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▎Editor of WuXi AppTec's content team recently, an antibody-conjugated drug (ADC)-Ogaituzumab for injection Bosa; English trade name BESPONSA), approved for marketing by the National Medical Products Administration (NMPA) of China, and indicated for "adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL)
.
"
Screenshot source: NMPA official website According to public information, Ogaituzumab is the first CD22-targeting antibody conjugate drug approved by the U.
S.
Food and Drug Administration (FDA); at the same time, Ogaituzumab It is also the first approved antibody-conjugated drug in the field of treatment of relapsed or refractory precursor B-cell acute lymphoblastic leukemia in China
.
The approval of this drug in China will provide patients with new treatment options
.
Common hematological malignancies Leukemia is a common hematological malignancy
.
According to data released by the International Agency for Research on Cancer (IARC), 85,000 new leukemia patients will be added to China in 2020, resulting in 62,000 deaths
.
According to the differentiation and maturity of leukemia cells and the natural course of the disease, leukemia can be divided into two categories: acute and chronic
.
Acute leukemia (AL) develops rapidly, with a natural course of only a few months
.
Chronic leukemia (CL) develops slowly, with a natural course of several years
.
In China, there are more patients with acute leukemia than chronic leukemia (about 5.
5:1); the incidence of men is slightly higher than that of women (1.
81:1)
.
According to the main cell series involved, acute leukemia can be divided into acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML); chronic leukemia can be divided into chronic myeloid leukemia (CML) and chronic lymphocytic leukemia (CLL) And rare types of leukemia
.
Acute lymphocytic leukemia accounts for about 15% of all leukemias, and accounts for 30%-40% of acute leukemias.
It is a malignant tumor disease in which B-line or T-line cells derived from lymphocytes proliferate abnormally in the bone marrow
.
Abnormally proliferated primitive cells can accumulate in the bone marrow and inhibit normal hematopoietic function, and can also invade tissues outside the bone marrow
.
For the treatment of acute lymphoblastic leukemia, the current standard therapy is long-term high-intensity chemotherapy
.
However, after the initial treatment, 10%-20% of patients cannot be effectively relieved, which means that they have not responded to the treatment
.
Among those patients who appear in remission, half of the patients will relapse, and the five-year overall survival rate is less than 10%
.
Under traditional standard chemotherapy regimens, it is difficult for patients with relapsed or refractory acute lymphoblastic leukemia to achieve complete remission and achieve long-term survival.
It is estimated that their median survival time is only 4.
5-6 months
.
Therefore, these patients urgently need innovative treatment methods
.
Image source: 123RF antibody-conjugated drug Ogaituzumab is an antibody-conjugated drug targeting CD22
.
CD22 is a cell surface antigen found on tumor cells.
In patients with precursor B-cell acute lymphoblastic leukemia, at least 90% of patients express CD22 on the surface of tumor cells
.
Ogaituzumab consists of two parts
.
One part is a monoclonal antibody targeting CD22, and the other part is the cytotoxic drug calicheamicin
.
Monoclonal antibodies are "navigators" that identify tumor cells and can achieve precise guidance
.
When the monoclonal antibody of Ogaituzumab recognizes and binds to the CD22 antigen on the surface of the tumor cell, the antibody-conjugated drug will be brought into the tumor cell; then the cytotoxic drug is released in the tumor cell— -Caulisomycin, which launches a fierce attack from the inside and eventually kills tumor cells
.
▲The safety and efficacy of antibody-conjugated drugs combined with antigen molecules on the surface of cancer cells (picture source: produced by WuXi AppTec's content team) have been evaluated for safety and efficacy
.
The safety and effectiveness of Ogaituzumab have been evaluated .
Based on the data when Ogaituzumab was approved in the United States, a total of 326 precursor B-cell acute lymphoid patients were recruited in a phase 3 randomized, open-label, multi-center international clinical trial named INO-VATE ALL.
Adult patients with cell leukemia
.
