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更新于：2026-04-03
Gadoquatrane
更新于：2026-04-03
概要
基本信息
结构/序列
分子式C81H128N24O32.4Gd |
InChIKeyHGIZCBUSWUYZEQ-UHFFFAOYSA-B |
CAS号2048221-65-2 |
关联
7
项与 Gadoquatrane 相关的临床试验NCT05915026
A Multicenter, Prospective, Open-label Study to Evaluate the Pharmacokinetics and Safety of Gadoquatrane in Pediatric Participants (From Birth to <18 Years) Undergoing Contrast-enhanced Magnetic Resonance Imaging (CE-MRI)
Researchers are looking for a better way to help children under the age of 18 with any known or suspected problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve their evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd), which is needed for the increase in signal intensity and contrast in MRI. The gadolinium in these contrast agents is caged in a molecule (chelate complex). Researchers are developing new contrast agents with a lower amount of Gd needed per CE-MRI investigation. Gadoquatrane is one of these new contrast agents. It has been tested in several studies previously.
The main purpose of this study is to learn how gadoquatrane moves into, through, and out of the body and how safe it is in children. The researchers will measure the amount of gadoquatrane in the blood at different time points after a single injection.
The participants will undergo an MRI examination and receive gadoquatrane once at a dose of 0.04 mmol Gd/kg (corresponding to 0.1 mL/kg). It is injected into the participant's vein (also called an intravenous injection) during the MRI examination.
Each participant will be in the study for between 8 and 38 days with up to 5 doctor visits, including the screening phase of up to 28 days with no more than 2 visits. Once a participant has received the injection of gadoquatrane, the remaining study duration is 7 (±1) days.
At the start or during the study, the doctors and their study team will:
* check the weight and height of the participant,
* ask for information including age and medical history,
* take participants' blood samples,
* ask participants and/or their guardians questions about medicines they are taking,
* check blood pressure, heart rate and body temperature,
* check the area where the participants had the intravenous injection,
* do pregnancy tests in girls of childbearing age,
* review the MRI scans obtained in the study and decide on the diagnosis
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve their evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd), which is needed for the increase in signal intensity and contrast in MRI. The gadolinium in these contrast agents is caged in a molecule (chelate complex). Researchers are developing new contrast agents with a lower amount of Gd needed per CE-MRI investigation. Gadoquatrane is one of these new contrast agents. It has been tested in several studies previously.
The main purpose of this study is to learn how gadoquatrane moves into, through, and out of the body and how safe it is in children. The researchers will measure the amount of gadoquatrane in the blood at different time points after a single injection.
The participants will undergo an MRI examination and receive gadoquatrane once at a dose of 0.04 mmol Gd/kg (corresponding to 0.1 mL/kg). It is injected into the participant's vein (also called an intravenous injection) during the MRI examination.
Each participant will be in the study for between 8 and 38 days with up to 5 doctor visits, including the screening phase of up to 28 days with no more than 2 visits. Once a participant has received the injection of gadoquatrane, the remaining study duration is 7 (±1) days.
At the start or during the study, the doctors and their study team will:
* check the weight and height of the participant,
* ask for information including age and medical history,
* take participants' blood samples,
* ask participants and/or their guardians questions about medicines they are taking,
* check blood pressure, heart rate and body temperature,
* check the area where the participants had the intravenous injection,
* do pregnancy tests in girls of childbearing age,
* review the MRI scans obtained in the study and decide on the diagnosis
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
开始日期2023-08-16 |
申办/合作机构 |
NCT05915728
A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)
Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
* take blood and urine samples
* do physical examinations
* check blood pressure and heart rate
* review the MRI scans obtained in the study and decide on the diagnosis
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
* take blood and urine samples
* do physical examinations
* check blood pressure and heart rate
* review the MRI scans obtained in the study and decide on the diagnosis
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
开始日期2023-07-24 |
申办/合作机构 |
NCT05915702
A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)
Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
* take blood and urine samples
* do physical examinations
* check blood pressure and heart rate
* review the MRI scans obtained in the study and decide on the diagnosis
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
* take blood and urine samples
* do physical examinations
* check blood pressure and heart rate
* review the MRI scans obtained in the study and decide on the diagnosis
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
开始日期2023-07-24 |
申办/合作机构 |
100 项与 Gadoquatrane 相关的临床结果
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100 项与 Gadoquatrane 相关的转化医学
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100 项与 Gadoquatrane 相关的专利（医药）
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11
项与 Gadoquatrane 相关的文献（医药）2025-04-01·JOURNAL OF CHROMATOGRAPHY A
Quantification of Gd species in a tetrameric Gd-based contrast agent using HPLC-ICP-MS
Article
作者: Holkenjans, Wiebke ; Sperling, Michael ; Jeremias, Anne ; Balzer, Sandra ; Weishaupt, Sonja ; Karst, Uwe ; Vogel, Martin
This study presents a newly developed high-performance liquid chromatography-inductively coupled plasma-mass spectrometry (HPLC-ICP-MS) method for quantification of Gd complexes in a tetrameric, macrocyclic Gd-based MRI contrast agent (GBCA). Since for the multimeric GBCA Gadoquatrane, currently in Phase III clinical development, mainly multinuclear Gd complexes are expected as by-products from the route of synthesis, HPLC-ICP-MS is suitable for the quantitative determination of these Gd species. The developed HPLC-ICP-MS method offers high sensitivity and accurate quantification based on external calibration with a generic Gd standard and is thus a powerful alternative to routinely used HPLC-UV in the pharmaceutical industry. The method allows for quantitatively detecting six different multimeric Gd-containing by-products in a Gadoquatrane sample taken from the early process development. A limit of quantification (LOQ) of 38 nmol/L is achieved for monomeric Gd complexes, which allows the quantitative determination of Gd species at levels as low as 0.004 mass% in the product. With this method, unknown Gd-containing by-products in GBCAs even at trace levels can be well assessed regarding their relevance in the further synthesis process optimization and in the drug substance control strategy. The elaborative synthesis of reference compounds for quantification of unknowns may be omitted, which can significantly accelerate the synthesis process optimization.
2024-12-01·INVESTIGATIVE RADIOLOGY
Relationship of Dose and Signal Enhancement Properties of Gadoquatrane, a New Tetrameric, Macrocyclic Gadolinium-Based Contrast Agent, Compared With Gadobutrol
Article
作者: Riecke, Kai ; Palkowitsch, Petra ; Klein, Stefan ; Posch, Helena ; Klemens, Mark A ; Ebert, Wolfgang ; Kahn, Johannes F ; Berse, Matthias ; Hofmann, Birte M
Objectives:
To investigate the signal-enhancement properties of the tetrameric gadolinium-based contrast agent (GBCA) gadoquatrane in relation to the administered dose and compare its properties to those of a standard dose of gadobutrol, as a representative of the currently established macrocyclic GBCAs for magnetic resonance imaging.
Materials and Methods:
In this randomized, single-blind, 4 × 4 crossover study, 43 healthy adults (19–50 years of age) received 3 single IV injections of gadoquatrane (0.01, 0.03, and 0.06 mmol gadolinium/kg body weight) and 1 injection of gadobutrol (0.1 mmol gadolinium/kg body weight) in randomized sequence with 1-week washout periods between administrations. The relative signal enhancement (RSE) was determined in predefined areas of interest in magnetic resonance image sets of the head-neck region. RSE-vs-dose curves (dose-response curves) were established by linear regression, and comparator-equivalent doses were determined by Bayesian inverse regression analysis. Further, 3 blood samples were taken after each injection for pharmacokinetic analyses, and safety data were assessed.
Results:
The RSE increased with gadoquatrane dose. A linear function adequately fitted this relationship. In line with the more than 2-fold higher r1 relaxivity of gadoquatrane per gadolinium ion, gadobutrol-equivalent RSE was achieved with gadoquatrane at less than half the gadolinium dose and less than one eighth of the molecule dose.Administration of gadoquatrane and gadobutrol resulted in very similar dose-normalized gadolinium concentrations in plasma, indicating that the pharmacokinetic profiles are essentially the same. Both contrast agents were well tolerated. Adverse events were rare and not dependent on the dose administered.
Conclusions:
Gadoquatrane has the potential to be an effective GBCA that can be used at substantially lower doses in clinical routine than the currently established macrocyclic GBCAs.
2024-05-01·European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
Pharmacokinetics, safety, and tolerability of the novel tetrameric gadolinium-based MRI contrast agent gadoquatrane in healthy Chinese and Japanese men: Two randomized dose-escalation studies including concentration–QTc modeling
Article
作者: Kexin Li ; Gabriele Sutter ; Yubin Sui ; Kumi Matsuno ; Xuemei He ; Mengyuan Ren ; Shunji Matsuki ; Birte Maria Hofmann
PURPOSE:
To investigate the pharmacokinetics, safety, and tolerability of the novel tetrameric high-relaxivity gadolinium-based contrast agent gadoquatrane in Japanese (Study 1) and Chinese men (Study 2).
PARTICIPANTS AND METHODS:
In two similarly designed single-center, randomized, single-blind, placebo-controlled, consecutive-cohort dose-escalation studies, healthy volunteers were randomly assigned to intravenous administration of gadoquatrane (0.01-0.1 mmol gadolinium/kg body weight) or placebo. Study procedures included blood sampling and collection of urine for pharmacokinetic analyses and safety assessments.
