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Bispecific antibody drug (abbreviated as double antibody) is a new type of second-generation antibody with two specific antigen binding sites, which can interact with target cells and functional cells at the same time, thereby enhancing the killing of target cells
.
In recent years, as the targets of monoclonal antibodies continue to enter the state of competition in the Red Sea, the enthusiasm for research and development of double-antibody projects has continued to rise
.
Compared with monoclonal antibodies, double antibodies add a specific antigen binding site, which is more specific, can more accurately target tumor cells and reduce off-target toxicity
.
However, at the same time, the development of double-antibody drugs is more complex, and the technical barriers and adaptability requirements for technology platform and target selection are also higher
.
It is also because of this that the development of double-antibody drugs in the world has been slow.
It is reported that currently only 4 double-antibody drugs have been approved for marketing in the world, and no PD-1-targeted double-antibody drugs have been approved for marketing
.
It is understood that the currently listed dual-antibody drugs are Removab, Blincyto, Hemlibra, and Rybrevant
.
Among them, Removab is the world's first commercialized dual-antibody drug, developed by Trion Pharma.
It can simultaneously target the T cell surface antigen receptor CD3 and the cancer cell marker EpCAM.
CD3 is a T cell recruitment target.
EpCAM stands for epithelial cell adhesion molecule.
, plays an important role in various biological functions such as tumor cell proliferation, differentiation, migration and immune escape
.
Blincyto is a dual-antibody drug developed based on Amgen's BiTE platform.
It was approved by the FDA in 2014 for the treatment of adults and children with relapsed or refractory precursor B-cell acute lymphoblastic leukemia; in 2018, Blincyto expanded its indications to Minimal residual disease (MRD)-positive precursor B-cell acute lymphoblastic leukemia
.
In December 2020, Blincyto was approved by the NMPA for the treatment of adults with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL)
.
Domestically, BeiGene holds its development and commercialization rights
.
Hemlibra is a double antibody product developed by Roche, a recombinant humanized IgG4 bispecific monoclonal antibody
.
Rybrevant is a bispecific EGF receptor-directed and MET receptor-directed antibody, produced and developed by Janssen Biotech, Inc.
, USA, and approved by the FDA for EGFR exon 20 insertion mutation, platinum-based chemotherapy or subsequent Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progressive disease
.
Although there are not many double-antibody drugs currently on the market, according to statistics, there are now hundreds of double-antibody drugs in clinical stage in the world, and some of them are already in clinical phase III.
The era of double-antibody drugs is expected to fully open in the next 3-5 years
.
Among them, on December 29, 2021, Johnson & Johnson announced that its subsidiary, Janssen, has submitted a Biologics License Application (BLA) to the U.
S.
FDA for the BCMA/CD3 bispecific antibody teclistamab for the treatment of relapsed or refractory multiple myeloma (r/r MM).
)
.
From a domestic point of view, there are currently more than 100 double antibody projects under development in China.
The data shows that the number of CDE double antibody projects accepted in the first four months of 2021 is 29, an increase of about 9 times compared with the same period of the previous year
.
In the domestic double antibody project research, the research and development results of Kangfang Bio and Corning Jereh are outstanding
.
For example, Kangfang Bio's AK104 is a new generation of potential human-derived tetrameric bispecific antibody drugs, targeting both PD-1 and CTLA-4.
Currently, more than 10 clinical trials are being carried out at the same time, with indications covering cervical cancer, nasopharyngeal cancer, gastric cancer, liver cancer, non-small cell lung cancer,
etc.
AK112 can simultaneously recognize and bind the immunosuppressive molecule PD-1 and the vascular endothelial growth factor VEGF
.
Recently, Kangfang Bio announced that its Phase Ib/II clinical trial application of AK104 combined with AK112 has been approved by China's CDE, with or without chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC)
.
On January 13, 2022, Corning Jereh Biopharmaceutical announced that a phase II clinical study of KN026 (HER2 dual antibody) and KN046 (PD-L1/CTLA-4 dual antibody) combination therapy was conducted in China (Study No.
: KN026-203) successfully completed the enrollment of all patients, and an interim analysis is expected in the second quarter of 2022
.
In addition, on January 4, 2022, Henlius announced that the company's self-developed HLX35 (recombinant human anti-EGFR and anti-4-1BB bispecific antibody injection) has been approved by the State Food and Drug Administration for a clinical trial application (IND).
