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Recently, CT Tianqing Pharmaceutical's self-developed Class 1 new drug TQB2102 for injection has obtained the implied license of clinical trials and is intended to be used for the treatment of advanced malignant tumors
.
This is a dual antibody ADC targeting HER2, and no similar products have been approved
at home and abroad.
Anti-tumor drugs are the key R&D areas of Chia Tai Tianqing Pharmaceutical, and TQB2102 for injection is the company's first ADC drug
.
Source: State Food and Drug Administration official website
TQB2102 for injection is an antibody conjugate drug (ADC)
independently developed by Chia Tai Tianqing Pharmaceutical targeting two non-overlapping epitopes of HER2, ECD2 and ECD4.
After intravenous blood injection of TQB2102 for injection, the antibody part binds to ECD2 and ECD4 on the surface of HER2-positive tumor cells, and the ADC complex is transported to lysosomes by intracellular swallowing, and the linker is digested and released small molecule drugs, resulting in DNA damage and cell death
。
According to the global new drug R&D database of Minai.
com, three ADCs targeting HER2 targets have been approved for marketing (excluding biosimilars) in the world, namely Roche's enmetrastuzumab, Rongchang/Seagen's vedicitumab and Daiichi Sankyo/AstraZenecadecab's dremituzumab
。
Globally approved for marketing HER2-targeting ADCs
Source: Minainet new version of the database
Emmetrastuzumab and vedicitumab have been approved for marketing in China, of which the sales of emmetrastuzumab in China's three major terminal markets in 2021 (see the end of this article for statistical scope) were close to 300 million yuan, a year-on-year increase of 102.
9%.
In recent years, the sales of enmetrastuzumab (: 10,000 yuan) in China's three major terminal markets (: 10,000 yuan) picture
Source: Minai Grid Bureau database
At present, no HER2-targeting bispecific ADCs have been approved for marketing at home and abroad, and many products under development are in the early stage of clinical practice
.
Compared with monoclonal antibody and monoclonal antibody ADC, HER2 bispecific antibody ADC has stronger binding, internalization efficiency and killing effect on tumor cells, and has advantages
for tumors with low expression of HER2.
At the same time, the specificity of biepitopes and the mechanism of action of ADC can effectively solve the drug resistance of monoclonal antibody and monoclonal antibody
.
Global development of some HER2-targeting bispecific ADCs
Source: Minainet new version of the database
Chia Tai Tianqing Pharmaceutical said that the approval of the clinical trial of TQB2102 advanced malignant tumor for injection will further enrich the company's pipeline of innovative oncology drugs and bring new treatment options
to the majority of patients with malignant tumors 。
Anti-tumor drugs are the key R&D areas of CP Tianqing Pharmaceutical, since the beginning of this year, the company has submitted 7 anti-tumor class 1 new drugs for clinical applications, and all of them have been approved for clinical trials; Two anti-tumor class 1 new drugs were submitted for marketing applications, namely TQ-B3101 capsules (ROS1/ALK/c-Met inhibitors) and TQ-B3139 capsules (ALK inhibitors).
According to data from Minai.
com, in 2021, the market size of anti-tumor and immunomodulators in China's three major terminal markets exceeded 200 billion yuan, a year-on-year increase of about 12.
5%.
Source: Minai.
com database, State Food and Drug Administration, etc.
Note: Minai.
com "China's three major terminal six major markets drug competition pattern", the statistical scope is: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, excluding county and rural pharmacies; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of December 27, if there is any omission, welcome to correct!
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