RESULTS:
Twenty-five healthy Japanese men (mean age ± standard deviation: 26±5.9 years) and 23 healthy Chinese men (31±7.6 years old) were evaluated. In both studies, the pharmacokinetic profile of gadoquatrane was characterized by rapid distribution of the drug into the extracellular space and fast renal elimination. Postdose gadolinium concentrations rapidly declined with a geometric mean effective half-life of 1.3-1.4 h. The exposure increased approximately dose-proportionally with dose. The body weight-normalized volume of distribution was constant across dose levels (0.21-0.24 L/kg). Total recovery of gadolinium in urine amounted to 82-95 % (Study 1) and 96-99 % (Study 2) of the dose administered. Only a few mild, transient adverse events were reported, none of which gave rise to any safety concerns. Exploratory drug concentration-QTc modeling indicated no risk of a clinically relevant QT/QTc prolongation at the anticipated diagnostic dose.
CONCLUSION:
Gadoquatrane was safe and well tolerated at all doses tested. The pharmacokinetic profile was essentially the same as that of other extracellular macrocyclic gadolinium-based contrast agents and was consequentially also similar for Japanese and Chinese participants.
37
项与 Gadoquatrane 相关的新闻（医药）2026-04-02
·科学网
4月1日，在拜耳举行的处方药全球媒体日活动上，拜耳集团管理委员会成员、处方药事业部全球总裁Stefan Oelrich表示，公司正凭借坚定的科学态度与业务准则，推动变革性战略落地，为当下与未来的增长注入强劲动力。
“得益于强大的处方药产品组合、多元化的研发管线以及日益人工智能化的运营模式，我们有望从2027年起恢复中个位数增长，并从2028年起扩大利润率，到2030年达到30%。”Oelrich在活动中指出。
拜耳处方药执行副总裁、全球产品战略与商业化负责人Christine Roth在活动中表示，公司致力于提供“同类首创”或“同类最佳”的产品。她强调：“过去几年我们做出的大胆选择，正在加速创新，最终将为患者和公司带来实实在在的影响。”
拜耳明确了驱动未来业绩增长的五大核心产品。
一是Asundexian（在研）：一种活化凝血因子XI（XIa）抑制剂。临床研究显示，在非心源性缺血性卒中或高风险短暂性脑缺血发作患者中，联合抗血小板治疗在减少卒中复发方面优于安慰剂。该药物已获美国食品药品监督管理局快速通道资格。
二是达罗他胺（诺倍戈）：首个与雄激素受体抑制剂联合用于转移性激素敏感性前列腺癌的雄激素受体抑制剂。拜耳目标成为第二代雄激素受体抑制剂的全球领导者。
三是非奈利酮（可申达）：首个在五项关键III期研究中显示出心血管和/或肾脏获益的选择性非甾体类盐皮质激素受体拮抗剂。该药已在全球100多个国家获批用于2型糖尿病相关慢性肾脏病，并在美国、日本和欧盟获批用于左心室射血分数≥40%的心力衰竭。
四是Acoramidis（Beyonttra）：用于治疗转甲状腺素蛋白淀粉样变性心肌病的根本原因。该药已在欧盟获批用于野生型或变异型转甲状腺素蛋白淀粉样变性心肌病成年患者。
五是Elinzanetant（Lynkuet）：全球首个双重神经激肽靶向疗法（NK-1和NK-3受体拮抗剂）。在美国获批用于绝经相关中重度血管舒缩症状，在欧盟获批用于绝经相关或乳腺癌辅助内分泌治疗引起的中重度血管舒缩症状。
拜耳处方药执行副总裁、全球研发负责人Christian Rommel介绍，2025年公司取得了3项新产品获批、2项新适应症获批、6项III期临床试验积极结果的突破性成绩。“2026年，我们预计将在心血管和肿瘤等核心治疗领域的精准治疗、再生细胞与基因疗法，以及分子影像等多个领域取得关键里程碑，进一步验证以创新驱动影响的战略。”
在精准药物研发方面，拜耳正在推进多项前沿项目：用于晚期转移性去势抵抗性前列腺癌的靶向α疗法225Ac-PSMA-Trillium；全球首个进入临床试验的WRN共价抑制剂VVD-214，针对微卫星不稳定性高表达的实体瘤；用于控制房颤患者心脏电活动的高选择性GIRK4抑制剂；以及已在中美获得突破性疗法认定的HER2突变非小细胞肺癌治疗药物塞伐艾替尼。
在基因疗法与细胞疗法领域，拜耳同样取得重要进展。针对射血分数降低的心力衰竭的基因疗法AB-1002已完成II期临床随机分组；针对帕金森病的基因疗法Ametefgene parvec和细胞疗法Bemdaneprocel均处于临床开发阶段；用于原发性感光细胞疾病的OpCT-001已获美国食品药品监督管理局快速通道资格和孤儿药认定。
在医学影像领域，拜耳持续推动创新。新一代低剂量大环状钆基MRI对比剂Gadoquatrane已于2026年3月在日本获批，与现有制剂相比每次检查可减少高达60%的钆剂量。此外，在研的泛淀粉样分子影像示踪剂AT-01和AT-05有望为心脏淀粉样变性等疾病的准确诊断提供新的解决方案。
拜耳处方药研发数据科学与人工智能高级副总裁Sai Jasti表示，公司目标到2030年利用人工智能将研发生产力提升40%。通过构建结合匿名化数据与人工智能分析的全球生态系统，并与范德比尔特大学医学中心、FinnGen、PRECISE及Cradle等机构建立战略合作，拜耳正加速心血管和肾脏病等关键领域的药物研发进程。人工智能已日益融入拜耳从端到端规划到智能工具套件的整个价值链。
2026-04-01
·拜耳中国
五大增长催化剂助力拜耳处方药打造史上最强大的产品组合；
2025年创下纪录，获得五项首次获批（三项新产品获批、两项新适应症获批），以及六项积极III期临床试验结果；
预计2026年将在重点治疗领域取得多项关键研发管线里程碑；
拜耳处方药确认双重目标：从2027年起恢复中个位数增长，并从2028年起实现营业利润率提升，到2030年达到30%。
柏林，2026年4月1日——在拜耳处方药2026年全球媒体日活动上，拜耳集团管理委员会成员、拜耳处方药事业部全球总裁Stefan Oelrich阐述了公司如何通过持续专注于科学和业务优先，推动实现2030年业务增长目标。
Stefan Oelrich
拜耳集团管理委员会成员、拜耳处方药事业部全球总裁
“凭借坚定的业务准则和严谨的科学态度，我们正在见证变革性战略带来的回报，它正推动着当下和未来的增长。得益于史上最强大的处方药产品组合、多元化的研发管线以及日益人工智能化的运营模式，我们有望从2027年起恢复中个位数增长，并从2028年开始扩大利润率，到2030年达到30%。”
关键治疗领域的五大增长催化剂
推动拜耳处方药未来十年的业绩增长
Christine Roth
拜耳处方药执行副总裁、全球产品战略与商业化负责人兼领导团队成员
“我们的目标是提供first-in-class或best-in-class产品，满足患者需求。过去几年，我们做出的大胆选择正在赋能团队，加速创新，最终将为患者和公司带来实实在在的影响。”
ASUNDEXIAN（在研）
向上滑动阅览
最新进展：
拜耳正在对一款活化凝血因子XI（XIa）抑制剂进行临床开发，即asundexian。在非心源性缺血性卒中或高风险短暂性脑缺血发作（TIA）患者中，在接受抗血小板联合治疗基础上， asundexian在减少缺血性卒中复发方面优于安慰剂。
Asundexian已被美国食品药品监督管理局（FDA）授予快速通道资格。
凝血因子XIa是凝血途径中的一种蛋白质，抑制凝血因子XIa的目的，是将止血与血栓形成进行解耦，从而在保留正常止血功能的同时，防止病理性血栓的形成。1，2，3
迄今，asundexian尚未被任何国家的监管机构批准用于任何适应症治疗。
重要性：
全球每年约有1200万人发生卒中4，其中80%为缺血性卒中5。尽管当前已有不少卒中二级预防的治疗措施，仍有五分之一的卒中幸存者将在五年内再次发生卒中。6
达罗他胺/诺倍戈Ⓡ
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最新进展：
达罗他胺是首个与雄激素受体抑制剂（ADT）联合使用用于治疗转移性激素敏感性前列腺癌（mHSPC）的雄激素受体抑制剂（ARi），无论患者是否接受化疗。
拜耳的目标是成为第二代雄激素受体抑制剂的全球领导者。
一项III期临床试验正在评估在激素敏感性前列腺癌（HSPC）治疗中，达罗他胺联合ADT对比单独使用ADT对激素敏感性高风险生化复发（BCR）前列腺癌患者的疗效。这些患者经传统影像学检查未证实疾病转移，而基线PSMA PET/CT结果为阳性。
达罗他胺具有独特的分子结构，能够通过抑制雄激素受体功能，抑制前列腺癌细胞的生长。
重要性：
前列腺癌是男性第二常见癌症7。2022年，全球约有40万男性死于该疾病。8
非奈利酮/可申达Ⓡ
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最新进展：
非奈利酮是一种选择性非甾体类盐皮质激素受体拮抗剂（nsMRA），也是首个在五项关键性的III期研究中显示出心血管和/或肾脏获益的靶向盐皮质激素受体（MR）的药物，这些研究针对的是：
左心室射血分数（LVEF）≥40%的心力衰竭患者
2型糖尿病相关的慢性肾脏病（CKD）患者
1型糖尿病相关的慢性肾脏病患者
以及非糖尿病慢性肾脏病患者
基于其心血管和肾脏获益，我们预期非奈利酮将成为综合治疗方案中的重要支柱。
拜耳非奈利酮在全球100多个国家获批用于治疗2型糖尿病相关的慢性肾脏病成人患者，在中国的商品名为可申达Ⓡ。在美国和、日本和欧盟，非奈利酮也已获批用于治疗LVEF≥40%的心力衰竭（HF），该适应症的上市申请目前在中国等多个市场接受审评。
非奈利酮的临床项目包括十项III期研究，分别针对心力衰竭和慢性肾脏病，其中五项已完成。
非奈利酮是一种选择性非甾体类盐皮质激素受体拮抗剂，具有独特的作用机制，可靶向心血管和肾脏病中的炎症和纤维化病理过程。
重要性：
全球有超过8.75亿人患有慢性肾脏病和/或心力衰竭9，10，由于全球生活方式趋势、人口老龄化和糖尿病发病率上升，同时罹患这两种疾病的风险正不断攀升9，11，12，13，14。无论是慢性肾脏病还是心力衰竭患者，均面临较低的生存率。当这两种疾病同时存在，住院、疾病进展和死亡的风险会进一步增加。15
ACORAMIDIS / BEYONTTRA™
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最新进展：
Beyonttra旨在通过模拟转甲状腺素蛋白（TTR）基因中一种天然存在的“保护性突变”（T119M），有效稳定TTR四聚体，从而用于治疗转甲状腺素蛋白淀粉样变性心肌病（ATTR-CM）的根本原因。
拜耳致力于在欧洲快速且持续地推广Beyonttra，用于治疗转甲状腺素蛋白淀粉样变性心肌病。
该药已在欧盟获批用于治疗野生型或变异型转甲状腺素蛋白淀粉样变性心肌病的成年患者。16
重要性：
转甲状腺素蛋白淀粉样变性心肌病是一种常被漏诊的进行性、潜在致命的心脏病，由转甲状腺素蛋白不稳定引起。这种不稳定会导致淀粉样蛋白沉积在心脏中，从而严重损害心脏功能17，18。据估计，转甲状腺素淀粉样变性心肌病正在影响全球40万人19，其中欧洲约有19万人。20
ELINZANENTANT / LYNKUET™
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最新进展：
Elinzanetant是全球首个双重神经激肽靶向疗法（NK-1和NK-3受体拮抗剂）。
Elinzanetant在美国和其他市场以LynkuetTM的商品名获批用于治疗绝经相关中重度血管舒缩症状（VMS），在欧盟获批用于治疗与绝经相关的或乳腺癌辅助内分泌治疗（AET）引起的中重度血管舒缩症状，使其成为欧盟该适应症中唯一获批的治疗选择。
不断增加的证据表明，雌激素活性下降会导致表达NK-1和NK-3受体的kisspeptin、神经激肽B和强啡肽（KNDy）过度活跃，从而导致调节体温和睡眠的中枢功能紊乱，最终引发VMS。
Elinzanetant通过拮抗NK-1和NK-3受体发挥作用，不仅能够降低血管舒缩症状的发生频率和严重程度，还能在改善睡眠障碍和提升生活质量方面带来额外获益。
重要性：
预计到2030年，全球绝经期女性人数将增至12亿，而这一生理阶段正值女性社交和职业活跃期21。2020年，全球新增乳腺癌病例230万例，其中近70%为激素受体阳性肿瘤，患者需要接受抗雌激素治疗，而这可能会引发绝经期症状。22，23，24，25
重塑研发管线，助力未来增长
Christian Rommel 博士
拜耳处方药执行副总裁、全球研发负责人兼领导团队成员
