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更新于：2026-01-09

Genistein

染料木素

更新于：2026-01-09

概要

基本信息

药物类型

小分子化药

别名

4',5,7-trihydroxyisoflavone、5,7,4'-trihydroxyisoflavone、5,7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one

+ [16]

靶点

SRC x Top II

作用方式

抑制剂、刺激剂

作用机制

SRC抑制剂(酪氨酸蛋白激酶SRC抑制剂)、Top II抑制剂(拓扑异构酶II抑制剂)、细胞凋亡刺激剂

治疗领域

肿瘤感染呼吸系统疾病+ [6]

在研适应症

结缔组织病相关间质性肺疾病非小细胞肺癌Ⅰ期非小细胞肺癌 II期+ [16]

非在研适应症

急性放射综合征前列腺腺癌晚期恶性实体瘤+ [7]

原研机构

The Henry M. Jackson Foundation

在研机构

National Institutes of Health

北师香港浸会大学

Tokyo Medical & Dental University

+ [7]

非在研机构

National Cancer Institute

Uman Pharma, Inc.

中国人民解放军第四军医大学药物研究所

+ [2]

权益机构

StemoniX, Inc.

Humanetics Corp.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床前

特殊审评快速通道 (美国)

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结构/序列

分子式C15H10O5

InChIKeyTZBJGXHYKVUXJN-UHFFFAOYSA-N

CAS号446-72-0

关联

项与染料木素相关的临床试验

NCT07323732

/ Recruiting临床2期IIT

A Phase II Study of BIO 300 to Reduce the Toxicity of Thoracic Radiotherapy for Patients With Early-Stage Non-Small Cell Lung Cancer and Interstitial Lung Disease (BREATHE)

The purpose of this study to find out whether giving BIO 300 in combination with thoracic radiation therapy is effective in preventing pneumonitis in people with non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD).

开始日期2026-01-06

申办/合作机构

Memorial Sloan Kettering Cancer Center

NCT07033767

/ Not yet recruiting临床1/2期IIT

Exploring a Natural Solution for Childhood Obesity

This study aims to assess the safety tolerability, adherence and effectiveness of genistein as an anti-obesity treatment for children and adolescents. The primary goal is determining how well genistein is tolerated and adhered to by pediatric patients with obesity. Secondary goals include evaluating its impact on body mass index z-scores and cardiometabolic risk factors, such as inflammation.
Participants aged 4-18 will be recruited from the Paediatric HEAL (Healthy Eating, Activity & Lifestyle) Program at the Children's Hospital - London Health Science Center in London, Ontario. They will receive genistein treatment over 6 months, with interim assessments at 3 and 6 months to monitor efficacy, safetytolerability, and adherence, and efficacy, and potentially increase the dose at the 3-month visit. A final assessment will occur after a 3-month washout to observe any lasting effects.
Blood and urine samples will be collected to analyze various adherence and health markers, including inflammatory and cardiometabolic factors. For participants who are of childbearing potential and have had their first menses, the blood analysis will also include pregnancy testing. Laboratory testing will be performed at baseline, at three and six months while taking genistein and three months after the washout period. Urine samples will also confirm that genistein has been taken appropriately throughout the study.
The study expects that genistein will be well-tolerated by children, reduce BMI z-scores by 0.2 (0.5), and improve cardiometabolic risk factors such as blood pressure, lipid profiles, and inflammation. A sample size of 60 participants has been calculated to achieve statistically significant results, which will inform more extensive studies on genistein's potential for managing pediatric obesity.

开始日期2025-08-01

申办/合作机构

Western University

[+1]

CTRI/2025/03/083415

/ Not yet recruiting临床2期IIT

Effect of Genistein on Fecal Microbial Diversity, Modified Mayo Score, and Biomarkers in Patients with Ulcerative Colitis: A Placebo-Controlled Study. - NIL

开始日期2025-05-21

申办/合作机构-

100 项与染料木素相关的临床结果

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100 项与染料木素相关的转化医学

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100 项与染料木素相关的专利（医药）

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16,140

项与染料木素相关的文献（医药）

2026-12-01·MAMMALIAN GENOME

The use of genistein and ambroxol may be an effective approach in correcting cellular dysfunctions of mucopolysaccharidosis-plus syndrome

