Zhi Tong Cai Jing·2026-01-30 11:24Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the drug listing application of HR20013, an injectable formulation of fosaprepitant dimeglumine, indicating progress in its regulatory approval process [1] Group 1: Drug Development and Clinical Trials - The new indication application is based on a multicenter, randomized, double-blind, positive-controlled Phase III clinical trial (HR20013-302) evaluating the efficacy and safety of HR20013 for preventing nausea and vomiting induced by moderately emetogenic anticancer drugs [1] - The study was led by Sun Yat-sen University Cancer Prevention and Treatment Center, with Professors Zhang Li and Li Yuhong as principal investigators, and involved 96 clinical research centers nationwide, enrolling a total of 706 subjects [1] - The primary and key secondary endpoints of the study were the proportion of subjects achieving complete response during the delayed phase and overall phase after administration of moderately emetogenic anticancer drugs [1] Group 2: Study Results - The results indicated that the complete response rates during the delayed phase and overall phase in the trial group were significantly superior to those in the control group [1] - The trial group demonstrated consistent advantages over the control group in multiple dimensions, including symptom control, quality of life improvement, time to treatment failure, and various subgroup characteristics [1] - Regarding safety, the trial group exhibited good safety and tolerability, with no new safety signals identified [1]