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These "anti-new crown drugs" may be approved in China in the first half of this year! What are the advantages?

 Last Update: 2023-02-03
 Source: Internet
 Author: User

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Lead

In a previous article, we took stock of the anti-coronavirus drugs
that are currently on the market.
In this article, we will take stock of the anti-coronavirus drugs
that are expected to be on the market in the first half of this year.

Readers are welcome to read the previous article, review the inventory of new crown treatment drugs currently on the market in China, and understand the two major targets of anti-new crown virus - RdRp and 3CL protease
.

01 VV116 Head-to-Head Trial Wins Paxlovid? But not too optimistic

On December 26, 2022, the New England Journal of Medicine published an article announcing the results of the head-to-head test of the new crown oral drug VV116 and Paxlovid jointly developed by Junshi Biologics and Wangshan Wangshui: VV116 is not inferior to Paxlovid, and the median recovery time of VV116 group is shorter
than that of Paxlovid group.

VV116 is not inferior to Paxlovid, and the VV116 group has a shorter
median recovery time than the Paxlovid group.

However, due to its experimental design problems, this conclusion is currently controversial
.
The head-to-head trial did not adopt a double-blind design, and time to symptom relief was the only primary endpoint, abandoning "severe disease and mortality" as the other primary endpoint
.
For the results of the head-to-head test of VV116, the Chinese drug regulatory authorities are still cautious.

According to 21 financial news, relevant people in the investment relationship department of Junshi Biotech said that at present, VV116 drugs have not submitted a marketing application, and maintain continuous communication
with the drug regulatory department.
"At present, the results of this phase III trial, the regulatory authorities believe that more data is needed, so we do not support the use of this phase III clinical study to submit a marketing application
.
" It may take some time
before the VV116 goes on the market.

For the results of the head-to-head test of VV116, the Chinese drug regulatory authorities are still cautious.

Although VV116 underwent a head-to-head trial with Paxlovid, the drug target is different from Paxlovid, but uses the same RdRp target as azvudine and monoravir
.
The mechanism of action of RdRp target drugs is generally similar, both of which replace normal adenosine triphosphate (ATP) with specific compounds during viral RNA synthesis, thereby inhibiting viral replication and achieving the effect
of treating new coronavirus infection.

But at least VV116 will not have as many contraindications as Paxlovid, which will be VV116's unique clinical advantage
.
The main component of Paxlovid nematevir is metabolized quickly, and in order to ensure efficacy, it needs to be used in combination with ritonavir, which blocks the metabolism of liver enzymes, and all other drugs metabolized by liver enzymes will be affected
.

But at least VV116 will not have as many contraindications as Paxlovid, which will be VV116's unique clinical advantage
.

According to the reference protocol for the diagnosis and treatment of new coronary pneumonia in the Department of Respiratory and Critical Care Medicine of Peking Union Medical College Hospital (December 2022 version), patients with severe and critical new crown have symptoms of pulmonary embolism and need anticoagulation therapy
.
The common anticoagulant drug rivaroxaban cannot be combined
with Paxlovid.

02 SIM0417 and RAY1216 are the only 3CL target domestic oral drugs that have carried out phase 3 clinical trials

The 3CL protease target is currently the most promising target to end the
new crown epidemic.
Although there are more than 40 anti-new crown virus drugs based on 3CL protease targets under development, only Paxlovid is currently on the market in China
.
The research progress of domestic drugs SIM0417 and RAY1216 is outstanding, and both are expected to be approved for marketing
in the first half of this year.

The research progress of domestic drugs SIM0417 and RAY1216 is outstanding, and both are expected to be approved for marketing
in the first half of this year.

SIM0417, jointly developed by Simcere Pharmaceutical, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Wuhan Institute of Virology, Chinese Academy of Sciences, is the domestic 3CL target drug with the fastest research progress, and has completed the enrollment of all patients on December 16, 2022, and if all goes well, it will be launched
in February this year at the earliest.

After the failure of Paxlovid's trial of post-exposure prophylaxis for the new crown close contact, SIM0417 continues to challenge this blank field
.
In May 2022, SIM0417 was approved for clinical trial for post-exposure prophylaxis, and the results of the trial have not yet been published, if this clinical trial is successful, SIM0417 will become the only drug
that can be clearly used to prevent new crown infection.

