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In recent years, the track of PD-1, CAR-T cell therapy, antibody-conjugated drugs (ADC), etc.
has been hot, with more and more entrants at home and abroad, capital has continued to enter the game, and news of the R&D pipeline has been reported frequently
.
Among them, racetracks such as PD-1 have even become very crowded, and the competition between enterprises and enterprises has become increasingly fierce
.
In this context, some institutions are also looking for new outlets
.
The industry believes that after PD-1, CAR-T, and ADC, double-antibody drugs are becoming a new trend
.
Different from the single targeting of monoclonal antibodies, double antibodies contain two specific antigen binding sites, which can stimulate specific biological functions such as stimulating a directed immune response by binding to different epitopes
.
According to statistics, currently 61 dual-antibiotic varieties have been approved for clinical trials in China, involving 46 companies in deployment, of which the first dual-antibiotic drugs may be approved for marketing in 2022
.
In addition, 58 dual-antibody projects have been declared clinically this year, an increase of 75% compared with the 33 in 2020
.
The author has learned that there is good news about the progress of dual anti-drugs in the near future
.
For example, on August 24, Kangfang Biotechnology announced that the Center for Drug Evaluation had agreed to the company's submission of a new drug application for Cadonilimab (AK104, PD-1/CTLA4 dual antibody) for the treatment of recurrent or metastatic cervical cancer, and gave priority review qualifications
.
The clinical study has reached the primary endpoint and achieved significant positive results
.
Cadonilimab is therefore expected to be the first PD-1 based bispecific antibody drug approved for marketing
.
The product is expected to be approved in 2022.
According to brokerage estimates, the peak sales of Cadonilimab are expected to reach 5 billion yuan
.
On the evening of August 23, Corning Jereh also announced that the company and CSPC have reached a cooperation agreement on the HER2 dual-antibody KN026 that Corning Jereh is researching
.
The content is about the exclusive development and commercial authorization of KN026 in breast and gastric cancer (in this field)
.
Based on this authorization, Corning Jerry will receive up to 1 billion yuan in advance and milestone payments
.
It is reported that KN026 is a bispecific antibody drug targeting HER2 with independent intellectual property rights developed by Corning Jereh.
At present, KN026 is conducting a number of phase I/II clinical studies in China and the United States to evaluate the treatment of low HER2 expression or HER2.
Positive breast cancer; advanced HER2-positive gastric cancer, gastroesophageal junction cancer and other HER2-positive solid tumors and other indications
.
According to company disclosures, KN026 is expected to be commercialized in 2023
.
According to the forecast of Soochow Securities, KN026 is expected to exceed one billion sales in 2026 for gastric cancer, esophageal cancer, and breast cancer indications, and reach 1.
66 billion yuan in 2028
.
In addition to these two fast-moving companies, Cinda Bio, BeiGene, and Baili Pharmaceuticals are actively deploying in the field of double antibodies in China
.
Among them, Cinda Bio has seven dual antibodies that have entered the clinic, and the PD-1/PD-L1 dual antibody IBI318 is progressing faster.
A phase Ib/III clinical trial has been launched at the end of November 2020 to evaluate IBI318 combined with paclitaxel.
It is used for small cell lung cancer patients who have failed standard first-line chemotherapy or above; BeiGene currently has 6 imported double antibody products, of which the fastest-growing one is the HER2/HER2 double antibody ZW25 jointly developed by the company and Zymeworks, which is currently under development in China.
Phase clinical
.
After sorting out the industry, there are currently three main growth paths for dual antibody drug R&D companies, including: companies master dual antibody platform technology and focus on dual antibody drug development; companies based on their own mastery of antibody technology or other biotechnology, cut into dual antibody technology In the field of resistance: Comprehensive large-scale pharmaceutical companies rely on their own years of development, and quickly cut into the emerging subdivision track with capital, technology and human resources
.
The industry believes that in recent years, the hot trend in the research and development of anti-double-antibodies has become longer.
With more and more companies in the field of anti-double-antibodies, the phenomenon of R&D may appear in the future, the track will also become crowded, and the homogenization competition will become more intense.
.
