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Highlights
Since the beginning of this year, CTTQ's innovative R&D has entered an intensive harvest period, with 3 Category 1 new drugs and liraglutide biosimilars approved for marketing one after another, and IND application and approval of Category 1 new drugs are progressing. In addition to the approved innovative drugs, CT Tianqing also has 75 Category 1 new drugs in the clinical application stage and above, and 7 in the NDA or Phase III clinical stage; 13 high-end innovative drugs are under development, and 4 are expected to be marketed; 66 varieties have been evaluated (23 first), and 10 are preparing for the tenth batch of centralized procurement.
Won 3 Class 1 new drugs! 75 new Class 1 drugs are on the way
In the first half of 2024, CT Tianqing's innovative R&D progress continued: three Class 1 new drugs, Anectinib Fumarate Capsule, Bemosubaemab Injection, and Ebonacre Citrate Capsule, were approved for marketing; 14 Category 1 new drugs, including TQB3702 tablets, TQB2868 injections, and AL2846 capsules, were declared for IND; 21 Category 1 new drugs, including TQG3020 tablets, TQH3906 capsules, and TQB2928 injections, have been approved for clinical trials......
Since 2024, CT Tianqing has been approved for marketing as a Class 1 new drug
Anecutinib Fumarate Capsule is a novel small molecule receptor tyrosine kinase inhibitor with strong inhibitory effects on ALK, ROS1 and MET gene mutations, and is the first domestic targeted drug approved for adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.
Bemosubasumab injection is a novel humanized anti-PD-L1 monoclonal antibody with a new sequence, the first approved indication for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with anlotinib hydrochloride capsules, carboplatin and etoposide.
Ebonacre citrate capsule is a tyrosine kinase receptor inhibitor indicated for the treatment of ALK-positive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not been treated with anaplastic lymphoma kinase (ALK) inhibitors.
Three Category 1 new drugs are expected to participate in the 2024 national talks, achieving "listing in the same year and insurance in the same year". As a leading innovative drug enterprise in China, CT Tianqing has 7 Category 1 new drugs approved for marketing, including magnesium isoglycyrrhizinate injection, anlotinib hydrochloride capsules, penpulimab injection, iberigrastim α injection, anectinib fumarate capsules, bemosubasumab injection, and ebonac citrate capsules.
Chia Tai Tianqing is mainly developing Class 1 new drugs
In recent years, CT Tianqing has taken comprehensive innovation as the first place in the company's core development strategy, driven by innovation, continuously increased R&D investment, deepened the pipeline layout of core therapeutic areas such as oncology, liver disease, and respiratory, and continuously optimized the R&D and innovation ecology through internal R&D innovation, international advanced platforms and pipeline cooperation. In 2023, the company's R&D investment accounted for 17% of total sales.
In addition to the innovative drugs that have been approved for marketing, CT Tianqing currently has 75 Category 1 new drugs in the clinical application stage and above, and the innovative R&D projects are at the forefront of the industry. Among them, there are 57 small molecule chemical innovative drugs and 18 large molecule biological innovative drugs, involving tumors, liver diseases, respiratory, metabolism, autoimmunity and other diseases, covering fusion proteins, monoclonal antibodies, bispecific antibodies, ADCs and other drug forms.
Among the 75 Category 1 new drugs, the marketing application for Gesuprexib tablets is under review, and it is expected to be approved for marketing in 2024 at the earliest; TQB3616 capsules, TQB3823 tablets, AL2846 capsules, Lanifibranor tablets, antimicrobial peptide PL-5 spray, TQB3454 tablets, etc., are in the phase III clinical stage and can be marketed.
It is not difficult to find that CTTQ's innovative drug pipeline has formed a virtuous cycle of "listing a batch, clinical batch, and developing a batch", building a strong innovation and R&D capability, and gradually entering an intensive period of innovation harvest. It is expected that from 2024, the company will have at least 3 innovative drugs approved for marketing every year.
13 high-end innovative preparations! Seize the 13 billion market
In addition to Class 1 innovative drugs, CT Tianqing also continues to deploy biosimilars, improved chemical drugs and other biological products, and gradually ushers in the market harvest period.
