In recent years, with the normalization of collection, the continuous deepening of pharmaceutical reform, and the continuous intensification of market competition, pharmaceutical companies are actively promoting the evaluation work, and the competition is fierce
.
According to the data, as of the end of July this year, the total acceptance number of generic drug consistency evaluation has reached 4112, and 2603 acceptance numbers have been passed, which is regarded as 2205
.
At present, judging from the public information of various pharmaceutical companies, pharmaceutical companies are still very positive
in their evaluation.
In the past week, a number of drugs have been evaluated
.
On August 25, Northeast Pharmaceutical announced that the company recently received the "Notice of Approval of Drug Supplement Application" on amantadine hydrochloride tablets approved and issued by the State Drug Administration, and the drug passed the consistency evaluation
of generic drug quality and efficacy.
It is understood that the generic drug amantadine hydrochloride tablets developed by it are suitable for the prevention and treatment of signs and symptoms caused by influenza A virus infection, and can also be used to treat Parkinson's disease and various Parkinson's syndromes (such as post-encephalitis Parkinson's syndrome, vascular Parkinson's syndrome and carbon monoxide toxic Parkinson's syndrome), as well as for the treatment of drug-induced extrapyramidal reactions
.
For this evaluation, Northeast Pharmaceutical said that it means that the drug has the qualification conditions to participate in the centralized procurement of national drugs, which is conducive to enhancing the competitiveness of the product market and accumulating valuable experience
for the company's subsequent products to carry out generic drug consistency evaluation.
On August 24, ConnBei issued an announcement that Zhejiang Jinhua Kangbei Biopharmaceutical Co.
, Ltd.
(hereinafter referred to as "Jinhua Kangbei"), a holding subsidiary, received a notice
of approval for the clinical trial of EVT-401 tablets approved by the State Food and Drug Administration.
The indication for this clinical trial application for EVT-401 tablets is rheumatoid arthritis
.
On the same day, the company also announced that Jinhua Kangbai's 0.
6g specification acetylcysteine effervescent tablets passed the consistency evaluation
of generic drug quality and efficacy.
As of the date of the announcement disclosure, Jinhua Kangbei has invested about 8.
867 million yuan
in research and development expenses for the evaluation of generic drug quality and efficacy consistency.
On August 23, the website of the State Drug Administration showed that the injectable voriconazole of Sichuan Meida Kanghuakang Pharmaceutical Passed the consistency evaluation
of generic drugs.
Voriconazole is a broad-spectrum triazole antifungal for the treatment of candidiasis in patients with invasive aspergillosis, non-neutropenia, severe invasive infections caused by fluconazole-resistant Candida (including Candida clerubi), and severe infections
caused by the genus Actinomycetes apodae and Fusarium spp.
It is reported that at present, there are 4 enterprises with voriconazole for injection, including Beite Pharmaceutical, Puli Pharmaceutical, Qilu Pharmaceutical, Sichuan Meida Kanghuakang Pharmaceutical, forming a 4+1 pattern and meeting the conditions for
collection and procurement.
