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Recently, the R&D pipeline of CP Tianqing Pharmaceutical welcomes new progress: class 1 new drug TQB2102 is declared for clinical for the first time, the introduction of heavy NASH new drugs, and class 4 generic drugs are reported for production of bicarutamide tablets.
.
.
CP Tianqing Pharmaceutical, known as the "king of first imitation", has 16 first imitations (including the first imitation of dosage forms) approved for marketing since 2017, in addition to 18 newly classified products under review; In terms of innovative drugs, the company currently has 77 new drugs (61 Class 1 new drugs) in the clinical application stage or above, of which 14 new drugs (5 Class 1 new drugs) are in phase III and above, and 7 biosimilars focus on global blockbuster varieties
.
Won 16 blockbuster imitations, 6 varieties to break through the new medical insurance A
few days ago, the list of declared drugs that passed the formal review of the 2022 national medical insurance
catalogue adjustment was officially announced to the public, and CP Tianqing Pharmaceutical has 6 non-catalogue varieties listed, all of which meet the off-list conditions1, that is, from January 1, 2017 to June 30, 2022, New generic drugs
approved for marketing by the national drug regulatory department.
According to data from Intranet, since 2017, the number of newly approved varieties of CP Tianqing Pharmaceutical has exceeded 40, of which 16 are the first imitation (including the first imitation of dosage form), and the "king of the first imitation" is well deserved
.
In addition, since 2017, the company has 18 new classification products (in terms of drug name) under review, of which 4 are inhalants
.
Since 2017, CP Tianqing has been approved for the first imitation
0 China Drug Review Database
The 16 first generic drugs cover 8 therapeutic categories, including 6 anti-tumor and immunomodulators, and 2 digestive and metabolic drugs, miscellaneous, blood and hematopoietic drugs
.
A number of blockbuster varieties with more than 1 billion US dollars in the world, including rivaroxaban, sitagliptin, pomalidomide, tofacitinib, lenvatinib, dabigatran etexilate, vothioxetine, etc.
, the global sales of original products in 2021 will exceed 7 billion US dollars, 3 billion US dollars, 3 billion US dollars, 2 billion US dollars, 2 billion US dollars, 1 billion US dollars, 1 billion US dollars, etc
.
In the domestic market, including generic drug sales, the market size of many varieties in China's three major terminal markets (see the end of this article for details) in 2021 has exceeded 1 billion yuan, including lenvatinib mesylate capsules (1.
7 billion +), dabigatran etexilate capsules (1.
3 billion +), sitagliptin phosphate tablets (2 billion +), budesonide suspension for inhalation (6.
8 billion +), rivaroxaban tablets (5 billion +
。
Among the varieties that have passed the 2022 national medical insurance form review, chloroacetylcholine for inhalation is the exclusive variety of CP Tianqing Pharmaceutical, in addition, the sales scale of fosaprepitant dimeglumine for injection, vothioxetine hydrobromide tablets, and trafluridine tepitipidine tablets have increased significantly in
recent years.
In recent years, sales of fosapitan dimeglutamine, vothioxetine, trafluridine tepitimidine in China's three major terminal markets (10,000 yuan) Source: Intranet database
License-in accelerated, introducing a number of innovative and differentiated new drugs
On September 21, China Biopharma announced that its subsidiary CP Tianqing Pharmaceutical has reached a cooperation agreement with Inventiva to jointly develop and commercialize Lanifibranor, Inventiva's lead new drug candidate, for the treatment of nonalcoholic steatohepatitis (NASH) and potentially other metabolic diseases
.
CP Tianqing Pharmaceutical will make an upfront payment of US$12 million and potential clinical and regulatory milestone payments
of up to US$40 million to Inventiva.
Lanifibronor is a peroxisome proliferator-activated receptor (PPARs) full agonist that improves insulin sensitivity, activates macrophages, and reduces liver fibrosis and inflammation gene expression by activating receptor subtypes that function α, γ, and
δ in vivo.
Since the beginning of this year, CP Tianqing Pharmaceutical has reached cooperation with a number of domestic and foreign pharmaceutical companies to develop or commercialize a number of innovative and differentiated products, including Inventiva, Symphogen, Anyuan Pharmaceutical, XtalPi and so on
.
From 2022 to the present, CP Tianqing Pharmaceutical Part of the introduction project Source: Company announcement, Intranet collation
Among the new drugs
introduced, AP025 and lanifibranor are both new NASH drugs, and in this therapeutic field, only Saroglitazar (PPARα/ of Zydus Cadila, India) in the world γ dual agonists) have been approved, while no related new drugs have been approved for marketing in China, which has a large clinical demand
.
According to Evaluate Pharm, the global market for NASH drugs will reach $40 billion
by 2025.
A number of new drugs have not been approved
for the same target in China.
AP025 is the first domestic FGF21 long-acting fusion protein to enter the clinic, and is currently undergoing phase I clinical trials for NASH indications in China; AP026 is a FGF21/GLP-1 bifunctional protein, which is currently undergoing phase I clinical trials in New Zealand, and clinical applications have been submitted in China; Sym022 is a fully human recombinant LAG-3 monoclonal antibody, and the world's highest research and development progress has entered phase I clinical trials, and has not yet been declared for clinical trials
in China.
61 Class 1 new drugs are on the way, and these 5 can be expected
to be listed
Through independent research and development, M&A investment, external introduction, etc.
, CP Tianqing Pharmaceutical has continuously expanded its product line under research, promoted the company's transformation from "liver disease mainly" to "two cores and multiple strong", and formed a liver disease drug and anti-tumor drugs as the main body, digestive system, anti-infection, R&D pattern
of coordinated development in respiratory system and other fields.
Including the products introduced through cooperation, CP Tianqing Pharmaceutical has 77 new drugs (excluding new indications for new drug development that have been marketed) in the clinical application stage or above in China, of which 49 are chemical drugs and 28 are therapeutic biological products; From the registration classification, 61 of the 77 new drugs are Class 1 new drugs
.
CP Tianqing Pharmaceutical is developing new drugs in China
