Recently, Jianyou Co.
, Ltd.
issued an announcement that the company recently received the approval notice of drug supplement application for dalteparin sodium injection 0.
2ml: 5000IU (drug approval number: Sinopharm Quasi-word H20153024) issued by the National Medical Products Administration (hereinafter referred to as "NMPA"), and the product was approved to pass the consistency evaluation
of generic drug quality and efficacy.
This product is used to treat acute deep vein thrombosis
.
Prevention of coagulation in the extracorporeal circulation system during hemodialysis and hemofiltration in patients with acute renal failure or chronic renal insufficiency
.
Coincidentally, on December 29, Qianhong Pharmaceutical also announced that the company recently received the "Drug Supplement Application Approval Notice" on "dalteparin sodium injection" approved and issued by the State Food and Drug Administration, and approved the drug to pass the consistency evaluation
of the quality and efficacy of generic drugs.
Data show that dalteparin sodium injection is used for the treatment of acute deep vein thrombosis; Prevention of coagulation in the extracorporeal circulation system during hemodialysis and hemofiltration in patients with acute renal failure or chronic renal insufficiency; Treatment of unstable coronary artery disease
.
For pharmaceutical companies, the more varieties that have been evaluated, especially the first to be evaluated or enter the top three, the greater their competitive advantage in the market
.
Therefore, in recent years, it can be clearly found that many pharmaceutical companies are actively promoting the evaluation work
.
At present, from the perspective of the number of evaluated varieties, Yangzijiang, Qilu Pharmaceutical, Kelun Pharmaceutical, CSPC Pharmaceutical Group, Beite Pharmaceutical, Fosun Pharma, Hengrui Pharmaceutical, etc.
have performed very well and have entered the harvest period
.
For example, as of November 29, 2022, 14 varieties of Beite Pharmaceutical have been approved for production, focusing on the two therapeutic areas
of systemic anti-infective drugs and respiratory drugs.
Among them, 13 varieties were reported for production with the newly registered classification, and after being approved for production, they were regarded as having been evaluated, 3 varieties of cefuroxime ester dry suspension, voriconazole for injection, and salbutamol sulfate injection were the first to be evaluated, iopromide injection was the first imitation + first in China, and oseltamivir phosphate dry suspension was the second in China and the first in China to be approved
.
At present, the company has 18 first imitations approved for marketing, 67 varieties have been evaluated (20 are the first), of which 12 have met the "entry" conditions for collective procurement; There are more than 230 research projects, covering more than 30 Class 1 new drugs and more than 10 improved new drugs, and 46 new classification generic drugs are under review, of which 11 have not been approved
for the first generic (including the first generic of the dosage form).
In addition to Beite Pharmaceutical, Hengrui Pharmaceutical has also actively promoted the consistency evaluation of generic drugs in recent years, as of December last year, the company has accumulated 26 products have been evaluated, 32 products are deemed to have been evaluated, and 8 products are under application for approval
.
Industry analysts believe that under the background of normalization of centralized procurement, the evaluation of generic drugs has been regarded as the "ticket" for pharmaceutical companies to participate in centralized procurement, and in the future, pharmaceutical companies are expected to continue to accelerate the consistency evaluation of generic drugs in order to enhance their competitiveness
.
It is reported that on December 20, when Lisheng Pharmaceutical replied to investors on the investor relations platform, it said that in 2023, the company will continue to maintain the intensity of R&D investment and accelerate the development of 10 consistency evaluation projects, but the specific investment situation should be determined according to the progress of specific projects
.
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