NMPA
Burning Rock, Dizal Get Chinese Approval for Lung Cancer CDx
The test, approved by Chinese regulators in early 2022, is designed for the detection of multiple mutation statuses for nine genes.
Enhertu Approved in China for HER2-Positive Gastric, Gastroesophageal Junction Cancer
The approval was based on two Phase II trials conducted in Asia that demonstrated response rates of 29 percent and 41 percent, respectively, on Enhertu.
China's NMPA Approves Zai Lab's Augtyro in ROS1-Positive NSCLC
In a Phase I/II trial, 38 percent of patients who had prior tyrosine kinase inhibitor treatment responded, while the response rate among those who were TKI-naïve was 79 percent.
Avistone Biotechnology, Apollomics Net c-Met Inhibitor Approval for Certain Glioma Patients in China
The NMPA approved the drug for patients with IDH-mutant astrocytoma or glioblastoma with PTPRZ1-MET gene fusions who have failed previous treatments.
AnHeart, Innovent File for Frontline ROS1-Positive NSCLC Taletrectinib Approval in China
China's NMPA will decide whether to approve the tyrosine kinase inhibitor in advanced ROS1-positive NSCLC patients who haven't received prior ROS1 inhibitors.