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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
.
At present, as the targets of monoclonal antibodies continue to enter the state of competition in the Red Sea, double antibodies have become a new hot field of pharmaceutical research and development
.
In China, bispecific antibodies have ushered in a research and development boom in recent years, and new progress has continued
.
Since the beginning of this year, there have been many good news in the field of double-antibody drugs in China
.
On February 17, BeiGene’s HER2-targeted dual antibody ZW25 introduced from Zymeworks was included in the breakthrough therapy category by CDE.
The proposed indications are: monotherapy for HER2-positive locally advanced unresectable or Metastatic biliary tract cancer (BTC)
.
On January 13, 2022, Corning Jereh Biopharmaceuticals announced that a Phase II clinical study of the combination therapy of KN026 (HER2 dual antibody) and KN046 (PD-L1/CTLA-4 dual antibody) 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
.
On January 6, Henlius announced that the company's PD-L1/TIGIT dual antibody HLX301 clinical trial application was accepted by NMPA for the treatment of various advanced solid tumors.
This is also the third PD-L1/TIGIT clinical trial application in China.
L1/TIGIT dual antibody
.
On January 5, Pharmaco announced that its self-developed Kadeninumab (AK104) combined with AK112 double antibody phase Ib/II clinical trial application was approved by NMPA, with or without chemotherapy for the treatment of advanced non-small cell lung cancer.
The clinical study is the world's first dual-antibody + dual-antibody combination therapy to enter the clinical stage
.
.
.
.
According to incomplete statistics, there are currently about 80 dual-antibody drugs in the clinical stage in China, of which at least 8 are in Phase III clinical trials and 25 are in Phase II clinical trials
.
From the perspective of progress, Kadeninumab is already in the stage of application for marketing.
In September 2021, the marketing application of Kadeninumab injection was accepted by the CDE, which is used for recurrent or metastatic patients who have failed platinum-containing chemotherapy in the past.
cervical cancer patients
.
In addition, according to public information, although the double antibodies under research in China are mainly used for the treatment of tumors, the targets of these double antibodies are very diverse, such as PD-L1/4-1BB, EGFR/MET, CD3/CD20, etc.
is a popular target
.
Among them, the research and development of double antibodies against the PD-(L)1 target is particularly hot.
The companies that have deployed include Innovent Bio, Junshi Bio, Chia Tai Tianqing, Sunshine Guojian,
etc.
In this regard, the industry believes that the research and development of new domestic double-antibody drugs has exploded, and it is expected that domestic double-antibody drugs are expected to usher in a wave of listing in 2022-2023, and begin to enter the stage of commercialization competition
.
According to this development trend, it is expected that the domestic market of double-antibody drugs will reach 5 billion yuan by 2024
.
However, it should be noted that in recent years, the popular trend of double antibody research and development has grown, and its huge market potential is attracting more and more companies to increase their layout
.
Affected by this, in the future, there may be a phenomenon of R&D crowding together, and the track will become crowded.
Therefore, pharmaceutical companies need to make arrangements in advance to avoid the intensification of homogeneous competition
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
At present, as the targets of monoclonal antibodies continue to enter the state of competition in the Red Sea, double antibodies have become a new hot field of pharmaceutical research and development
.
In China, bispecific antibodies have ushered in a research and development boom in recent years, and new progress has continued
.
Since the beginning of this year, there have been many good news in the field of double-antibody drugs in China
.
On February 17, BeiGene’s HER2-targeted dual antibody ZW25 introduced from Zymeworks was included in the breakthrough therapy category by CDE.
The proposed indications are: monotherapy for HER2-positive locally advanced unresectable or Metastatic biliary tract cancer (BTC)
.
On January 13, 2022, Corning Jereh Biopharmaceuticals announced that a Phase II clinical study of the combination therapy of KN026 (HER2 dual antibody) and KN046 (PD-L1/CTLA-4 dual antibody) 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
.
On January 6, Henlius announced that the company's PD-L1/TIGIT dual antibody HLX301 clinical trial application was accepted by NMPA for the treatment of various advanced solid tumors.
This is also the third PD-L1/TIGIT clinical trial application in China.
L1/TIGIT dual antibody
.
On January 5, Pharmaco announced that its self-developed Kadeninumab (AK104) combined with AK112 double antibody phase Ib/II clinical trial application was approved by NMPA, with or without chemotherapy for the treatment of advanced non-small cell lung cancer.
The clinical study is the world's first dual-antibody + dual-antibody combination therapy to enter the clinical stage
.
.
.
.
According to incomplete statistics, there are currently about 80 dual-antibody drugs in the clinical stage in China, of which at least 8 are in Phase III clinical trials and 25 are in Phase II clinical trials
.
From the perspective of progress, Kadeninumab is already in the stage of application for marketing.
In September 2021, the marketing application of Kadeninumab injection was accepted by the CDE, which is used for recurrent or metastatic patients who have failed platinum-containing chemotherapy in the past.
cervical cancer patients
.
In addition, according to public information, although the double antibodies under research in China are mainly used for the treatment of tumors, the targets of these double antibodies are very diverse, such as PD-L1/4-1BB, EGFR/MET, CD3/CD20, etc.
is a popular target
.
Among them, the research and development of double antibodies against the PD-(L)1 target is particularly hot.
The companies that have deployed include Innovent Bio, Junshi Bio, Chia Tai Tianqing, Sunshine Guojian,
etc.
In this regard, the industry believes that the research and development of new domestic double-antibody drugs has exploded, and it is expected that domestic double-antibody drugs are expected to usher in a wave of listing in 2022-2023, and begin to enter the stage of commercialization competition
.
According to this development trend, it is expected that the domestic market of double-antibody drugs will reach 5 billion yuan by 2024
.
However, it should be noted that in recent years, the popular trend of double antibody research and development has grown, and its huge market potential is attracting more and more companies to increase their layout
.
Affected by this, in the future, there may be a phenomenon of R&D crowding together, and the track will become crowded.
Therefore, pharmaceutical companies need to make arrangements in advance to avoid the intensification of homogeneous competition
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