“我们通过创新和差异化产品重塑研发管线，这一战略正在释放潜力：2025年，三个新产品获批，重磅产品的两项新适应症获批，六项III期临床试验取得积极结果，创下业绩纪录。2026年，我们预计将在心血管和肿瘤等核心治疗领域的精准治疗、再生细胞和基因疗法，以及分子影像等多个领域取得关键里程碑，进一步验证以创新驱动影响的战略。”
精准药物研发进展
225Ac-PSMA-Trillium (BAY 3563254)
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最新进展：
225Ac-PSMA-Trillium（BAY 3563254）是一种在研靶向α疗法（TAT），用于治疗晚期转移性去势抵抗性前列腺癌（mCRPC）患者。
正在进行的全球I期首次人体剂量递增PAnTHa研究取得了令人振奋的结果，支持将225Ac-PSMA-Trillium推进到下一阶段的临床开发。
靶向α疗法是拜耳精准肿瘤学战略支柱，有望加速为转移性去势抵抗性前列腺癌患者的新型治疗方案的开发进程。
重要性：
前列腺癌是男性第二常见癌症7，其中转移性去势抵抗性前列腺癌患者中位生存期小于三年。26，27
Vividion Therapeutics总裁兼首席执行官Aleksandra Rizo博士表示：
“
小分子药物凭借其可及性、可预测性和全球可扩展性，仍然是提供具有深远影响疗法的最有效途径之一。我们正利用化学蛋白质组学筛选平台，针对以往被认为无法成药的驱动基因，推进癌症和免疫疾病口服疗法的研发。随着我们自主研发的三种分子进入临床开发阶段，我们正致力于将研究成果转化为有望改变患者命运的新药。
”
WRN抑制剂（VVD-214）
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最新进展：
WRN抑制剂（VVD-214）是一种新型的共价、不可逆的Werner解旋酶（WRN）抑制剂，旨在利用微卫星不稳定性高表达（MSI-High）的癌细胞对WRN介导的DNA修复机制的特异性依赖。这种癌症特异性机制有望在降低毒性和副作用的情况下控制疾病进展并提高患者生存率。它是全球首个进入临床试验的WRN共价抑制剂。
在一项I期临床试验中，VVD-214耐受性良好，并在微卫星不稳定性高表达的实体瘤患者中显示出令人鼓舞的活性。
拜耳计划继续开展Ib期临床试验，并启动II期临床试验，以评估VVD-214在晚期微卫星不稳定性高表达（MSI-High）或错配修复缺陷型（dMMR）结直肠癌患者中的有效性。
重要性：
结直肠癌（CRC）是全球第三大常见癌症，每年新增病例近200万28。约15%的结直肠癌为MSI-High，这构成了规模最大的MSI-High患者人群29，也为靶向治疗提供了巨大的机会。VVD-214在其他MSI-High癌症中也具有潜在的治疗价值，包括子宫内膜癌、卵巢癌和胃癌。
GIRK4抑制剂（BAY 3670549）
最新进展：
GIRK4抑制剂（BAY 3670549）是一种高选择性G蛋白偶联内向整流钾通道4（GIRK4）抑制剂，有望帮助控制房颤（AFib）患者心脏细胞的电活动。
该GIRK4抑制剂源于与美国麻省理工学院和哈佛大学博德研究所的战略研究联盟。
I期临床试验已启动。
重要性：
房颤是最常见的心律失常（心律不齐）类型，正在影响全球超过6000万人，也是卒中和心力衰竭的重要危险因素。30，31，32
塞伐艾替尼
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最新进展：
塞伐艾替尼是一种新型口服、可逆性的小分子酪氨酸激酶抑制剂（TKI），可阻断参与癌细胞生长的特定酪氨酸激酶活性。
塞伐艾替尼已在美国和中国获得突破性疗法认定，用于携带人表皮生长因子受体2（HER2）激活突变的非小细胞肺癌（NSCLC）成人患者的一线治疗。
在美国和加拿大，塞伐艾替尼以商品名HyrnuoTM获批用于既往接受过治疗的晚期HER2突变非小细胞肺癌患者。
重要性：
非小细胞肺癌是最常见的肺癌类型，占所有肺癌病例的85%以上33，其中2-4%为HER2突变非小细胞肺癌。34，35
基因疗法和细胞疗法产品组合
有望为患者带来变革性影响
基因疗法
AskBio首席执行官Gustavo Pesquin表示：
“
通过将 AskBio 的腺相关病毒一体化平台（从衣壳创新到生产）与拜耳的全球开发和运营能力相结合，我们正在努力开发有望改变罕见病和常见病患者生活的药物。
”
AB-1002
最新进展：
AB-1002 是一种单次给药的在研基因疗法，目前正被开发用于治疗射血分数降低的心力衰竭（HFrEF）患者。
II期临床研究的最后一名受试者已完成随机分组。
重要性：
据估计，全球约有6400万人患有心力衰竭。尽管疗法不断优化，但死亡率和发病率仍然很高。36，37
Ametefgene parvec (AB-1005)
最新进展：
Ametefgene parvec是一种单次给药的在研基因疗法，旨在针对帕金森病（PD）的潜在生物学机制，从而恢复神经元功能，并有可能延缓疾病进展。
进行中的II期临床试验正在美国、德国、波兰和英国的多个临床中心招募受试者。
重要性：
过去25年间，帕金森病的患病率翻了一番。目前全球约有近1200万人罹患帕金森病。现有治疗方案的疗效通常会在数年后逐渐减退，患者随后会出现运动波动及治疗相关性运动障碍。38，39
细胞疗法
BlueRock Therapeutics公司总裁兼首席执行官Seth Ettenberg表示：
“
对于以不可逆细胞损失为特征的疾病，再生医学提供了一种根本性的全新治疗方法。我们正在推进新型细胞疗法进入临床开发阶段，同时实现可规模化、可重复的制造。
”
Bemdaneprocel
最新进展：
Bemdaneprocel是一种单次给药的在研细胞疗法，旨在替代帕金森病中丢失的多巴胺能神经元。
Bemdaneprocel目前正在美国、加拿大和澳大利亚的多个临床中心进行III期临床试验。
重要性：
过去25年间，帕金森病的患病率翻了一番。目前全球约有近1200万人罹患帕金森病。现有治疗方案的疗效通常会在数年后逐渐减退，患者随后会出现运动波动及治疗相关性运动障碍。38，39
OpCT-001
最新进展：
OpCT-001是一种研究性诱导多能干细胞（iPSC）衍生的感光细胞疗法，用于治疗原发性感光细胞疾病。
OpCT-001已获得美国FDA快速通道资格认定，目前正在进行I/IIa期临床试验。美国FDA已授予OpCT-001治疗视网膜色素变性的孤儿药资格认定。
重要性：
原发性感光细胞疾病是遗传性视网膜疾病的一个亚群，会导致儿童和成人不可逆的视力丧失。目前针对原发性感光细胞疾病的治疗选择非常有限。仅在美国，受该疾病影响的人数预估为11万人。40，41，42
推动医学影像领域的创新
拜耳影像诊断业务全球研发负责人Konstanze Diefenbach博士表示：
“
医学影像正在迅速发展，变得更加个性化，并越来越深入地融入患者的就医流程。在拜耳，我们正在引领推动这一领域的创新——从低剂量对比剂、更智能的互联工作流，到新的分子方法。通过实现更早、更准确的诊断，我们帮助临床医生选择精确的治疗方案，改善患者护理。
”
Gadoquatrane
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最新进展：
Gadoquatrane是一种新一代高弛豫率、低剂量的大环状钆基MRI对比剂，用于检测和显示成人及儿童（包括新生儿）全身各部位及中枢神经系统的病变。
Gadoquatrane在所有大环状MRI对比剂中钆剂量最低，与目前市售其他制剂相比，每次检查可减少高达 60%的钆剂量，同时仍能保持图像质量。
拜耳于2026年3月宣布，该产品在日本以 Ambelvist™ 为商品名获全球首次批准上市。目前拜耳已向包括中国等在内的多个国家和地区的监管机构递交了gadoquatrane的上市申请。
重要性：
MRI对比剂有助于疾病的诊断、治疗决策以及多种疾病的随访监测。低剂量MRI对比剂之所以重要，是因为可以降低患者一生中的钆暴露量。各国监管机构和医学学会一贯建议，在满足诊断目的的前提下使用尽可能低的钆剂量。这一原则适用于所有患者，尤其是那些需要多次进行MRI增强检查的患者（如癌症等慢性疾病患者）、肾功能受损患者以及儿童。据估计，2024年全球使用的钆基对比剂剂量超过6000万剂次。43
分子示踪剂AT-01和 AT-05
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最新进展：
AT-01 和 AT-05 是在研的非侵入性泛淀粉样分子影像示踪剂，专门用于以高敏感性和高特异性检测淀粉样蛋白沉积，从而支持对心脏淀粉样变性及其他类型系统性淀粉样变性的准确诊断。
通过进军诊断示踪剂领域，拜耳进一步彰显其在分子影像领域持续拓展的雄心，同时巩固其在心血管精准医疗领域的领先地位。
AT-01（124-Iodine-evuzamitide）是一种 PET（正电子发射断层显像）示踪剂，是首个用于心脏淀粉样变性的淀粉样蛋白沉积影像剂，已获得美国FDA授予的“突破性疗法”认定，并在美国和欧盟均获得“孤儿药”资格，目前其Ⅲ期临床研究已完成给药。
AT-05（99mTc-p5+14）是一种SPECT（单光子发射计算机断层显像扫描）示踪剂，目前处于I期临床试验阶段，有望拓宽诊断选择。
重要性：
随着针对既往治疗手段不足的疾病不断出现新疗法，在分子水平上对疾病进行精准检测和监测变得愈发重要。AT-01和AT-05的研发有望满足对系统性淀粉样变性，尤其是心脏淀粉样变性，进行早期且准确诊断的迫切临床需求。心脏淀粉样变性是一种目前明显诊断不足且常常致命的心脏疾病，据估计在全球范围内影响超过40万名患者。44，45
通过将内部人工智能与
战略合作伙伴关系相结合，提升研发生产力
拜耳处方药研发数据科学与人工智能高级副总裁兼负责人Sai Jasti表示：
“
我们的目标是到2030年利用人工智能将研发生产力提高40%。通过将人工智能平台架构与匿名的以患者为中心的数据相结合，数据科学家能够最大化内部生物制剂产品组合，验证人工智能模型，拓展解决方案，最终加快药物发现进程。
”
拜耳已与美国范德比尔特大学医学中心、芬兰FinnGen以及新加坡PRECISE等组织建立战略合作伙伴关系，利用结合了匿名化数据和人工智能驱动分析的全球生态系统，加快心血管和肾脏病等关键领域的药物研发进程。
拜耳公司近期也与Cradle公司签署了合作协议。Cradle公司的平台旨在压缩研发周期，并以更优的速度和精度，推动更高质量的分子进入临床开发阶段。
在整个价值链中，人工智能正日益成为拜耳运营中不可或缺的一部分。从全球产品和市场的端到端规划，到新一代智能体工具套件，人工智能正在重塑拜耳员工的工作方式。
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参考文献
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关于拜耳
拜耳作为一家跨国企业，在生命科学领域的医疗健康与农业方面具有核心竞争力。秉承“共享健康，消除饥饿”的使命，公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2025财年，拜耳的员工人数约为88,000名，销售额为456亿欧元。不计特殊项目的研究开发投入为58亿欧元。更多信息请见www.bayer.com。
前瞻性声明
本新闻稿包括拜耳集团管理层基于当前设想和预测所作的前瞻性声明。各种已知和未知的风险、不确定性和其它因素均可能导致公司未来的实际运营结果、财务状况、发展或业绩与上述前瞻性表述中所作出的估计产生重大差异。这些因素包括在拜耳官方网站www.bayer.com上公开的拜耳各项报告中。拜耳没有责任更新这些前瞻性声明或使其符合未来发生的事件或发展。拜耳是一家在全球范围内运营子公司的控股公司。本文中所提及的“拜耳”或“公司”可能根据具体语境指一个或多个子公司。
2026-04-01
·动脉网
