The Zhitong Finance App learned that on November 6, Hengrui Pharmaceutical (600276.SH) announced that the full text of a randomized, double-blind, parallel-controlled, multicenter 3 clinical study on locally advanced or metastatic pancreatic cancer after failure with gemcitabine treatment with irinotecan liposome (II) and 5-FU/LV second-line treatment was published in the “Nature” magazine sub-journal “Signal Transduction and Targeted Therapy”. Research results showed that compared to the control group, the risk of death in patients with pancreatic cancer was reduced by 37% compared to the irinotecan liposome (II) combination regimen.

According to public information from Hengrui Pharmaceutical, the company used liposome technology to wrap irinotecan in a phospholipid bilayer to develop a new formulation that can be passively targeted and distributed to tumors - irinotecan hydrochloride liposome (II). The design of lipid formulations protects irinotecan from being converted into the active metabolite SN-38 early, helps irinotecan maintain circulation for a longer period of time, increases drug deposition and contact within tumors, and enhances the inhibitory effect on tumor growth.

In terms of the main study endpoints, the irinotecan liposome (II) group increased the median OS by 2.4 months (7.39 months versus 4.99 months) compared to the placebo group, and the risk of death decreased by 37%. In terms of secondary study endpoints, the irinotecan liposome (II) group significantly extended the PFS period by 2.73 months (4.21 months versus 1.48 months) compared to the placebo group, reducing the risk of disease progression or death by 64%. Good safety.

Based on this phase 3 clinical study, irinotecan liposome (II) was approved for marketing by the Chinese NMPA in December 2023, in combination with 5-FU and LV for the treatment of patients with unresectable locally advanced or metastatic pancreatic cancer who have previously failed gemcitabine-based chemotherapy treatment.