Qilu Pharmaceutical's new breakthrough!

Recently, Qilu Pharmaceutical's supplementary application for consistency evaluation of oseltamivir phosphate capsules was approved by the State Food and Drug Administration, which means that the product passed the consistency evaluation
.
Oseltamivir is a potent, highly selective neuraminidase inhibitor that reduces viral spread by inhibiting viral release from infected cells, effectively preventing influenza and relieving symptoms
.
According to data from Minet.
com, in 2020, the sales of terminal oseltamivir in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) exceeded 2.
7 billion yuan
.
The original research company of this product is Roche, and there are 7 domestic companies that have the production approval for oseltamivir phosphate capsules, including Sunshine Pharmaceuticals, Borui Pharmaceuticals, Shanghai Pharmaceuticals Chinese and Western Pharmaceuticals, Shijiazhuang Pharmaceutical Group, Kelun Pharmaceuticals, and Beite Pharmaceuticals.
etc.
, and the products of these 7 companies have passed/deemed to pass the consistency evaluation
.
In addition, more than 10 companies' listing applications are under review
.
It is understood that in the seventh batch of the collection and reporting volume catalog, there are also oral normal-release dosage forms of oseltamivir
.
Qilu Pharmaceutical's successful approval of this variety will be regarded as over-evaluation, which means that it has obtained the admission ticket for centralized procurement
.
Recently, Qilu Pharmaceutical has made good news in the aspect of consistency evaluation.
In addition to Oseltamivir Phosphate Capsules, not long ago, the company's supplementary application for consistency evaluation of new specifications of docetaxel injection received good news that it was approved.
Clinically, the drug is mainly used for the treatment of advanced or metastatic breast cancer that has failed prior chemotherapy, and the treatment of advanced or metastatic non-small cell lung cancer that has failed cisplatin-based chemotherapy
.
At present, the specifications of this variety have been reviewed: single bottle 1ml: 20mg and 4ml: 80mg, double bottle 0.
5ml: 20mg and 1ml: 40mg, with the enrichment of product specifications, patients will be provided with more clinical medication options
.
According to data from Minet.
com, sales of docetaxel injections in public medical institutions in China have exceeded 4 billion yuan in recent years
.
At present, there are more than 20 companies in the market of this variety
.
In terms of consistency evaluation, the manufacturers of docetaxel injection in the domestic market that have passed the consistency evaluation (or are deemed to have passed the consistency evaluation) include Hengrui Medicine, Huiyu Pharmaceutical, Chia Tai Tianqing, Qilu Pharmaceutical, Yangzijiang Pharmaceutical, and the United States.
Dakangjiale Pharmaceutical, Osaikang, etc.
, in the fifth batch of national centralized drug procurement, the docetaxel injections of 6 pharmaceutical companies including Hengrui Pharmaceutical, Qilu Pharmaceutical, Chia Tai Tianqing, and Yangzijiang Pharmaceutical were successfully selected, with a decrease of all More than 90%, and the original research Sanofi is out
.
In addition, at the end of March, Qilu Pharmaceutical's supplementary application for the consistency evaluation of carvedilol tablets was also approved by the State Food and Drug Administration, which means that the product has passed the consistency evaluation for the first time in China
.
Carvedilol Tablets is a neurohumoral antagonist with multiple effects, which is clinically used for the treatment of essential hypertension and symptomatic congestive heart failure
.
There are more than 10 domestic enterprises that have the approval for the production of carvedilol tablets
.
According to data from Minet.
com, the terminal sales of this product in China's public medical institutions will exceed 100 million yuan in 2020, of which Qilu Pharmaceutical accounts for 70% of the market
.
At present, only Qilu Pharmaceutical has successfully passed the evaluation of this variety, which is conducive to consolidating the original market
.
According to industry statistics, up to now, Qilu Pharmaceutical has accumulated 99 products that have passed the consistency evaluation, of which 42 are the first in China
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.