Is dacomitinib/dacomitinib a domestic drug or an imported drug?

Dacomitinib (Dacomitinib) is a second-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) developed by Pfizer. It was originally developed abroad and approved by the U.S. FDA for the treatment of epidermal growth factor receptor (EGFR) gene mutation-positive metastatic non-small cell lung cancer (NSCLC). Dacomitinib currently on the market in China is still an imported original drug, and no domestic generic version has yet been released. Therefore, the dacomitinib drugs that patients can obtain in domestic hospitals or pharmacies are imported drugs produced by Pfizer.

Dacomitinib was officially approved by China's National Medical Products Administration in 2019 and entered the Chinese market as an original researcher, becoming an important treatment option for patients with non-small cell lung cancer with EGFR-sensitive mutations. It is different from the first-generation reversible EGFR-TKI (such as gefitinib and erlotinib). It is an irreversible inhibitor that not only acts on EGFR, but also inhibits receptors such as HER2 and HER4, thereby achieving broader-spectrum and sustained anti-tumor activity. Because it is an imported original drug, its production, packaging, transportation and other processes comply with international GMP standards, and there is usually a high level of guarantee in terms of drug quality and efficacy consistency.

Currently, although there are many domestic generics of EGFR-TKIs in China, such as domestic versions of gefitinib and osimertinib, which are already on the market, domestic generics of dacomitinib are still in the early stages of clinical trials or approval, and no domestic generics have yet been specifically sold on the market. This is mainly related to the late entry of dacomitinib into the Chinese market and its patent protection period, as well as the long registration process for generic drugs. Therefore, if patients want to use the drug, they still need to purchase the imported version through formal medical channels. Some patients will also obtain drug information from overseas medical resources or third-party international pharmacies, but attention must be paid to ensuring medication safety and legal compliance.

Reference materials:https://www.pfizer.com/products/product-detail/vizimpro