RAY1216 developed by Zhongsheng Pharmaceutical completed the enrollment of all patients in the phase 3 clinical trial on January 3, 2022, and the research progress closely follows SIM0417, with a time gap of no more than one month
.

03 FB2001 "flattering" 3CL protease-targeted nebulized inhaler

FB2001, jointly developed by Frontier Biologics, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Wuhan Institute of Virology, Chinese Academy of Sciences, is another anti-new coronavirus drug
based on 3CL protease target.
However, unlike the above two drugs, FB2001 has a special route of administration, which can be administered by nebulized inhalation or intravenous injection
.

FB2001 has a special route of administration, which can be administered by nebulized inhalation or intravenous injection
.

Nebulized inhalation has a dosage form advantage
.
This mode of administration can directly reach the target organ of the new crown infection and achieve high drug concentration
locally.
Since less drug enters the bloodstream, the system is less exposed and fewer drug interactions are expected, there is no need to adjust the dose
according to liver and kidney function impairment.
FB2001 is expected to break through the drug contraindications faced by Paxlovid in the same target in this way
.

Nebulized inhalation has a dosage form advantage
.
FB2001 is expected to break through the drug contraindications faced by Paxlovid in the same target in this way
.

According to the news disclosed by Frontier Biotech at the 2022 China Chemical Pharmaceutical CMC Innovation Summit, the phase 1 clinical trial of FB2001 for nebulized inhalation performed well, with high local drug concentration in the respiratory tract, good clinical safety and tolerability, and no dose-limiting toxicity
.

At present, FB2001 for nebulized inhalation has been approved for domestic phase 2/3 clinical trials, and the specific results have not yet been announced
.

04 Ensitrelvir will become "Paxlovid.
" Pro Plus"?

After talking about domestic anti-new crown virus drugs, let's look at the marketing progress
of an imported anti-new crown drug.

Just two months ago, Shionogi developed the drug Ensitrelvir received emergency approval
in Japan.
Shionogi has always been striving to list in China, and in July last year, Ensitrelvir's listing application was submitted to CDE for approval
.

In December 2022, Shionogi reached an agreement with two Chinese companies in the same month, and the pace of Ensitrelvir's mainland listing accelerated
significantly.
Chia Tai Tianqing, a subsidiary of China Biologics, has entered into an exclusive marketing agreement with Shionogi to obtain the exclusive marketing rights
of Ensitrelvir for an initial five-year Chinese mainland.
Shanghai Pharmaceutical Holdings, a subsidiary of Shanghai Pharmaceutical, became the exclusive importer and distributor
of Ensitrelvir in Chinese mainland.

Ensitrelvir was born to "go against Paxlovid.
"
As a 3CL protease target drug, Ensitrelvir may not be as good as Paxlovid, only shortening the first elimination time of new crown infection symptoms by about 24 hours, and the current main adaptation population is also mild and moderate patients; But Ensitrevir does not need to be used in combination with other drugs, and the drug is less contraindicated than Paxlovid
.
Ensitrelvir is likely to alleviate the current Paxlovid drug-free dilemma after the market
.

The efficacy of Ensitrelvir may not be as good as Paxlovid, only shortening the first elimination time of new crown infection symptoms by about 24 hours, and the current main adaptation population is also mild and moderate patients; But Ensitrevir does not need to be used in combination with other drugs, and the drug is less contraindicated than Paxlovid
.

Resources

vv116 versus nirmatrelvir-ritonavir for oral treatment ofcovid-19

Milestone! The anti-new crown innovative drug candidate Xiannoxin ™ (SIM0417) completed the enrollment of all patients

Zhongsheng Pharmaceutical's new crown oral drug RAY1216 tablets completed the enrollment of patients in the phase III study

Accelerating the launch of the new crown oral drug Ensitrelvir in China, Shanghai Pharmaceutical and Ping An Shionogi reached a strategic cooperation

Frontier Biotech unveiled at the 2022 China Chemical Pharmaceutical CMC Innovation Summit to update the latest progress of FB2001 for aerosol inhalation

Other public information

Smart Bud New Drug Database

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