Rilvegostomig

Positive high-level results from the EMERALD-3 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), lenvatinib and transarterial chemoembolisation (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone for patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation. At this interim analysis for overall survival (OS), a key secondary endpoint, this combination also demonstrated a trend toward OS improvement versus TACE alone. Patients in the investigational arms were treated with the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), with or without lenvatinib, before TACE, and then alongside TACE. Although not formally tested at this time, data for the treatment arm evaluating the STRIDE regimen plus TACE versus TACE alone showed strong trends toward improved PFS and OS. The trial will continue to follow OS and other key secondary endpoints in both investigational arms. HCC is the most common type of liver cancer.1 In 2026, more than 200,000 patients with HCC will be eligible for embolisation, a standard-of-care procedure that blocks the blood supply to the tumour and can also deliver chemotherapy directly to the liver.2-4 However, most patients who receive embolisation experience disease progression or recurrence within six to ten months.5 Ghassan Abou-Alfa, MD, JD, MBA, PhD(hc), Attending Physician, Professor of Medicine at Memorial Sloan Kettering Cancer Center, and principal investigator in the trial said, “Dual immunotherapy with durvalumab and tremelimumab in the STRIDE regimen represents a meaningful advance for patients with embolisation-eligible liver cancer, who currently lack systemic treatment options to keep their cancer from progressing or recurring, with a trend of improving survival. EMERALD‑3 shows we can now significantly reduce the risk of disease progression with STRIDE as the immunotherapy backbone alongside lenvatinib and TACE.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “EMERALD‑3 now shows that bringing the dual immunotherapy STRIDE regimen earlier, alongside TACE and lenvatinib, can further improve outcomes in earlier‑stage liver cancer. This builds on the HIMALAYA Phase III trial data in patients with advanced, unresectable disease, where the STRIDE regimen has already demonstrated durable overall survival benefit. We are discussing these positive data with global regulatory authorities while awaiting the final results from the key secondary endpoints.” The safety profile for each combination was consistent with the known profiles of each medicine, and there were no new safety findings. