Is entrectinib a domestic drug or an imported drug?

Entrectinib (Entrectinib) is not a domestic drug, but an imported targeted drug originally developed by Ignyta, a subsidiary of the Swiss Roche Group. It is a new generation of TRK (NTRK) and ROS1 fusion protein inhibitors. The drug first received accelerated approval from the U.S. FDA in 2019 for the treatment of adult and pediatric patients with advanced solid tumors associated with NTRK gene fusions, as well as patients with ROS1-positive non-small cell lung cancer. In overseas clinical practice, entrectinib has shown a high objective response rate and durable remission period due to its good central nervous system penetration and broad-spectrum anti-cancer effect, especially in tumor patients carrying specific fusion mutations.

In China, entrectinib has been approved for import and marketing by the State Food and Drug Administration in 2022. The trade name is Rozlytrek and is sold in capsule form. Currently, the drugs currently on the market in China are original imported drugs, and no generic drugs have been approved. Therefore, all entrectinib sold on the market is imported from original packaging. Common specifications of the medicine include 100mg/30 capsules and 200mg/90 capsules, which can be selected according to the patient’s specific dosage needs. Considering the high price of the drug, China's National Medical Insurance Administration has included it in the national medical insurance drug catalog in recent years, which means that eligible patients can obtain the drug through medical insurance channels with a prescription and receive partial or large-scale reimbursement, effectively easing the financial burden.

Currently, no domestic pharmaceutical company has successfully developed and marketed a generic version of entrectinib. Although some companies have deployed related NTRK or ROS1 target drugs, it still takes time to advance on the clinical approval and marketing path. It is worth noting that patients should strictly follow the physician's instructions during use and avoid changing drug sources on their own or purchasing drugs through informal channels to ensure drug safety.

Reference materials:https://www.roche.com/products/rozlytrek