For the new crown oral drug research and development enterprises, the biggest problem is that TheOmilon is too weak, especially in China

For the new crown oral drug research and development enterprises, the biggest problem is that TheOmilon is too weak, especially in China

For the new crown oral drug research and development enterprises, the biggest problem is that TheOmilon is too weak, especially in China

According to the public information disclosed by mainland provinces and cities, the severe + critical illness rate caused by Aumicron in Jilin is 0.

This will greatly increase the difficulty

The primary clinical endpoint for mild or general patients can be a measure of clinical recovery time, but the clinical outcome of

Because the severe illness rate is extremely low, it is much more difficult for pharmaceutical companies to make differences

However, the situation has changed

Because clinical outcomes are difficult to achieve, improvement in clinical efficacy measures (assessed over an appropriate period of time to sustained clinical recovery) may be considered as the primary efficacy endpoint and virological indicators as the key secondary efficacy endpoints

Does this mean that the spring of domestic new crown oral drugs has come?

Does this mean that the spring of domestic new crown oral drugs has come?

/ 01 // 01 // 01 /

Clinical endpoint altered by Omikeron

Clinical endpoint altered by Omikeron Clinical endpoint altered by Omikeron Clinical endpoint altered by Omikeron

According to the Principles, there are two main endpoint options for mild or ordinary patients:

According to the Principles, there are two main endpoint options for mild or ordinary patients:

The main clinical outcome was "an indicator of reducing severe illness and mortality"
.
This is also the main endpoint of the oral drug research of Merck and Pfizer; The secondary primary endpoint is the clinical efficacy indicator "to promote the effectiveness and safety of clinical recovery", that is, the option
to be "corrected" today.

The main clinical outcome was "an indicator of reducing severe illness and mortality"
.
This is also the main endpoint of the oral drug research of Merck and Pfizer; The secondary primary endpoint is the clinical efficacy indicator "to promote the effectiveness and safety of clinical recovery", that is, the option
to be "corrected" today.

Previously, the Principles have also realized that in the case of an overall low conversion rate of severe/critical illness, it may be more difficult to choose "indicators of reducing severe illness and mortality" as the main endpoint, so it is specifically pointed out:

Previously, the Principles have also realized that in the case of an overall low conversion rate of severe/critical illness, it may be more difficult to choose "indicators of reducing severe illness and mortality" as the main endpoint, so it is specifically pointed out:

Studies
can be conducted in areas where historical data show high conversion rates, or in specific populations with high risk factors for disease progression.

Studies
can be conducted in areas where historical data show high conversion rates, or in specific populations with high risk factors for disease progression.

After this requirement has been clarified, reference to "time to assess to sustained clinical recovery within an appropriate time" can be used as a therapeutic endpoint option
.

After this requirement has been clarified, reference to "time to assess to sustained clinical recovery within an appropriate time" can be used as a therapeutic endpoint option
.

If the clinical recovery time is selected as an indicator, the definition of clinical recovery should be clarified in the protocol in advance, generally referring to the current clinical treatment guidelines, and a joint evaluation including clinical symptoms, imaging, and etiology can be considered, of which the evaluation of symptoms and imaging improvement should be standardized and have a definite basis
.

If the clinical recovery time is selected as an indicator, the definition of clinical recovery should be clarified in the protocol in advance, generally referring to the current clinical treatment guidelines, and a joint evaluation including clinical symptoms, imaging, and etiology can be considered, of which the evaluation of symptoms and imaging improvement should be standardized and have a definite basis
.

Overall, the "indicators for reducing the rate of severe illness and mortality" are bound to be paid more attention to, and they are not easy to cross
.

Overall, the "indicators for reducing the rate of severe illness and mortality" are bound to be paid more attention to, and they are not easy to cross
.

However, the research and development of new crown oral drugs, whether it is pharmaceutical companies or regulators, is originally intended to bring us highly effective oral drugs and end the epidemic
as soon as possible.
Obviously, at a time when Aumi kerong is becoming the mainstream strain, cde is the first to change according to the status quo
.

However, the research and development of new crown oral drugs, whether it is pharmaceutical companies or regulators, is originally intended to bring us highly effective oral drugs and end the epidemic
as soon as possible.
Obviously, at a time when Aumi kerong is becoming the mainstream strain, cde is the first to change according to the status quo
.

