HENGRUI PHARMA (01276) announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., recently received a Notice of Acceptance from the National Medical Products Administration (NMPA) for the marketing authorization application of its Fosnetupitant/Palonosetron (HR20013) Injection.
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 Injection for preventing nausea and vomiting induced by moderately emetogenic anticancer chemotherapy.
This study was led by Sun Yat-sen University Cancer Center as the coordinating institution, with Professor Zhang Li and Professor Li Yuhong serving as principal investigators, and involved the participation of 96 clinical research centers nationwide, which collectively randomized 706 subjects.
The primary and key secondary endpoints of the study were the proportion of subjects achieving a complete response during the delayed phase and the overall phase, respectively, following the initiation of moderately emetogenic chemotherapy.
Results demonstrated that the complete response rates for both the delayed phase and the overall phase in the test group were significantly superior to those in the control group.
Furthermore, the test group exhibited consistent advantages over the control group across multiple dimensions, including symptom control, quality of life improvement, time to treatment failure, and various subgroup analyses based on patient characteristics.
Regarding safety, the test group showed a favorable safety and tolerability profile, with no new safety signals identified.
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