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Recently, news about the clinical progress of the Claudin 18.
On the same day, CSPC’s SYSA1801 was approved for clinical use.
Claudin 18.
One, Claudin 18.
One, Claudin 18.
Claudin-18 contains two isomers of Claudin-18.
Claudin 18.
Claudin 18.
Two, Claudin 18.
At ASCO in 2019, Astellas announced the data of the controlled trial of Zolbetuximab combined with EOX (epirubicin + oxaliplatin + capecitabine) and EOX single agent group.
At ASCO in 2021, Astellas announced the trial data of Zolbetuximab combined with mFOLFOX6 (oxaliplatin, leucovorin, fluorouracil).
Domestic Aosai Kang, Kai Hing life science, bio-pharmaceutical and other companies are Mai Bosi layout of Claudin 18.
Three, Claudin 18.
Three, Claudin 18.
In addition, the CAR-T therapy LB1904 of Legendary Bio-targeting Claudin 18.
Four, Claudin 18.
Four, Claudin 18.
2 double antibody
The AMG910 jointly developed by Amgen and Baekje is a CD3×Claudin 18.
2 double antibody, built on the Amgen HLE BiTE platform (Half-Life Extended), which extends the half-life of the drug
.
AMG910 recruits T cells to kill tumor cells by binding to Claudin 18.
2 on tumor cells and CD3 on T cells
.
AMG910 is currently in clinical stage Ⅰ
.
HLE BiTE structure
HLE BiTE structure HLE BiTE structureQiyu Biologics Q-1802 is a PD-L1×Claudin 18.
2 bispecific antibody.
On the one hand, it can kill tumors through Claudin 18.
2 antibody-mediated effects, and on the other hand, it can block PD-1 signal through PD-L1 antibody.
, Activating natural immunity and adaptive immunity at the same time
.
In December 2020, Q-1802 entered Phase I clinical trials
.
Five, Claudin 18.
2 ADC
2 ADC
Connoa/Meac's CMG901 is a drug that targets Claudin 18.
2 ADC.
It received the NMPA's "Drug Clinical Trial Approval Notice" on October 19, 2020.
It is currently in the phase I clinical research phase of dose exploration and dose expansion
.
CSPC’s SYSA1801 pre-clinical in vitro and animal experiments show that it can effectively target tumor cells through anti-Claudin 18.
2 antibody and undergo endocytosis, bringing small molecule toxins into tumor cells to play a therapeutic effect, and is expected to play a good role in gastric cancer and pancreatic cancer.
Therapeutic effect
.
Hengrui Medicine (SHR-A1904) and Kelun Pharmaceutical have also deployed Claudin 18.
2 ADC.
The former is in clinical phase I, and the latter is expected to be approved for clinical trials in Q3-Q4 this year
.
Six, summary
Six, summaryThe remarkable efficacy of Claudin 18.
2 in the field of gastric cancer excites the medical community, especially for gastric cancer patients with low expression of HER2, which is expected to make up for the insufficient treatment of HER2 ADC drugs
.
But over time, the competition in this track are becoming intense, more than ten varieties are in clinical stage Ⅰ
.
Moreover, the ORR of Claudin 18.
2 CAR-T third-line treatment of gastric cancer by Keji Pharmaceuticals is as high as 50%, and there is no CRS and NT toxicity of grade 3 or above.
The good efficacy and safety data are exciting, but for other varieties, research and development pressure Sharp increase
.
Facing the competition of CAR-T, double antibodies and ADC drugs must firstly strive for better efficacy and safety data; secondly, they must compete from the perspective of commercialization, relying on price advantages to increase the availability of drugs, and thirdly, accelerate research and development.
Strive to go public with Phase II data and use the first-mover advantage to lay out the market
.
Claudin 18.
2 drug clinical data comparison
2 drug clinical data comparison Claudin 18.
2 drug clinical data comparison
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