Bosutinib’s full drug name and related registration information

Bosutinib (Bosutinib) is an oral second-generation tyrosine kinase inhibitor (TKI<) developed by Pfizer (Pfizer) /span>), mainly used to treat Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). Its full name is "Bosutinib Monohydrate" (Bosutinib monohydrate), and its trade name is Bosulif®. The drug effectively blocks the abnormal proliferation of leukemia cells by inhibiting BCR-ABL fusion proteins and Src family kinases. It is a new generation of CML targeted therapy after imatinib, and is especially suitable for patients who are intolerant or resistant to imatinib.

Bosutinib was first approved by the U.S. Food and Drug Administration (FDA) in September 2012 for the treatment of patients with chronic phase, accelerated phase or outbreak phase Ph+ CML. It is suitable for adults who have received at least one tyrosine kinase inhibitor in the past. Later, it successively obtained marketing approval in the European Union, Japan, Canada and other countries and regions. In recent years, its indications have been continuously expanded. In 2023, the FDA further approved it for use in children 1 years old and above. The treatment scope further covers the pediatric population and provides more clinical options.

In Europe, bosutinib is licensed by Pfizer (Pfizer Europe MA EEIG), the drug registration number is EMEA/H/C/002373, and the drug regulatory agency is EMA. Its marketing authorization in Europe covers adult patients, and is recommended to be extended to children aged 6 and above in 2025, including the use of new dosage forms 50mg and 100mg capsules to better meet the needs of pediatric dose adjustment. The drug enjoys "orphan drug" status in many countries, which means it has certain policy and registration support advantages in the treatment of rare diseases.

Although bosutinib has not yet been officially launched in mainland China, it has been widely registered and clinically used in many countries and regions around the world. For Chinese patients in need, they can legally obtain overseas approved versions of bosutinib (such as generic drugs or original drugs in the United States, India, Laos, etc.) through international drug purchasing platforms, cross-border medical service agencies, etc. However, it is recommended to consult a professional hematologist in detail before use to ensure that the drug indications and dosage match the individual treatment plan, while paying attention to drug safety and adverse reaction management.

Reference materials:https://www.drugs.com/