Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received acceptance from the National Medical Products Administration for the marketing authorization application of HR20013, an injectable drug for preventing nausea and vomiting caused by moderately emetogenic chemotherapy in adult patients [1][2]. Drug Basic Information - Drug Name: Injectable Phosphor-Rolapitant Palonosetron - Dosage Form: Injectable - Acceptance Number: CXHS2600019 - Application Stage: Marketing - Applicant: Fujian Shengdi Pharmaceutical Co., Ltd. - Indication: Prevention of acute and delayed nausea and vomiting induced by moderately emetogenic anticancer drugs in adult patients [1]. Clinical Trial Information - The application for the new indication is based on a Phase III clinical trial (HR20013-302) evaluating the efficacy and safety of the drug. The trial was led by Sun Yat-sen University Cancer Center and involved 96 clinical research centers across the country, enrolling 706 participants [2]. - The primary and key secondary endpoints were the proportion of patients achieving complete response during the delayed and overall phases after administration of moderately emetogenic anticancer drugs. Results showed that the trial group had significantly higher complete response rates compared to the control group, with consistent advantages in symptom control, quality of life improvement, and time to treatment failure [2]. Other Drug Information - Nausea and vomiting induced by anticancer drugs are common adverse reactions in cancer treatment, potentially leading to dehydration, electrolyte imbalance, nutritional deficiencies, and esophageal mucosal tears, significantly affecting patients' quality of life and treatment adherence [3]. - Current guidelines recommend using NK1 receptor antagonists and 5-HT3 receptor antagonists in combination for preventing nausea and vomiting from highly emetogenic chemotherapy, while a dual regimen is suggested for moderately emetogenic drugs. However, adherence to these guidelines is often suboptimal due to various clinical factors [3]. Drug Characteristics - Injectable Phosphor-Rolapitant Palonosetron is a combination formulation that activates both NK-1 and 5-HT3 receptors to inhibit the vomiting reflex. It has a long half-life and high central nervous system penetration, providing advantages in preventing delayed and ultra-delayed vomiting [4]. - The product was approved for marketing in May 2025 for preventing acute and delayed nausea and vomiting caused by highly emetogenic chemotherapy in adults. Similar products available internationally include Helsinn Healthcare's AKYNZEO [4]. Research and Development Investment - Cumulative R&D investment for Injectable Phosphor-Rolapitant Palonosetron is approximately 247 million yuan (unaudited) [5].