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

 Last Update: 2023-02-01
 Source: Internet
 Author: User

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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.

Recently, the State Medical Products Administration approved the listing of Class 1 innovative drug anomiti tablets (trade name: Fubonde) declared by Jiangsu Addi Pharmaceutical Co.

, Ltd.
This product is a compound preparation composed of inovirin, lamivudine and tenofovir disoproxil fumarate for the treatment of adult HIV-1 infection-naïve patients
.

The launch of this drug provides a new treatment option
for adult HIV-1 infected patients.

Reference source: [1] NMPA official website

Reference source: Reference source: [1] NMPA official website

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