此次申报新适应症，是基于一项评价注射用磷罗拉匹坦帕洛诺司琼用于预防中度致吐性抗肿瘤药物引起 恶心呕吐的有效性和安全性的多中心、随机、双盲、阳性对照的Ⅲ期临床试验(HR20013-302)。该研究 由中山大学肿瘤防治中心作为牵头单位，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。研究结果表明，试验组延迟期完全缓解率和总体期完全 缓解率均显著优于对照组，且试验组在症状控制、生活质量改善、至治疗失败时间以及不同特征人群亚 组等多个维度均较对照组显示出一致的优势;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。 恒瑞医药（600276）(01276)公布，近日，公司子公司福建盛迪医药有限公司收到国家药品监督管理局 下发的《受理通知书》，公司注射用磷罗拉匹坦帕洛诺司琼(HR20013)的药品上市许可申请获国家药监 局受理。 ...

格隆汇11月21日丨人福医药（维权）(600079.SH)公布，控股子公司宜昌人福药业有限责任公司（简 称"宜昌人福"，公司持有其80%的股权）近日收到国家药品监督管理局核准签发的二甲磺酸利右苯丙胺 胶囊的药品注册上市许可申请《受理通知书》，二甲磺酸利右苯丙胺胶囊原研最早于美国获批上市，用 于治疗成人和6岁及以上儿科患者的注意缺陷多动障碍（ADHD），以及成人中度至重度暴食症 （BED）。 ...

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received acceptance for its drug application for SHR-A1811, which is intended for the treatment of HER2-positive breast cancer, and it has been included in the priority review process by the National Medical Products Administration (NMPA) [1] Group 1: Drug Information - The drug SHR-A1811 is an injectable formulation intended for adult patients with locally advanced or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [1] - The application for SHR-A1811 is currently in the listing phase, with the acceptance number CXSS2500094 [1] - The drug has already been approved for treating non-small cell lung cancer (NSCLC) in adults with HER2 mutations who have received at least one systemic therapy [2] Group 2: Clinical Trial Details - The SHR-A1811-Ⅲ-301 study is a randomized, open-label, positive drug-controlled, multi-center Phase III clinical trial comparing SHR-A1811 with pyrotinib plus capecitabine in HER2-positive breast cancer patients [2] - The primary endpoint of the study is progression-free survival (PFS) assessed by an independent imaging review committee (BIRC) based on RECIST v1.1 [2] - The interim analysis confirmed that SHR-A1811 met the predefined superiority criteria for PFS, significantly reducing the risk of disease progression or death compared to the control group [2] Group 3: Market Context - Breast cancer is one of the leading causes of morbidity and mortality among women globally, with HER2-positive breast cancer accounting for approximately 15-20% of all breast cancer cases [4] - There is a significant unmet medical need for effective treatments for advanced HER2-positive breast cancer due to limited drug options and early resistance to existing therapies [4] - The global sales of similar products are projected to reach approximately $6.557 billion by 2024, indicating a substantial market opportunity for SHR-A1811 [5] Group 4: Additional Drug Information - HRS-5635 injection, developed by the company's subsidiary, has been included in the list of proposed breakthrough therapies for chronic hepatitis B [8] - The drug is a new generation of liver-targeted siRNA therapy, showing potential for improving functional cure rates in chronic hepatitis B patients [11] - The current global burden of chronic hepatitis B is significant, with approximately 257 million infected individuals, highlighting the need for more effective treatment options [10]

Core Viewpoint - Heng Rui Medicine has received acceptance notification from the National Medical Products Administration for its drug application of Haequibopam Ethanolamine Tablets, aimed at treating chemotherapy-induced thrombocytopenia in adult patients [1] Group 1: Drug Development - The Phase III clinical trial (SHR8735-301) for Haequibopam Ethanolamine Tablets achieved its primary research endpoint as planned in May 2025 [1] - The study evaluated the efficacy and safety of Haequibopam Ethanolamine Tablets in patients with chemotherapy-induced thrombocytopenia through a multicenter, randomized, double-blind, placebo-controlled design [1] - A total of 213 adult patients with chemotherapy-induced thrombocytopenia were enrolled in the study, led by Professor Ma Jun from Harbin First Hospital and Professor Qin Shukui from Nanjing Tianyinshan Hospital [1] Group 2: Study Results - The results indicated that the treatment group significantly outperformed the control group on the primary efficacy endpoint [1] - The safety and tolerability of Haequibopam Ethanolamine Tablets were reported to be good [1]