Gadopiclenol

Key Facts: Bayer’s AMBELVIST ® (gadoquatrane) becomes the lowest-dose macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) approved in the U.S., with a recommended dose of 0.01 mmol/kg actual body weight delivering 0.04 mmol Gd/kg body weight 1 Approval is supported by data from the Phase III QUANTI clinical studies, which demonstrated efficacy at a fraction of the dose compared to mGBCAs dosed at 0.1 mmol Gd/kg body weight 1 WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) approved AMBELVIST ® (gadoquatrane), a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) indicated for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates. 1 AMBELVIST is a next-generation mGBCA with a novel tetrameric structure and high relaxivity (a measure of signal enhancement). 1 With this approval, AMBELVIST becomes the lowest-dose mGBCA in the U.S. AMBELVIST has a recommended dose of 0.01 mmol/kg actual body weight (which delivers 0.04 mmol Gd/kg body weight), representing 60% less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight and 20% less Gd compared to gadopiclenol with a Gd content of 0.05 mmol Gd/kg body weight. 1,2 WHY THIS APPROVAL MATTERS: Contrast-enhanced MRI is a medical imaging examination often used by clinicians to gain insight into what’s happening in the human body. This type of study can play an important role in detecting abnormalities, monitoring disease progression and informing treatment decisions. 3 For some adults and children with chronic diseases or conditions that require close, long-term monitoring—such as multiple sclerosis, other neurological or spinal conditions as well as different types of cancer—regular, serial images may be required. “I often rely on contrast-enhanced MRI exams to inform clinical decision making,” said Dr. Christopher Hancock, Director of Neuroradiology at HALO Diagnostics Desert Cities and an investigator for the QUANTI clinical studies. “With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic GBCA dose, reducing gadolinium exposure while preserving the clinical information we often need.” KEY CLINICAL TRIAL FINDINGS: The FDA approval is based on the global pivotal Phase III QUANTI clinical studies, which evaluated the efficacy and safety of A MBELVIST in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI. 1 Key findings demonstrated: Increased lesion visualization with the combined pre-contrast and post-contrast MRI sets with the decreased Gd dose in AMBELVIST compared with only pre-contrast MRI images. 1 Visualization scores and number of lesions identified per blinded independent reader for AMBELVIST dosed at 0.01 mmol/kg body weight (which delivers 0.04 mmol Gd/kg body weight) were similar to other tested mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight in descriptive analyses. 1 The safety and effectiveness of AMBELVIST for use with MRI to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system) have been established in pediatric patients, including term neonates. Use of AMBELVIST in this age group is supported by evidence from adequate and well-controlled studies of AMBELVIST in adults, with additional pharmacokinetic and safety data from 93 pediatric patients aged 28 days to less than 18 years who received one 0.01 mmol/kg dose of AMBELVIST and underwent MRI of any body region. 