclolamide, which was urgently approved in Paraguay last July for the treatment
of critically ill hospitalized patients.
Japan's Shionogi has also released the data for three phases and announced that it has submitted preparatory materials
for the marketing application to the China Food and Drug Administration.
It is followed by several companies
that have been in phase 2/3 clinical trials.
Zhongsheng Pharmaceutical, which has recently been approved for phase 3 clinical trials, has been up and down
for two consecutive trading days.
Also at this stage are Simcere Pharmaceutical's SIM0417 and Frontier Biologics' FB2001
.
The new crown oral drugs of many companies such as Sinovac, Ascletis, Guangshengtang, Tide Pharmaceutical, a subsidiary of China Biopharmaceutical, and Shanghai Gusen Pharmaceutical, have also entered the clinical stage
.
After azvudine, no new crown oral drug has been approved so far, which is partly because, according to the previous review criteria, the endpoint of the clinical trial is
"Reducing the proportion of hospitalized or dying patients", and in an era of the Omicron pandemic and the vast majority of patients with mild disease, it is difficult
to verify this effect.
to verify this effect.
In August this year, the NMPA revised the evaluation criteria for new crown oral drugs: the primary endpoint of clinical trials is no longer "Proportion of patients hospitalized or dead" was changed to clinical symptom improvement
.
At the same time, viral load indicators rose to the secondary endpoint
.
This modification greatly increases the likelihood of
new oral drugs being approved.
new oral drugs being approved.
-03-
-03-What else is included in the complete toolkit?
What else is included in the complete toolkit?In addition to oral dosage forms, antiviral drugs have other dosage forms under development
.
Rapidly advancing include FB2001 for injection (3CL protease inhibitor) from Frontier Biologics, which is undergoing global phase 2 and 3 trials
.
The drug for aerosol inhalation has been approved for clinical trials
of post-exposure prophylaxis.
In addition, antiviral drugs have a more important direction, that is, the prevention
of infection after exposure.
of infection after exposure.
Compared with the treatment of "mild symptoms", new crown infection is a clearer and quantifiable indicator, which is much
easier in clinical design.
The prevention of new crown infection is also a very important way in the current form of epidemic prevention and control, which in a sense may be a key
to solving the deadlock between epidemic prevention and control and economic development.
At present, Simcere Pharmaceutical has launched the first phase clinical study
of this indication in China.
However, under the current high R0 value of the variant, this also puts forward higher requirements
for the molecular and pharmacological design of drugs.
At the same time, the development of neutralizing antibody drugs is also in progress
.
In China, Tengsheng Bo Yao's combination therapy of ambavirimab and romisivimab has been commercialized, becoming the first approved domestic new crown neutralizing antibody combination therapy drug for the treatment of adult and adolescent new crown patients
with mild and ordinary types with high-risk factors for progression to severe (including hospitalization or death).
At present, there are more than 10 new crown neutralizing antibody drugs that have entered the clinical research stage in China
.
The secondary market has also been hot in ventilator-related stocks
recently.
For people who have lived in areas where the epidemic has hit, it may be strange that the ventilator has been hyped up to this extent in China - when it is needed, what patients really need is the professional treatment
of the hospital.
of the hospital.
However, in the face of the increasingly severe epidemic in various places in recent days, the strengthening of any tool in the big toolkit of new crown prevention and control means that we can better respond
.
Therefore, back to the secondary market, the corresponding targets of these "toolkits", any small variable, will definitely be concentrated at some time in the future to lead the madness
of the anti-epidemic sector again.
