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Recent popular reports from Yimaike ★Oncolytic virus events: A new journey of tumor immunityYimai new observations ★The commercialization process of China's CAR-T cell therapy: large-scale purification of viral vectorsYimai Meng broke the news.
Click on the picture and sign up immediately for 2021 July 14/eMedClub News/--Recently, Johnson & Johnson's Janssen company announced that the US Food and Drug Administration (FDA) approved the anti-CD38 monoclonal antibody Darzalex Faspro combined with Poma Dolamine and dexamethasone are used in the second-line treatment of adult patients with multiple myeloma
.
Multiple myeloma (MM) is a malignant tumor that originates from the abnormal proliferation of plasma cells in the bone marrow of pre-B cells
.
During the progression of MM, the plasma cells in the bone marrow will rapidly diffuse and replace normal cells, and at the same time abnormally proliferate a large number of monoclonal immunoglobulin molecules (M proteins), posing a serious threat to health
.
It is estimated that by 2021, more than 34,000 people in the United States will be diagnosed and nearly 12,000 people will die from the disease
.
Traditional chemotherapy is the standard method for the treatment of multiple myeloma.
Chemotherapy can kill multiple myeloma cells in most patients.
This is also one of the most direct ways to eliminate tumors
.
However, due to the special pathogenesis of hematological tumors, MM often requires high-dose chemotherapy, which has obvious side effects and is prone to drug resistance
.
In addition, because there are no obvious symptoms in the early stage of the disease, the recurrence rate of multiple myeloma after treatment is quite high.
MM is often the target of doctors' headaches, so people began to explore new treatment options
.
Darzalex (Daratumumab) is an intravenously injected CD38 monoclonal antibody, and Darzalex Faspro is a subcutaneous preparation of Darzalex.
It is the first CD38-targeted antibody approved for subcutaneous injection for the treatment of multiple myeloma, which can increase the treatment time Significantly shortened from a few hours to 3-5 minutes
.
▲Darzalex Faspro and Darzalex Darzalex Faspro and Darzalex have the same curative effect, and significantly shorten the treatment time (from several hours to 3-5 minutes), which greatly reduces the incidence of systemic drug-related reactions (ARR)
.
This approval marks an important milestone and will help positively change the lives of MM patients who rely on Darzalex treatment
.
This approval is based on an ongoing multi-center, phase 3 clinical study APOLLO, which aims to evaluate the combination of daratumomab with pomalidomide and dexamethasone (hereinafter referred to as the D-Pd group) and the use of po Comparison of the curative effect of madomide and dexamethasone (hereinafter referred to as Pd group)
.
The results of the study showed that the D-Pd regimen reached the primary endpoint of improving progression-free survival (PFS)
.
To learn more about the data, scan the QR code for a complete read.
"We focus on the continuous development of Darzalex Faspro and advance this innovative therapy for patients who need additional treatment options
.
" Dr.
Craig Tendler, Vice President of Clinical Development and Global Medical Affairs, Janssen Said, “Today’s approval further differentiates Darzalex Faspro in the treatment of multiple myeloma because it is the first and only subcutaneous anti-CD38 approved in combination with the widely used pomalidomide and dexamethasone regimen.
Monoclonal antibodies
.
"▲ Dr.
Craig Tendler, Vice President of Clinical Development and Global Medical Affairs of Janssen (Image source: Janssen’s official website) Currently, Darzalex has been approved for marketing in China in October 2019 and is suitable for single-drug treatment of adult patients with relapsed and refractory MM.
listing application was also Darzalex Faspro® 2020 November 6 won CDE accepted
.
CD38 antibody treatment of multiple myeloma, CD38 is highly expressed on myeloma cells, and in normal lymphocytes, myeloid cells and some non-hematopoietic tissue sources It is also expressed at low levels, so the use of anti-CD38 antibodies has little effect on the activity of normal cells
.
In recent years, a variety of new immunotherapies targeting CD38 have been verified in preclinical models and clinical trials, including Darzalex The success of a typical CD38 monoclonal antibody has made CD38 a popular target for the treatment of MM
.
In October 2019, Tianjing Biotechnology (Shanghai) Co.
, Ltd.
(hereinafter referred to as "Tianjing Bio") and German MorphoSys announced that The source monoclonal CD38 antibody (TJ202/MOR202) was approved by the China National Medical Products Administration (NMPA) for Phase II and Phase III clinical trials.
