Introduction to the main manufacturers of ponatinib and the background, production qualifications and clinical use of the original drug

Ponatinib (ponatinib) is a third-generation oral tyrosine kinase inhibitor (TKI), mainly targeting BCR-ABL fusion gene-positive chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (Ph+ ALL) patients. The drug is produced by the American pharmaceutical company AROUND (formerly Ariad Pharmaceuticals), the original drug was approved for marketing by the U.S. FDA in 2012 , used to treat CML and Ph+ that are resistant or intolerant to other TKIs such as imatinib, dasatinib or nilotinib. ALLpatients. The research and development background of ponatinib focuses on solving the treatment problems caused by drug-resistant mutant strains, especially the T315I mutation, making it have unique clinical value in patients with refractory leukemia.

In terms of production qualifications, the original drug of ponatinib is produced by AROUND Pharmaceutical Company in a GMP factory that meets FDA and EMA standards, ensuring the quality, purity and stability of the drug. Other overseas versions include Hong Kong original drugs and some generic drugs, which are produced by companies that have passed local drug registration and regulatory approval to ensure that the drug ingredients are consistent with the original drugs. Production qualifications strictly require the source of raw materials, production environment and quality testing to ensure that each batch of drugs meets clinical standards in terms of safety and effectiveness. Original drugs are currently on the market in China, but it is difficult to purchase them. Patients mainly obtain them through overseas channels, which must comply with local regulations and import requirements.

In terms of clinical use, ponatinib is mainly used for refractory CML and Ph+ ALL patients. Its advantage is that it can inhibit BCR-ABL including T315I and other drug-resistant mutant strains, and has shown significant efficacy in patients who have failed previous TKI treatment. Clinical data show that ponatinib can significantly improve the hematological response rate, cytogenetic response rate and molecular response rate, while prolonging the progression-free survival of refractory patients (PFS). During use, attention should be paid to adverse reactions such as cardiovascular risk, thrombosis, and increased blood pressure. Individualized dose adjustment and strict follow-up monitoring are usually required under the guidance of a professional doctor.

In general, ponatinib, as a third-generation TKI, plays an important role in drug-resistant or intolerant patients with CML and Ph+ ALL. The qualifications of its manufacturers are perfect, the quality of the drugs is stable and reliable, and overseas original drugs and generic drugs are available worldwide. Clinical use emphasizes precise management, dose optimization and adverse reaction monitoring based on the patient's specific condition to ensure maximum efficacy and medication safety, and provide practical treatment options for patients with refractory leukemia.

Keyword tags: ponatinib, manufacturer, originator drug background, clinical use, CML, Ph+ ALL, TKI, drug resistance mutations, cardiovascular risk.

Reference materials:https://go.drugbank.com/drugs/DB09078