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According to incomplete statistics from the Medical Cloud Studio, 3181 product regulations have passed the consistency evaluation, and 375 product regulations have been evaluated by more than three (including three).
According to statistics from the Medical Cloud Studio, from October 17, 2021 to October 23, 2021, 18 new varieties (deemed as equivalent) passed the consistency evaluation, of which 2 were the first in the country to have passed the evaluation
.
details as follows:
Chengdu Beite: Emtricitabine propofol tenofovir tablets were approved as the first in the country
Chengdu Beite: Emtricitabine propofol tenofovir tablets were approved as the first in the country Emtricitabine propofol tenofovir is a compound preparation consisting of emtricitabine and propofol tenofovir, combined with other antiretroviral drugs to treat adults and adolescents (12 years and older) And the body weight ≥ 35kg) HIV-1 infection
.
The product was developed by Gilead (trade name: Descovy) and was approved by the FDA in April 2016 to combine with other antiretroviral drugs for the treatment of HIV infection in patients weighing ≥35 kg
.
In October 2019, the drug was approved by the FDA for HIV pre-exposure prevention (PrEP).
In China, the original research emtricitabine propofol tenofovir was approved by the NMPA in December 2018 to be used in combination with other antiretroviral drugs to treat adults and adolescents (aged 12 years and older and weighing at least 35kg) HIV-1 infection, the trade name is Da Kehui
.
According to its financial report, Descovy entered the blockbuster in its second year of listing, with sales of US$1.
861 billion in 2020
.
It is reported that the patent WO2004064845 of the original research emtricitabine propofol tenofo will expire on 2024-01-13
.
At present, there are three domestic companies, Chengdu Better, Qilu Pharmaceutical, and Desano, who are deploying the generic drug market.
Jiangsu Tasly Diyi Pharmaceutical: Bezafibrate Sustained Release Tablets are approved as the first in the country
Jiangsu Tasly Diyi Pharmaceutical: Bezafibrate Sustained Release Tablets are approved as the first in the country Bezafibrate is a blood lipid regulator that can reduce elevated blood lipid levels and treat certain lipid metabolism disorders; it is used to treat lipid metabolism disorders that cannot be effectively controlled by diet therapy, enhanced physical exercise, and weight reduction.
Diseases can also be used for various primary diseases (such as diabetes) secondary to lipid metabolism disorders that still exist after appropriate treatment of the primary diseases
.
The original drug, bezafibrate sustained-release tablets (0.
4g), was marketed under the trade name of Bezalip®SR in December 1994 and was licensed by Actavis Specialty Pharmaceuticals Co.
in Canada
.
In October 2019, Diyi Pharmaceutical's bezafibrate sustained-release tablets completed the BE test, and applied for the CDE technical review in November 2019 (acceptance number: CYHS1900855), and in December 2019, the listing application was submitted, which lasted nearly two years.
Successfully won the first copy of this product and the first review
.
Up to now, Diyi Pharmaceutical has invested a total of RMB 9,082,700 in the research and development of the project
Public data shows that in China, the competitive situation of bezafibrate sustained-release tablets is relatively good.
The latest national review data bulletin:
The latest national review data bulletin:According to incomplete statistics from the Medical Cloud Studio, 3181 product regulations have passed the consistency evaluation, and 375 product regulations have been evaluated by more than three (including three)
3181 375
