Bayda Pharmaceutical: Third Generation EGFR-TKI Befortini Sealant Tiliacsom (Semena ®) is approved for sale

Recently, the official website of the State Drug Administration (NMPA) showed that the State Drug Administration approved the listing of the Class 1 innovative drug Befortinib mesylate capsule (trade name: Semegna ®) declared by Beida Pharmaceutical Industry. It is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFRT790M mutation and disease progression after previous epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy.
Lung cancer is the leading cause of cancer death worldwide, and the majority of cases are non-small cell lung cancer (NSCLC). In the Asian race, 30%-50% of patients with advanced NSCLC have epidermal growth factor receptor (EGFR) gene mutations detected by genetic testing [1]. At present, EGFR-TKI is the main treatment for non-small cell lung cancer with EGFR mutation. Patients will develop drug resistance in about a year after treatment, and T790M mutation is one of the main resistance mechanisms, accounting for about 60% of secondary drug resistance [2]. Behfortinib mesylate gel is a third-generation EGFR-TKI targeting the T790M mutation with substantial clinical need.
The clinical trial of Behfortinib mesylate gel for second-line indications of NSCLC was led by Professor Shun Lu from Shanghai Chest Hospital. To study the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who developed T790M mutation after resistance to first-generation EGFR-TKI. The objective response rate (ORR) was 67.6%, the disease control rate (DCR) was 94.8%, the median PFS was 16.6 months, and the median DOR was 18.0 months. Thirty-four subjects had intracranial target lesions at baseline, and the iORR was 55.9%. The study showed that in terms of ORR and intracranial efficacy, befortinib mesylate capsules were basically consistent with similar drugs. The clinical research data have been presented in international academic conferences such as AACR, ESMO, and WCLC, and a number of clinical research results have been published in internationally renowned journals such as The Lancet Respiratory Medicine and the Journal of Thoracic Oncology. In an editor's note, The Lancet Respiratory Medicine commented that, as a new candidate drug for EGFR-mutated advanced non-small cell lung cancer, befortinib can be used as a new drug option for Chinese patients.