Is brigatinib/brigatinib marketed in China domestically produced or imported?

Brigatinib is an anti-cancer drug that is included in the national medical insurance catalog. It is an imported drug. Brigatinib is produced by foreign manufacturers and marketed domestically under the name Brigatinib Tablets (ALUNBRIG). At present, there are no domestic generic drugs of brigatinib produced and put on the market, and the specific relevant information is not yet clear.

Brigatinib is a next-generation oralALK inhibitor that effectively inhibits a broad range of clinically relevant ALK mutations. In non-clinical studies, brigatinib demonstrated potent activity against all ALK resistance mutations tested and overcame resistance mechanisms to crizotinib, ceritinib and aletinib at clinically achievable concentrations.

A pivotal Phase 2 trial ALTA (Brigatinib in ALK Lung Cancer Trial) found that brigatinib has significant efficacy and acceptable safety in patients with ALK+ non-small cell lung cancer refractory to crizotinib. Under the recommended brigatinib dosing regimen (180 mg orally once daily, 90 mg orally once daily 7 days before), the confirmed objective response rate was 56%, and the median progression-free survival was 16.7 months. Based on ALTA's efficacy and safety data, brigatinib received accelerated approval in the United States and other places for the treatment of patients with advanced metastatic ALK+ non-small cell lung cancer.

Currently, the original brigatinib drug sold in China, common drug specifications in the city include 30mg*14 tablets*2 plates, 90mg*7 tablets or 7 tablets*4 plates, and 180mg*7 tablets*4 plates, etc. However, it is expensive, with each box likely to cost around RMB 10,000. Although it has been included in medical insurance, the price after reimbursement may be slightly different.