In 2023, another Class 1 new drug was approved, and the NMPA conditionally approved the marketing of mobosetinib succinate capsules

Recently, the State Medical Products Administration (NMPA) conditionally approved the listing of Mobosetinib succinate capsules (trade name: ENVIRIX/EXKIVITY) declared by Takeda Pharmaceutical Co.
, Ltd.
through the priority review and approval process
.
It is indicated for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) who progress during or after platinum-containing chemotherapy and carry an epidermal growth factor receptor (EGFR) exon 20 insertion mutation
.

Mobosetinib is an irreversible tyrosine kinase inhibitor
targeting EGFR exon 20 insertion mutations.
The launch of this drug provides a new treatment option
for patients with advanced non-small cell lung cancer who carry EGFR exon 20 insertion mutation positive.

Previously, NMPA had approved the listing of Class 1 innovative drug anomiti tablets (trade name: Fubonde) declared by Jiangsu Addi Pharmaceutical Co.

, Ltd.