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On April 25, the official website of NMPA showed that the review status of Roche’s new anti-influenza drug Mabaloxavir Tablets (Xofluza) ( acceptance numberJXHS2000074/75 ) was changed to "under review " , which means that this new mechanism of action Innovative anti-influenza drugs are not far from being launched in China
.
Xofluza was developed by Shiono Yoshihide, a Japanese pharmaceutical company.
Roche reached a cooperation agreement with Shiono Yoshito in 2016 to jointly be responsible for the research and development of the drug outside Japan and Taiwan.
Among them, Roche owns products in regions other than Japan and Taiwan.
Commercial promotion rights
.
In February 2018, Xofluza was the first to be approved in Japan for the treatment of influenza caused by influenza A and B strains; in October 2018, it was approved by the FDA for the treatment of acute and Simple flu
.
Xofluza is a single-dose oral drug with a brand-new anti-influenza mechanism of action.
This drug is a Cap-dependent endonuclease inhibitor designed to inhibit the CAP structure-dependent endonuclease in influenza viruses.
It is essential for the replication of influenza virus
.
It is worth noting that this drug is the first anti-flu drug approved in the United States in the past 20 years
.
The currently widely used anti-influenza oral medications are neuraminidase inhibitor antiviral drugs (oseltamivir), which need to be taken twice a day for 5 consecutive days
.
The brand-new mechanism of action Xofluza can directly inhibit virus replication.
Patients only need to take it once during the entire course of the disease to stop the virus detoxification within 24 hours
.
In a multi-center, randomized, double-blind phase 3 clinical study, the enrolled volunteers were administered Xofluza, oseltamivir, and placebo .
The clinical results showed that the average symptoms of Xofluza were shortened to 53.
7 hours, which was similar to oseltamivir (oseltamivir 75 mg twice a day for 5 consecutive days), while the placebo group was as long as 80.
2 hours .
Its adverse reactions are consistent with placebo .
In addition, Xofluza can also target Tamiflu-resistant strains of the avian influenza viruses H5N1 and H7N9.
The rapid killing of the virus can prevent the spread of the virus in time.
In some secondary endpoints, compared with Tamiflu, it even performs A stronger therapeutic effect, including stopping the release of the virus and reducing the time of the virus level in the body
.
At present, Xofluza has been approved in many countries and regions around the world, and it is approved in Japan for the treatment of influenza A or B virus infection; in the United States, Singapore, Thailand, Hong Kong and Taiwan, etc.
It is used for acute and uncomplicated influenza patients 12 years of age and older whose symptoms appear for no more than 48 hours
.
On March 26, 2020, Roche’s Genentech announced that the U.
S.
FDA has accepted its new drug NDA for Xofluza oral suspension single-dose granules (2 mg/mL), providing a more convenient choice for children and people with swallowing difficulties; At the same time, the FDA also accepted two Supplemental New Drug Applications (sNDAs), one of which is Xofluza for the treatment of acute uncomplicated influenza in other healthy children under the age of 1 to 12 years with symptoms not exceeding 48 hours
.
For oral suspensions and approved tablets, the FDA has also accepted sNDA for the prevention of influenza in people one year and older after exposure
.
The FDA is expected to make a decision on these approvals by November 23, 2020
.
According to the Insight database (https://db.
dxy.
cn/), Mabaloxavir tablets were approved for clinical use as early as February 2019 in China, and the Phase 3 clinical study of influenza has been completed; in addition, it is used for treatment Phase 1 clinical trial of influenza A or B virus infection has also been completed
.
Mabaloxavir Suspension Granules have also been approved for clinical use in China, and no clinical start has been found yet
.
In November 2019, Roche Pharmaceuticals China also signed a strategic cooperation agreement with Lecheng International Medical Tourism Pioneer Zone in Hainan Province, and took the lead in bringing mabaloxavir (Xofluza) into Hainan through the Hainan Free Trade Zone’s “Pilot, Pilot” policy In the pilot zone, for the first time, the clinical application of "special imported anti-influenza treatment drugs" through the bonded drug warehouse in Hainan Free Trade Zone hospitals has been realized
.
As Roche's another major anti-influenza drug after Tamiflu (oseltamivir), only a single medication can shorten the relief time of flu symptoms by more than one day, bringing patients a more convenient treatment plan
.
However, according to public data query, the price of the drug abroad is not cheap, and the price of 10 mg/10 tablets/box specification is 400 US dollars
.
