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The adjustment of the medical insurance catalogue in 2022 has entered a critical period, and Qilu Pharmaceutical has 3 non-catalogue varieties listed
.
Recently, Qilu Pharmaceutical's Class 1 new drug QLS31903 for injection was declared clinical, and daptomycin for injection was approved and regarded as evaluated.
.
.
At present, Qilu Pharmaceutical has 40 new drugs (30 Class 1 new drugs) in the declared clinical stage or above, and 5 have entered the phase III clinical or NDA stage; A total of 111 products have been evaluated, and 45 are the first in China; 61 new classified products are under review, and 14 have not yet been approved
.
.
Recently, Qilu Pharmaceutical's Class 1 new drug QLS31903 for injection was declared clinical, and daptomycin for injection was approved and regarded as evaluated.
.
.
At present, Qilu Pharmaceutical has 40 new drugs (30 Class 1 new drugs) in the declared clinical stage or above, and 5 have entered the phase III clinical or NDA stage; A total of 111 products have been evaluated, and 45 are the first in China; 61 new classified products are under review, and 14 have not yet been approved
.
Won 13 blockbuster varieties, 14 varieties to imitate
According to the previously announced list of drugs that passed the formal review, Qilu Pharmaceutical has 3 non-catalogue varieties, including tofacitinib citrate sustained-release tablets, memantine hydrochloride oral lytic film, trifluridine tepitipurine tablets, and the 2022 version of the national medical insurance catalogue
.
Among them, tofacitinib citrate sustained-release tablets and memantine hydrochloride oral dissolved film are the varieties
approved for marketing in the first half of this year.
.
Among them, tofacitinib citrate sustained-release tablets and memantine hydrochloride oral dissolved film are the varieties
approved for marketing in the first half of this year.
Since the beginning of this year, 13 varieties of Qilu Pharmaceutical have been approved for marketing, further enriching the company's product pipeline
.
Among them, aripiprazole oral lytic film, memantine hydrochloride oral lytic film, tadalafil oral lytic film are the first in China to be approved, aprepitant injection, tofacitinib citrate sustained-release tablets are the first imitation + first to be evaluated in China, diquafossol sodium eye drops are the second in China, and dutasteride softgels are the third in China
.
.
Among them, aripiprazole oral lytic film, memantine hydrochloride oral lytic film, tadalafil oral lytic film are the first in China to be approved, aprepitant injection, tofacitinib citrate sustained-release tablets are the first imitation + first to be evaluated in China, diquafossol sodium eye drops are the second in China, and dutasteride softgels are the third in China
.
Since 2022, Qilu Pharmaceutical has been approved for marketing
Source: MED2.
0 China Drug Evaluation Database
0 China Drug Evaluation Database
In terms of consistency evaluation, Qilu Pharmaceutical currently has a total of 111 products evaluated, of which 45 varieties are the first in China to be evaluated, and a total of 50 varieties have won the bid for national centralized procurement
.
.
Among the 2 first generic drugs, tofacitinib citrate sustained-release tablets are small molecule targeted JAK kinase inhibitors for the treatment of rheumatoid arthritis, and Qilu Pharmaceutical has previously laid out tofacitinib citrate tablets, which was approved as the second domestic company
in October 2019.
According to Pfizer's financial report, the global sales of tofacitinib (trade name: Shangjie/Xeljanz) in 2021 were $2.
455 billion
.
Arepitant is the first NK-1 inhibitor for antiemetic, is a commonly used antiemetic drug for anti-tumor chemotherapy, Qilu Pharmaceutical's layout of aprepitant capsules, aprepitant injection has been approved for marketing, are the first in
China.
in October 2019.
According to Pfizer's financial report, the global sales of tofacitinib (trade name: Shangjie/Xeljanz) in 2021 were $2.
455 billion
.
Arepitant is the first NK-1 inhibitor for antiemetic, is a commonly used antiemetic drug for anti-tumor chemotherapy, Qilu Pharmaceutical's layout of aprepitant capsules, aprepitant injection has been approved for marketing, are the first in
China.
The battle for the first imitation continues! At present, Qilu Pharmaceutical still has 61 new registration classification generic drug marketing applications under review, and after approval for production, it will be regarded as passing the consistency evaluation
.