Article

作者: Rintz, Estera ; Węgrzyn, Grzegorz ; Pierzynowska, Karolina ; Cyske, Zuzanna ; Gaffke, Lidia

Mucopolysaccharidosis-plus syndrome (MPS plus or MPSPS) is an ultrarare inherited metabolic disease, caused by mutations in the VPS33A gene. Like in different types of mucopolysaccharidosis (MPS), glycosaminoglycan (GAG) storage in cells of patients is evident. However, unlike MPS, the genetic defects in MPSPS cause impairment in the VPS33A protein level rather than inactivation of lysosomal hydrolases responsible for GAG degradation. Recent works demonstrated that low abundance of mutated VPS33A causes defective endosomal trafficking, resulting in poor delivery of GAGs (and perhaps also other compounds) to lysosomes, preventing their effective turnover. Here, we tested the hypothesis that impairment of protein degradation machineries, proteasomes by genistein (5,7-dihydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one) and endoplasmic-reticulum-associated protein degradation (ERAD) by ambroxol (4-((2-amino-3,5-dibromophenyl)methylamino) cyclohexan-1-ol), might result in elevation of levels of the mutated, partially active VPS33A and improvement of cellular functions. Using a line of MPSPS patient-derived fibroblasts, we demonstrated that treatment with genistein and ambroxol resulted in elevation of the mutant VPS33A protein level, as well as in improvement or correction of various previously reported cellular defects, including GAG levels, endosomal markers, and cytoskeleton elements. In the light of these results, and since both genistein and ambroxol were previously demonstrated to be safe when used in relatively high amounts, we suggest that the use of these compounds, and especially their combination, might be considered as a potential therapeutic approach in MPSPS, which is currently an incurable disease.

2026-02-01·FOOD CHEMISTRY

Impact of storage and light exposure on the technological and phytochemical quality of yellow, black, and brown soybeans

Article

作者: de Oliveira, Maurício ; Ramos, Adriano Hirsch ; da Silva Timm, Newiton ; Hoffmann, Jessica Fernanda ; Ferreira, Cristiano Dietrich ; da Costa Corrêa Cañizares, Lázaro

Pigmented soybean varieties, such as black and brown, are rich in bioactive compounds, including isoflavones and phenolics, which exhibit antioxidant properties. This study evaluated yellow, brown, and black soybean grains stored for 12 months under light and dark conditions. During storage, acidity increased by up to 28 % and lipase activity by up to 45 % under light exposure, while soluble proteins decreased by 18-25 %, with smaller losses in black soybean. Free phenolics remained relatively stable across genotypes, but black soybean showed the highest levels of bound phenolics. Glycosylated isoflavones declined by 15-30 %, especially the malonyl derivatives, while aglycones, such as daidzein and genistein, remained stable and were detected only in black soybean. Genotype was the main determinant of compound stability, while storage time modulated losses, and light selectively accelerated degradation. Black soybean stands out as a promising source of bioactive compounds for functional foods.

2026-02-01·NEUROCHEMICAL RESEARCH

Genistein Exerts Neuroprotective Effects in an Ouabain-Induced Model of Bipolar Disorder: Behavioral and Molecular Insights

Article

作者: Arafat, Mariam T ; Ghaiad, Heba R ; Elbaz, Eman M

Abstract:

Bipolar disorder (BD) is a chronic and prevalent psychiatric disease that has been considered a leading cause of disability among psychiatric conditions. Taking into account that there is yet no satisfactory disease-modifying treatment, we investigated the effect of genistein on ouabain-induced BD in male C57BL/6 mice. Animals were categorized into control, genistein control, ouabain model, lithium (Li)-treated, and genistein-treated groups. BD was induced by bilateral intracerebroventricular injection of 0.625 nmol ouabain. Genistein (10 mg/kg/day) was orally administered for 2 weeks following a single dose of ouabain. Open field test, sucrose preference test, and forced swim test were performed. Na⁺/K⁺-ATPase activity was evaluated through measuring the hippocampal levels of phosphorylated epidermal growth factor receptor, proto-oncogene tyrosine-protein kinase, extracellular signal-regulated kinase, and cAMP response element-binding protein (p-CREB) by western blot analysis. The levels of brain-derived neurotrophic factor (BDNF), serotonin, oxidative stress, and inflammatory markers were quantified by ELISA. The BCL-2-associated X protein (BAX) to B-cell Lymphoma/Leukemia (BCL2) ratio was assessed by qRT-PCR. Genistein reduced manic and anxious behaviors during the manic phase and showed an antidepressant effect during the depression phase, all while maintaining an effective metabolic balance on body weight. Additionally, genistein increased serotonin, p-CREB, and BDNF levels while decreasing inflammation and apoptosis produced by ouabain. Furthermore, genistein restored the normal architecture in both hippocampal and cortical H&E-stained sections. Taken together, genistein was able to activate the Na⁺/K⁺-ATPase signalosome via a multifaceted mode of action, exerting a neuroprotective effect in an animal model of BD, promoting genistein as a therapeutic candidate for BD.Graphical Abstract

