On January 5, NMPA released its latest batch, with 15 more generics approved and 17 generics evaluated consistently.
Among them, 11 generic drugs were the first to be evaluated, including 7 injections; 8 fourth batch of national varieties and enterprises were evaluated, the competitive situation is becoming increasingly fierce;
Today's review/approved varieties are detailed in the table below: 6 billion heavy-weight varieties "injection of sodium omeprazole", Osaikang first over-rated omeprazole is a representative of proton pump inhibitors (PPI).
injection with sodium omeprazole has the effect of inhibiting H-K-ATP enzyme, is currently clinically mainstream anti-gastric acid drugs, mainly used for peptic ulcers and their bleeding, clinical treatment effect is good, few adverse reactions.
public data show that the PPI drugs currently on the market have a market size of more than 1 billion, of which the injection of sodium omeprazole as the leader, its 2019 domestic public medical institutions terminal sales reached 6.39 billion yuan.
2019 sales of another heavy PPI injection of sodium vitolazole also reached $6.71 billion.
, however, has only gradually had PPI-type drug reviews since November 2020.
The Insight database shows that the current injection of omeprazole sodium in addition to the original research AstraZeneta, the evaluation of Osaikang for the first review.
addition, 20 companies have submitted applications for consistency evaluation supplements, and competition is fierce;
from insight database () Jiangsu Osaikang is the first company to submit a conformity evaluation supplement application for this variety, which will be declared in September 2018.
addition, it's worth noting that Osaikang was also the first company to evaluate sodium vitolazole for another heavy PPI injection.
Qilu Pharmaceutical Harvest 1 first imitation, 1 first evaluation According to the NMPA official website, Qilu Pharmaceuticals "Prakso hydrochloride tablets" "trafluorourine tablets" were approved with a new registration classification, "hydrochloric acid Fashudir injection" newly adopted a consistent evaluation.
, Qufluorourucleotide tablets for the domestic first imitation, Fashudir injection for the first evaluation, Praxo belongs to the fourth batch of national varieties.
Insight database shows that, in addition to Qilu Pharmaceuticals, five companies have submitted supplementary applications for hydrochloric acid Fashudir injections, one has submitted applications for a new registration classification listing, and 31 companies have no progress.
from the Insight database () Qufluorourucleotide tablets are currently only in the domestic research Japan Dapeng was approved, Qilu Pharmaceuticals this time approved as the first domestic imitation.
addition to Qilu Pharmaceuticals, only Zhengda Tianqing submitted a new registration classification listing application.
from the Insight database () hydrochloric acid Prakso tablets are the fourth batch of national varieties, after this Qilu review, a total of 4 enterprises competed: Qilu Pharmaceuticals, Jingxin Pharmaceuticals, Stone Pharmaceuticals Group and the original research Bronger Ingham, and 2 other enterprises have submitted new registration classification listing applications.
: 4th batch of state-picked latest product regulations and business details (as of 2021.1.5)