, intended for the treatment of advanced malignant solid tumors
.
The company plans to launch a Phase I clinical trial in the near future
.
.
In recent years, as the targets of monoclonal antibodies continue to enter the state of competition in the Red Sea, the enthusiasm for research and development of double-antibody projects has continued to rise
.
Compared with monoclonal antibodies, double antibodies add a specific antigen binding site, which is more specific, can more accurately target tumor cells and reduce off-target toxicity
.
However, at the same time, the development of double-antibody drugs is more complex, and the technical barriers and adaptability requirements for technology platform and target selection are also higher
.
It is also because of this that the development of double-antibody drugs in the world has been slow.
It is reported that currently only 4 double-antibody drugs have been approved for marketing in the world, and no PD-1-targeted double-antibody drugs have been approved for marketing
.
It is understood that the currently listed dual-antibody drugs are Removab, Blincyto, Hemlibra, and Rybrevant
.
Among them, Removab is the world's first commercialized dual-antibody drug, developed by Trion Pharma.
It can simultaneously target the T cell surface antigen receptor CD3 and the cancer cell marker EpCAM.
CD3 is a T cell recruitment target.
EpCAM stands for epithelial cell adhesion molecule.
, plays an important role in various biological functions such as tumor cell proliferation, differentiation, migration and immune escape
.
Blincyto is a dual-antibody drug developed based on Amgen's BiTE platform.
It was approved by the FDA in 2014 for the treatment of adults and children with relapsed or refractory precursor B-cell acute lymphoblastic leukemia; in 2018, Blincyto expanded its indications to Minimal residual disease (MRD)-positive precursor B-cell acute lymphoblastic leukemia
.
In December 2020, Blincyto was approved by the NMPA for the treatment of adults with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL)
.
Domestically, BeiGene holds its development and commercialization rights
.
Hemlibra is a double antibody product developed by Roche, a recombinant humanized IgG4 bispecific monoclonal antibody
.
Rybrevant is a bispecific EGF receptor-directed and MET receptor-directed antibody, produced and developed by Janssen Biotech, Inc.
, USA, and approved by the FDA for EGFR exon 20 insertion mutation, platinum-based chemotherapy or subsequent Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progressive disease
.
Although there are not many double-antibody drugs currently on the market, according to statistics, there are now hundreds of double-antibody drugs in clinical stage in the world, and some of them are already in clinical phase III.
The era of double-antibody drugs is expected to fully open in the next 3-5 years
.
Among them, on December 29, 2021, Johnson & Johnson announced that its subsidiary, Janssen, has submitted a Biologics License Application (BLA) to the U.
S.
FDA for the BCMA/CD3 bispecific antibody teclistamab for the treatment of relapsed or refractory multiple myeloma (r/r MM).
)
.
From a domestic point of view, there are currently more than 100 double antibody projects under development in China.
The data shows that the number of CDE double antibody projects accepted in the first four months of 2021 is 29, an increase of about 9 times compared with the same period of the previous year
.
In the domestic double antibody project research, the research and development results of Kangfang Bio and Corning Jereh are outstanding
.
For example, Kangfang Bio's AK104 is a new generation of potential human-derived tetrameric bispecific antibody drugs, targeting both PD-1 and CTLA-4.
Currently, more than 10 clinical trials are being carried out at the same time, with indications covering cervical cancer, nasopharyngeal cancer, gastric cancer, liver cancer, non-small cell lung cancer,
etc.
AK112 can simultaneously recognize and bind the immunosuppressive molecule PD-1 and the vascular endothelial growth factor VEGF
.
Recently, Kangfang Bio announced that its Phase Ib/II clinical trial application of AK104 combined with AK112 has been approved by China's CDE, with or without chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC)
.
On January 13, 2022, Corning Jereh Biopharmaceutical announced that a phase II clinical study of KN026 (HER2 dual antibody) and KN046 (PD-L1/CTLA-4 dual antibody) combination therapy was conducted in China (Study No.
: KN026-203) successfully completed the enrollment of all patients, and an interim analysis is expected in the second quarter of 2022
.
In addition, on January 4, 2022, Henlius announced that the company's self-developed HLX35 (recombinant human anti-EGFR and anti-4-1BB bispecific antibody injection) has been approved by the State Food and Drug Administration for a clinical trial application (IND).
, intended for the treatment of advanced malignant solid tumors
.
The company plans to launch a Phase I clinical trial in the near future
.