I wonder how the new drug will be priced after it is launched in China? Can you give a more affordable price ?
.
Xofluza was developed by Shiono Yoshihide, a Japanese pharmaceutical company.
Roche reached a cooperation agreement with Shiono Yoshito in 2016 to jointly be responsible for the research and development of the drug outside Japan and Taiwan.
Among them, Roche owns products in regions other than Japan and Taiwan.
Commercial promotion rights
.
In February 2018, Xofluza was the first to be approved in Japan for the treatment of influenza caused by influenza A and B strains; in October 2018, it was approved by the FDA for the treatment of acute and Simple flu
.
Xofluza is a single-dose oral drug with a brand-new anti-influenza mechanism of action.
This drug is a Cap-dependent endonuclease inhibitor designed to inhibit the CAP structure-dependent endonuclease in influenza viruses.
It is essential for the replication of influenza virus
.
It is worth noting that this drug is the first anti-flu drug approved in the United States in the past 20 years
.
The currently widely used anti-influenza oral medications are neuraminidase inhibitor antiviral drugs (oseltamivir), which need to be taken twice a day for 5 consecutive days
.
The brand-new mechanism of action Xofluza can directly inhibit virus replication.
Patients only need to take it once during the entire course of the disease to stop the virus detoxification within 24 hours
.
In a multi-center, randomized, double-blind phase 3 clinical study, the enrolled volunteers were administered Xofluza, oseltamivir, and placebo .
The clinical results showed that the average symptoms of Xofluza were shortened to 53.
7 hours, which was similar to oseltamivir (oseltamivir 75 mg twice a day for 5 consecutive days), while the placebo group was as long as 80.
2 hours .
Its adverse reactions are consistent with placebo .
In addition, Xofluza can also target Tamiflu-resistant strains of the avian influenza viruses H5N1 and H7N9.
The rapid killing of the virus can prevent the spread of the virus in time.
In some secondary endpoints, compared with Tamiflu, it even performs A stronger therapeutic effect, including stopping the release of the virus and reducing the time of the virus level in the body
.
At present, Xofluza has been approved in many countries and regions around the world, and it is approved in Japan for the treatment of influenza A or B virus infection; in the United States, Singapore, Thailand, Hong Kong and Taiwan, etc.
It is used for acute and uncomplicated influenza patients 12 years of age and older whose symptoms appear for no more than 48 hours
.
On March 26, 2020, Roche’s Genentech announced that the U.
S.
FDA has accepted its new drug NDA for Xofluza oral suspension single-dose granules (2 mg/mL), providing a more convenient choice for children and people with swallowing difficulties; At the same time, the FDA also accepted two Supplemental New Drug Applications (sNDAs), one of which is Xofluza for the treatment of acute uncomplicated influenza in other healthy children under the age of 1 to 12 years with symptoms not exceeding 48 hours
.
For oral suspensions and approved tablets, the FDA has also accepted sNDA for the prevention of influenza in people one year and older after exposure
.
The FDA is expected to make a decision on these approvals by November 23, 2020
.
According to the Insight database (https://db.
dxy.
cn/), Mabaloxavir tablets were approved for clinical use as early as February 2019 in China, and the Phase 3 clinical study of influenza has been completed; in addition, it is used for treatment Phase 1 clinical trial of influenza A or B virus infection has also been completed
.
Mabaloxavir Suspension Granules have also been approved for clinical use in China, and no clinical start has been found yet
.
In November 2019, Roche Pharmaceuticals China also signed a strategic cooperation agreement with Lecheng International Medical Tourism Pioneer Zone in Hainan Province, and took the lead in bringing mabaloxavir (Xofluza) into Hainan through the Hainan Free Trade Zone’s “Pilot, Pilot” policy In the pilot zone, for the first time, the clinical application of "special imported anti-influenza treatment drugs" through the bonded drug warehouse in Hainan Free Trade Zone hospitals has been realized
.
As Roche's another major anti-influenza drug after Tamiflu (oseltamivir), only a single medication can shorten the relief time of flu symptoms by more than one day, bringing patients a more convenient treatment plan
.
However, according to public data query, the price of the drug abroad is not cheap, and the price of 10 mg/10 tablets/box specification is 400 US dollars
.
I wonder how the new drug will be priced after it is launched in China? Can you give a more affordable price ?
