What are the domestic manufacturers of entrectinib?

Entrectinib (Entrectinib) is an innovative targeted treatment drug targeting specific gene fusion mutations. It was developed by the Swiss pharmaceutical company Roche and is clinically promoted and sold globally through its subsidiary Genentech. The drug is mainly used to treat patients with advanced or metastatic non-small cell lung cancer (NSCLC) and other solid tumors with ROS1 and NTRK1/2/3 fusions. As a precision treatment drug with extremely clear molecular targets, entrectinib has been approved for marketing in many countries in recent years, including China, the United States, Japan and EU countries, and has gradually entered the clinical treatment system and medical insurance catalog.

In the Chinese market, no local pharmaceutical company has obtained generic drug production qualifications or formal approval number for entrectinib. Therefore, the drug is still an original drug that is completely dependent on imports in China. Currently, the versions that can be circulated in China are Roche's original products. The drug form is oral capsules. The common specifications are 100mg × 30 capsules and 200mg × 90 capsules. They are all approved in the name of "entrectinib capsules" and are purchased and supplied by relevant pharmacies and tertiary hospitals. Due to the complex synthesis and preparation process of the drug’s raw materials, as well as the patent protection and transnational technical barriers involved, no Chinese company has yet applied to pass the consistency evaluation of generic drugs or conduct large-scale clinical development.

However, as the country advances its policy on high-quality generic drugs and the expiration of drug patents approaches, it cannot be ruled out that Chinese companies will start corresponding generic research and development work based on the indication needs and market prospects of entrectinib in the next few years. But for now, if patients want to use entrectinib, they still have to rely on imported original drugs, and the acquisition channels are mainly concentrated in oncology hospitals in large cities, international pharmacies, and some platforms with overseas procurement qualifications.

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