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. +++ Notes Liver cancer Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death.1,6 In 2026, more than 200,000 patients will be diagnosed with embolisation-eligible HCC.2 Embolisation is a standard-of-care procedure that blocks the blood supply to the tumour and can also deliver chemotherapy directly to the liver.3-4 Immunotherapy is a proven treatment modality in HCC with approved options available for patients in later-line settings.7 EMERALD-3 EMERALD-3 is a randomised, open-label, sponsor-blinded, multicentre, global Phase III trial of a single priming dose of Imjudo 300mg added to Imfinzi 1500mg followed by Imfinzi every four weeks (STRIDE regimen) plus TACE with or without lenvatinib versus TACE alone in a total of 760 patients with unresectable HCC eligible for embolisation. Participants were randomised in a 1:1:1 ratio to Arm A (TACE, Imfinzi, Imjudo, lenvatinib), Arm B (TACE, Imfinzi, Imjudo) and Arm C (TACE) until each arm reached 175 participants. Randomisation was then continued in a 1:1 ratio to treatment Arms A and C until each reached approximately 275 participants. Patients received Imfinzi with Imjudo, plus TACE as needed, with or without lenvatinib concurrently, followed by Imfinzi with or without lenvatinib until progression. The trial was conducted in 171 centres across 22 countries, including in North America, Europe, South America and Asia. The primary endpoint is PFS for Imfinzi plus Imjudo, lenvatinib and TACE versus TACE alone. Secondary endpoints include OS for Imfinzi plus Imjudo, lenvatinib and TACE, and PFS and OS for Imfinzi plus Imjudo and TACE versus TACE alone. Imfinzi Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. In gastrointestinal (GI) cancer, Imfinzi is approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo in unresectable HCC. Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In addition to its indications in GI cancers, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC. Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved in the US, EU, Japan and other countries for patients with muscle-invasive bladder cancer based on results from the NIAGARA Phase III trial. Additionally, in May 2025, Imfinzi added to Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial. Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan. Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI cancers. Imjudo Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. In addition to its approved indications in liver and lung cancers, Imjudo is being tested in combination with Imfinzi across multiple tumour types including in SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE). AstraZeneca in GI cancers AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease. In 2022, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.8 Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic and colorectal cancers. In addition to its indications in BTC and HCC, Imfinzi is being assessed in combinations, including with Imjudo, in oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings. Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), is approved in the US and several other countries for HER2-positive advanced gastric cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Lynparza, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada). The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, in combination with bevacizumab with or without Imjudo as a 1st-line treatment in patients with advanced HCC, and as a 1st-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric and gastroesophageal junction cancers. Rilvegostomig is also being evaluated in combination with Enhertu in previously untreated, HER2-expressing, locally advanced or metastatic BTC. AstraZeneca is advancing multiple modalities that provide complementary mechanisms for targeting Claudin 18.2, a promising therapeutic target in gastric cancer. These include sonesitatug vedotin, a potential first-in-class ADC licensed from KYM Biosciences Inc., currently in Phase III development; AZD5863, a novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development; and AZD4360, an ADC, currently being evaluated in a Phase I/II trial in patients with advanced solid tumours. In early development, AstraZeneca is developing AZD7003, a Glypican 3 (GPC3) armoured CAR T, in HCC. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Dr. Abou-Alfa provides consulting and advisory services to AstraZeneca. Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

本周药品注册受理数据，分门别类呈现，一目了然。(3.23-3.29） 新药上市申请 药品名称 企业 注册分类 受理号 重组人白蛋白注射液 通化安睿特生物制药股份有限公司 2.4 CXSS2600050 新药临床申请 药品名称 企业 注册分类 受理号 JYP0035胶囊 嘉越(成都)医药科技有限公司 1 CXHL2600394 JYP0015片 广州嘉越医药科技股份有限公司 1 CXHL2600393 JYP0015片 广州嘉越医药科技股份有限公司 1 CXHL2600392 WXFL10030390片 上海嘉坦医药科技有限公司 1 CXHL2600391 JYP0015片 广州嘉越医药科技股份有限公司 1 CXHL2600390 WXFL10030390片 上海嘉坦医药科技有限公司 1 CXHL2600389 JYP0015片 广州嘉越医药科技股份有限公司 1 CXHL2600388 TJ0113胶囊 杭州天玑济世生物科技有限公司 1 CXHL2600383 INV-6452片 广东省创新药转化医学研究院有限公司 1 CXHL2600382 INV-6452片 广东省创新药转化医学研究院有限公司 1 CXHL2600381 RGT-490片 上海齐鲁锐格医药研发有限公司 1 CXHL2600387 RGT-490片 上海齐鲁锐格医药研发有限公司 1 CXHL2600386 拉尼兰诺片 正大天晴(广州)医药有限公司 1 CXHL2600380 BY101921片 康百达(四川)生物医药科技有限公司 1 CXHL2600379 BY101921片 康百达(四川)生物医药科技有限公司 1 CXHL2600378 VCT220片 成都闻泰医药科技股份有限公司 1 CXHL2600372 VCT220片 成都闻泰医药科技股份有限公司 1 CXHL2600371 VCT220片 成都闻泰医药科技股份有限公司 1 CXHL2600370 CH3127片 苏州春海生物医药有限公司 1 CXHL2600369 CH3127片 苏州春海生物医药有限公司 1 CXHL2600368 CH3127片 苏州春海生物医药有限公司 1 CXHL2600367 APH03571片 广州一品红制药有限公司 1 CXHL2600374 APH03571片 广州一品红制药有限公司 1 CXHL2600373 TUL321胶囊 珠海联邦制药股份有限公司 1 CXHL2600376 TUL321胶囊 珠海联邦制药股份有限公司 1 CXHL2600377 TUL321胶囊 珠海联邦制药股份有限公司 1 CXHL2600375 ODV混悬滴眼液 深圳若见辉瞳生物科技有限公司 1 CXHL2600366 ODV混悬滴眼液 深圳若见辉瞳生物科技有限公司 1 CXHL2600365 ODV混悬滴眼液 深圳若见辉瞳生物科技有限公司 1 CXHL2600364 XNW5004片 苏州信诺维医药科技股份有限公司 1 CXHL2600363 XNW5004片 苏州信诺维医药科技股份有限公司 1 CXHL2600362 ANS014004片 北京鞍石生物科技股份有限公司 1 CXHL2600358 ANS014004片 北京鞍石生物科技股份有限公司 1 CXHL2600357 DMI019鼻喷雾剂 江苏德迈药业有限公司 2.2 CXHL2600360 DMI019鼻喷雾剂 江苏德迈药业有限公司 2.2 CXHL2600359 DMI019鼻喷雾剂 江苏德迈药业有限公司 2.2 CXHL2600361 GT201注射液 北京沙砾生物医药股份有限公司 1 CXSL2600355 SCTB10注射液 神州细胞工程有限公司 1 CXSL2600354 9MW5211注射液 迈威(上海)生物科技股份有限公司 1 CXSL2600352 注射用SKB571 四川科伦博泰生物医药股份有限公司 1 CXSL2600350 ATG-201注射液 德琪(杭州)生物有限公司 1 CXSL2600349 人脐带间充质干细胞注射液 安明康源制药(吉林)有限公司 