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ArticleMedicine Guanlan
On October 27th, Yaojieankang announced that the US FDA has granted the company's core product TT-00420 fast track qualification for the treatment of cholangiocarcinoma (CCA) patients without standard treatment options
.
TT-00420 is a small molecule innovative compound in phase 2 clinical phase.
Public information shows that TT-00420 was discovered after multiple rounds of structural optimization.
It is a selective focused kinase inhibitor with a brand-new structure that inhibits tumor proliferation through the dual mechanism of immune regulation and targeted cell cycle inhibition
.
This product solves the highly unmet clinical needs in the field of cholangiocarcinoma through a unique mechanism: a) Targeting FGFR acquired drug-resistant mutations and primary drug-resistant mutations of cholangiocarcinoma; b) unique multi-kinase inhibitors synergistically target high Heterogeneity includes cholangiocarcinoma without a clear genetic mutation
Previously, TT-00420 has demonstrated a good safety in a clinical study, the tumor has already carried out a number of clinical trials around the world, including test center MD Anderson Cancer Center, Chinese Academy of Medical Sciences Cancer Hospital and so on
.
According to the press release, the product is expected to be marketed in the United States for its first indication.
Fast Track Designation (Fast Track Designation) is one of the FDA’s policies to accelerate drug review, aimed at accelerating the development of drugs for the treatment of serious or fatal diseases and meeting unfinished medical needs
.
The qualification of TT-00420 means that the FDA recognizes the potential of TT-00420 in early clinical trials to meet unfinished medical needs
Reference materials:
[1] Yaojieankang's core product TT-00420 has been accredited by the US FDA Fast Track.
