On December 5, Betta Pharmaceuticals issued a press release stating that it has received a new drug clinical trial approval notice issued by the US FDA, agreeing to its fourth-generation EGFR inhibitor BPI-361175 tablets for the treatment of EGFR C797S mutations and others Drug clinical trial application for non-small cell lung cancer with EGFR-related mutations.

As we all know, the morbidity and mortality of lung cancer remain high regardless of whether it is in the world or in China. Lung cancer is divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which non-small cell lung cancer accounts for 80%-85%. Studies have found that many non-small cell lung cancers are related to a protein called epidermal growth factor receptor (EGFR). In about 80% of patients with non-small cell lung cancer, the EGFR protein is overexpressed. In addition, about one-third of lung cancer patients carry EGFR gene mutations. Therefore, drug resistance has become a common problem in the treatment of such patients.

According to the press release, BPI-361175 is a new molecular entity compound independently developed by Betta Pharmaceuticals. It is a new type of potent and selective fourth-generation EGFR oral small molecule inhibitor, intended to treat EGFR C797S mutations and others Non-small cell lung cancer with EGFR-related mutations. EGFR C797S mutations are more common in tumors that are resistant to third-generation EGFR inhibitors.

Preclinical data shows that BPI-361175 has the same biological activity in vivo and in vitro, can effectively inhibit the proliferation of tumor cells carrying EGFR C797S mutations, and has shown good anti-tumor effects on multiple xenograft tumor models carrying EGFR-related mutations. Betta Pharmaceuticals believes that BPI-361175 is expected to provide a new molecularly targeted treatment method that will provide more benefits for patients with EGFR C797S mutations and other EGFR-related mutations.

The press release also pointed out that the current domestic and foreign drugs that carry the EGFR C797S mutation are in the preclinical or early clinical stage, and no drugs are on the market. In February of this year, BPI-361175 has been approved by the National Medical Products Administration (NMPA) to conduct clinical trials. In August of this year, the first subject of the Phase 1 clinical study of the project was successfully enrolled in the group and successfully completed the first administration. This time, BPI-361175 was approved for clinical use in the United States and belongs to the product declared according to the 505(b)(1) route.