The indication is relapsed or refractory myeloma
.
Recommended reading: CD38 monoclonal antibody has been approved more In a clinical trial, the target became the backbone of targeted therapy for multiple myelomaYimai Meng broke the news in March 2020, Sanofi’s CD38 monoclonal antibody isatuximab combined with standard care (pomalidomide + dexamethasone, pom) -dex) The Biologics License Application (BLA) for the treatment of relapsed/refractory multiple myeloma (r/r MM) was approved by the FDA, and isatuximab became the second CD38 monoclonal antibody drug approved by the FDA for the treatment of MM
.
2021 On January 12, the recombinant anti-CD38 fully human monoclonal antibody injection (HLX15) of Shanghai Fuhong Hanlin Biopharmaceutical Co.
, Ltd.
, a subsidiary of Shanghai Fosun, obtained the implied license for clinical trials from the China National Medical Products Administration.
The indication is multiple bone marrow.
Tumor (MM)
.
Recommended reading: Fuhong Hanlius' CD38 monoclonal antibody was approved for clinical use, and the CD38 target has become a popular target for the treatment of multiple myelomaYimai Meng broke the news in July 2021, XNK Therapeutics' autologous natural killer (NK) cell therapy candidate drug The first patient has been included in the Phase II clinical study of CellProtect.
The drug is used in combination with Sanofi's anti-CD38 antibody Sarclisa (Isatuximab) to treat patients with multiple myeloma
.
Recommended reading: NK cells combined with CD38 antibody for the treatment of multiple myeloma Yimai Meng revealed that myeloma has long been related to the number and function of defective T cells, especially in progressive and refractory diseases
.
Methods such as obtaining T cells from healthy donors and subcutaneous immediate-release drug delivery are powerful solutions to the quality problems and insufficient quantity of CAR-T
.
Based on the current innovative therapies, we look forward to more work to understand how to use these therapies to better manage such diseases
.
Reference materials: 1.
https:// -and-dexamethasone-for-patients-with-multiple-myeloma-after-first-or-subsequent-relapse/ Yimike has always been committed to the cutting-edge technology, industry trends, industry insights and other original news reports of innovative biological drugs, all media Matrix users have reached 160,000+, of which industrial users accounted for over 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%
.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups
.
Click on the picture and sign up immediately for 2021 July 14/eMedClub News/--Recently, Johnson & Johnson's Janssen company announced that the US Food and Drug Administration (FDA) approved the anti-CD38 monoclonal antibody Darzalex Faspro combined with Poma Dolamine and dexamethasone are used in the second-line treatment of adult patients with multiple myeloma
.
Multiple myeloma (MM) is a malignant tumor that originates from the abnormal proliferation of plasma cells in the bone marrow of pre-B cells
.
During the progression of MM, the plasma cells in the bone marrow will rapidly diffuse and replace normal cells, and at the same time abnormally proliferate a large number of monoclonal immunoglobulin molecules (M proteins), posing a serious threat to health
.
It is estimated that by 2021, more than 34,000 people in the United States will be diagnosed and nearly 12,000 people will die from the disease
.
Traditional chemotherapy is the standard method for the treatment of multiple myeloma.
Chemotherapy can kill multiple myeloma cells in most patients.
This is also one of the most direct ways to eliminate tumors
.
However, due to the special pathogenesis of hematological tumors, MM often requires high-dose chemotherapy, which has obvious side effects and is prone to drug resistance
.
In addition, because there are no obvious symptoms in the early stage of the disease, the recurrence rate of multiple myeloma after treatment is quite high.
MM is often the target of doctors' headaches, so people began to explore new treatment options
.
Darzalex (Daratumumab) is an intravenously injected CD38 monoclonal antibody, and Darzalex Faspro is a subcutaneous preparation of Darzalex.
It is the first CD38-targeted antibody approved for subcutaneous injection for the treatment of multiple myeloma, which can increase the treatment time Significantly shortened from a few hours to 3-5 minutes
.
▲Darzalex Faspro and Darzalex Darzalex Faspro and Darzalex have the same curative effect, and significantly shorten the treatment time (from several hours to 3-5 minutes), which greatly reduces the incidence of systemic drug-related reactions (ARR)
.
This approval marks an important milestone and will help positively change the lives of MM patients who rely on Darzalex treatment
.
