The time when capicetinib/capacertinib was launched in the Chinese market

Capivasertib tablets (Capivasertib), trade name TRUQAP (TRUQAP), is an innovative oral kinase inhibitor developed by AstraZeneca UK Limited. The drug was officially approved for marketing by the China State Food and Drug Administration on April 18, 2025, becoming an important breakthrough in the field of domestic breast cancer treatment. As a Category 1 innovative drug, the approval of carpiseti not only enriches the selection of targeted breast cancer drugs in China, but also provides the possibility of precise treatment for patients with specific genetic changes.

The clinical application of capiseti is mainly for patients with locally advanced or metastatic breast cancer who are hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and accompanied by genetic changes such as PIK3CA, AKT1 or PTEN. These patients still experience disease progression after previous endocrine therapy or adjuvant therapy, and their treatment options are relatively limited. The launch of Tufencord provides this special patient group with a new targeted treatment method, which is expected to improve their survival outcomes and quality of life.

After its launch, the supply and accessibility of carpiseti in the domestic market gradually increased. As an oral medication, it can be used in combination with fulvestrant, providing patients with a convenient home treatment option while reducing reliance on intravenous chemotherapy. In clinical practice, doctors will evaluate the use of capicistat based on the patient's genetic test results, previous treatment history and overall health status to achieve individualized treatment.

The launch of carpiseti also reflects the gradual improvement of the domestic innovative drug approval system. Through the rapid review and priority approval channels, domestic patients can have earlier access to internationally leading targeted drugs, shortening the gap with international standard treatments. In addition, drug launches also promote relevant clinical research and real-world data collection, providing support for subsequent indication expansion and optimization of treatment options.

Reference materials:https://www.drugs.com/mtm/capivasertib.html