Some of the patients were treated with Ogaituzumab, and the other received chemotherapy
.
The study found that the complete remission rate (CR) of patients in the ozaituzumab group was 81%, while the data in the chemotherapy group was only 29%
.
Among all patients who achieved complete remission, patients in the Ogaituzumab group had a higher negative rate of minimal residual disease (MRD) at 78%, compared with 28% in the chemotherapy group
.
The median overall survival of patients in the Ogaituzumab group was 7.
7 months, and that of the chemotherapy group was 6.
2 months
.
In terms of safety, the researchers pointed out that Ogaituzumab may cause liver toxicity
.
Image source: 123RF We expect that with the approval of Ogaituzumab for injection in China, patients can have more treatment options and save more patients' lives
.
Recommended reading Another new drug was approved in China, reducing the recurrence rate by more than 50% every year! You can get the first-line treatment of non-small cell lung cancer at home, and the new PD-L1 monoclonal antibody was approved for marketing.
Another new cancer drug was approved in China! This refractory tumor has a new choice for China to usher in the first new crown neutralizing antibody combination therapy! The risk of hospitalization and death of patients is significantly reduced in urgent clinical needs! For the treatment of this disease, Stuximab was approved for marketing reference materials [1] The information on the drug approval documents pending receipt of the China National Medical Products Administration on December 22.
Retrieved Dec 23, 2021, from https:// gov.
cn/zwfw/sdxx/sdxxyp/yppjfb/20211222083936105.
html[2] Acute leukemia "breakers"! Pfizer's innovative drug Bebossa® (Ogaituzumab for injection) was approved in China.
Retrieved Dec 23, 2021, from http:// /news_cn.
aspx?id=683[3] Pfizer Receives US FDA Approval for BESPONSA® (inotuzumab ozogamicin).
Retrieved Dec 23, 2021, from https:// -detail/pfizer_receives_u_s_fda_approval_for_besponsa_inotuzumab_ozogamicin[4] Ge Junbo, Xu Yongjian, Wang Chen.
Internal Medicine [M].
9th edition.
Beijing: People's Medical Publishing House, 2018.
Disclaimer: WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
.
"
Screenshot source: NMPA official website According to public information, Ogaituzumab is the first CD22-targeting antibody conjugate drug approved by the U.
S.
Food and Drug Administration (FDA); at the same time, Ogaituzumab It is also the first approved antibody-conjugated drug in the field of treatment of relapsed or refractory precursor B-cell acute lymphoblastic leukemia in China
.
The approval of this drug in China will provide patients with new treatment options
.
Common hematological malignancies Leukemia is a common hematological malignancy
.
According to data released by the International Agency for Research on Cancer (IARC), 85,000 new leukemia patients will be added to China in 2020, resulting in 62,000 deaths
.
According to the differentiation and maturity of leukemia cells and the natural course of the disease, leukemia can be divided into two categories: acute and chronic
.
Acute leukemia (AL) develops rapidly, with a natural course of only a few months
.
Chronic leukemia (CL) develops slowly, with a natural course of several years
.
In China, there are more patients with acute leukemia than chronic leukemia (about 5.
5:1); the incidence of men is slightly higher than that of women (1.
81:1)
.
According to the main cell series involved, acute leukemia can be divided into acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML); chronic leukemia can be divided into chronic myeloid leukemia (CML) and chronic lymphocytic leukemia (CLL) And rare types of leukemia
.
Acute lymphocytic leukemia accounts for about 15% of all leukemias, and accounts for 30%-40% of acute leukemias.
It is a malignant tumor disease in which B-line or T-line cells derived from lymphocytes proliferate abnormally in the bone marrow
.
Abnormally proliferated primitive cells can accumulate in the bone marrow and inhibit normal hematopoietic function, and can also invade tissues outside the bone marrow
.
For the treatment of acute lymphoblastic leukemia, the current standard therapy is long-term high-intensity chemotherapy
.