This approval is based on an ongoing multi-center, phase 3 clinical study APOLLO, which aims to evaluate the combination of daratumomab with pomalidomide and dexamethasone (hereinafter referred to as the D-Pd group) and the use of po Comparison of the curative effect of madomide and dexamethasone (hereinafter referred to as Pd group)
.
The results of the study showed that the D-Pd regimen reached the primary endpoint of improving progression-free survival (PFS)
.
To learn more about the data, scan the QR code for a complete read.
"We focus on the continuous development of Darzalex Faspro and advance this innovative therapy for patients who need additional treatment options
.
" Dr.
Craig Tendler, Vice President of Clinical Development and Global Medical Affairs, Janssen Said, “Today’s approval further differentiates Darzalex Faspro in the treatment of multiple myeloma because it is the first and only subcutaneous anti-CD38 approved in combination with the widely used pomalidomide and dexamethasone regimen.
Monoclonal antibodies
.
"▲ Dr.
Craig Tendler, Vice President of Clinical Development and Global Medical Affairs of Janssen (Image source: Janssen’s official website) Currently, Darzalex has been approved for marketing in China in October 2019 and is suitable for single-drug treatment of adult patients with relapsed and refractory MM.
listing application was also Darzalex Faspro® 2020 November 6 won CDE accepted
.
CD38 antibody treatment of multiple myeloma, CD38 is highly expressed on myeloma cells, and in normal lymphocytes, myeloid cells and some non-hematopoietic tissue sources It is also expressed at low levels, so the use of anti-CD38 antibodies has little effect on the activity of normal cells
.
In recent years, a variety of new immunotherapies targeting CD38 have been verified in preclinical models and clinical trials, including Darzalex The success of a typical CD38 monoclonal antibody has made CD38 a popular target for the treatment of MM
.
In October 2019, Tianjing Biotechnology (Shanghai) Co.
, Ltd.
(hereinafter referred to as "Tianjing Bio") and German MorphoSys announced that The source monoclonal CD38 antibody (TJ202/MOR202) was approved by the China National Medical Products Administration (NMPA) for Phase II and Phase III clinical trials.
The indication is relapsed or refractory myeloma
.
Recommended reading: CD38 monoclonal antibody has been approved more In a clinical trial, the target became the backbone of targeted therapy for multiple myelomaYimai Meng broke the news in March 2020, Sanofi’s CD38 monoclonal antibody isatuximab combined with standard care (pomalidomide + dexamethasone, pom) -dex) The Biologics License Application (BLA) for the treatment of relapsed/refractory multiple myeloma (r/r MM) was approved by the FDA, and isatuximab became the second CD38 monoclonal antibody drug approved by the FDA for the treatment of MM
.
2021 On January 12, the recombinant anti-CD38 fully human monoclonal antibody injection (HLX15) of Shanghai Fuhong Hanlin Biopharmaceutical Co.
, Ltd.
, a subsidiary of Shanghai Fosun, obtained the implied license for clinical trials from the China National Medical Products Administration.
The indication is multiple bone marrow.
Tumor (MM)
.
Recommended reading: Fuhong Hanlius' CD38 monoclonal antibody was approved for clinical use, and the CD38 target has become a popular target for the treatment of multiple myelomaYimai Meng broke the news in July 2021, XNK Therapeutics' autologous natural killer (NK) cell therapy candidate drug The first patient has been included in the Phase II clinical study of CellProtect.
The drug is used in combination with Sanofi's anti-CD38 antibody Sarclisa (Isatuximab) to treat patients with multiple myeloma
.
Recommended reading: NK cells combined with CD38 antibody for the treatment of multiple myeloma Yimai Meng revealed that myeloma has long been related to the number and function of defective T cells, especially in progressive and refractory diseases
.
Methods such as obtaining T cells from healthy donors and subcutaneous immediate-release drug delivery are powerful solutions to the quality problems and insufficient quantity of CAR-T
.
Based on the current innovative therapies, we look forward to more work to understand how to use these therapies to better manage such diseases
.
Reference materials: 1.
https:// -and-dexamethasone-for-patients-with-multiple-myeloma-after-first-or-subsequent-relapse/ Yimike has always been committed to the cutting-edge technology, industry trends, industry insights and other original news reports of innovative biological drugs, all media Matrix users have reached 160,000+, of which industrial users accounted for over 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%
.
In order to promote interactive exchanges in industry segments, we have established a number of professional WeChat groups, welcome to scan the QR code to add groups
.