01 01April 四月2026 2026| |13:00 PM 下午1:00Europe/Amsterdam 欧洲/阿姆斯特丹Bayer’s strongest-ever pharma portfolio and promising pipeline drive future growth 拜耳有史以来最强大的医药产品组合和充满希望的管道推动未来增长Not intended for U.S. and UK Media 不适用于美国和英国媒体Summary 摘要Five growth catalysts fuel the pharma portfolio of Bayer / Record-breaking 2025 with five first-approvals (three new product approvals; two new indications) and six positive Phase III readouts / Multiple key pipeline milestones expected in 2026 in priority therapeutic areas / Bayer confirms dual ambition for Pharmaceuticals to return to mid-single-digit growth from 2027 onwards, and from 2028 to achieve an operating margin expansion towards 30 percent by 2030. 五大增长动力推动拜耳制药产品组合 / 2025年将创纪录迎来五个首次批准（三个新产品批准；两个新适应症）和六个积极的III期试验结果 / 预计2026年在重点领域将迎来多项关键管线里程碑 / 拜耳确认其制药业务的双重目标：从2027年起恢复中个位数增长，并从2028年起实现营业利润率逐步扩大，到2030年接近30%。Berlin, April 1, 2026 柏林，2026年4月1日– On the occasion of Bayer’s Pharma Media Day 2026, Stefan Oelrich, Member of the Board of Management of Bayer AG and President of the company’s Pharmaceuticals Division, revealed how a sustained focus on science- and business-prioritization is driving a projected growth trajectory towards 2030. – 在拜耳2026年医药媒体日之际，拜耳集团管理委员会成员、公司制药部门总裁斯特凡·奥尔里希透露，持续专注于科学和业务优先化如何推动公司预计到2030年的增长轨迹。“With our unwavering focus on our strategic priorities and scientific rigor, we are seeing the rewards of our transformative strategy to drive growth,” said “通过我们对战略重点和科学严谨性的坚定关注，我们正看到推动增长的转型战略带来的回报，”Stefan Oelrich, 斯特凡·奥尔里希，Member of the Board of Management of Bayer AG and President of the company’s Pharmaceuticals Division. “Thanks to our strongest ever Pharma portfolio, our multimodal pipeline, and an increasingly AI-enabled operating model, we are on track to return to mid-single-digit growth from 2027 onwards, and to expand our margin from 2028 towards 30 percent by 2030.”. 拜耳公司管理委员会成员兼公司制药部门总裁。“得益于我们有史以来最强大的制药产品组合、多模式的管道以及越来越以人工智能为驱动的运营模式，我们有望从2027年起恢复到中等个位数增长，并在2028年将利润率扩大至30%。”Five growth catalysts to drive Pharmaceuticals’ performance into the next decade 推动制药业未来十年发展的五大增长催化剂“Our intention is to be first- or best-in-class because patients deserve no less,” said “我们的目标是成为同类产品中的佼佼者，因为患者理应得到最好的，”Christine Roth 克里斯汀·罗斯, Executive Vice President, Global Head of Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “The bold choices we’ve made over the past few years, along with our empowered teams, are accelerating innovation and delivering real impact for patients and for Bayer.”. 拜耳制药执行副总裁、全球产品战略与商业化主管及制药领导团队成员。“我们在过去几年中做出的大胆选择，以及我们授权的团队，正在加速创新，并为患者和拜耳带来真正的影响力。”ASUNDEXIAN (Development Candidate) ASUNDEXIAN（开发候选人）Latest updates 最新更新Bayer has a factor XIa-inhibitor in clinical development. Asundexian has demonstrated superiority in reducing ischemic stroke, compared to placebo, when both were combined with antiplatelet therapy, in patients who experienced a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).. 拜耳公司有一种因子XIa抑制剂正处于临床开发阶段。阿桑德昔在减少缺血性中风方面表现出优于安慰剂的效果，该效果是在与抗血小板疗法联合使用时观察到的，适用于经历过非心源性缺血性中风或高风险短暂性脑缺血发作（TIA）的患者。Asundexian has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). 阿桑地昔获得了美国食品药品监督管理局（FDA）的快速通道资格。Factor XIa is a protein in the blood coagulation pathway. The goal of inhibiting Factor XIa is to uncouple hemostasis from thrombosis, thus preventing pathological clot formation while leaving hemostasis intact. 因子XIa是血液凝固途径中的一种蛋白质。抑制因子XIa的目标是将止血与血栓形成分离，从而防止病理性凝块形成，同时保持止血功能完好。 1,2,3 1,2,3To date, asundexian has not yet been approved by any health authority for use in any country, for any indication. 迄今为止，asundexian 尚未获得任何卫生当局的批准，也未在任何国家用于任何适应症。Why this matters 为什么这很重要Around 12 million people worldwide experience a stroke each year, 全世界每年大约有 1200 万人罹患中风，4 4of which 80 percent are ischemic strokes. 其中80％是缺血性中风。5 5Approximately one in five ischemic stroke survivors will have another stroke within five years, even with available secondary stroke prevention strategies. 大约五分之一的缺血性中风幸存者在五年内会再次中风，即使有可用的二级中风预防策略。6 6DAROLUTAMIDE / NUBEQA™ 达罗鲁胺 / NUBEQA™Latest updates 最新更新Darolutamide is the first androgen receptor inhibitor (ARi) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), with or without chemotherapy. 达罗鲁胺是首个用于治疗转移性激素敏感性前列腺癌（mHSPC）的雄激素受体抑制剂（ARi），与雄激素剥夺疗法（ADT）联合使用，无论是否接受化疗。Bayer’s ambition is to globally lead this second generation class of ARis. 拜耳的雄心是在全球范围内引领第二代ARis类药物的发展。Looking ahead, a Phase III trial is evaluating darolutamide plus ADT vs ADT alone in HSPC, in patients with high-risk biochemical recurrence (BCR) with no evidence of metastatic disease by conventional imaging and a positive positron emission tomography / computer tomography (PSMA PET/CT) at baseline.. 展望未来，一项 III 期试验正在评估达洛鲁胺联合雄激素剥夺疗法 (ADT) 与单独使用 ADT 在高危生化复发 (BCR) 的激素敏感性前列腺癌 (HSPC) 患者中的效果，这些患者通过常规影像学检查未发现转移性疾病，但在基线时正电子发射断层扫描/计算机断层扫描 (PSMA PET/CT) 呈阳性。Darolutamide has a unique chemical structure. It inhibits the receptor function of androgens (male hormones) and through this inhibits the growth of prostate cancer cells. 达洛鲁胺具有独特的化学结构。它抑制雄激素（男性激素）的受体功能，从而抑制前列腺癌细胞的生长。Why this matters 这件事为什么重要Prostate cancer is the second most common cancer in men. 前列腺癌是男性中第二常见的癌症。7 7In 2022, almost 400,000 men died from the disease worldwide. 2022年，全球有近40万名男性死于该疾病。8 8FINERENONE / KERENDIA™ 非奈利酮 / 可申达™Latest updates 最新更新Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist (nsMRA), and the first drug targeting the MR pathway that has demonstrated clinically proven heart and/or kidney benefits in five pivotal Phase III studies in patients with: Finerenone是一种选择性、非甾体类盐皮质激素受体拮抗剂（nsMRA），是首个在五项关键的III期研究中证明对心脏和/或肾脏有临床益处的针对MR通路的药物，适用于以下患者：o Heart failure with left ventricular ejection fraction (LVEF) ≥40% 左心室射血分数 (LVEF) ≥40% 的心力衰竭o Chronic kidney disease (CKD) associated with type 2 diabetes 与2型糖尿病相关的慢性肾病 (CKD)o CKD associated with type 1 diabetes 与1型糖尿病相关的慢性肾脏病o CKD of non-diabetic causes 非糖尿病原因引起的慢性肾脏病Based on its proven outcomes in heart and kidney disease, we expect finerenone to become an important pillar within comprehensive care. 基于其在心脏病和肾病方面已证明的疗效，我们预计finerenone将成为综合护理中的重要支柱。Finerenone is marketed as Kerendia™ or in selected countries as Firialta™, and is approved in more than 100 countries worldwide for the treatment of adult patients with CKD associated with type 2 diabetes. In the U.S., in the EU, in Japan and some other markets, finerenone is also approved for the treatment of heart failure (HF) with LVEF ≥40%. Finerenone 以 Kerendia™ 或在部分国家以 Firialta™ 的名称上市，已被全球 100 多个国家批准用于治疗与 2 型糖尿病相关的慢性肾病（CKD）成年患者。在美国、欧盟、日本及其他一些市场，finerenone 还被批准用于治疗左心室射血分数（LVEF）≥40% 的心力衰竭（HF）。Applications in HF in additional markets, including China, are under review.. 包括中国在内的其他市场的高频（HF）应用正在审查中。The clinical study program with finerenone currently comprises ten Phase III studies with dedicated programs in heart failure (HF) and CKD, respectively, five of which have been completed. 目前，非奈利酮的临床研究计划包括十个 III 期研究，其中分别针对心力衰竭（HF）和慢性肾脏病（CKD）的专项计划，其中五项已经完成。