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News on April 23, 2021 // --Henlius recently announced that its independently developed and innovative PD-1 inhibitor slulimumab (serplulimab, HLX10, recombinant humanized anti-PD-1 monoclonal antibody) injection has been treated with standard treatment The failed, unresectable or metastatic highly microsatellite unstable (MSI-H) solid tumor indication marketing registration application (NDA) was officially accepted by the National Medical Products Administration (NMPA), and it is planned to be included in the priority review process
.
.
Serplulimab (serplulimab) has the potential to become the first anti-PD-1 monoclonal antibody for the treatment of MSI-H solid tumors in China
.
This indication is screened based on specific MSI-H tumor markers, and is not distinguished by cancer types, covering a wide range of patient groups
.
Focusing on slulimumab, Henlius has adopted a differentiated development strategy of "Combo+Global" (combination therapy + internationalization), focusing on the selection of indications and combination therapy, and it has been carried out simultaneously on a global scale.
10 clinical trials
.
Serplulimab (serplulimab) has the potential to become the first anti-PD-1 monoclonal antibody for the treatment of MSI-H solid tumors in China.
This indication is screened based on specific MSI-H tumor markers, and is not distinguished by cancer types, covering a wide range of patient groups
.
Focusing on slulimumab, Henlius has adopted a differentiated development strategy of "Combo+Global" (combination therapy + internationalization), focusing on the selection of indications and combination therapy, and it has been carried out simultaneously on a global scale.
10 clinical trials
.
.
Oncology clinical trials
The NDA of slulimumab for the treatment of MSI-H solid tumor indications is based on the positive results of a single-arm, open-label, multi-center, phase 2 clinical trial
.
The trial was conducted in patients with unresectable or highly metastatic microsatellite instability or mismatch repair defect (MSI-H/dMMR) solid tumors who failed standard treatments, and evaluated the efficacy of slulimumab as a single-agent treatment , Safety and tolerance
.
The primary efficacy endpoint is the objective response rate (ORR) assessed by the independent imaging evaluation committee based on the RECIST v1.
1 standard
.
Secondary endpoints include the objective response rate assessed by the investigator, duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety and tolerability
.
Clinical Trials.
The trial was conducted in patients with unresectable or highly metastatic microsatellite instability or mismatch repair defect (MSI-H/dMMR) solid tumors who failed standard treatments, and evaluated the efficacy of slulimumab as a single-agent treatment , Safety and tolerance
.
The primary efficacy endpoint is the objective response rate (ORR) assessed by the independent imaging evaluation committee based on the RECIST v1.
1 standard
.
Secondary endpoints include the objective response rate assessed by the investigator, duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety and tolerability
.
On March 28 this year, Fuhong Henlius announced that the above-mentioned Phase 2 clinical trial had reached the primary endpoint
.
The results showed that slulimumab showed good efficacy and safety in this indication
.
The company will share specific test data in future academic conferences
.
Clinical Trial Conference.
The results showed that slulimumab showed good efficacy and safety in this indication
.
The company will share specific test data in future academic conferences
.
Clinical research progress of slulimumab (click on the picture to see the larger picture)
Microsatellite instability (MSI) is usually caused by the loss of the mismatch repair function of genes, which causes the insertion or mismatch of bases in the microsatellite sequence during DNA replication, resulting in the accumulation of wrong bases
.
Among them, high degree of microsatellite instability (MSI-H) often occurs in multiple cancers, such as endometrial cancer, colorectal cancer, gastric cancer, renal cell cancer, ovarian cancer, etc.
Studies have shown that MSI-H is in all cancers.
The incidence of these species is about 14%.
This type of patients usually has a higher response rate to immune checkpoint inhibitors.
MSI-H is increasingly becoming an important biomarker for predicting the effect of immunotherapy in patients with solid tumors
.
If the patient’s tumor marker is positive and meets the treatment criteria, the corresponding tumor immunotherapy can be performed, without the need to screen patients according to the traditional tumor primary tumor site and pathological classification, which is in line with the advanced concept of precision treatment.
Wide range of applicable cancers
.
Biomarker Tumor.
Among them, high degree of microsatellite instability (MSI-H) often occurs in multiple cancers, such as endometrial cancer, colorectal cancer, gastric cancer, renal cell cancer, ovarian cancer, etc.
Studies have shown that MSI-H is in all cancers.
The incidence of these species is about 14%.
This type of patients usually has a higher response rate to immune checkpoint inhibitors.
MSI-H is increasingly becoming an important biomarker for predicting the effect of immunotherapy in patients with solid tumors
.
