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[Pharmaceutical Network Industry News] The new progress of drug clinical trials has attracted the attention of the industry
.
Recently, there has been good news about the approval of clinical trials for a number of drugs, from domestic and foreign pharmaceutical companies such as Novartis, Innovent, Simcere, Zhongsheng Pharmaceutical, and Antengene
.
On March 29, CDE information announced that Novartis' TIM-3 receptor-targeting monoclonal antibody MBG453 and anti-TGF-β monoclonal antibody NIS793 obtained the implied license for clinical trials, and their indications are low-risk myeloid hyperplasia.
abnormal syndrome (MDS)
.
This is a heterogeneous group of myeloid clonal diseases originating from hematopoietic stem cells
.
The immature blood cells in the bone marrow of MDS patients fail to mature, resulting in lower levels of blood cells or platelets, making the patient less able to fight infection and clot
.
Some MDS patients also develop acute myeloid leukemia
.
Currently, there are still unmet therapeutic needs for MDS patients
.
On the same day, Innovent announced that its self-developed bispecific antibody targeting recombinant Claudin 18.
2 (Claudin18.
2) and cluster of differentiation 3 (CD3) (R&D code: IBI389) was used in the treatment of advanced malignant tumors.
The first patient was dosed in a phase I clinical trial
.
IBI389 can kill CLDN18.
2-expressing tumor cells with high efficiency and selectivity, increase lymphocyte tumor infiltration and enhance tumor immune response, but at the same time, it has a lower risk of CRS (cytokine release syndrome)
.
Preclinical results show that even in cell lines with low expression of CLDN18.
2, IBI389 can still bind to tumor cells, with obvious anti-tumor effect.
range
.
Recently, Antengene announced that the National Medical Products Administration has officially approved a drug designed to evaluate the safety, tolerability and efficacy of nuclear export inhibitor (SINE) ATG-016 for the treatment of high-risk myelodysplastic syndromes (MDS).
An open-label phase II clinical study
.
MDS is a malignant disease derived from bone marrow hematopoietic stem cells, and its incidence increases significantly with age
.
According to research data previously presented by Karyopharm at the American Society of Hematology (ASH) annual meeting, the survival of patients who received ATG-016 and whose efficacy was evaluable was significantly improved
.
Sino Biopharma recently announced that the Group's self-developed Class I anti-tumor innovative drug "FHND5071" has been approved for clinical trials for the treatment of advanced solid tumors
.
In addition, the product has submitted a drug clinical trial application to the US FDA
.
FHND5071 is a new transfection time-heavy drug developed by the group's research team using computer-aided drug design and traditional drug design methods, and through medicinal chemistry structure-activity analysis, structure optimization, in vitro and in vivo biological activity and pharmacokinetic (DMPK) screening.
Removal (RET) selective inhibitors have the characteristics of longer-lasting in vivo efficacy, higher tumor tissue distribution, and lower effective doses, and can cross the blood-brain barrier and inhibit primary or metastases to the central nervous system.
Tumors play a role
.
In addition, Jiangsu Simcere Pharmaceutical also recently reported that the company's SSD8432 has been approved by the State Food and Drug Administration for clinical trials
.
According to reports, SSD8432 targets the 3CL protease that plays a key role in the replication of the new coronavirus.
clinical potential
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
Recently, there has been good news about the approval of clinical trials for a number of drugs, from domestic and foreign pharmaceutical companies such as Novartis, Innovent, Simcere, Zhongsheng Pharmaceutical, and Antengene
.
On March 29, CDE information announced that Novartis' TIM-3 receptor-targeting monoclonal antibody MBG453 and anti-TGF-β monoclonal antibody NIS793 obtained the implied license for clinical trials, and their indications are low-risk myeloid hyperplasia.
abnormal syndrome (MDS)
.
This is a heterogeneous group of myeloid clonal diseases originating from hematopoietic stem cells
.
The immature blood cells in the bone marrow of MDS patients fail to mature, resulting in lower levels of blood cells or platelets, making the patient less able to fight infection and clot
.
Some MDS patients also develop acute myeloid leukemia
.
Currently, there are still unmet therapeutic needs for MDS patients
.
On the same day, Innovent announced that its self-developed bispecific antibody targeting recombinant Claudin 18.
2 (Claudin18.
2) and cluster of differentiation 3 (CD3) (R&D code: IBI389) was used in the treatment of advanced malignant tumors.
The first patient was dosed in a phase I clinical trial
.
IBI389 can kill CLDN18.
2-expressing tumor cells with high efficiency and selectivity, increase lymphocyte tumor infiltration and enhance tumor immune response, but at the same time, it has a lower risk of CRS (cytokine release syndrome)
.
Preclinical results show that even in cell lines with low expression of CLDN18.
2, IBI389 can still bind to tumor cells, with obvious anti-tumor effect.
range
.
Recently, Antengene announced that the National Medical Products Administration has officially approved a drug designed to evaluate the safety, tolerability and efficacy of nuclear export inhibitor (SINE) ATG-016 for the treatment of high-risk myelodysplastic syndromes (MDS).
An open-label phase II clinical study
.
MDS is a malignant disease derived from bone marrow hematopoietic stem cells, and its incidence increases significantly with age
.
According to research data previously presented by Karyopharm at the American Society of Hematology (ASH) annual meeting, the survival of patients who received ATG-016 and whose efficacy was evaluable was significantly improved
.
Sino Biopharma recently announced that the Group's self-developed Class I anti-tumor innovative drug "FHND5071" has been approved for clinical trials for the treatment of advanced solid tumors
.
In addition, the product has submitted a drug clinical trial application to the US FDA
.
FHND5071 is a new transfection time-heavy drug developed by the group's research team using computer-aided drug design and traditional drug design methods, and through medicinal chemistry structure-activity analysis, structure optimization, in vitro and in vivo biological activity and pharmacokinetic (DMPK) screening.
Removal (RET) selective inhibitors have the characteristics of longer-lasting in vivo efficacy, higher tumor tissue distribution, and lower effective doses, and can cross the blood-brain barrier and inhibit primary or metastases to the central nervous system.
Tumors play a role
.
In addition, Jiangsu Simcere Pharmaceutical also recently reported that the company's SSD8432 has been approved by the State Food and Drug Administration for clinical trials
.
According to reports, SSD8432 targets the 3CL protease that plays a key role in the replication of the new coronavirus.
clinical potential
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