However, after the initial treatment, 10%-20% of patients cannot be effectively relieved, which means that they have not responded to the treatment
.
Among those patients who appear in remission, half of the patients will relapse, and the five-year overall survival rate is less than 10%
.
Under traditional standard chemotherapy regimens, it is difficult for patients with relapsed or refractory acute lymphoblastic leukemia to achieve complete remission and achieve long-term survival.
It is estimated that their median survival time is only 4.
5-6 months
.
Therefore, these patients urgently need innovative treatment methods
.
Image source: 123RF antibody-conjugated drug Ogaituzumab is an antibody-conjugated drug targeting CD22
.
CD22 is a cell surface antigen found on tumor cells.
In patients with precursor B-cell acute lymphoblastic leukemia, at least 90% of patients express CD22 on the surface of tumor cells
.
Ogaituzumab consists of two parts
.
One part is a monoclonal antibody targeting CD22, and the other part is the cytotoxic drug calicheamicin
.
Monoclonal antibodies are "navigators" that identify tumor cells and can achieve precise guidance
.
When the monoclonal antibody of Ogaituzumab recognizes and binds to the CD22 antigen on the surface of the tumor cell, the antibody-conjugated drug will be brought into the tumor cell; then the cytotoxic drug is released in the tumor cell— -Caulisomycin, which launches a fierce attack from the inside and eventually kills tumor cells
.
▲The safety and efficacy of antibody-conjugated drugs combined with antigen molecules on the surface of cancer cells (picture source: produced by WuXi AppTec's content team) have been evaluated for safety and efficacy
.
The safety and effectiveness of Ogaituzumab have been evaluated .
Based on the data when Ogaituzumab was approved in the United States, a total of 326 precursor B-cell acute lymphoid patients were recruited in a phase 3 randomized, open-label, multi-center international clinical trial named INO-VATE ALL.
Adult patients with cell leukemia
.
Some of the patients were treated with Ogaituzumab, and the other received chemotherapy
.
The study found that the complete remission rate (CR) of patients in the ozaituzumab group was 81%, while the data in the chemotherapy group was only 29%
.
Among all patients who achieved complete remission, patients in the Ogaituzumab group had a higher negative rate of minimal residual disease (MRD) at 78%, compared with 28% in the chemotherapy group
.
The median overall survival of patients in the Ogaituzumab group was 7.
7 months, and that of the chemotherapy group was 6.
2 months
.
In terms of safety, the researchers pointed out that Ogaituzumab may cause liver toxicity
.
Image source: 123RF We expect that with the approval of Ogaituzumab for injection in China, patients can have more treatment options and save more patients' lives
.
Recommended reading Another new drug was approved in China, reducing the recurrence rate by more than 50% every year! You can get the first-line treatment of non-small cell lung cancer at home, and the new PD-L1 monoclonal antibody was approved for marketing.
Another new cancer drug was approved in China! This refractory tumor has a new choice for China to usher in the first new crown neutralizing antibody combination therapy! The risk of hospitalization and death of patients is significantly reduced in urgent clinical needs! For the treatment of this disease, Stuximab was approved for marketing reference materials [1] The information on the drug approval documents pending receipt of the China National Medical Products Administration on December 22.
Retrieved Dec 23, 2021, from https:// gov.
cn/zwfw/sdxx/sdxxyp/yppjfb/20211222083936105.
html[2] Acute leukemia "breakers"! Pfizer's innovative drug Bebossa® (Ogaituzumab for injection) was approved in China.
Retrieved Dec 23, 2021, from http:// /news_cn.
aspx?id=683[3] Pfizer Receives US FDA Approval for BESPONSA® (inotuzumab ozogamicin).
Retrieved Dec 23, 2021, from https:// -detail/pfizer_receives_u_s_fda_approval_for_besponsa_inotuzumab_ozogamicin[4] Ge Junbo, Xu Yongjian, Wang Chen.
Internal Medicine [M].
9th edition.
Beijing: People's Medical Publishing House, 2018.
Disclaimer: WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