Finerenone is a selective nsMRA with a distinct mode of action addressing the inflammatory and fibrotic disease pathophysiology involved in both heart and kidney disease. Finerenone是一种选择性nsMRA，具有独特的作用机制，能够针对心脏和肾脏疾病中涉及的炎症和纤维化病理生理过程。Why this matters 为什么这很重要More than 875 million people globally are affected by CKD and/or HF, 全球有超过 8.75 亿人受到 CKD 和/或 HF 的影响，9,10 9,10with the likelihood of developing both conditions escalating due to global lifestyle trends, an aging population, and the rising incidence of diabetes. 由于全球生活方式趋势、人口老龄化以及糖尿病发病率的上升，这两种疾病同时发病的可能性也在增加。9,11,12,13,14 9，11，12，13，14Patients suffering from either CKD or HF face lower survival rates, and the risks of hospitalization, disease progression, and death increase when both conditions coexist. 慢性肾病或心衰患者生存率较低，当这两种疾病共存时，住院、疾病进展和死亡的风险都会增加。15 15ACORAMIDIS / BEYONTTRA™ ACORAMIDIS / BEYONTTRA™Latest updates 最新更新Beyonttra is designed to provide effective TTR tetramer stabilization by mimicking a naturally occurring 'protective mutation” of the TTR gene (T119M) that targets the root cause of transthyretin amyloidosis with cardiomyopathy (ATTR-CM). 贝昂特拉旨在通过模拟TTR基因（T119M）的自然“保护性突变”来提供有效的TTR四聚体稳定，该突变针对转甲状腺素蛋白淀粉样变心肌病（ATTR-CM）的根本原因。Bayer is striving for a rapid and sustained market-uptake of Beyonttra in ATTR-CM-treatment in Europe. 拜耳正在努力推动Beyonttra在欧洲ATTR-CM治疗中的快速且持续的市场应用。Beyonttra is approved in the EU for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). 贝恩特拉在欧盟被批准用于治疗患有心肌病的野生型或变异型转甲状腺素蛋白淀粉样变性成年患者（ATTR-CM）。16 16Why this matters 这件事为何重要ATTR-CM is an often underdiagnosed, progressive potentially fatal heart disease caused by the destabilization of transthyretin (TTR). This destabilization leads to the deposition of amyloid in the heart, which can result in significant impairments in heart function. ATTR-CM 是一种常被漏诊的、进行性的、可能致命的心脏病，由转甲状腺素蛋白 (TTR) 的不稳定引发。这种不稳定会导致淀粉样蛋白在心脏中沉积，从而可能显著损害心脏功能。17,18 17，18ATTR-CM is estimated to affect 400,000 people globally 据估计，ATTR-CM在全球影响40万人。19 19and approximately 190,000 people in Europe. 欧洲大约有190,000人。20 20ELINZANENTANT / LYNKUET™ ELINZANENTANT / LYNKUET™Latest updates 最新更新Elinzanetant is the first dual neurokinin (NK)-targeted therapy (NK‑1 and NK‑3 antagonist). Elinzanetant 是首个双重神经激肽（NK）靶向疗法（NK-1 和 NK-3 拮抗剂）。Elinzanetant is approved under the brand name Lynkuet™ in the U.S. and other markets for the treatment of vasomotor symptoms (VMS) associated with menopause, and in the EU for the treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy (AET) related to breast cancer, making it the only approved option in the EU in this indication.. Elinzanetant在美国和其他市场以品牌名Lynkuet™获批用于治疗与更年期相关的血管舒缩症状（VMS），并在欧盟获批用于治疗与更年期相关或由乳腺癌辅助内分泌治疗（AET）引起的中度至重度VMS，成为欧盟在该适应症中唯一获批的选项。Increasing evidence shows that declining estrogen activity leads to hyperactive kisspeptin, neurokinin B, and dynorphin (KNDy) - which express NK1 and NK3 receptors - leading to dysregulation of the centers that regulate temperature and sleep, resulting in VMS. 越来越多的证据表明，雌激素活性下降会导致吻肽、神经激肽B和强啡肽（KNDy）过度活跃——这些物质表达NK1和NK3受体——从而导致调节体温和睡眠的中枢功能失调，引发VMS。Elinzanetant works by antagonizing the NK1 and NK3 receptors, reducing frequency and severity of VMS, with additional benefits on improving sleep disturbance and quality of life. Elinzanetant通过拮抗NK1和NK3受体，减少VMS的频率和严重程度，并对改善睡眠障碍和生活质量有额外益处。Why this matters 为什么这很重要By 2030, the global population of women experiencing menopause is forecast to increase to 1.2 billion, with menopause affecting women at a time where they are very active socially and professionally. 到2030年，预计全球经历更年期的女性人口将增加到12亿，而更年期会在女性社交和职业活动都非常活跃的时期对她们产生影响。21 21In 2020, there were 2.3 million new cases of breast cancer globally, and nearly 70 percent of tumors being hormone-receptor positive, requiring anti-estrogen treatment which may trigger menopause symptoms. 2020 年，全球新增 230 万乳腺癌确诊病例，其中近 70% 的肿瘤为激素受体阳性，需要进行可能引发更年期症状的抗雌激素治疗。22,23,24,25 22,23,24,25Rejuvenated pipeline fuels future growth 焕然一新的产品线推动未来增长“Our rigorous strategy to rejuvenate our pipeline with innovative and differentiated assets is showing its potential, as seen in our record performance in 2025. Three new product approvals, two new indications for our growth drivers, as well as six positive Phase III readouts,” said “我们通过创新和差异化资产重振管道的严格战略展现了其潜力，正如我们在2025年创纪录的表现中所见。三项新产品获批，我们的增长驱动因素获得了两项新适应症，以及六项积极的三期试验结果。”Christian Rommel 克里斯蒂安·罗梅尔, Executive Vice President, Global Head of Research and Development and Member of the Pharmaceuticals Leadership Team. “In 2026, we anticipate several key milestones further validating our strategy of impact-by-innovation, such as precision medicine in our core therapeutic areas of cardiovascular and oncology, regenerative cell and gene therapies, as well as in molecular imaging.”. 执行副总裁，全球研发主管，制药领导团队成员。“到2026年，我们预计将迎来多个关键里程碑，进一步验证我们通过创新产生影响的战略，例如在心血管和肿瘤学等核心治疗领域的精准医疗、再生细胞和基因疗法，以及分子影像。”Advancements in precision drug development 精准药物开发的进展225Ac-PSMA-Trillium (BAY 3563254) 225Ac-PSMA-Trillium（BAY 3563254）Latest updates 最新更新225Ac-PSMA-Trillium (BAY 3563254) is an investigational targeted alpha therapy (TAT) for patients with advanced metastatic castration-resistant prostate cancer (mCRPC). 225Ac-PSMA-Trillium（BAY 3563254）是一种用于治疗晚期转移性去势抵抗性前列腺癌（mCRPC）患者的实验性靶向α疗法（TAT）。Encouraging results from the ongoing global Phase I first-in-human, dose-escalation PAnTHa study support advancing 225Ac-PSMA-Trillium to the next phase of clinical development. 正在进行的全球 I 期首次人体剂量递增 PAnTHa 研究的鼓舞人心的结果支持将 225Ac-PSMA-Trillium 推进到临床开发的下一阶段。TAT is a strategic pillar of precision oncology at Bayer, with the potential to accelerate novel treatment options for patients with mCRPC. TAT是拜耳精准肿瘤学的战略支柱，有可能加速为mCRPC患者提供新的治疗选择。Why this matters 为什么这很重要Prostate cancer is the second most common cancer in men worldwide 前列腺癌是全球男性中第二常见的癌症7 7with less than three years median overall survival among metastatic patients, who have developed castration-resistance. 在转移性去势抵抗患者中，中位总生存期不到三年。 