Is Zanubrutinib on the market?

Zanubrutinib (Zanubrutinib) is a second-generation BTK inhibitor that was discovered in 2012 by the Chinese companyBeiGene (BeiGene). A first-in-human study of the drug in patients with B-cell malignancies began in Australia in 2014, with expansion cohorts conducted in the United States and other countries in 2015. According to preliminary efficacy data, it was mainly based on a single-arm phase II trial involving Chinese patients with relapsed and/or refractory mantle cell lymphoma (R/R MCL). It was approved for marketing by the National Medical Products Administration in June 2020 under the trade name of Baiyueze.

Zanubrutinib was approved by the U.S. Food and Drug Administration (FDA) in November 2019. Its clinical trial results showed that the overall effective rate of zanubrutinib in treating patients with mantle cell lymphoma was 84%. It is currently marketed under the trade name BRUKINSA and is available in the form of oral capsules. It was subsequently approved for the treatment of Waldenströ macroglobulinemia and relapsed or refractory marginal zone lymphoma in adults who have received at least one anti-CD20-based regimen. In October 2022, the European Medicines Agency (EMA) decided that the benefits of zanubrutinib outweighed its risks, so it was authorized for marketing in the EU.

The original drug of zanubrutinib marketed in China has been included in the medical insurance, but it is only reimbursed for patients who meet the indications. The price of 80mg*64 capsules per box may be around 6,000 yuan. The original drug of zanubrutinib marketed overseas is more expensive, and there are currently no generic drugs of zanubrutinib on the market.