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On January 24, according to NMPA's official website, Qilu Pharmaceutical's 2.
2-type improved new drug tadalafil oral dissolving film entered the stage of administrative approval and is expected to be approved for marketing in the near future, becoming the first in China
.
Click here to view the review status of the acceptance number
from: NMPA official website Tadalafil tablets are used to treat symptoms and signs of erectile dysfunction (ED) and its associated benign prostatic hyperplasia (BPH) .
The drug was first developed and marketed by Lilly ICOS (a joint venture between Lilly and ICOS) and United Therapeutics.
It is an orally effective inhibitor of phosphodiesterase 5 (PDE5) .
According to the Insight database, tadalafil is currently available in 4 dosage forms in China, including ordinary tablets, chewable tablets, suspensions and oral dissolving films .
In addition to ordinary tablets, no other dosage forms have been approved yet, but the oral dissolving film is the most mainstream research and development of improved new dosage forms.
Four domestic companies have developed them.
Qilu was the first to apply for listing in March 2020, and Hengrui was late.
It was declared in Qilu for a year and a half, and Baili Pharmaceutical and Lipin Pharmaceutical are also in clinical development .
Among similar drugs, Kelun Pharmaceuticals has also developed an oral dissolving film for sildenafil and submitted a marketing application .
The domestic research and development situation of tadalafil oral dissolving film comes from the Insight database (http://db.
dxy.
cn/v5/home/) Oral instant dissolving film is a new type of oral preparation, which is processed by drugs and suitable film-forming materials.
The film-like preparation is put into the mouth and sticks to the administration site, it is not easy to spit out, and it disperses quickly, which can reduce the phenomenon that patients do not cooperate with taking the medicine.
over effect .
Under the circumstance that domestic generic drug competition is fierce and superimposed on centralized procurement, it may be a good choice to explore new and improved drugs that are more suitable for patients.
.
According to the Insight database, Qilu Pharmaceutical's new improved chemical drugs focus on the field of oral dissolving membranes, most of which are neurological drugs, and these patients especially need better-compliant administration methods
.
At present, Qilu has 8 oral dissolving film products in the clinical development stage, among which olanzapine oral dissolving film and montelukast sodium oral dissolving film have been approved successively in the first quarter of 2021, and tadalafil oral dissolving film will also be approved soon .
Approved, aripiprazole oral dissolving film and memantine hydrochloride oral dissolving film have been declared for marketing .
According to public information, the company has a self -built production workshop for oral dissolving drugs, and its production capacity has advantages in China .
While laying out the oral dissolving film agent, Qilu also developed multi-dosage forms for some ingredients .
For example, olanzapine has been approved for tablet, orally disintegrating tablet and orally dissolving film at the same time; montelukast has developed chewable tablet and oral dissolving film; tadalafil has also developed tablet and oral dissolving film .
Judging from the new applications of innovative drugs in the past five years, Qilu's innovative drugs have also entered the outbreak period, and 10 new drug projects have been declared in 2021 alone .
Qilu Pharmaceutical's new drug clinical application trend in the past five years Qilu Pharmaceutical's first application for clinical new drug project in 2021 is from the Insight database (http://db.
dxy.
cn/v5/home/)
2-type improved new drug tadalafil oral dissolving film entered the stage of administrative approval and is expected to be approved for marketing in the near future, becoming the first in China
.
Click here to view the review status of the acceptance number
from: NMPA official website Tadalafil tablets are used to treat symptoms and signs of erectile dysfunction (ED) and its associated benign prostatic hyperplasia (BPH) .
The drug was first developed and marketed by Lilly ICOS (a joint venture between Lilly and ICOS) and United Therapeutics.
It is an orally effective inhibitor of phosphodiesterase 5 (PDE5) .
According to the Insight database, tadalafil is currently available in 4 dosage forms in China, including ordinary tablets, chewable tablets, suspensions and oral dissolving films .
In addition to ordinary tablets, no other dosage forms have been approved yet, but the oral dissolving film is the most mainstream research and development of improved new dosage forms.
Four domestic companies have developed them.
Qilu was the first to apply for listing in March 2020, and Hengrui was late.
It was declared in Qilu for a year and a half, and Baili Pharmaceutical and Lipin Pharmaceutical are also in clinical development .
Among similar drugs, Kelun Pharmaceuticals has also developed an oral dissolving film for sildenafil and submitted a marketing application .
The domestic research and development situation of tadalafil oral dissolving film comes from the Insight database (http://db.
dxy.
cn/v5/home/) Oral instant dissolving film is a new type of oral preparation, which is processed by drugs and suitable film-forming materials.
The film-like preparation is put into the mouth and sticks to the administration site, it is not easy to spit out, and it disperses quickly, which can reduce the phenomenon that patients do not cooperate with taking the medicine.
over effect .
Under the circumstance that domestic generic drug competition is fierce and superimposed on centralized procurement, it may be a good choice to explore new and improved drugs that are more suitable for patients.
.
According to the Insight database, Qilu Pharmaceutical's new improved chemical drugs focus on the field of oral dissolving membranes, most of which are neurological drugs, and these patients especially need better-compliant administration methods
.
At present, Qilu has 8 oral dissolving film products in the clinical development stage, among which olanzapine oral dissolving film and montelukast sodium oral dissolving film have been approved successively in the first quarter of 2021, and tadalafil oral dissolving film will also be approved soon .
Approved, aripiprazole oral dissolving film and memantine hydrochloride oral dissolving film have been declared for marketing .
According to public information, the company has a self -built production workshop for oral dissolving drugs, and its production capacity has advantages in China .
While laying out the oral dissolving film agent, Qilu also developed multi-dosage forms for some ingredients .
For example, olanzapine has been approved for tablet, orally disintegrating tablet and orally dissolving film at the same time; montelukast has developed chewable tablet and oral dissolving film; tadalafil has also developed tablet and oral dissolving film .
Judging from the new applications of innovative drugs in the past five years, Qilu's innovative drugs have also entered the outbreak period, and 10 new drug projects have been declared in 2021 alone .
Qilu Pharmaceutical's new drug clinical application trend in the past five years Qilu Pharmaceutical's first application for clinical new drug project in 2021 is from the Insight database (http://db.
dxy.
cn/v5/home/)
