Dacomitinib/Dacomitinib was developed and produced in which country?

Dacomitinib/Dacomitinib (Dacomitinib), developed by the American pharmaceutical giant Pfizer, is a second-generation irreversible oral targeted drug for EGFR mutation-positive non-small cell lung cancer. Its research and development path was earlier, with clinical studies initially carried out in North America, Europe and the Asia-Pacific region, and it was successively approved for marketing in many countries. As a drug with a global layout, its production standards follow the internationally accepted quality system. Therefore, regardless of whether the patient is exposed to the original drug or different overseas packaging specifications, its drug ingredients and quality system are basically the same.

In the United States, dacomitinib was first approved under the trade name VIZIMPRO and is regarded as an important addition to the EGFR-targeted therapy sequence. Subsequently, South Korea, Japan, Canada, Australia and other countries successively approved its marketing for patients with confirmed EGFR mutation-positive lung cancer. Countries in the Asia-Pacific region, such as South Korea, have participated in earlier research and development cooperation and have rich experience in using it. Therefore, its listing has further promoted the Asian medical system's understanding of this drug.

China has also approved the marketing of dacomitinib, which is supplied by Pfizer. Although packaging specifications vary from country to country, such as tablet dosage and packaging quantity, there is no difference in the medicines themselves. Overseas drug regulatory agencies generally adopt ICH standards and are highly consistent in quality assessment. This also ensures that whether patients choose local original research or regular cross-border sources, drug efficacy and safety will remain at the same international level.

As an international drug, dacomitinib’s research background and production system are both led by an American team. However, the global production chain is relatively scattered, and some batches may be completed in GMP factories in the United States, Europe or Asia. Finally supplied to the global market. This layout ensures a stable supply of drugs and allows more countries to quickly obtain available resources.

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