Zhengda Tianqing won 14 blockbuster first imitating 52 new class 1 drugs

Recently, the product line of Chia Tai Tianqing welcomes new progress: Adalimumab is under approval, the first class 1 new drug TQH3910 is submitted to the IND, the 3.
3 class new drug mepolizumab is approved for clinical.
.
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Innovative drugs and first imitations It is the focus of CP Tianqing Pharmaceutical's layout.
Since 2019, the company has won 1 category 1 new drug and 14 first imitations
.
At present, Chia Tai Tianqing Pharmaceutical has 66 new drugs (52 new drugs in category 1) in the clinical application and above stage, 10 have entered the stage III and above, biological drugs will welcome the harvest period; in terms of generic drugs, 50 varieties Passed evaluation (20 are the first ones), 12 new classified products have not been approved for the first imitation, and contain a variety of inhalants
.
Intensive harvest period! In the past 3 years, 1 new class 1 drug and 14 first imitations have been approved.
As a leading domestic liver disease company, Chia Tai Tianqing has continuously expanded the product line under research through independent research and development, mergers and acquisitions, and external introductions, and promoted the company’s The transformation from “mainly” to “two cores and multiple powers” ​​has formed a research and development pattern of collaborative development in multiple fields such as liver disease drugs and anti-tumor drugs, and the digestive system, anti-infection, and respiratory system
.
Beginning in 2019, CP Tianqing Pharmaceutical has entered an intensive harvest period, with more than 10 newly approved varieties each year
.
In the past three years (2019-present), the company has approved more than 30 new products, of which 1 is a new category 1 drug, and 14 are the first imitation (including the first imitation of the dosage form)
.
Since 2019, Chia Tai Tianqing Pharmaceutical has approved the first class 1 new drug and the source of the first imitation: Meinenet MED2.
0 Chinese drug review database Class 1 new drug Paimrizumab is the fifth domestically approved PD-1 , Used to treat classic Hodgkin’s lymphoma (cHL)
.
This product has differentiated advantages.
It is the only new PD-1 monoclonal antibody in the world that adopts IgG1 subtype and modified the Fc segment.
It can enhance the efficacy of immunotherapy, reduce fever and adverse reactions such as infusion
.
In addition to cHL, the new indications for NSCLL and nasopharyngeal carcinoma of Paimrizumab have been declared for marketing.
In addition, the BLA was submitted to the FDA in May 2021, becoming the third domestic PD-1 seeking to be marketed in the United States.

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The 14 first generic drugs cover 8 treatment categories, of which 5 are anti-tumor and immunomodulators, and 2 are systemic anti-infective drugs, blood and hematopoietic system drugs
.
Many of the world’s most important varieties of over 1 billion U.
S.
dollars, including rivaroxaban, sitagliptin, pomalidomide, tofacitib, emtricitabine tenofovir, dabigatran etexilate, vomitor Tioxetine, lenvatinib, etc.
, the global sales of the original research products in 2020 will exceed 7 billion U.
S.
dollars, 3 billion U.
S.
dollars, 3 billion U.
S.
dollars, 2 billion U.
S.
dollars, 1 billion U.
S.
dollars, 1 billion U.
S.
dollars, 1 billion U.
S.
dollars, 1 billion U.
S.
dollars.
and so on
.
52 types of Class 1 new drugs are eye-catching, and 10 new drugs are expected to be launched.
After years of development, CP Tianqing Pharmaceuticals has gradually expanded from "combination of imitation and innovation" to "combination of innovation and imitation", and will shift to "innovation-led" in the future
.
According to data from Meinenet, there are currently 66 new drugs (excluding new indications for new drugs already on the market) in the clinical application and above stage of CP Tianqing Pharmaceutical, 52 of which are Class 1 new drugs
.
From the perspective of therapeutic targets, CP Tianqing has deployed multiple popular targets such as PD-(L)1, ALK, EGFR, PI3K, CDK4/6, MEK, c-Met, DPP4, etc.
From the perspective of drug types, the company New drugs under research are mainly chemical drugs (accounting for nearly 70%).
