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(Health Times reporter Zhao Mengmeng) Recently, Merck PD-L1/TGF-beta double anti-M7824 was accepted by the Drug Review Center of the State Food and Drug Administration of China. The drug combines PD-1 and TGF-beta dual targets and is known in the industry as the "second generation PD-1" drug.
TGF-beta:PD-1/PDL1 mono-resistant resistance
for cancer patients, PD-1/PDL1 inhibitors are the biggest breakthrough in the history of tumor immunotherapy, has been approved by the U.S. FDA for more than a dozen types of cancer, including non-small cell lung cancer, liver cancer and stomach cancer.
patients with the highest incidence and mortality of advanced lung cancer were treated with PD-1 inhibitors, and the five-year survival rate increased from 4% to 16%, a fourfold increase, and some patients even achieved clinical cure. But while giving hope to countless patients, PD-1/PDL1 inhibitors have an unavoidable problem, and for most tumors, PD-1 inhibitors are no more than 20 percent effective. And in the patients who are effective, most patients will relapse with drug resistance.
researchers analyzed tumor samples from 300 patients and found that one of the important factors influencing PD-1/PDL1 resistance was a protein called TGF-beta. It is simply understood that some tumors do not respond to PD-1/PDL1 drugs and may be related to TGF-beta.
dual targets of PD-1 and TGF-beta
known as PD-1/PDL1 antibody drug K, O, or T, only to help immune cells overcome the PD-1/PDL1 as a stumbling block. In fact, there are many other "roadblockers" in tumors, such as TGF-beta, while M7824 blocks both PD-1 and TGF-beta signaling pathways.
, deputy director of oncology medicine at the PLA General Hospital, Dr. Yang Bo, said, M7824 is an upgraded version of PD-1 monoab, can simultaneously fight TGF-beta and PD-L1, that is, a drug has two targets at the same time, anti-PD1 enhances the attack ability of anti-tumor T cells, anti-TGF-beta weakens the tumor's own protection ability, both systems can significantly improve the efficiency of the drug. Although the clinical efficacy and safety of the drug still need to be explored, but the prospects are promising.
M7824 clinical data: "Better than "PD-1/PDL1 monoanti-
clinical trials are key ways to test drug safety and efficacy." To date, M7824 has published a number of early clinical trial data with "superior" clinical data on PD1/PDL1 antibody monodrug.
a Phase II clinical trial of advanced non-small cell lung cancer showed good results in this innovative treatment - in PD-L1-positive patients, the drug was 40.7 percent effective, compared with 18-27 percent for PD-1, while m7824 was 71.4 percent effective in patients with high expression of PD-L1, compared with 29-44 percent for PD-1.
now, M7824 has been accepted by the Drug Review Center of The State Food and Drug Administration of China, and officially opened the road to listing in China.
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