Bosutinib/bosutinib launch progress in China

Bosutinib/Bosutinib was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in September 2012 and March 2013, respectively, for the treatment of adult patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who have developed resistance or intolerance to previous treatments. The applicable patient groups include Ph+ CML patients in the chronic phase, accelerated phase and blast phase. The drug is marketed under the brand name BOSULIF.

In September 2023, bosutinib was further approved by the FDA for the treatment of CML in children who are newly diagnosed or who are resistant/intolerant to previous treatments. Relevant clinical trial results show that bosutinib can significantly improve the condition of patients with chronic myelogenous leukemia, especially in the face of treatment resistance or intolerance. Its improvement in major molecular responses is particularly prominent.

However, as of the end of January 2025, bosutinib has not been officially launched in China, which means that domestic patients cannot obtain this drug through formal channels. Although bosutinib's widespread use in the international market and its good efficacy have aroused public expectations, its launch in China will still take some time due to various factors such as medical policies, market access, and medical insurance reimbursement. In clinical practice, the use of bosutinib is also restricted by these factors.

Regarding side effects, bosutinib is generally considered controllable. Common side effects include gastrointestinal reactions, liver function damage, and hematological abnormalities. However, the incidence and severity of these side effects vary among individuals, so patients' health needs to be closely monitored during treatment.

Reference materials:https://en.wikipedia.org/wiki/Bosutinib