The marketing status of sotoraxibu in China

As of May 2024, Sotoraxibu has been launched in some areas of China, but has not yet been launched in mainland China. For patients who need to purchase medicines, they can consult their doctors in advance and choose to purchase them under the guidance of professional doctors.

Sotoracib is available in China

As of May 11, 2024, has been listed in Taiwan, China and Hong Kong, China. The specific launch times are May 3, 2022 and April 29, 2022. On May 28, 2021, the U.S. FDA approved Amgen's sotoraxib for the treatment of non-small cell lung cancer in adults. It is suitable for patients who carry KRAS G12C gene mutations and have previously received at least one systemic therapy but failed to respond to treatment. This is the first targeted drug approved by the FDA for the treatment of KRAS gene-mutated non-small cell lung cancer.

Marketing process in China

In China, with the continuous deepening of the reform of the drug review and approval system, the introduction of innovative drugs has accelerated significantly. The marketing application of sotoracib has received great attention from the National Medical Products Administration (NMPA). The drug was rapidly advanced through the priority review and approval process, aiming to meet the needs of Chinese patients as quickly as possible.

Clinical Trial and Registration Application

Before officially entering the Chinese market, sotorasibu needs to complete clinical trials that comply with Chinese regulatory requirements to verify its safety and effectiveness in the Chinese patient population. These clinical trials not only follow international standards, but also take into account the specificity of the Chinese population to ensure the applicability and reliability of the data. After completing clinical trials, pharmaceutical companies will submit a new drug marketing application to NMPA, including detailed clinical research data and drug safety information.

Significance to patients

The launch of sotorasibu in some areas of China means that these patients no longer have to rely on overseas drug purchases or participation in clinical trials, and can obtain this innovative therapy through formal domestic channels. This is of great significance for improving treatment accessibility, reducing patients' economic burden, and improving patients' quality of life. In addition, the introduction of this drug has also promoted the development of domestic precision cancer medicine and provided an example for the subsequent introduction of more innovative drugs and the development of local innovative drugs.