Bosutinib/bosutinib marketing approval status in China

Bosutinib is a targeted therapy drug for chronic myelogenous leukemia (CML) and is a second-generation tyrosine kinase inhibitor (TKI). This drug was first developed by Pfizer and has been approved in many countries and regions such as Europe, the United States, and Japan for the treatment of CML patients who are resistant or intolerant to other TKIs. Bosutinib's main mechanism of action is to target the BCR-ABL fusion gene and also has a certain inhibitory effect on SRC family kinases, so it shows potential advantages in overcoming some TKI resistance mutations.

At present, the launch of bosutinib in China is in a steady advancement stage. According to information disclosed on the official website of the Center for Drug Evaluation (CDE) of the State Drug Administration, the drug’s import registration application has been accepted, marking its entry into a key step in China’s marketing approval. Although it has not yet officially obtained marketing authorization, it has been included in the priority review list, which shows that regulatory agencies attach great importance to its clinical value and patient needs. China's policy environment in the field of targeted treatment of rare blood diseases has been continuously optimized in recent years, and more and more imported innovative drugs are being introduced at an accelerated pace to provide more treatment options for domestic patients.

It is worth noting that before it is officially launched, some patients have obtained the original bosutinib drug through overseas medical service platforms, licensed imports or cross-border drug purchases. In actual use, doctors recommend that patients choose the drug carefully based on their own treatment response and mutation status, and comprehensively judge its applicability based on previous medication history and drug resistance. Once the drug is officially approved for marketing in China in the future, it is not only expected to improve patient access to medication, but may also gradually enter the medical insurance catalog, thus easing the financial burden of some patients.

Reference materials:https://go.drugbank.com/drugs/DB06616