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ADC drugs, antibody conjugate drugs, combine the high specificity of monoclonal antibody (Antibody) drugs with the high activity of small molecule cytotoxic drugs (Cytotoxic drugs) to improve the targeting of tumor drugs and reduce toxic side effects
.
In recent years, with the continuous maturity of ADC drug research and development technology, global ADC drug innovation has gradually entered a golden development period from the early "bumpy development", and a large number of domestic and foreign pharmaceutical companies have also begun to vie for deployment
.
According to data, as of now, 13 ADC drugs have been marketed worldwide, of which a total of 3 ADC drugs have been launched on the market in the 16 years from 2000 to 2016.
However, in the past five years, there have been a total of 10 ADC drugs launched.
From the perspective of the R&D pipelines of domestic and foreign companies, ADC drugs have become the key direction of global innovative pharmaceutical companies.
The industry predicts that a new peak may be ushered in in 3-5 years
.
Among them, it is worth noting that in terms of indications and target distribution, tumors are currently the core direction of drug companies’ R&D focus, but the focus has shifted from hematomas to solid tumors; although HER2 is still a popular target, it is a new target.
The exploration is also becoming more and more diverse
.
At present, out of optimism about the ADC drug market prospects, a large number of domestic pharmaceutical companies are also vigorously deploying the ADC market
.
According to ClinicalTrials.
gov, as of March 19, 2021, 29 ADC drug clinical trials are ongoing in China
.
According to incomplete statistics, there are more than 20 domestic companies developing ADC drugs
.
On the whole, most domestic pipelines are still in the pre-clinical development and laboratory research and development stages, and the number of entering the clinical stage is relatively small, and they are mainly concentrated in the I clinical stage
.
However, on June 9, 2021, Rongchang Biotech's Her2-ADC drug has been approved for marketing
.
It is understood that Rongchang Biotechnology is one of the domestic companies that have deployed ADC drug research and development.
Its self-developed vedixituzumab was approved for listing in China in June this year for HER2 overexpression that has received at least 2 types of systemic chemotherapy.
Treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma)
.
On September 10 this year, CDE information showed that the second indication of Rongchang Bio-Vedicituzumab has also been formally included in the priority review for the treatment of previous systemic chemotherapy and the expression of HER2 as an immunohistochemical test.
The result is Patients with 2+ or 3+ locally advanced or metastatic urothelial carcinoma
.
Based on the main indications of the three ADC drugs that have been listed in the Chinese market, the industry expects that Rongchang Biotechnology and Seagen have reached the development and commercialization of China's first new ADC drug, vedicitumumab, with a total potential revenue of up to US$2.
6 billion
.
In addition to Rongchang Biology, domestic pharmaceutical companies that have deployed ADC drug research and development include Hengrui Pharmaceuticals, Zhejiang Pharmaceutical's Xinma Biology, Kelun Pharmaceutical's Kelun Botai, and Duoxi Biology, Lepu Biology, Junshi Biology, etc.
Business
.
Among them, Hengrui Medicine has established an antibody toxin fusion (ADC) technology platform with independent intellectual property rights, and has applied for a number of ADC drugs
.
Kelun Pharmaceutical's bio-pharmaceutical research and development platform, Kelun Botai Bio, is also accelerating the deployment of ADCs for the two targets of HER2 and TROP2
.
It is reported that its A166 (HER2-ADC) is progressing fast and has been approved to carry out HER2-positive breast cancer II clinical trials
.
From the above, it can be seen that while the ADC market continues to attract companies to enter the game, competition in related targets is also becoming increasingly fierce
.
In addition to fierce competition, from the industry's perspective, the development of ADC drugs is also facing more challenges, with a high rate of R&D failure, and it is necessary to prove the effectiveness of the drugs and the toxicity related to ADC drugs
.
It is understood that due to the difficulty of research and development, there have been many failures in a group of companies
.
For example, at the beginning of March this year, Biotech announced the abandonment of the clinical development of its ADC drugs BAT8003 and monoclonal antibody BAT1306
.
In addition, Biotech's other ADC drug BAT8001 Phase III clinical trial has also failed
.
In this regard, the industry believes that while seeing the promising prospects of ADC drugs, pharmaceutical companies need to be cautious in entering the market.
.
