智通财经网·2026-01-30 11:24Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the drug application of HR20013, an injectable formulation of fosaprepitant for a new indication [1] Group 1: Drug Application and Clinical Trials - The application for the new indication is based on a multicenter, randomized, double-blind, positive-controlled Phase III clinical trial (HR20013-302) evaluating the efficacy and safety of HR20013 in preventing nausea and vomiting induced by moderately emetogenic chemotherapy [1] - The study was led by Sun Yat-sen University Cancer Prevention 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] Group 2: Study Results - 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 the administration of moderately emetogenic chemotherapy [1] - Results indicated that the complete response rates in the delayed phase and overall phase for the trial group were significantly better than those of the control group, with consistent advantages in symptom control, quality of life improvement, time to treatment failure, and various subgroup analyses [1] - The trial group demonstrated good safety and tolerability, with no new safety signals identified [1]