Tucatinib/tucatinib launch time in China

Tucatinib is a small molecule tyrosine kinase inhibitor targeting the HER2 receptor, developed by the American biopharmaceutical company Seagen. Since being approved by the US FDA in 2020, the drug has quickly become an important member of the treatment field for HER2-positive advanced breast cancer. Its main indication is the combination of trastuzumab and capecitabine for the treatment of patients with metastatic or brain metastatic breast cancer who have previously received HER2-targeted regimens. Compared with other HER2 inhibitors, tucatinib has high selectivity, low EGFR inhibition, and is therefore better tolerated.

Globally, tucatinib has been approved for marketing in the United States, the European Union, Japan, Australia, Canada and other countries and regions, and has been included in medical insurance or tumor drug plans in many countries. However, in mainland China, the marketing process of tucatinib is still progressing, and it has not yet been officially approved by the National Medical Products Administration (NMPA). According to public registration information, the import registration application for the drug has been submitted and is undergoing technical review at the Center for Drug Evaluation (CDE). Since the drug involves international original research rights and localized production evaluation, the official launch time has not yet been announced.

Some Chinese cancer hospitals are currently involved in the clinical research of tucatinib. The main research directions include "Tucatinib combined with trastuzumab and capecitabine in the treatment of brain metastases in HER2-positive breast cancer" and "research on the combined application of antibody conjugate drugs". Preliminary data from these studies are similar to overseas results, showing excellent performance in controlling brain metastases and extending progression-free survival.

In terms of price, currentlyTUKYSA’s original drug is only sold overseas. The retail price in Europe is equivalent to more than RMB 40,000 per box (150mg*84 tablets). Some cross-border pharmacies or international prescription drug platforms can provide legal channelsto purchase drugs, but they still need to follow the guidance of doctors and China’s relevant policies on drug imports. It is expected that after tucatinib is officially introduced into China, its price will drop significantly if it passes medical insurance negotiations, which is expected to improve treatment accessibility for patients with HER2-positive breast cancer.

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