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Hengrui Affiliate Files for US Approval of PD-1 in Early Liver Cancer

publication date: May 18, 2023

Jiangsu Hengrui Medicine reported a global Phase III trial of its PD-1 inhibitor camrelizumab and VEGFR inhibitor apatinib met its endpoint in newly diagnosed patients of liver cancer. The combination therapy offered improved overall survival compared to Bayer’s Nexavar. Evelvar, Hengrui’s US partner for the drugs, filed for US approval of the PD-1. Although the FDA has rejected two other China PD-1 candidates over the last year, Evelar’s NDA data derives from a global Phase III trial that includes US patients, which the earlier NDAs did not. There are two potential problems, however: Nexavar, the benchmark when Hengrui started trials, has now been replaced by Roche’s PD-L1/VEGF combination of Tecentriq/Avastin as the leading therapy, and neither camrelizumab nor apatinib are approved in the US, asking the FDA to approve both at one time. More details....

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