/ 02 /

/ 02 // 02 // 02 /

Challenges remain for clinical improvement

Clinical improvement still challenges Clinical improvement Still challenges Clinical improvement Still challenges

For oral drug research and development enterprises, the change in clinical standards means that the clinical rhythm is greatly advanced
.

For oral drug research and development enterprises, the change in clinical standards means that the clinical rhythm is greatly advanced
.

For example, according to the "indicators for reducing the rate of severe illness and mortality" stipulated in the Principles, the VV116 of Junshi Bio/Wangshan Wangshui may not be approved for listing until
2023.

For example, according to the "indicators for reducing the rate of severe illness and mortality" stipulated in the Principles, the VV116 of Junshi Bio/Wangshan Wangshui may not be approved for listing until
2023.

In February this year, Wangshan Wangshui/Junshi Bio launched the Phase III clinical trial of VV116 for patients with mild diseases, located in 6 provinces and cities
in China.
According to clinical disclosures, it is estimated that the clinical trial
of 2,000 people will not be completed until the end of the year, that is, in December.

In February this year, Wangshan Wangshui/Junshi Bio launched the Phase III clinical trial of VV116 for patients with mild diseases, located in 6 provinces and cities
in China.
According to clinical disclosures, it is estimated that the clinical trial
of 2,000 people will not be completed until the end of the year, that is, in December.

The reason why the clinical rhythm is slow is also a little helpless
.
As mentioned above, the domestic vaccination rate is high, coupled with the relatively complete medical facilities, the severe disease rate of Omikron is not high
.

The reason why the clinical rhythm is slow is also a little helpless
.
As mentioned above, the domestic vaccination rate is high, coupled with the relatively complete medical facilities, the severe disease rate of Omikron is not high
.

To this end, VV116 took a different path and carried out a phase III clinical trial of head-to-head comparison of Paxlovid, which directly changed its thinking:

To this end, VV116 took a different path and carried out a phase III clinical trial of head-to-head comparison of Paxlovid, which directly changed its thinking:

Replace the main clinical endpoints from the usual "indicators of symptom rate and mortality" with "effectiveness and safety to promote clinical recovery" and "indicators of severe illness and mortality"
.

Replace the main clinical endpoints from the usual "indicators of symptom rate and mortality" with "effectiveness and safety to promote clinical recovery" and "indicators of severe illness and mortality"
.

Obviously, Junshi Bio hopes to achieve the approval purpose
by proving that VV116 is not inferior to Paxlovid.

Obviously, Junshi Bio hopes to achieve the approval purpose
by proving that VV116 is not inferior to Paxlovid.

There are also companies that choose a more difficult path
.
For example, Simcere Pharmaceuticals' 3CL protease inhibitors, outside of conventional clinics, chose to move toward a "no man's land": for post-exposure prophylaxis
.

There are also companies that choose a more difficult path
.
For example, Simcere Pharmaceuticals' 3CL protease inhibitors, outside of conventional clinics, chose to move toward a "no man's land": for post-exposure prophylaxis
.

According to the Principles, the primary endpoint of this indication is relatively easy, with "incidence of infection after exposure prevention" being sufficient; But it's also more difficult to develop, with Pfizer's Paxlovid also a 3CL protease inhibitor, and previous studies for post-exposure prophylaxis have failed
.

According to the Principles, the primary endpoint of this indication is relatively easy, with "incidence of infection after exposure prevention" being sufficient; But it's also more difficult to develop, with Pfizer's Paxlovid also a 3CL protease inhibitor, and previous studies for post-exposure prophylaxis have failed
.

All in all, in the case of the low severe disease rate of Omi kerong, the research and development of domestic oral drugs has encountered great challenges
.
But now, the difficulty has been relatively reduced, which may mean that the pace of listing has been greatly advanced
.

All in all, in the case of the low severe disease rate of Omi kerong, the research and development of domestic oral drugs has encountered great challenges
.
But now, the difficulty has been relatively reduced, which may mean that the pace of listing has been greatly advanced
.

Of course, it is not easy
to get clinical symptom improvement results.
This is deeply appreciated
by the Japanese company Yoshino Shiono.

Of course, it is not easy
to get clinical symptom improvement results.
This is deeply appreciated
by the Japanese company Yoshino Shiono.

In July this year, Yoshitoku Shiono's 3CL protease inhibitor S-217622 was rejected
for listing in Japan because it reduced the viral load and improved respiratory symptoms, but could not improve systemic symptoms.