On June 25, according to the official website of the NMPA, Chia Tai Tianqing's liraglutide injection was approved for marketing for adult patients with type 2 diabetes to control blood sugar. Liraglutide is a long-acting analogue of glucagon-like peptide-1 (GLP-1), with terminal sales of more than 1.7 billion yuan in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (hereinafter referred to as China's public medical institutions) in 2023. The approval of this product marks CTTQ's official entry into the field of biological drug sugar control.
Previously, on January 18, 2022, CTTQ's first biosimilar, adalimumab injection, was approved for marketing, becoming the fifth domestic company; In 2023, the company's bevacizumab injection, rituximab injection, trastuzumab for injection, and recombinant human coagulation factor VIII for injection were successively approved for marketing, of which recombinant human coagulation factor VIII for injection was the second in China, and rituximab injection and trastuzumab for injection were the third in China.
At present, CTTQ has 13 high-end innovative preparations in the clinical application stage and above, involving 7 biosimilars, 4 improved chemical drugs and 2 blood products. In 2023, the total terminal sales of 9 biological products in China's public medical institutions will exceed 13 billion yuan, including more than 4 billion yuan of semaglutide injection, more than 3 billion yuan of pertuzumab injection, and more than 2 billion yuan of recombinant human coagulation factor VIII for injection.
CT Tianqing is mainly developing high-end innovative drugs
Among the 13 high-end innovative preparations, pertuzumab injection (for the treatment of HER2-positive breast cancer) and recombinant human coagulation factor VII.a for injection (for the treatment of hemophilia) have submitted marketing applications and are expected to be approved for marketing in 2024 or 2025; Insulin degludec injection (for the treatment of type 2 diabetes) and semaglutide injection (for the treatment of type 2 diabetes) for the treatment of type 2 diabetes have been in the phase III clinical stage and can be marketed.
66 varieties have been evaluated, and 10 varieties are ready for centralized procurement
On June 12, according to the official website of the NMPA, Chia Tai Tianqing was approved for marketing with generic 4 types of gadolinium terinium injection and was deemed to have been evaluated, making it the second domestic company. Gadolinium tertesol injection is a non-ionic MRI contrast agent, and data from Minenet shows that the sales of terminal contrast agents in China's public medical institutions will be close to 15 billion yuan in 2023.
In the field of medical imaging, in addition to gadolinium terethol injection (brand name: Daxian), Chia Tai Tianqing also has gadolinium-plugged acid disodium injection (brand name: Xianai), iodixanol injection (brand name: sabean), iopromide injection (brand name: polyiodine) and other contrast agent products have been approved for marketing.
Since the beginning of this year, CT Tianqing has approved the marketing of 4 varieties of eltrombopag ethanolamine tablets, tedizolid phosphate for injection, iodopromide injection and gadolinium teritol injection, further enriching the company's product line. Among them, eltrombopag ethanolamine tablets are the first imitation in China, and iopromide injection and gadolinium terinium alcohol injection are the second in China.
Since 2024, CT Tianqing has been approved as a generic drug
Source: Minenet China Listed Drugs (MID) Database
Up to now, 66 varieties of Chia Tai Tianqing have passed/deemed to have passed the consistency evaluation. Among them, 23 varieties are the first to be evaluated in China, and everolimus tablets, chlorethethophan for inhalation, eltrombopag ethanolamine, vortioxetine hydrobromide tablets, lenvatinib mesylate capsules, pomalidomide capsules, and fulvestrant injection are the first imitation + the first evaluation in China.
Chia Tai Tianqing passes/is deemed to have passed the consistency evaluation of varieties
The 66 over-rated varieties covered 10 therapeutic categories, mainly focusing on anti-tumor and immunomodulatory agents (20), digestive system and metabolic drugs (14), and systemic anti-infective drugs (13). Among them, 10 have met the full competition conditions of 5 or more companies and are expected to be included in the tenth batch of centralized procurement, including eltrombopag ethanolamine tablets, palbociclib capsules, sitagliptin phosphate tablets, vortioxetine hydrobromide tablets and other blockbuster varieties.
Data source: Minenet database, company announcement
Note: The statistical scope of "Drug Terminal Competition Pattern of China's Public Medical Institutions" by Minenet 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.