If the patient’s tumor marker is positive and meets the treatment criteria, the corresponding tumor immunotherapy can be performed, without the need to screen patients according to the traditional tumor primary tumor site and pathological classification, which is in line with the advanced concept of precision treatment.
Wide range of applicable cancers
.
At present, the U.
S.
Food and Drug Administration ( FDA ) has approved PD-1 target drugs for the treatment of MSI-H/dMMR advanced solid tumors and first-line and second-line MSI-H/dMMR colorectal cancer and second-line that have failed the previous standard first-line treatment.
dMMR endometrial cancer and other indications
.
In China, there is no approved anti-PD-1 monoclonal antibody for MSI-H/dMMR advanced solid tumors, and the treatment needs are far from being met
.
FDAS.
Food and Drug Administration ( FDA ) has approved PD-1 target drugs for the treatment of MSI-H/dMMR advanced solid tumors and first-line and second-line MSI-H/dMMR colorectal cancer and second-line that have failed the previous standard first-line treatment.
dMMR endometrial cancer and other indications
.
In China, there is no approved anti-PD-1 monoclonal antibody for MSI-H/dMMR advanced solid tumors, and the treatment needs are far from being met
.
The Phase II clinical study of slulimumab for the treatment of MSI-H/dMMR solid tumors and the lead investigator, Professor Qin Shukui from the Cancer Center of Nanjing Jinling Hospital, said: "Slulimumab has been used in preclinical and early clinical studies.
Demonstrates excellent anti- tumor activity.
The results of this phase II clinical study for MSI-H solid tumors show that the product has excellent efficacy and safety
.
It is expected that domestically-made innovative PD-1 inhibitors with guaranteed quality and efficacy will be launched as soon as possible.
More patients with MSI-H solid tumors receive new high-quality immunotherapy options
.
"
TumorDemonstrates excellent anti- tumor activity.
The results of this phase II clinical study for MSI-H solid tumors show that the product has excellent efficacy and safety
.
It is expected that domestically-made innovative PD-1 inhibitors with guaranteed quality and efficacy will be launched as soon as possible.
More patients with MSI-H solid tumors receive new high-quality immunotherapy options
.
"
PD-(L)1 tumor immunotherapy status: 12 models have been approved for marketing (click on the picture to see the larger picture)
Slulimumab (serplulimab, HLX10, recombinant humanized anti-PD-1 monoclonal antibody) is an innovative monoclonal antibody independently developed by Fuhong Henlius.
It is expected to be used in the treatment of a variety of solid tumors in preclinical and early clinical trials.
The study showed excellent PK, PD data and good safety, tolerability and anti- tumor activity
.
TumorIt is expected to be used in the treatment of a variety of solid tumors in preclinical and early clinical trials.
The study showed excellent PK, PD data and good safety, tolerability and anti- tumor activity
.
Slulimumab belongs to anti-PD-(L)1 tumor immunotherapy.
This type of therapy helps detect and fight tumor cells by improving the ability of the human immune system
.
Keytruda is an anti-PD-1 therapy that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes that may affect tumor cells and healthy cells
.
TumorThis type of therapy helps detect and fight tumor cells by improving the ability of the human immune system
.
Keytruda is an anti-PD-1 therapy that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes that may affect tumor cells and healthy cells
.
As of now, more than 10 anti-PD-(L)1 therapies have been approved for the market worldwide.
Merck’s anti-PD-1 therapy Keytruda is the leader.
In 2020, global sales reached 14.
38 billion U.
S.
dollars, compared with the previous one.
The annual growth rate is 30%
.
Bristol-Myers Squibb Opdivo ranked second with sales of US$6.
992 billion, a slight drop of 3.
0% from the previous year
.
Close behind are Roche Tecentriq, with sales of 2.
738 billion Swiss francs (up 55%), and AstraZeneca Imfinzi, with sales of US$2.
042 billion (up 39%)
.
()
AstraZenecaMerck’s anti-PD-1 therapy Keytruda is the leader.
In 2020, global sales reached 14.
38 billion U.
S.
dollars, compared with the previous one.
The annual growth rate is 30%
.
Bristol-Myers Squibb Opdivo ranked second with sales of US$6.
992 billion, a slight drop of 3.
0% from the previous year
.
Close behind are Roche Tecentriq, with sales of 2.
738 billion Swiss francs (up 55%), and AstraZeneca Imfinzi, with sales of US$2.
042 billion (up 39%)
.
()
Original source: Fuhong Henlius, US FDA New Drug Database
FDA