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Recently, Beijing Fuyuan Pharmaceutical entered the administrative examination and approval stage with the imitation of bedaquinoline fumarate tablets reported for production in category 4, and the product has not yet been approved for generic drugs in the country
.
According to data from Mi Nei.
com, Xi’an Janssen’s Betaquinoline Fumarate Tablets will sell close to 100 million yuan in China’s public medical institutions in 2021H1, an increase of 369.
26% over the same period last year
.
Source: The official website of the State Drug Administration.
Bedaquinoline is a diarylquinoline anti-mycobacterial drug that was first approved by the FDA for marketing in 2012
.
In December 2016, Xi’an Janssen’s Betaquinoline Fumarate Tablets were approved to enter the domestic market as part of a combination therapy for the treatment of adult multi-drug-resistant tuberculosis.
This is also the first approved domestic market in the past 40 years.
New anti-tuberculosis drug
.
Multidrug-resistant tuberculosis is the current difficulty in the treatment of tuberculosis.
It is caused by the Mycobacterium tuberculosis of some patients, which is resistant to isoniazid and rifampicin in the current first-line treatment drugs for tuberculosis, and cannot effectively kill the tuberculosis bacteria in the body.
, Leading to reduced therapeutic effects
.
The launch of bedaquinoline fumarate tablets has brought new treatment options for domestic MDR-TB and XDR-TB patients
.
In China, only Xi'an Janssen has the production approval for bedaquinoline fumarate tablets.
According to data from Meinenet, the product will be used in 2021H1 Chinese urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions).
Sales were close to 100 million yuan, an increase of 369.
26% over the same period last year
.
The report on the production status of bedaquinoline fumarate tablets.
Source: One-click search on Mynet.
com.
At present, only two companies, Beijing Fuyuan Pharmaceutical and Hainan Simcere Pharmaceuticals, have completed the BE test of bedaquinoline fumarate tablets and submitted them as imitations.
In the listing application, the products of Beijing Fuyuan Pharmaceutical have taken the lead in entering the administrative examination and approval stage and are expected to win the first imitation
.
Source: Minainet database, official website of the State Food and Drug Administration, etc.
Note: Data statistics are as of December 2nd, if any omissions, please correct me!
.
According to data from Mi Nei.
com, Xi’an Janssen’s Betaquinoline Fumarate Tablets will sell close to 100 million yuan in China’s public medical institutions in 2021H1, an increase of 369.
26% over the same period last year
.
Source: The official website of the State Drug Administration.
Bedaquinoline is a diarylquinoline anti-mycobacterial drug that was first approved by the FDA for marketing in 2012
.
In December 2016, Xi’an Janssen’s Betaquinoline Fumarate Tablets were approved to enter the domestic market as part of a combination therapy for the treatment of adult multi-drug-resistant tuberculosis.
This is also the first approved domestic market in the past 40 years.
New anti-tuberculosis drug
.
Multidrug-resistant tuberculosis is the current difficulty in the treatment of tuberculosis.
It is caused by the Mycobacterium tuberculosis of some patients, which is resistant to isoniazid and rifampicin in the current first-line treatment drugs for tuberculosis, and cannot effectively kill the tuberculosis bacteria in the body.
, Leading to reduced therapeutic effects
.
The launch of bedaquinoline fumarate tablets has brought new treatment options for domestic MDR-TB and XDR-TB patients
.
In China, only Xi'an Janssen has the production approval for bedaquinoline fumarate tablets.
According to data from Meinenet, the product will be used in 2021H1 Chinese urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions).
Sales were close to 100 million yuan, an increase of 369.
26% over the same period last year
.
The report on the production status of bedaquinoline fumarate tablets.
Source: One-click search on Mynet.
com.
At present, only two companies, Beijing Fuyuan Pharmaceutical and Hainan Simcere Pharmaceuticals, have completed the BE test of bedaquinoline fumarate tablets and submitted them as imitations.
In the listing application, the products of Beijing Fuyuan Pharmaceutical have taken the lead in entering the administrative examination and approval stage and are expected to win the first imitation
.
Source: Minainet database, official website of the State Food and Drug Administration, etc.
Note: Data statistics are as of December 2nd, if any omissions, please correct me!