1 AMBELVIST is associated with a Boxed Warning regarding risks associated with intrathecal administration and nephrogenic systemic fibrosis and is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. Additionally, there are Warnings and Precautions related to hypersensitivity reactions, gadolinium retention, acute kidney injury and interference with lesion visualization. Please see AMBELVIST Important Safety Information below for additional information. BAYER PERSPECTIVE ON AMBELVIST APPROVAL: Bayer has played a pioneering role in MRI contrast agent development, having launched the first GBCA in 1988, and is now adding AMBELVIST to its radiology portfolio as the lowest-dose mGBCA approved in the U.S. “At Bayer, our focus has always been on enhancing patient care, and we are proud to introduce AMBELVIST as our next-generation option for contrast-enhanced MRI,” said Jill Carbone, Vice President and Head of Radiology, North America Product & Pipeline, Bayer. “As a lower-gadolinium-dose GBCA, AMBELVIST supports healthcare providers in adhering to growing clinical guidance to utilize the lowest gadolinium dose necessary to adequately image patients.” 4 INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS AMBELVIST ® (gadoquatrane) is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) IMPORTANT SAFETY INFORMATION WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. AMBELVIST is not approved for intrathecal use. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of AMBELVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR 60 years, hypertension, or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended AMBELVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration. Contraindication and Important Information about Hypersensitivity Reactions: AMBELVIST ® is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST ® . Serious hypersensitivity reactions have occurred with GBCAs. Before AMBELVIST ® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma, and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to AMBELVIST ® . Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible. Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses. Interference with Lesion Visualization As with other GBCAs, AMBELVIST ® may obscure certain lesions that are visible on non-contrast MRI. When available, non-contrast MRI images should be reviewed during the interpretation of AMBELVIST ® MRI scans. Adverse Reactions: The most frequently observed adverse reactions (incidence ≥ 0.2%) were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus. Please click here for the Full Prescribing Information for AMBELVIST ® . About Radiology at Bayer Bayer’s Radiology business is a world leader among medical imaging solutions providers. The business transforms insight into technology and services with the goal of providing radiology solutions to help its customers enhance patient care. Its leading radiology portfolio features contrast agents and devices to help enable precise dose administration across modalities, equipment services, informatics and connected solution offerings. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Find more information at Follow us on Facebook: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. __________________________ 1 Bayer Pharmaceuticals. AMBELVIST (gadoquatrane) [package insert]. U.S. Food and Drug Administration. Available at: . 2 Bracco. Vueway (gadopiclenol) package insert. U.S. Food and Drug Administration. Available at: . 3 National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health. Magnetic Resonance Imaging (MRI). Available at: . Accessed: 15 April 2026. 4 ACR manual on contrast media (2026) ACR . Available at: . Accessed: 15 April 2026. Contacts Contact for media inquiries: Elaine Colón Phone: +1-732-236-1587 Email: elaine.colon@bayer.com Contact for investor inquiries: Bayer Investor Relations Team Phone: +49 214 30-72704 Email: ir@bayer.com