26,27 26，27‘‘Small molecule medicines remain one of the most effective ways to deliver impactful therapies through their accessibility, predictability, and global scalability,” said “小分子药物仍然是通过其可及性、可预测性和全球可扩展性提供高效疗法的最佳方式之一，”Aleksandra Rizo 亚历山德拉·里佐, M.D, Ph.D, President and CEO, Vividion Therapeutics. “We are advancing oral therapies for cancer and immunologic diseases that target drivers previously considered undruggable, enabled by our chemoproteomics screening platform. With three internally developed molecules now in clinical development, we are focused on translating this work into potentially transforming new medicines for patients.”. 医学博士、哲学博士，Vividion Therapeutics公司总裁兼首席执行官。“我们正在推进针对以前被认为无法成药的癌症和免疫疾病驱动因子的口服疗法，这得益于我们的化学蛋白质组学筛选平台。随着三个内部研发的分子现已进入临床开发阶段，我们正专注于将这些研究成果转化为可能为患者带来变革的新药。”WRN inhibitor (VVD-214) WRN抑制剂（VVD-214）Latest updates 最新更新WRN inhibitor (VVD-214) is a novel covalent, irreversible inhibitor of the enzyme Werner helicase (WRN) designed to exploit the dependency of microsatellite instability (MSI)-high cancer cells on WRN-mediated DNA repair. This cancer-specific mechanism has the potential to impact disease progression and improve patient survival with limited toxicity and side effects. WRN抑制剂（VVD-214）是一种新型的共价、不可逆的沃纳解旋酶（WRN）抑制剂，旨在利用高微卫星不稳定性（MSI）癌细胞对WRN介导的DNA修复的依赖性。这种针对癌症的特定机制有可能影响疾病进展，并在毒性与副作用有限的情况下改善患者的生存率。It was the first covalent inhibitor of WRN to enter clinical trials worldwide.. 它是全球首个进入临床试验的WRN共价抑制剂。In a Phase I clinical trial VVD-214 was well tolerated and showed promising signs of activity in patients with MSI-high solid tumors. 在一期临床试验中，VVD-214 耐受性良好，并在高微卫星不稳定性实体瘤患者中显示出令人鼓舞的活性迹象。The company plans to continue the Phase Ib and initiate Phase II clinical trials evaluating VVD-214 in patients with advanced MSI-high or dMMR colorectal cancer. 公司计划继续进行Ib期临床试验，并启动II期临床试验，评估VVD-214在晚期MSI高或dMMR结直肠癌患者中的疗效。Why this matters 这件事为何重要Colorectal cancer (CRC) is the third most common cancer worldwide, with nearly two million new cases diagnosed each year. 结直肠癌（CRC）是全球第三大常见癌症，每年新诊断病例接近两百万。28 28Approximately 15 percent of CRC tumors are MSI-high, 大约15%的结直肠癌肿瘤为MSI高，29 29representing the largest MSI-high patient population and a significant opportunity for targeted therapies. VVD-214 also has potential for therapeutic benefit in other MSI-high cancers, including endometrial, ovarian, and gastric. 代表了最大的MSI高患者群体，并为靶向治疗提供了重要机会。VVD-214在其他MSI高的癌症中也具有潜在的治疗益处，包括子宫内膜癌、卵巢癌和胃癌。GIRK4 inhibitor (BAY 3670549) GIRK4抑制剂（BAY 3670549）Latest updates 最新更新GIRK4 inhibitor (BAY 3670549) is a highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, which has the potential to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib). GIRK4抑制剂（BAY 3670549）是一种高选择性的G蛋白偶联内向整流钾通道4（GIRK4）抑制剂，具有帮助控制心房颤动（AFib）患者心肌细胞电活动的潜力。GIRK4 inhibitor derives from the strategic research alliance with the Broad Institute of MIT and Harvard. GIRK4抑制剂源自与麻省理工学院和哈佛大学Broad研究所的战略研究联盟。Phase I study initiated. 一期研究已启动。Why this matters 这件事为何重要AFib is the most common type of cardiac arrhythmia (irregular heart rhythm), affecting more than 60 million people worldwide, and a significant risk factor for stroke and heart failure. 心房颤动是最常见的心律失常（心跳不规律）类型，影响全球超过6000万人，并且是中风和心力衰竭的重要风险因素。30,31,32 30,31,32Sevabertinib 塞瓦贝替尼Latest updates 最新更新Sevabertinib is a new oral, reversible Tyrosine Kinase Inhibitor (TKI) which blocks certain enzymes called tyrosine kinases involved in the growth of cancer cells. 塞瓦伯替尼是一种新型的口服、可逆的酪氨酸激酶抑制剂（TKI），可阻断某些参与癌细胞生长的酪氨酸激酶酶。Sevabertinib has Breakthrough Therapy Designation in the U.S. and China as a first-line treatment for patients with HER2-mutant non-small cell lung cancer (NSCLC). Sevabertinib在美国和中国均获得了突破性疗法认定，作为HER2突变非小细胞肺癌（NSCLC）患者的一线治疗药物。HER2-mutant NSCLC is approved in the U.S. and Canada under the brand name Hyrnuo™ for adults with previously treated advanced HER2-mutant NSCLC. HER2突变型非小细胞肺癌在美国和加拿大以品牌名Hyrnuo™获批，用于治疗先前接受过治疗的晚期HER2突变型非小细胞肺癌成人患者。Why this matters 为什么这很重要NSCLC is the most common type of lung cancer, accounting for more than 85 percent of cases, 非小细胞肺癌是最常见的肺癌类型，占病例的85%以上，33 332-4 percent of which represent HER2-mutant NSCLC. 其中2-4％代表HER2突变的非小细胞肺癌。 34,35 34,35Gene therapy and cell therapy portfolios with potential to deliver transformative patient impact 具有交付变革性患者影响潜力的基因治疗和细胞治疗组合Gene Therapy 基因治疗“By combining AskBio’s integrated Adeno Associated Virus platform - from capsid innovation to manufacturing - with Bayer’s global development and operational capabilities, we are working to develop medicines with the potential to transform patient lives across both rare and more common diseases,” said . “通过将AskBio整合的腺相关病毒平台——从衣壳创新到制造——与拜耳的全球开发和运营能力相结合，我们正在努力开发有潜力改变罕见病和更常见疾病患者生活的药物，”该人士表示。Gustavo Pesquin 古斯塔沃·佩斯金, Chief Executive Officer, AskBio. ，首席执行官，AskBio。AB-1002 AB-1002Latest updates 最新更新AB-1002 is a single-dose investigational gene therapy being developed as a potential treatment for heart failure with reduced ejection fraction (HFrEF). AB-1002 是一种单剂量研究性基因疗法，正在开发作为治疗射血分数降低的心力衰竭 (HFrEF) 的潜在疗法。The final participant has been randomized in the Phase II study. II 期研究中的最后一名参与者已经随机化。Why this matters 为什么这很重要An estimated 64 million people worldwide are living with heart failure. Despite advances in treatment, mortality and morbidity remain very high. 据估计，全世界有6400万人患有心力衰竭。尽管治疗方面取得了进展，但死亡率和发病率仍然非常高。36,37 36，37Ametefgene parvec (AB-1005) 阿米特夫根副球菌 (AB-1005)Latest updates 最新更新Ametefgene parvec is an investigational one-time gene therapy designed to address the underlying biology of Parkinson’s Disease (PD), aiming to restore neuronal function and potentially slow disease progression. Ametefgene parvec 是一种研究性的一次性基因疗法，旨在解决帕金森病 (PD) 的潜在生物学机制，力求恢复神经元功能并可能减缓疾病进展。An ongoing Phase II trial enrolls participants across clinical centers in the U.S., Germany, Poland and the U.K. 一项正在进行的 II 期试验在美国、德国、波兰和英国的临床中心招募参与者。Why this matters 为什么这很重要The prevalence of PD has doubled over the past 25 years. Almost 12 million people live with PD globally. The effect of existing treatment options commonly fades after some years, and motor-fluctuations and treatment-dependent dyskinesia occur. 过去 25 年间，PD 的患病率翻了一番。全球约有 1200 万人患有 PD。现有治疗方案的效果通常在数年后减弱，并出现运动波动和治疗相关的运动障碍。