Among them, 14 varieties have not been approved for listing (including the first imitation of dosage form), and the company will compete with a number of enterprises for the first imitation
in China.
.
Among them, 14 varieties have not been approved for listing (including the first imitation of dosage form), and the company will compete with a number of enterprises for the first imitation
in China.
The new registration classification of Qilu Pharmaceutical is under review and there are no varieties approved for the first imitation
Source: MED2.
0 China Drug Evaluation Database
0 China Drug Evaluation Database
11 improved new drugs are eye-catching! Siege 7 over 1 billion varieties
Compared with innovative drugs, improved new drugs have the characteristics of low R&D risk, short R&D cycle and high rate of return, and are still a blue ocean market in China, and the popularity of domestic pharmaceutical companies for their R&D is heating up
year by year.
year by year.
As a traditional and established pharmaceutical company in China, Qilu Pharmaceutical not only maintains a leading position in generic drugs, but also continuously increases investment in the research and development of improved new drugs
.
.
Qilu Pharmaceutical has been deeply engaged in the field of improved new drugs for many years, and has begun to lay out the research and development of oral lytic film preparations since 2013, and has successively harvested 5 oral lytic film products, such as olanzapine oral lytic film, montelukast sodium oral lytic film, tadalafil oral lytic film, memantine hydrochloride oral lytic film, aripiprazole oral lytic film, etc.
, and is a leading enterprise
in the field of oral lytic film in China.
In addition to olanzapine oral dissolution film is the second in China, the remaining 4 products are the first approved
in China.
, and is a leading enterprise
in the field of oral lytic film in China.
In addition to olanzapine oral dissolution film is the second in China, the remaining 4 products are the first approved
in China.
Since the beginning of this year, Qilu Pharmaceutical has submitted clinical applications for 6 Class 2 improved new drugs, including risperidone oral dissolving film, lenvatinib mesylate capsules, atropine sulfate eye drops, semeglutide injection, tetrahexose ganglioside sodium monosialic acid injection, oseltamivir oral lytic membrane
phosphate.
Among them, class 2.
2 new dosage form risperidone oral lytic film, class 2.
4 new indication atropine sulfate eye drops and lenvatinib mesylate capsules have been approved for clinical trials
.
phosphate.
Among them, class 2.
2 new dosage form risperidone oral lytic film, class 2.
4 new indication atropine sulfate eye drops and lenvatinib mesylate capsules have been approved for clinical trials
.
Qilu Pharmaceutical Class 2 chemically improved new drugs
Source: China Drug Clinical Trial Publicity Database on Intranet
It is not difficult to find that Qilu Pharmaceutical mainly improves the classic first-line drugs, and the treatment area is mainly neurological diseases
.
.
Among the 11 improved new drugs, 7 products involved in the terminal sales of generic drugs in China's public medical institutions exceeded 1 billion yuan in 2021, including aripiprazole (1.
4 billion+), tadalafil (1.
5 billion+), olanzapine (2.
5 billion+), montelukast (1.
7 billion+), lenvatinib (1.
7 billion+), oseltamivir (1.
4 billion+), and gangliosides (1.
3 billion+).
In addition to lenvatinib, Qilu Pharmaceutical has laid out a variety of preparation products
for the above varieties.
4 billion+), tadalafil (1.
5 billion+), olanzapine (2.
5 billion+), montelukast (1.
7 billion+), lenvatinib (1.
7 billion+), oseltamivir (1.
4 billion+), and gangliosides (1.
3 billion+).
In addition to lenvatinib, Qilu Pharmaceutical has laid out a variety of preparation products
for the above varieties.
30 Class 1 new drugs are under development, with monoclonal antibodies, bispecific antibodies, and ADCs all laid out
In recent years, Qilu Pharmaceutical has continued to increase investment in research and development and actively innovated corner overtaking
.
Through the model of independent research and development as the main and license in supplement, Qilu Pharmaceutical's innovation pipeline currently has 30 Class 1 new drugs in the clinical application stage or above, including 21 large molecule biological drugs and 9 small molecule chemical drugs
.
