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Zanubrutinib: Chinese new BTK inhibitor Launched
Zanubrutinib: Chinese new BTK inhibitor Launched. Chinese innovative cancer drug: Zanubrutinib apporved by FDA in 2019 was launched.
China BeiGene’s self-developed BTK inhibitor zanubrutinib was approved by the US FDA in November 2019 for the treatment of mantle cell lymphoma (MCL) patients who have received at least one therapy in the past. It is considered that Chinese innovative drugs have taken a crucial step in the process of going global, achieving a breakthrough from 0 to 1. In addition, this approval was nearly 4 months earlier than the FDA scheduled response date, which shows that the FDA attaches great importance to this new drug.
This marks that Zebutinib has become the first anti-cancer drug independently developed by a Chinese company and approved by the FDA for listing, and has achieved a “zero breakthrough” in the overseas market of the original Chinese anti-cancer drug.
Approved clinical data
Zebutinib was approved by the FDA based on the effectiveness data of two clinical trials. In one of the multi-center phase 2 clinical trials BGB-3111-206 for the treatment of patients with relapsed/refractory MCL, patients were receiving Zebutin. After nib treatment, the overall response rate (ORR) reached 84%, including 59% complete response (CR). The median duration of response (DOR) in this trial was 19.5 months, and the median follow-up time was 18.4 months.
The anti-cancer principle of Zebutinib
Cancer is mainly due to the abnormal function of certain proteins in the human body, causing certain cells to grow uncontrollably, or cells that should have died no longer die, continue to proliferate and become tumors, and these problematic proteins are the targets. point. Zebutinib’s working principle is to inhibit the BTK target related to mantle cell lymphoma, and Zebutinib only has an inhibitory effect on the BTK protein, so as not to affect the functions of other proteins in the human body. Zebutinib’s inhibitory effect is sufficient and lasting.