38,39 38，39Cell Therapy 细胞治疗“For diseases characterized by irreversible cell loss, regenerative medicine offers a fundamentally new approach,” said “对于以不可逆的细胞损失为特征的疾病，再生医学提供了一种根本上的新方法，”Seth Ettenberg 塞思·埃滕贝格, President and CEO of BlueRock Therapeutics. “We are advancing novel cell therapies into clinical development along with scalable, reproducible manufacturing.” ，BlueRock Therapeutics 总裁兼首席执行官。“我们正在将新型细胞疗法推进到临床开发阶段，并实现可扩展且可重复的生产。”Bemdaneprocel 贝姆达内普罗塞尔Latest updates 最新更新Bemdaneprocel is a single-dose investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s Disease (PD). Bemdaneprocel 是一种单剂量研究性细胞疗法，旨在替代帕金森病 (PD) 中丧失的多巴胺生成神经元。Bemdaneprocel is currently under evaluation in a Phase III study across clinical centers in the U.S., Canada and Australia. 贝马丹普罗赛尔目前在美国、加拿大和澳大利亚的临床中心进行III期研究评估。Why this matters 为什么这很重要The prevalence of PD has doubled over the past 25 years. Almost 12 million people live with PD globally. The effect of existing treatment options commonly fades after some years, and motor-fluctuations and treatment-dependent dyskinesia occur. 过去 25 年间，帕金森病的患病率翻了一番。全球近 1200 万人患有帕金森病。现有治疗方案的效果通常在数年后减弱，并出现运动症状波动和治疗相关的运动障碍。38,39 38，39OpCT-001 OpCT-001Latest updates 最新更新OpCT-001 is an investigational induced pluripotent stem cell (iPSC) derived photoreceptor cell therapy for the treatment of primary photoreceptor diseases. OpCT-001 是一种研究性诱导多能干细胞 (iPSC) 衍生的光感受器细胞疗法，用于治疗原发性光感受器疾病。OpCT-001 has received U.S. FDA Fast Track designation and is progressing in its Phase I/IIa study. The U.S. FDA granted OpCT-001 Orphan Drug Designation for treating retinitis pigmentosa. OpCT-001 已获得美国 FDA 快速通道资格，并正在其 I/IIa 期研究中取得进展。美国 FDA 授予 OpCT-001 治疗视网膜色素变性的孤儿药资格。Why this matters 为什么这很重要Primary photoreceptor diseases are a subgroup of inherited retinal disorders, leading to irreversible vision loss in children and adults. Limited treatment options currently exist for treating primary photoreceptor diseases which affect an estimated 110,000 people in the U.S. alone. 原发性光感受器疾病是遗传性视网膜疾病的一个亚组，会导致儿童和成人不可逆的视力丧失。目前针对影响美国约11万人的原发性光感受器疾病的治疗选择非常有限。40,41,42 40，41，42Advancing innovation across Medical Imaging 推进医学影像领域的创新“Medical imaging is rapidly evolving to become more personalized and integrated into the patient’s journey,” said “医学影像技术正在迅速发展，变得更加个性化，并且融入患者的诊疗过程，”Konstanze Diefenbach 康斯坦策·迪芬巴赫, Head of Radiology R&D at Bayer. “At Bayer, we are pioneering the innovations that drive this evolution – from low-dose contrast agents and smarter, connected workflows to new molecular approaches. By enabling earlier, more accurate diagnosis, we empower clinicians to select precise treatment and improve care for their patients.”. 拜耳放射学研发部门负责人。“在拜耳，我们正在引领推动这一演变的创新——从低剂量对比剂、更智能互联的工作流程到新的分子方法。通过实现更早、更准确的诊断，我们助力临床医生选择精确的治疗方案，改善患者的护理。”Gadoquatrane 加多夸特ранLatest updates 最新更新Gadoquatrane is a next-generation high relaxivity low-dose macrocyclic gadolinium-based MRI contrast agent for detecting and visualizing pathologies in all body regions and the central nervous system in adults and pediatric patients including newborns. Gadoquatrane 是一种新一代高松弛度、低剂量的环状钆基MRI对比剂，用于检测和可视化成人及包括新生儿在内的儿科患者全身各区域及中枢神经系统的病变。Gadoquatrane delivers the lowest gadolinium dose of all macrocyclic MRI contrast agents, with an up to 60 percent gadolinium reduction per procedure compared to current options on the market while maintaining image quality. 加多曲酸提供了所有大环状MRI对比剂中最低的钆剂量，与市场上现有的选择相比，每次操作可减少高达60%的钆使用量，同时保持图像质量。Bayer announced in March 2026 the world’s first approval in Japan under the brand name Ambelvist™. Further submissions to health authorities worldwide are underway. 拜耳公司于2026年3月宣布，该药物已在全球首次获得日本的批准，品牌名为Ambelvist™。目前正向全球其他卫生当局提交申请。Why this matters 为什么这很重要MRI contrast agents support diagnosis, inform treatment, and enable monitoring of a vast variety of diseases. A low-dose MRI contrast agent matters because of reducing patients’ lifetime gadolinium exposure. Health authority guidance and medical societies consistently recommend the lowest gadolinium dose required to achieve diagnostic goals. 磁共振成像（MRI）造影剂辅助诊断、指导治疗并实现对多种疾病的监测。低剂量MRI造影剂之所以重要，是因为它能够减少患者一生中接触钆元素的总量。卫生主管部门和医学协会一致建议使用能达到诊断目的所需的最低钆剂量。This is relevant for all patients and particularly for those requiring multiple MRI examinations, for example with chronic conditions like cancer, as well as for those with renal impairment and for children. For 2024, it is estimated that over 60 million doses of gadolinium-based contrast agents were administered worldwide.. 这与所有患者都相关，尤其是那些需要多次进行核磁共振检查的患者，例如患有癌症等慢性疾病的患者，以及肾功能不全的患者和儿童。据估计，2024年全球使用了超过6000万剂含钆造影剂。43 43Molecular Tracers T-01 and AT-05 分子示踪剂 T-01 和 AT-05Latest updates 最新更新AT-01 and AT-05 are investigational non-invasive pan-amyloid molecular imaging agents specifically designed to detect amyloid deposits with high sensitivity and specificity, supporting accurate diagnosis of cardiac as well as other types of systemic amyloidosis. AT-01 和 AT-05 是研究性的非侵入性泛淀粉样蛋白分子成像剂，专门设计用于高灵敏度和高特异性地检测淀粉样蛋白沉积物，支持对心脏及其他类型的系统性淀粉样变病进行准确诊断。By entering into diagnostic tracers, Bayer reinforces its ambition to expand in molecular imaging, while bolstering its position in precision cardiology. 通过进入诊断示踪剂领域，拜耳加强了其在分子影像领域扩张的雄心，同时巩固了其在精准心脏病学领域的地位。AT-01 (124-Iodine evuzamitide) is a PET (Positron Emission Tomography) tracer and the first amyloid-deposit imaging agent to receive U.S. FDA Breakthrough Therapy Designation for cardiac amyloidosis and has Orphan Drug status in both the U.S. and EU, with its Phase III study having completed dosing.. AT-01（124-碘依夫肽）是一种PET（正电子发射断层扫描）示踪剂，也是首个获得美国FDA突破性疗法认定的心脏淀粉样变性淀粉样沉积成像剂，并在美国和欧盟拥有孤儿药资格，其III期研究已完成给药。AT-05 (99mTc-p5+14) is a SPECT (Single Photon Emission Computed Tomography) tracer currently in Phase I that has the potential to broaden diagnostic options. AT-05（99mTc-p5+14）是一种目前处于第一阶段的SPECT（单光子发射计算机断层扫描）示踪剂，有潜力拓宽诊断选择。Why this matters 为什么这很重要With new therapies emerging for often insufficiently treated conditions, it becomes increasingly relevant to precisely detect and monitor diseases on the molecular level. The development of AT-01 and AT-05 has the potential to address the urgent need for earlier and accurate diagnosis of systemic and specifically cardiac amyloidosis, a currently underdiagnosed and often fatal heart disease that affects more than 400,000 people globally.. 