Betta Pharmaceuticals (300558.SZ): Clinical trial application for IA2 high-risk adjuvant treatment indications for post-operative phase IB tablets approved

^{Zhitong Financial App News, Beida Pharmaceutical (300558.SZ) issued an announcement. Recently, the company received the “Drug Clinical Trial Approval Notice” issued by the National Drug Administration (“NMPA”), and the company declared that the company has obtained a clinical trial application for adjuvant treatment of excitinib hydrochloride tablets (trade name: Kaimena®, “ectinib” for short) IA2 high risk - stage IB with epidermal growth factor receptor (EGFR) gene sensitive mutation non-small cell lung cancer (NSCLC) NMPA approved.}

According to the announcement, ectinib is the first targeted drug in China to treat lung cancer independently developed by the company. This drug is a potent and highly selective small-molecule oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). In 2011, ectinib was approved for “locally advanced or metastatic NSCLC after receiving at least one previous chemotherapy regimen failure” (second/third-line treatment indication), filling the gap in small-molecule targeted anti-cancer drugs in China; in 2014, ectinib for “first-line treatment indications for patients with locally advanced or metastatic NSCLC with sensitive EGFR gene mutations” was approved; in 2021, it is suitable for “adjuvant treatment of patients with locally advanced or metastatic NSCLC with sensitive EGFR gene mutations”; in 2021, it is suitable for “adjuvant treatment of patients with locally advanced or metastatic NSCLC with sensitive EGFR gene mutations” Listed in batches. Since the launch of the drug, it has been widely recognized by experts and patients with extensive clinical evidence-based medical evidence to fully prove its clinical necessity, safety and effectiveness. This is a clinical trial application for the fourth indication of ectinib.