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Pharmaceutical network September 18, recently, the East Sunshine pharmaceutical product line came good news, O nitrogen flat tablets were approved and treated as a review, 2 new drugs recombinant anti-VEGF humanized monoclonal antibody injection was approved clinical, 1 new drug HEC95468 clinical applications were accepted ... So far this year, 9 varieties (17 product regulations) have been approved for market, of which 5 varieties are diabetes drugs;
currently 18 varieties of Dongsong medicine have been evaluated (10 for the first).
the second half of 2020, Dongsun medicine is expected to win a new class of drug phosphate emitawe capsules, the first imitation of entacarbon tablets.
4 billion varieties approved! This year has taken 9 new products september 16, NMPA official website shows that the East Sunshine drug according to the imitation of 4 categories of reported production of O nitrogen flat tablets (receiving number CYHS1800223, CYHS1800224) was approved and treated as the same, the approval number is the national drug code H20203493, the national drug code H20203494.
is the first atypical antipsychotic drug approved for long-term treatment of schizophrenia and the first atypical antipsychotic drug approved for the treatment of acute bipolar mania.
2019, China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) terminal sales of more than 4 billion yuan, according to the
-meter intranet data.
domestic market of O nitrogen flat tablets, O nitrogen flat-mouth collapse, O nitrogen flat-chip for the first batch of collection varieties, O nitrogen flat-mouth collapse for the third batch of collection varieties.
of The O nitrogen flat-mouth chip, which is used in the Eastern Sunshine Drug, was approved for production in June 2020.
this year, 9 varieties (17 product regulations) have been approved for the market, of which 5 varieties are diabetes drugs.
It is worth mentioning that the Four varieties of Liglitatin tablets, Esomeprazole magnesium intestinal capsules, Liglitatin metformin tablets and Sigletin metformin tablets are the first imitation in China, phosphate siglitin tablets are the second domestic, O nitrogen flat mouth collapse tablets are the third domestic.
recombinant human insulin injection is the first insulin product approved by Dongsan.
2020 to date, Dongsian medicine has been approved for listing of product sources: MED2.0 China Drug Review Database 18 varieties over-evaluation, 26 new products on the road so far, Dongsian pharmaceutical has 18 varieties (29 product regulations) through / as if through the consistency evaluation.
6 of the 18 varieties used throughout the body with anti-infective drugs, 5 digestive and metabolic drugs and 2 cardiovascular drugs.
from the evaluation order, 10 of the 18 over-rated varieties of East Sunshine Medicine were the first to be evaluated.
kramycin slow release tablets, liglitatin metformin tablets, liglitatin tablets, osetatin capsules phosphate, Esomeprazole magnesium intestinal capsules, benzo bromine malone tablets, siglitin metformin tablets and other 7 varieties for the East Sunshine drug exclusive review.
in the three batches carried out in the country, the Total of 5 varieties of Dongsun medicine were selected, namely, Omeshatan ester tablets, Fodostam tablets, hydrochloric acid Moxisa tablets, O nitrogen flat-mouth collapse tablets, kramycin tablets.
East Sunshine Drug through / as if through consistency evaluation of varieties Source: Mi Intranet consistency evaluation database MiNet data show that East Sunshine Pharmaceutical in the review of the new registration classification of generic drugs produced by 26 varieties (68 acceptance numbers), approved for production will be treated as passing consistency evaluation.
among them, six varieties, such as tigrillo tablets, rhysovastatin calcium tablets, entacarbon tablets, hydrochloric acid loxitin intestinal capsules, benzoic acid agritin tablets, and sadalla non-tablets, are expected to be approved for market in 2020.
is also worth noting that The East Sunshine Pill's Entakapen tablet is expected to be the first imitation.
East Sunshine Drug in the review of the new registered classification generic drug source: Minet MED2.0 China Drug Review Database 5 new drugs 1 class struck, anti-hepatitis C new drugs will be taken on September 15, Dongsian Drug 2 new drug recombinant anti-VEGF humanized monoclonal antibody injection was implied clinical trial license.
this year, Dongsian medicine has 6 new drugs submitted clinical applications, respectively, hydrochloric acid esphonoid tablets, toluene sulfonate ningerini capsules, HEC89736PTSA.0.5H2O tablets, HEC122505 MSOH tablets, HEC95468 tablets, recombinant anti-VEGF human-origin monoclonal antibody injections, the first five of which are 1 new class of drugs.
6 new drugs,
, ifygenone, ningtinifynia first declared clinical, HEC89736PTSA.0.5H2O tablets have been approved clinically, will be used to treat chronic lymphocytic leukemia, small lymphocyte lymphoma, filthy lymphoma and other blood tumors.
it is understood that heC95468 tablets are intended to carry out the adaptation of pulmonary hypertension and heart failure, HEC122505 MSOH tablets are intended to be used to treat Parkinson's disease.
2020 to date, Dongsian drug declared clinical new drug source: MED2.0 China drug review database can be seen, Dongsian drug research and development pipeline of 1 new drugs are constantly entering the clinical research stage.
is also worth noting that the research and development pipeline of Dongsian Pharmaceuticals will also enter the harvest period, the first reported class 1 new drug phosphate imitawe capsules are expected to be approved for listing in the second half of 2020.
East Sunshine Drug Phosphate Emitavir Capsule Review Timeline Source: MED2.0 China Drug Review Database Phosphate Emitavir Capsule is a full oral direct anti-HCV drug (DAA) independently developed by Dongsian Pharmaceuticals, whose listing application was undertaken by CDE on September 13, 2019 and included in the priority review on November 8, 2019.
is the main method of hepatitis C treatment, the drug is expected to become China's future treatment of hepatitis C virus important products.
source: Minet database, company announcement.