The third domestically produced lenvatinib is here!

On August 5, the NMPA official website showed that Nanjing Chia Tai Tianqing's application for listing of lenvatinib (acceptance number: CYHS2000033) has entered the approval stage and is expected to be approved in the near future

Lenvatinib is an inhibitor of vascular endothelial growth factor receptor (VEGFR) 1 to 3, fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptor (PDGFR) α, RET and KIT, ranking second in China A first-line targeted therapy drug for liver cancer

In 2017, the annual meeting of the American Society of Clinical Oncology (ASCO) announced the success of the Phase III clinical trial (REFLECT study) of lenvatinib for the first-line treatment of unresectable HCC.

The REFLECT study enrolled 954 patients worldwide, of which 288 patients were enrolled in the Chinese subgroup (about 83% of patients with HBV-related liver cancer)

Based on the results of the REFLECT study, Eisai submitted a marketing application for lenvatinib liver cancer indications in China in October 2017, and was granted priority review and approval on December 18

Data show that there are 854,000 new cases of primary liver cancer each year in the world, and China is 466,000, accounting for about 55% of the world’s total.

After lenvatinib was approved, its domestic sales also increased rapidly

It is a pity that in the 2019 medical insurance negotiations, lenvatinib came back unfavorably, disappointing countless liver cancer patients; fortunately, lenvatinib was successfully included in the medical insurance during the 2020 medical insurance negotiations with a price reduction of 80%.

According to the Insight database, in addition to the approved products, there are currently 10 other companies with generic lenvatinib listed on the market