.
Through the model of independent research and development as the main and license in supplement, Qilu Pharmaceutical's innovation pipeline currently has 30 Class 1 new drugs in the clinical application stage or above, including 21 large molecule biological drugs and 9 small molecule chemical drugs
.
Qilu Pharmaceutical is mainly developing pictures of Class 1 new drugs
Source: China Drug Clinical Trial Publicity Database on Intranet
30 Class 1 new drugs focus on tumor, infection, liver disease, autoimmunity and other therapeutic areas, involving EGFR, ALK, CLDN18.
2, PD-1/L1, HER2, TIGIT, 4-1BB and other
targets, covering monoclonal antibodies, bispecific antibodies, ADCs and fusion proteins.
2, PD-1/L1, HER2, TIGIT, 4-1BB and other
targets, covering monoclonal antibodies, bispecific antibodies, ADCs and fusion proteins.
Among the 9 chemical drugs, Iluok tablets (ALK/ROS1 inhibitors) have submitted marketing applications and are expected to be approved for marketing in the second half of this year; Serlatinib tosylate tablets, QL-007 tablets, FL058 for injection, CEND-1 for injection, etc.
are in the phase II clinical stage; QLH11906 tablets and QLH11811 tablets quickly started phase I clinical trials after obtaining the implied approval for clinical trials
this year.
are in the phase II clinical stage; QLH11906 tablets and QLH11811 tablets quickly started phase I clinical trials after obtaining the implied approval for clinical trials
this year.
Among the 21 biological drugs, VB4-845 injection (EpCAM ADC), QL1706 injection (CTLA4/PD-1 bispecific antibody), recombinant human thrombopoietin peptidomimetic-Fc fusion protein (TPOR agonist) for injection are in the phase III clinical stage and can be marketed
.
.
Biopharmaceuticals are the focus of Qilu Pharmaceutical's pipeline research and development, and the research and development of bispecific antibodies is the top priority
.
Among the 6 bispecific antibodies with known targets, QL1706 injection (CTLA4/PD-1 bispecific antibody) is in the phase III clinical stage, QLS31901 for injection (PD-L1/TGF-β), QLS31905 for injection (CLDN18.
2/CD3), QLF31907 for injection (PD-L1/4-1BB), QLP31907 injection (CD20/CD37), QLS31904 for injection (DLL3/ CD3) and other 5 bispecific antibodies are in the phase I clinical stage
.
.
Among the 6 bispecific antibodies with known targets, QL1706 injection (CTLA4/PD-1 bispecific antibody) is in the phase III clinical stage, QLS31901 for injection (PD-L1/TGF-β), QLS31905 for injection (CLDN18.
2/CD3), QLF31907 for injection (PD-L1/4-1BB), QLP31907 injection (CD20/CD37), QLS31904 for injection (DLL3/ CD3) and other 5 bispecific antibodies are in the phase I clinical stage
.
In addition to Class 1 innovative drugs and Class 2 improved new drugs, Qilu Pharmaceutical has also made a layout
in biosimilars.
As the first bevacizumab biosimilar approved enterprise in China, Qilu Pharmaceutical's sales results are remarkable
.
At present, Qilu Pharmaceutical also has 4 biosimilars under development, including denosumab, ropremide, etanercept, and aflibercept
.
Among them, the global sales of denosumab protogen drug in 2021 will be 5.
266 billion US dollars, and Qilu Pharmaceutical is the first domestic company to report production
.
in biosimilars.
As the first bevacizumab biosimilar approved enterprise in China, Qilu Pharmaceutical's sales results are remarkable
.
At present, Qilu Pharmaceutical also has 4 biosimilars under development, including denosumab, ropremide, etanercept, and aflibercept
.
Among them, the global sales of denosumab protogen drug in 2021 will be 5.
266 billion US dollars, and Qilu Pharmaceutical is the first domestic company to report production
.
Source: Intranet database
Note: Intranet's "Terminal Competition Pattern of China's Public Medical Institutions", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics, and village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of October 18, if there are any omissions, welcome to correct!
based on the average retail price of the product at the terminal.
Data statistics as of October 18, if there are any omissions, welcome to correct!