However, in recent years, efforts have been made to develop biological drugs, and they have shifted to "simultaneous development of chemical drugs and biological drugs"
.
From the perspective of research and development progress, 10 new drugs (3 new class 1 drugs) are in phase III clinical phase and above, and they are expected to be marketed
.
Biosimilar drugs will meet the intensive harvest period, adalimumab and bevacizumab have been reported for production, of which adalimumab has entered the administrative approval stage; trastuzumab, pertuzumab, rituximab Monoclonal antibodies have entered phase III clinical trials
.
The source of new drugs being developed by CP Tianqing Pharmaceuticals: Meinenet China Drug Clinical Trial Public Library From the perspective of the therapeutic field, the product line of CP Tianqing Pharmaceuticals under development is mainly anti-tumor drugs (more than 50%), and at the same time, it is anti-infective.
Expansion in the fields of, digestion, breathing, blood, etc.
, while ensuring the status in the field of liver disease, further enhance the competitiveness in the field of anti-tumor, and at the same time open up other therapeutic fields to form a rich product chain
.
In terms of anti-tumor drugs, Anlotinib and Paimrizumab have been approved for marketing, and TQB2450 (PD-L1 monoclonal antibody) and TQ-B3139 (ALK inhibitor) are undergoing phase III clinical trials; TQ-B3525 (PI3K) Inhibitors), TQ-B3101 (ROS1 inhibitor), TQB3616 (CDK4/6 inhibitor), AL2846 (c-Met/HGF inhibitor), TQ05105 (selective JAK2 inhibitor), etc.
are currently undergoing phase II clinical trials
.
Anti-infectives are mainly used for hepatitis, 4 of which are new hepatitis B drugs, TQ-A3334 (TLR7 agonist) is undergoing phase II clinical trials; the new hepatitis C drug TQ-A3326 (NS5A inhibitor) has completed phase I clinical trials
.
In the field of respiratory diseases, 3 new class 1 drugs under development are suitable for asthma, and all have entered phase I clinical; digestive system drugs are mainly used for diabetes, and class 1 new drug TQ-F3083 (DPP-4 inhibitor) is in progress In phase II clinical trials, non-category 1 new drugs insulin deglubber and liraglutide have entered phase III clinical trials
.
20 varieties are the first to be reviewed, and 12 varieties are the first to be copied.
Recently, the official website of the State Food and Drug Administration showed that Chia Tai Tianqing’s lurasidone hydrochloride tablets were approved for production and deemed to have been reviewed
.
According to data from Meinenet, the company currently has 50 varieties passed or deemed to have passed the consistency evaluation, covering 10 treatment categories, focusing on anti-tumor and immunomodulators (17 varieties), digestive system and metabolic drugs (10 Varieties) and anti-infective drugs for systemic use (8 varieties)
.
CP Tianqing Pharmaceuticals has reviewed the varieties.
Note: The first review with *, ** the exclusive review Source: Meinenet MED2.
0 Chinese drug review database 20 varieties of the first / exclusive review, of which most of them are used for injection Colistin E sodium methanesulfonate, lenvatinib mesylate capsules, pomalidomide capsules, fulvestrant injection, dabigatran etexilate capsules, budesonide suspension for inhalation, etc.
Variety first imitation + first review
.
Among the 14 generic drugs that have been reported for production under the new classification and have not yet been approved, 12 have not yet been approved for the first imitation (including the first imitation of the dosage form), and contain a variety of inhalants.
It can be seen that the high-end preparations and the first imitation are The direction of the key layout of generic drugs
.
CP Tianqing Pharmaceutical's new classification is reported for production and there is no first copy approval.
Source: Meinenet MED2.
0 Chinese drug review database Novartis's sacubitril and valsartan, GlaxoSmithKline's salmeterol The global sales of pine, Novartis’ everolimus, GlaxoSmithKline’s fluticasone and vilanterol, and Novartis’s Eltrombopag will exceed 1 billion U.
S.
dollars in 2020
.
Source: Minet.
com database Note: Statistics are as of December 22.
If there are any omissions, please correct me!