恒瑞医药创新止吐药拓展新适应症，为中度致吐化疗患者带来新选择

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1月30日，恒瑞医药宣布其自主研发的注射用磷罗拉匹坦帕洛诺司琼新适应症上市许可申请获正式受理。该药拟定用于预防成年患者因中度致吐性抗肿瘤药物引起的急性和迟发性恶心呕吐。化疗恶心呕吐长期以来是肿瘤患者治疗过程中的常见不良反应。根据国内外权威指南，这些症状严重时可导致脱水、电解质紊乱、营养缺乏甚至食管黏膜撕裂等严重后果，显著影响患者生活质量和治疗依从性。在预防策略上，临床指南已有明确分层：对于高致吐性...

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chemotherapy","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01276":1.5},"content_text":"1月30日，恒瑞医药宣布其自主研发的注射用磷罗拉匹坦帕洛诺司琼新适应症上市许可申请获正式受理。该药拟定用于预防成年患者因中度致吐性抗肿瘤药物引起的急性和迟发性恶心呕吐。化疗恶心呕吐长期以来是肿瘤患者治疗过程中的常见不良反应。根据国内外权威指南，这些症状严重时可导致脱水、电解质紊乱、营养缺乏甚至食管黏膜撕裂等严重后果，显著影响患者生活质量和治疗依从性。在预防策略上，临床指南已有明确分层：对于高致吐性化疗方案，推荐使用包含NK-1受体拮抗剂和5-HT3受体拮抗剂的三联或四联方案。而对于中度致吐性化疗，传统上主要推荐5-HT3受体拮抗剂联合地塞米松的二联方案。对于那些使用中度致吐风险相对较高的抗肿瘤药物、合并高危因素，或先前接受二联预防仍出现恶心呕吐的患者，指南推荐升级为三联方案。预防性用药是控制恶心呕吐的关键，但受联合用药繁琐、对迟发性呕吐预期不足、患者居家漏服等因素影响，临床中的指南依从性并不理想。注射用磷罗拉匹坦帕洛诺司琼是一款复方制剂，能够同时拮抗NK-1受体和5-HT3受体，通过双途径抑制呕吐反射。从药物成分来看，该产品由磷罗拉匹坦和帕洛诺司琼组成，其中HRS5580作为罗拉匹坦前药，进入体内后能够迅速转化为活性成分罗拉匹坦。这一转化过程主要通过非CYP450酶系水解完成，避免了与多种药物的相互作用。帕洛诺司琼作为第二代5-HT3受体拮抗剂，能够有效阻断外周和中枢的5-HT3受体，对化疗急性期（化疗后24小时内）的恶心呕吐控制效果显著且持久。而罗拉匹坦作为长效NK-1受体拮抗剂，半衰期长且具有高度的中枢神经系统渗透性，在预防延迟期（化疗后24-120小时）和超延迟期的呕吐中展现出独特优势。此次新适应症的申请，基于一项代号为HR20013-302的多中心、随机、双盲、阳性对照的Ⅲ期临床试验。该研究由中山大学肿瘤防治中心牵头，张力教授和李宇红教授担任主要研究者，全国96家临床研究中心共同参与，共随机入组706例受试者。研究的主要终点和关键次要终点分别为中致吐性抗肿瘤药物给药开始后延迟期和总体期完全缓解的受试者比例。研究结果显示，试验组在延迟期完全缓解率和总体期完全缓解率方面均显著优于对照组。除主要疗效终点外，试验组在症状控制、生活质量改善、至治疗失败时间以及不同特征人群亚组分析等多个维度，均较对照组显示出一致优势。在安全性方面，试验组的安全性与耐受性良好，未发现新的安全性信号。这款药物已于2025年5月在国内首次获批上市，用于预防成人高致吐性化疗导致的急性和迟发性恶心呕吐。支持其首个适应症获批的关键Ⅲ期PROFIT研究（NCT05509634）主要结果已发表于国际著名肿瘤学期刊《临床肿瘤学杂志》。研究表明，磷罗拉匹坦帕洛诺司琼在每个治疗周期内仅需用药一次，便可同时覆盖高致吐性化疗给药后引起的急性期、延迟期及超延迟期恶心呕吐。在全球范围内，已上市的同类NK-1受体/5-HT3受体拮抗剂复方制剂主要为瑞士Helsinn 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