随着针对常被治疗不足的疾病的新疗法不断涌现，精确检测和监测分子水平上的疾病变得越来越重要。AT-01 和 AT-05 的开发有可能满足对系统性淀粉样变，特别是心脏淀粉样变早期且准确诊断的迫切需求。这是一种目前诊断不足且常常致命的心脏病，影响着全球超过 40 万人。44,45 44，45Boosting R&D productivity by synergizing in-house AI with strategic partnerships 通过将内部人工智能与战略合作伙伴关系协同作用，提升研发生产力“Our ambition is to leverage AI to increase R&D productivity by 40 percent by 2030,” said “我们的目标是利用人工智能，到2030年将研发生产力提高40%，”Sai Jasti 萨伊·贾斯蒂, Senior Vice President, Head of Data Science & Artificial Intelligence, Bayer Pharmaceuticals R&D. “By integrating AI platform architecture with anonymized patient-centric data, our data scientists are empowered to maximize our in-house biologics portfolio, validate AI models, and scale solutions, thereby ultimately speeding up drug discovery.”. 拜耳制药研发部高级副总裁，数据科学与人工智能主管表示：“通过将人工智能平台架构与匿名化的以患者为中心的数据相结合，我们的数据科学家能够最大化我们在生物制品领域的内部投资组合，验证人工智能模型并扩展解决方案，从而最终加速药物发现。”Bayer’s strategic partnerships with organizations Vanderbilt University Medical Center in the U.S., FinnGen in Finland, and PRECISE in Singapore, leverage a global ecosystem that combines anonymized data and AI-driven analytics, expediting drug discovery in critical areas like cardiovascular and renal diseases.. 拜耳与美国范德比尔特大学医学中心、芬兰 FinnGen 和新加坡 PRECISE 等机构的战略合作，利用了一个结合匿名数据和人工智能分析的全球生态系统，加速了在心血管和肾脏疾病等关键领域的药物研发进程。Bayer has also recently signed a partnership with Cradle, a company whose platform is designed to compress development timelines and advance higher-quality molecules into clinical development with greater speed and precision. 拜耳最近还与Cradle公司签署了一项合作协议，该公司的平台旨在压缩开发时间，并以更快的速度和更高的精度将更高质量的分子推进到临床开发阶段。Across the value chain, AI is increasingly becoming an integral part of Bayer’s operations. From end-to-end planning across products and worldwide markets to a next-generation suite of agentic tools, employees are empowered with AI-enabled ways of working. 在整个价值链中，人工智能正日益成为拜耳运营的组成部分。从跨产品和全球市场的端到端规划，到新一代的代理工具套件，员工都得到了人工智能赋能的工作方式的支持。About Bayer 关于拜耳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. 拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无人饥饿”的使命，公司通过支持应对不断增长和老龄化全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。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. 拜耳致力于推动可持续发展，并通过其业务产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。2025财年，集团拥有约88,000名员工，销售额达456亿欧元。R&D expenses amounted to 5.8 billion euros. For more information, go to . 研发费用总计达58亿欧元。欲了解更多信息，请访问 。www.bayer.com www.bayer.com. 。Find more information at 更多信息请访问https://pharma.bayer.com https://pharma.bayer.comFollow us on Facebook: 在Facebook上关注我们：http://www.facebook.com/bayer http://www.facebook.com/bayerForward-Looking Statements 前瞻性声明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. 本发布可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司实际的未来结果、财务状况、发展或业绩与这里给出的估计存在重大差异。These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . 这些因素包括拜耳公开报告中讨论的因素，该报告可在拜耳网站上查阅。www.bayer.com www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 公司不承担任何更新这些前瞻性声明或使其符合未来事件或发展的责任。Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. 拜耳集团是一家在全球拥有运营子公司的控股公司。文中提到的“拜耳”或“该公司”可能根据上下文需要指代一个或多个子公司。References 参考文献1 1Fredenburgh JC, Weitz JI. 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Myhre PL, 等。心力衰竭中的数字工具：解决未满足的需求。Lancet Digit Health 柳叶刀数字健康. 2024;6(10):e755-e766. . 2024；6(10):e755-e766。38 38Mayo Clinic. Parkinson’s disease. 2024. Available at: 梅奥诊所。帕金森病。2024。可访问于：https://www.mayoclinic.org/diseases-conditions/parkinsons-disease/diagnosis-treatment/drc-20376062 https://www.mayoclinic.org/diseases-conditions/parkinsons-disease/diagnosis-treatment/drc-20376062. Last accessed: March 2026. 最后访问时间：2026年3月。39 39Luo Y, et al. Global, regional, national epidemiology and trends of Parkinson's disease from 1990 to 2021: findings from the Global Burden of Disease Study 2021. 罗毅等。1990年至2021年全球、区域及国家帕金森病流行病学与趋势：2021年全球疾病负担研究结果。Front Aging Neurosci 衰老神经科学前沿. 2025;16:1498756. doi: 10.3389/fnagi.2024.1498756. . 2025;16:1498756. doi: 10.3389/fnagi/2024.1498756.40 40National Institute on Deafness and Other Communications Disorders. Usher Syndrome. 2017. Available at: 国家耳聋与其他沟通障碍研究所。 usher综合症。 2017。 可用地址：https://www.nidcd.nih.gov/health/usher-syndrome#b https://www.nidcd.nih.gov/health/usher-syndrome#b. Last accessed: March 2026. 最后访问时间：2026年3月。41 41Hamel CP. Cone rod dystrophies. Available at: Hamel CP。锥杆营养不良。可用资源：https://pmc.ncbi.nlm.nih.gov/articles/PMC1808442/ https://pmc.ncbi.nlm.nih.gov/articles/PMC1808442/. Last accessed: March 2026. 最后访问时间：2026年3月。42 42O’Neal TB, et al. Retinitis Pigmentosa. 奥尼尔 TB，等。视网膜色素变性。StatPearls StatPearls. 2024. Available at: . 2024. 可在以下地址获取：https://www.ncbi.nlm.nih.gov/books/NBK519518/ https://www.ncbi.nlm.nih.gov/books/NBK519518/. Last accessed: March 2026. 最后访问时间：2026年3月。43 43Endrikat, J et al. Rationales for Non-standard GBCA Dosing—Low?—High?—When? and Why?: A Literature-based Study. Endrikat, J 等。非标准GBCA剂量的理由——低？高？何时？为什么？：一项基于文献的研究。Investigative Radiology 放射学调查. 2025. doi: 10.1097/RLI.0000000000001259. . 2025. doi: 10.1097/RLI.0000000000001259.44 44Kim M, et al. 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100 项与 Gadoquatrane 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 中枢神经系统疾病 | 日本 | 2026-03-23 | |
| 造影剂 | 日本 | 2026-03-23 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 中枢神经系统感染 | 临床3期 | 加拿大 | 2025-09-01 | |
| 中枢神经系统结核 | 临床3期 | 美国 | 2023-07-24 | |
| 中枢神经系统结核 | 临床3期 | 中国 | 2023-07-24 | |
| 中枢神经系统结核 | 临床3期 | 日本 | 2023-07-24 | |
| 中枢神经系统结核 | 临床3期 | 阿根廷 | 2023-07-24 | |
| 中枢神经系统结核 | 临床3期 | 保加利亚 | 2023-07-24 | |
| 中枢神经系统结核 | 临床3期 | 加拿大 | 2023-07-24 | |
| 中枢神经系统结核 | 临床3期 | 捷克 | 2023-07-24 | |
| 中枢神经系统结核 | 临床3期 | 法国 | 2023-07-24 | |
| 中枢神经系统结核 | 临床3期 | 德国 | 2023-07-24 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | - | 齋觸鹹餘壓糧鏇網簾鬱(築網淵範鏇遞鏇糧網獵) = Gadoquatrane successfully met the primary and main secondary endpoints of all QUANTI studies. 衊夢範簾鏇壓襯觸鹽淵 (廠艱壓餘鏇餘艱遞齋觸 ) 达到 更多 | 积极 | 2025-01-10 | |||
临床2期 | 57 | 齋衊廠醖築夢選觸遞餘 = 襯願選鏇糧簾獵窪鹹壓 夢鑰鬱壓鹽鹹淵積築鹽 (觸憲顧選範鹹繭壓觸遞, 築廠廠襯壓夢觸繭顧鑰 ~ 遞廠窪選糧構願醖蓋簾) 更多 | - | 2023-11-15 |
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