After entering the game, it is also necessary to continue to explore solutions to overcome the challenges in ADC development and accelerate the improvement of research and development efficiency in order to better benefit the patients and usher in more room for development
.
.
In recent years, with the continuous maturity of ADC drug research and development technology, global ADC drug innovation has gradually entered a golden development period from the early "bumpy development", and a large number of domestic and foreign pharmaceutical companies have also begun to vie for deployment
.
According to data, as of now, 13 ADC drugs have been marketed worldwide, of which a total of 3 ADC drugs have been launched on the market in the 16 years from 2000 to 2016.
However, in the past five years, there have been a total of 10 ADC drugs launched.
From the perspective of the R&D pipelines of domestic and foreign companies, ADC drugs have become the key direction of global innovative pharmaceutical companies.
The industry predicts that a new peak may be ushered in in 3-5 years
.
Among them, it is worth noting that in terms of indications and target distribution, tumors are currently the core direction of drug companies’ R&D focus, but the focus has shifted from hematomas to solid tumors; although HER2 is still a popular target, it is a new target.
The exploration is also becoming more and more diverse
.
At present, out of optimism about the ADC drug market prospects, a large number of domestic pharmaceutical companies are also vigorously deploying the ADC market
.
According to ClinicalTrials.
gov, as of March 19, 2021, 29 ADC drug clinical trials are ongoing in China
.
According to incomplete statistics, there are more than 20 domestic companies developing ADC drugs
.
On the whole, most domestic pipelines are still in the pre-clinical development and laboratory research and development stages, and the number of entering the clinical stage is relatively small, and they are mainly concentrated in the I clinical stage
.
However, on June 9, 2021, Rongchang Biotech's Her2-ADC drug has been approved for marketing
.
It is understood that Rongchang Biotechnology is one of the domestic companies that have deployed ADC drug research and development.
Its self-developed vedixituzumab was approved for listing in China in June this year for HER2 overexpression that has received at least 2 types of systemic chemotherapy.
Treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma)
.
On September 10 this year, CDE information showed that the second indication of Rongchang Bio-Vedicituzumab has also been formally included in the priority review for the treatment of previous systemic chemotherapy and the expression of HER2 as an immunohistochemical test.
The result is Patients with 2+ or 3+ locally advanced or metastatic urothelial carcinoma
.
Based on the main indications of the three ADC drugs that have been listed in the Chinese market, the industry expects that Rongchang Biotechnology and Seagen have reached the development and commercialization of China's first new ADC drug, vedicitumumab, with a total potential revenue of up to US$2.
6 billion
.
In addition to Rongchang Biology, domestic pharmaceutical companies that have deployed ADC drug research and development include Hengrui Pharmaceuticals, Zhejiang Pharmaceutical's Xinma Biology, Kelun Pharmaceutical's Kelun Botai, and Duoxi Biology, Lepu Biology, Junshi Biology, etc.
Business
.
Among them, Hengrui Medicine has established an antibody toxin fusion (ADC) technology platform with independent intellectual property rights, and has applied for a number of ADC drugs
.
Kelun Pharmaceutical's bio-pharmaceutical research and development platform, Kelun Botai Bio, is also accelerating the deployment of ADCs for the two targets of HER2 and TROP2
.
It is reported that its A166 (HER2-ADC) is progressing fast and has been approved to carry out HER2-positive breast cancer II clinical trials
.
From the above, it can be seen that while the ADC market continues to attract companies to enter the game, competition in related targets is also becoming increasingly fierce
.
In addition to fierce competition, from the industry's perspective, the development of ADC drugs is also facing more challenges, with a high rate of R&D failure, and it is necessary to prove the effectiveness of the drugs and the toxicity related to ADC drugs
.
It is understood that due to the difficulty of research and development, there have been many failures in a group of companies
.
For example, at the beginning of March this year, Biotech announced the abandonment of the clinical development of its ADC drugs BAT8003 and monoclonal antibody BAT1306
.
In addition, Biotech's other ADC drug BAT8001 Phase III clinical trial has also failed
.
In this regard, the industry believes that while seeing the promising prospects of ADC drugs, pharmaceutical companies need to be cautious in entering the market.
.
After entering the game, it is also necessary to continue to explore solutions to overcome the challenges in ADC development and accelerate the improvement of research and development efficiency in order to better benefit the patients and usher in more room for development
.