In this context, the layout of enterprises may also face severe challenges
.
has been hot, with more and more entrants at home and abroad, capital has continued to enter the game, and news of the R&D pipeline has been reported frequently
.
Among them, racetracks such as PD-1 have even become very crowded, and the competition between enterprises and enterprises has become increasingly fierce
.
In this context, some institutions are also looking for new outlets
.
The industry believes that after PD-1, CAR-T, and ADC, double-antibody drugs are becoming a new trend
.
Different from the single targeting of monoclonal antibodies, double antibodies contain two specific antigen binding sites, which can stimulate specific biological functions such as stimulating a directed immune response by binding to different epitopes
.
According to statistics, currently 61 dual-antibiotic varieties have been approved for clinical trials in China, involving 46 companies in deployment, of which the first dual-antibiotic drugs may be approved for marketing in 2022
.
In addition, 58 dual-antibody projects have been declared clinically this year, an increase of 75% compared with the 33 in 2020
.
The author has learned that there is good news about the progress of dual anti-drugs in the near future
.
For example, on August 24, Kangfang Biotechnology announced that the Center for Drug Evaluation had agreed to the company's submission of a new drug application for Cadonilimab (AK104, PD-1/CTLA4 dual antibody) for the treatment of recurrent or metastatic cervical cancer, and gave priority review qualifications
.
The clinical study has reached the primary endpoint and achieved significant positive results
.
Cadonilimab is therefore expected to be the first PD-1 based bispecific antibody drug approved for marketing
.
The product is expected to be approved in 2022.
According to brokerage estimates, the peak sales of Cadonilimab are expected to reach 5 billion yuan
.
On the evening of August 23, Corning Jereh also announced that the company and CSPC have reached a cooperation agreement on the HER2 dual-antibody KN026 that Corning Jereh is researching
.
The content is about the exclusive development and commercial authorization of KN026 in breast and gastric cancer (in this field)
.
Based on this authorization, Corning Jerry will receive up to 1 billion yuan in advance and milestone payments
.
It is reported that KN026 is a bispecific antibody drug targeting HER2 with independent intellectual property rights developed by Corning Jereh.
At present, KN026 is conducting a number of phase I/II clinical studies in China and the United States to evaluate the treatment of low HER2 expression or HER2.
Positive breast cancer; advanced HER2-positive gastric cancer, gastroesophageal junction cancer and other HER2-positive solid tumors and other indications
.
According to company disclosures, KN026 is expected to be commercialized in 2023
.
According to the forecast of Soochow Securities, KN026 is expected to exceed one billion sales in 2026 for gastric cancer, esophageal cancer, and breast cancer indications, and reach 1.
66 billion yuan in 2028
.
In addition to these two fast-moving companies, Cinda Bio, BeiGene, and Baili Pharmaceuticals are actively deploying in the field of double antibodies in China
.
Among them, Cinda Bio has seven dual antibodies that have entered the clinic, and the PD-1/PD-L1 dual antibody IBI318 is progressing faster.
A phase Ib/III clinical trial has been launched at the end of November 2020 to evaluate IBI318 combined with paclitaxel.
It is used for small cell lung cancer patients who have failed standard first-line chemotherapy or above; BeiGene currently has 6 imported double antibody products, of which the fastest-growing one is the HER2/HER2 double antibody ZW25 jointly developed by the company and Zymeworks, which is currently under development in China.
Phase clinical
.
After sorting out the industry, there are currently three main growth paths for dual antibody drug R&D companies, including: companies master dual antibody platform technology and focus on dual antibody drug development; companies based on their own mastery of antibody technology or other biotechnology, cut into dual antibody technology In the field of resistance: Comprehensive large-scale pharmaceutical companies rely on their own years of development, and quickly cut into the emerging subdivision track with capital, technology and human resources
.
The industry believes that in recent years, the hot trend in the research and development of anti-double-antibodies has become longer.
With more and more companies in the field of anti-double-antibodies, the phenomenon of R&D may appear in the future, the track will also become crowded, and the homogenization competition will become more intense.
.
In this context, the layout of enterprises may also face severe challenges
.
