When will sotoraxibu (AMG510) be available in China?

Sotorasiib (AMG510) is a new type of targeted inhibitor, that is, a targeted drug, used to treat advanced non-small cell lung cancer (NSCLC) with positive KRAS gene mutations. KRAS mutation is one of the most common mutations in NSCLC and a key factor that currently makes it difficult to treat. The development of sotoracib is considered a breakthrough in the treatment of lung cancer.

Sotorasiib blocks the abnormal increase in cell signaling by inhibiting the active protein of KRAS G12C mutant, thus inhibiting the growth and spread of tumors. Clinical trials have shown that sotorasiib has significant efficacy in the treatment of patients with advanced NSCLC with KRAS G12C mutations. Results from early clinical trials show that sotoraxib can shrink or stabilize tumors in some patients and extend their survival.

The CodeBreaK 100 trial by Amgen tests the efficacy of sotoraxib in people with solid tumors including KRAS G12C. This mutation is a hallmark of smoking damage and is most common in lung cancer. Most trial participants with NSCLC had previously received immunotherapy and/or chemotherapy. Everyone in the study received sotorasiib, and four had complete tumor disappearance and 42 had partial tumor shrinkage. Another 54 people had stable disease, meaning their cancer was not getting better or getting worse.

Currently, sotoracib has been authorized by the U.S. Food and Drug Administration (FDA) and is already on the market. However, in March 2024, sotorasibu had not yet obtained marketing approval in China. Generally speaking, drugs to be marketed in China need to go through multiple stages such as clinical trials, registration applications, review and approval, etc., and they need to meet the relevant requirements of the State Food and Drug Administration. It is therefore impossible to determine when sotorasibu will be available in China.