1 CXSL2600351 QLS2311注射液 齐鲁制药有限公司 1 CXSL2600353 注射用BL-M08D1 成都百利多特生物药业有限责任公司 1 CXSL2600348 GenSci161注射液 长春金赛药业有限责任公司 1 CXSL2600347 IBR854细胞注射液 英百瑞(杭州)生物医药有限公司 1 CXSL2600346 IBR854细胞注射液 英百瑞(杭州)生物医药有限公司 1 CXSL2600345 HB0056注射液 上海华奥泰生物药业股份有限公司 1 CXSL2600344 治疗用(合成肽)乙型肝炎疫苗 诺合泰生物科技(重庆)有限公司 1 CXSL2600343 特瑞普利单抗注射液 上海君实生物医药科技股份有限公司 2.2 CXSL2600357 特瑞普利单抗注射液 上海君实生物医药科技股份有限公司 2.2 CXSL2600356 仿制药申请 药品名称 企业 注册分类 受理号 磷酸奥司他韦颗粒 湖南普道医药技术有限公司 3 CYHS2600737 洛索洛芬钠口服溶液 重庆万霖生物医药科技有限公司 3 CYHS2600731 盐酸丁螺环酮片 北京诚济制药股份有限公司 3 CYHS2600729 碘化钾片 浙江普洛康裕制药有限公司 3 CYHS2600721 维生素K1注射液 北京福元医药股份有限公司 3 CYHS2600717 双氯芬酸钠搽剂 景时(杭州)药业有限公司 3 CYHS2600704 盐酸左沙丁胺醇雾化吸入溶液 盈科瑞(珠海金湾)制药有限公司 3 CYHS2600703 培美曲塞二钠注射液 四川双通医疗科技有限公司 3 CYHS2600712 培美曲塞二钠注射液 四川双通医疗科技有限公司 3 CYHS2600711 阿仑膦酸钠口服溶液 北京双鹭药业股份有限公司 3 CYHS2600709 头孢克肟干混悬剂 海南广升誉制药有限公司 3 CYHS2600697 硫酸特布他林口服溶液 苏州弘森药业股份有限公司 3 CYHS2600696 苯磺酸美洛加巴林片 山东京卫制药有限公司 4 CYHS2600742 苯磺酸美洛加巴林片 山东京卫制药有限公司 4 CYHS2600741 盐酸头孢卡品酯颗粒 苏州二叶制药有限公司 4 CYHS2600738 头孢托仑匹酯颗粒 苏州盛达药业有限公司 4 CYHS2600736 头孢托仑匹酯颗粒 苏州盛达药业有限公司 4 CYHS2600735 甘油磷酸钠注射液 瑞阳制药股份有限公司 4 CYHS2600727 羟考酮纳洛酮缓释片 甘肃农垦药物碱厂有限公司 4 CYHS2600734 羟考酮纳洛酮缓释片 甘肃农垦药物碱厂有限公司 4 CYHS2600733 羟考酮纳洛酮缓释片 甘肃农垦药物碱厂有限公司 4 CYHS2600732 克唑替尼胶囊 重庆圣华曦药业股份有限公司 4 CYHS2600730 阿达帕林过氧苯甲酰凝胶 山西振东安欣生物制药有限公司 4 CYHS2600728 他克莫司缓释胶囊 合肥力成药业有限公司 4 CYHS2600739 他克莫司缓释胶囊 合肥力成药业有限公司 4 CYHS2600740 巴瑞替尼片 山东朗诺制药有限公司 4 CYHS2600723 巴瑞替尼片 山东朗诺制药有限公司 4 CYHS2600722 莫匹罗星软膏 黑龙江天辰药业有限公司 4 CYHS2600720 佩玛贝特片 云南龙津康佑生物医药有限公司 4 CYHS2600719 利丙双卡因乳膏 国大(吉林)制药集团有限公司 4 CYHS2600718 注射用氨曲南阿维巴坦钠 上海欣峰制药有限公司 4 CYHS2600716 注射用盐酸万古霉素 亿腾医药(珠海)有限公司 4 CYHS2600726 注射用磷酸左奥硝唑酯二钠 海南元盈医药科技有限公司 4 CYHS2600725 磷酸奥司他韦胶囊 湖南先施制药有限公司 4 CYHS2600724 复方氨基酸注射液(18AA-VII) 湖北长联杜勒制药有限公司 4 CYHS2600713 恩他卡朋片 河北龙海药业股份有限公司 4 CYHS2600715 枸橼酸氢钾钠颗粒 成都克莱蒙医药科技有限公司 4 CYHS2600714 头孢地尼颗粒 浙江莎普爱思药业股份有限公司 4 CYHS2600702 头孢地尼颗粒 浙江莎普爱思药业股份有限公司 4 CYHS2600701 注射用头孢呋辛钠/氯化钠注射液 海南倍特药业有限公司 4 CYHS2600710 吡嘧司特钾滴眼液 石家庄格瑞药业有限公司 4 CYHS2600708 维生素K1滴剂 宏越科技(湖州)有限公司 4 CYHS2600707 磷酸芦可替尼片 重庆药友制药有限责任公司 4 CYHS2600706 二十碳五烯酸乙酯软胶囊 浙江华海药业股份有限公司 4 CYHS2600705 盐酸乙哌立松片 黑龙江亿达鸿药业有限公司 4 CYHS2600699 瑞舒伐他汀依折麦布片(Ⅰ) 安徽正善生物药业有限公司 4 CYHS2600698 硫酸氢氯吡格雷片 吉林道君药业股份有限公司 4 CYHS2600700 进口申请 药品名称 企业 注册分类 受理号 贝普若韦生注射液 GlaxoSmithKline Trading Services Limited 1 JXHS2600033 Brenipatide注射液 Eli Lilly and Company 1 JXHL2600094 Brenipatide注射液 Eli Lilly and Company 1 JXHL2600093 Brenipatide注射液 Eli Lilly and Company 1 JXHL2600092 Brenipatide注射液 Eli Lilly and Company 1 JXHL2600091 那米司特片 Boehringer Ingelheim International GmbH 2.4 JXHL2600090 那米司特片 Boehringer Ingelheim International GmbH 2.4 JXHL2600089 那米司特片 Boehringer Ingelheim International GmbH 2.4 JXHL2600088 AZD2936 AstraZeneca AB 1 JXSL2600087 注射用precemtabart tocentecan Merck Healthcare KGaA 1 JXSL2600085 阿伏利尤单抗注射液 AstraZeneca AB 2.2 JXSL2600086 中药相关申请 药品名称 企业 注册分类 受理号 香术调脾和中颗粒 山西省中医药研究院(山西省中医院) 1.1 CXZL2600032 麦门冬汤颗粒 广东一方制药有限公司 3.1 CXZS2600017 注：绿色字体部分为潜在首仿品种； 咸达数据2026年1月每月药讯已出！ 关注“咸达数据”，微信关键词回复 ” 年+月，如202601” 获得最新药迅！ 不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。