药政日报 | 2026年6月17日 每日药政资讯，尽在掌握国内药政动态1. 施维雅拓舒沃®（艾伏尼布）AML一线适应症在华获批 发布时间：2026-06-156月10日，国家药品监督管理局正式批准拓舒沃®（艾伏尼布片）新增适应症，用于联合阿扎胞苷治疗携带易感异柠檬酸脱氢酶-1（IDH1）突变、因合并症无法使用强诱导化疗或者年龄≥75岁的新诊断急性髓系白血病（AML）患者。 此前，拓舒沃已在中国获批用于治疗携带IDH1突变的复发性或难治性AML成人患者。此次一线适应症获批标志着该联合疗法正式跨入AML全程管理新阶段，填补了国内新诊断、不适合强化疗患者无特异性靶向药的临床空白。 此次获批基于全球多中心、随机、双盲、安慰剂对照的Ⅲ期AGILE研究数据。研究显示，艾伏尼布联合阿扎胞苷治疗组中位无事件生存期显著延长，中位总生存期提升至近30个月。该药已于2025年底纳入国家医保目录。2. 默沙东安福畅®（克莱罗韦单抗）在华获批 发布时间：2026-06-11     国家药监局通过优先审评审批程序批准默沙东申报的克莱罗韦单抗注射液（商品名：安福畅）上市，用于即将进入或出生在第一个呼吸道合胞病毒（RSV）流行季的新生儿和婴儿预防RSV所致的下呼吸道感染。 安福畅是国内首款、现阶段唯一固定剂量长效RSV单抗，所有符合适应症的新生儿、婴儿统一采用105mg剂量单次肌肉注射，无需测量体重，大幅简化临床接种流程。该药基于CLEVER全球关键性Ⅲ期临床研究，可将RSV相关住院率降低84.3%，单次注射提供长达6个月防护。 这是继赛诺菲/阿斯利康尼塞韦单抗（乐唯初）后，国内第二款获批的RSV预防性单抗。3. 泽璟制药盐酸吉卡昔替尼片斑秃适应症获批 发布时间：2026-06-15 泽璟制药公告，公司自主研发的盐酸吉卡昔替尼片（曾用名：盐酸杰克替尼）用于治疗成人重度斑秃的上市申请获得NMPA批准。这是该药继中、高危骨髓纤维化适应症后第二个获批的适应症，也是首个获批的治疗免疫炎症性疾病的临床适应症。 本次批准基于Ⅲ期临床试验数据：治疗24周后，脱发严重程度工具量表（SALT）评分≤20分（头发覆盖面积大于80%）的受试者比例，吉卡昔替尼片50mg Bid组为34.5%，安慰剂组为3.5%，差异具有统计学意义。4. 两款原料药同日通过CDE审评 发布时间：2026-06-16~17 天宇股份（300702）6月17日公告，公司美阿沙坦钾原料药近日通过CDE审评，适用于治疗成人原发性高血压。目前国内已有10家厂家获得CDE审评通过，公司尚需完成GMP符合性检查后方可上市销售。 同和药业（300636）6月16日公告，公司罗沙司他原料药（登记号Y20240001574）通过CDE审批，审评结果为"A"（已批准在上市制剂中使用）。罗沙司他主要用于治疗慢性肾脏病（CKD）引起的贫血，2025年中国大陆医院采购金额约25.93亿元。5. CDE发布第107批参比制剂目录征求意见 发布时间：2026-06-12 CDE组织遴选了第一百零七批化学仿制药参比制剂目录，现予以公示征求意见。公示期间，社会各界如对公示内容有不同意见，可通过仿制药质量和疗效一致性评价专栏提出。6. NMPA发布第106批仿制药参比制剂目录 发布时间：2026-06-15 经国家药监局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第一百零六批）。行业动态1. 康宁杰瑞恩尼妥®（KN026）全国首批商业发货 发布时间：2026-06-16来源：康宁杰瑞公告 6月16日，康宁杰瑞自主研发、与石药集团合作开发的恩尼妥®（安尼妥单抗注射液，研发代号KN026）全国首批商业发货仪式在苏州工业园区举行，标志着中国首个国产自研HER2双特异性抗体药物正式投入临床应用。 恩尼妥®于2026年5月28日获NMPA优先审评审批程序批准上市，用于联合化疗治疗既往至少接受过一种含曲妥珠单抗治疗方案的局部晚期或转移性HER2阳性成人胃或胃食管结合部腺癌患者。 该药物基于Fc异二聚体平台技术（CRIB）开发，可同时精准结合HER2受体两个非重叠表位，全面阻断下游肿瘤信号通路。其关键性Ⅲ期研究显示，恩尼妥联合化疗可将晚期胃癌患者中位生存期提升至20.9个月。2. 常山药业艾本那肽收到CDE二次发补通知 发布时间：2026-06-12 常山药业在投资者互动平台确认，其核心创新药艾本那肽注射液（现通用名：阿贝那肽）在6月8日完成首轮发补、五大专业审评全部办结后，再次收到CDE补充资料通知。公司表示正在准备补充资料，无法预计完成审评时间。 艾本那肽是一款GLP-1受体激动剂，用于2型糖尿病治疗，2024年4月提交上市申请。此次二次发补属于专业技术类资料补充，而非单纯文书整改。受此影响，该产品大概率将错过2026年医保谈判窗口。3. 三款仿制药同日获批上市 发布时间：2026-06-17 千金药业子公司湖南千金湘江药业获得盐酸氨溴索口服溶液（100ml:0.3g，化药4类，按甲类非处方药管理）和非布司他片（20mg、40mg，化药4类）《药品注册证书》。 华润双鹤子公司获得三款药品注册证书：利格列汀二甲双胍片(Ⅱ)（2型糖尿病，视同通过一致性评价）、黄体酮注射液(Ⅱ)、氢溴酸伏硫西汀片。4. 励晶太平洋创新药Senstend™获NMPA上市批准 发布时间：2026-06-17 励晶太平洋(00575)宣布旗下创新疗法Senstend™的新药申请正式获得NMPA上市批准，并附带为期四年数据保护期。此次获批触发商业合作伙伴江苏万邦医药（复星医药控股子公司）向励晶太平洋支付500万美元（约3900万港元）里程碑款项，预计2026年下半年首次商业销售时将再支付200万美元。国际药政动态1. FDA批准拜耳Ambelvist™ 成为美国最低剂量大环钆造影剂 发布时间：2026-06-15（美国时间） 拜耳宣布，美国FDA已批准Ambelvist™（gadoquatrane）用于成人及儿科患者（包括足月新生儿）的对比增强磁共振成像（MRI）检查，以检测和显示中枢神经系统及非中枢神经系统体区血管异常病变。 Ambelvist是一种新一代大环钆基造影剂（mGBCA），采用新型四聚体结构，具有高弛豫率。推荐剂量为0.01 mmol/kg体重（相当于0.04 mmol Gd/kg），与传统0.1 mmol Gd/kg的大环钆造影剂相比，钆含量减少60%；与0.05 mmol Gd/kg的gadopiclenol相比，钆含量减少20%。该药是目前美国市场上剂量最低的大环类钆造影剂。 此次批准基于全球Ⅲ期QUANTI系列研究数据，证明在较低钆剂量下仍能有效增强病灶可视化效果。2. FDA批准赛诺菲Tzield® 用于3期1型糖尿病 发布时间：2026-06-12（美国时间） 美国FDA通过加速批准程序，批准赛诺菲Tzield®（替利珠单抗，teplizumab-mzwv）的补充生物制剂许可申请（sBLA），用于延缓近期被诊断为3期1型糖尿病（T1D）的8至17岁儿科患者内源性胰岛素分泌功能的衰退。 Tzield成为全球首个针对新诊断3期T1D患者的疾病修饰疗法。此前，该药已于2022年获批用于延缓2期T1D进展为3期疾病，2024年4月进一步扩大至1岁及以上儿童。 此次加速批准基于Ⅲ期PROTECT研究数据：治疗组患者平均C肽水平下降速度较安慰剂组显著减缓（最小二乘差异：0.13 pmol/mL，p<0.001）。替利珠单抗是一种抗CD3单克隆抗体，通过与效应T细胞表面的CD3结合，抑制T细胞对胰岛β细胞的攻击。3. Gilead lenacapavir每周一次口服HIV预防疗法获FDA受理 发布时间：2026-06-16（美国时间） Gilead Sciences宣布，FDA已受理其lenacapavir（商品名：Yeztugo）作为每周一次口服剂型用于HIV暴露前预防（PrEP）的补充新药申请（sNDA）。PDUFA目标日期为2027年2月2日。 Lenacapavir是一款新一代衣壳抑制剂，通过阻断HIV病毒衣壳的组装和分解来发挥作用。如果获批，将为HIV预防领域提供新的长效选择。4. EMA发布多项监管更新 发布时间：2026-06-15~17 6月15日，EMA管理委员会批准多项议程，包括支持欧盟埃博拉疫情应对、2025年年度活动报告评估等。6月16-18日，孤儿药委员会（COMP）、兽药委员会（CVMP）会议召开。6月17日，先进疗法委员会（CAT）会议、临床试验信息系统（CTIS）信息日活动举行。