In July this year, Yoshitoku Shiono's 3CL protease inhibitor S-217622 was rejected
for listing in Japan because it reduced the viral load and improved respiratory symptoms, but could not improve systemic symptoms.

For a long time, the S-217622 was seen as the seeded player
to surpass Pfizer Paxlovid.
But even so, it is still challenged in terms of symptom improvement, and it will obviously be a challenge for domestic players
.

For a long time, the S-217622 was seen as the seeded player
to surpass Pfizer Paxlovid.
But even so, it is still challenged in terms of symptom improvement, and it will obviously be a challenge for domestic players
.

/ 03 /

/ 03 // 03 // 03 /

Who can replicate the Paxlovid miracle

Who can copy the Paxlovid miracle Who can copy the Paxlovid miracle Who can copy the Paxlovid miracle

But in any case, after the change of clinical standards, domestic new crown oral drugs or will usher in an intensive marketing period
.

But in any case, after the change of clinical standards, domestic new crown oral drugs or will usher in an intensive marketing period
.

In fact, before that, the real creature Azvedine had already taken the lead
.
On July 25, the Food and Drug Administration conditionally approved the real organism of Azfedine to increase the registration application for
the treatment of new coronavirus pneumonia indications.
Azvedine thus became the first domestic oral drug
.

In fact, before that, the real creature Azvedine had already taken the lead
.
On July 25, the Food and Drug Administration conditionally approved the real organism of Azfedine to increase the registration application for
the treatment of new coronavirus pneumonia indications.
Azvedine thus became the first domestic oral drug
.

The clinical data publicly disclosed by Azvedine is that it has a significant effect
on improving clinical symptoms.
It also means that Azfdine has taken the lead in benefiting from the new rules that have been adjusted
.

The clinical data publicly disclosed by Azvedine is that it has a significant effect
on improving clinical symptoms.
It also means that Azfdine has taken the lead in benefiting from the new rules that have been adjusted
.

After Azfedine, the domestic new crown oral drugs developed by pharmaceutical companies, including Junshi Bio and Simcere Pharmaceutical, may also be approved for the market
soon for patients with mild diseases.

After Azfedine, the domestic new crown oral drugs developed by pharmaceutical companies, including Junshi Bio and Simcere Pharmaceutical, may also be approved for the market
soon for patients with mild diseases.

According to the previous network transmission of Ruijin Hospital exchange information, V116 head-to-head Paxlovid clinical completion, will submit a listing application to the regulatory agency; Simcere Pharmaceuticals' 3CL protease inhibitors have also entered the Phase II/III clinical phase
.

According to the previous network transmission of Ruijin Hospital exchange information, V116 head-to-head Paxlovid clinical completion, will submit a listing application to the regulatory agency; Simcere Pharmaceuticals' 3CL protease inhibitors have also entered the Phase II/III clinical phase
.

In the future, domestic new crown oral drugs will be intensively approved for marketing, which will undoubtedly play a greater role
in China's epidemic prevention work.
Of course, from an investment point of view, it is not easy
for domestic new crown oral drugs to replicate the Paxlovid miracle.

In the future, domestic new crown oral drugs will be intensively approved for marketing, which will undoubtedly play a greater role
in China's epidemic prevention work.
Of course, from an investment point of view, it is not easy
for domestic new crown oral drugs to replicate the Paxlovid miracle.

The most fundamental thing is that under China's dynamic zeroing policy, the space for domestic new crown oral drugs will be relatively limited; To be the next Paxlovid, you have to go overseas
.

The most fundamental thing is that under China's dynamic zeroing policy, the space for domestic new crown oral drugs will be relatively limited; To be the next Paxlovid, you have to go overseas
.

However, as stated in the "Q&A on Non-clinical and Clinical Evaluation Criteria for New Antiviral Drugs Infected by New Epidemic Strains of Novel Coronavirus", overseas guidelines mainly recommend clinical outcomes as the main efficacy endpoints
.

However, as stated in the "Q&A on Non-clinical and Clinical Evaluation Criteria for New Antiviral Drugs Infected by New Epidemic Strains of Novel Coronavirus", overseas guidelines mainly recommend clinical outcomes as the main efficacy endpoints
.

This also means that going to sea may need more clinical data as a support
.
So, who can break through first?

This also means that going to sea may need more clinical data as a support
.
So, who can break through first?