Osaikang Pharmaceutical's third-generation EGFR-TKI new drug listing application accepted

ArticleMedicine Guanlan

On November 16, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that Osaikang Pharmaceutical has submitted a listing application for the new class 1 drug ASK120067 tablets

Screenshot source: CDE official website

EGFR is a group of cell surface receptors of the epidermal growth factor family with tyrosine kinase activity.

Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) is an earlier developed targeted drug for the treatment of NSCLC and has undergone three generations of product evolution

The ASK120067 declared by Osaikang Pharmaceutical this time is also a highly selective and irreversible third-generation EGFR-TKI

In clinical studies that have completed enrollment, ASK120067 is mainly used for locally advanced or metastatic NSCLC adult patients who have experienced disease progression during or after treatment with EGFR-TKI, and have been tested to confirm the presence of EGFR T790M mutation-positive adult patients with locally advanced or metastatic NSCLC

According to a press release issued by Osaikang Pharmaceuticals earlier, ASK120067 was approved by the CDE in 2019 based on the outstanding Phase 1/2 clinical study results.

The drug clinical trial registration and information disclosure platform shows that ASK120067 tablets are still in the phase 3 trial of the first-line treatment of locally advanced or metastatic NSCLC patients with EGFR-sensitive mutations

In addition, Osaikang Pharmaceutical is also developing Class 1 new drugs for the treatment of NSCLC with Exon14 mutations and third-generation EGFR inhibitor resistance

Reference materials:

[1] The official website of the Center for Drug Evaluation of China National Medical Products Administration.

[3] Zhang T, Qu R, Chan S, et al.