项与染料木素相关的新闻（医药）

2026-01-06

·星际微光

新药动向 | 恒瑞医药：拟用于肥胖或超重的HRS9531注射液、HRS-5817注射液获药物临床试验批准 - 第448期

摘要：新药获批上市海融医药：“负荷药物”瑞加诺生注射液获药品注册证广誉远：安宫牛黄丸收到澳门中成药注册证明书新药临床试验科伦药业：拟用于晚期实体瘤的ITGB6ADCSKB105新药临床试验申请获批海思科：创新药HSK44459片新增适应症获药物临床试验批准恒瑞医药：拟用于前列腺癌的HRS-4357注射液、HRS-5041片联用方案获得药物临床试验批准恒瑞医药：拟用于肥胖或超重的HRS9531注射液、HRS-5817注射液获药物临床试验批准康弘药业：拟用于糖尿病黄斑水肿的KH631眼用注射液收到药物临床试验批准康希诺：24价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素）获得药物临床试验批准亿帆医药：在研产品F-652国内新增适应症移植物抗宿主病获得临床试验批准 ST人福：拟用于晚期实体瘤的HW221043片获得药物临床试验批准报告分享：《2025 FDA approvals》书籍介绍： Humanitarian Myths and Hubris: A Critical Self-Portrait from Médecins Sans Frontières 有问题，问星光智能体！人类基地：OpenAI的天价薪酬，靠 “AI带货”赚？AI的答案中，哪句是广告？星际微光数据资源（背景图片：Wallpaper）哈哈第1部分 The first story 白 1 新药动向 ~ 新药获批上市 ~ 海融医药：“负荷药物”瑞加诺生注射液获药品注册证证券代码：870070 证券简称：海融医药主办券商：恒泰长财证券南京海融医药科技股份有限公司参股子公司南京瑞克卫生物医药有限公司于近日收到国家药品监督管理局核准签发的瑞加诺生注射液《药品注册证书》。一、《药品注册证书》主要内容药品名称：瑞加诺生注射液剂型：注射剂规格：5ml:0.4mg 申请事项：药品注册（境内生产）注册分类：化学药品2.4类证书编号：2025S04070 药品批准文号：国药准字H20213800 药品批准文号有效期：至2026年10月25日上市许可持有人：南京瑞克卫生物医药有限公司生产企业：南京海融制药有限公司审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求，批准增加适应症，具体为：“瑞加诺生注射液作为超声心动图负荷试验中使用的一种负荷药物，适用于不宜接受运动负荷试验的患者”。生产工艺和质量标准不变，说明书和标签按所附执行。药品生产企业应当符合药品生产质量管理规范要求方可生产销售。二、药品的其他相关情况瑞加诺生注射液是全球首个选择性腺苷A2a 受体激动剂，选择性激活腺苷 A2a 受体使冠状动脉血管扩张用于冠心病的诊断，具有选择性扩张冠状动脉、起效迅速、固定剂量给药、副作用少等特点，为《核素心肌显像临床应用指南（2018 版）》《慢性冠状动脉综合征负荷超声心动图检查临床实践指南（2023 版）》《稳定性冠心病诊断与治疗指南（2025 版）》等多项指南推荐冠心病诊断负荷药物。 2021年 10 月，海诺生®瑞加诺生注射液在中国首次获批为放射性核素心肌灌注显像（MPI）中使用的一种负荷药物，适用于不能接受运动负荷试验的患者。该项目获得国家“十三五”重大新药创制科技重大专项立项支持，并在 2023 年正式纳入国家医保目录，有效填补了国内核素心肌灌注显像负荷药物的空白。 2024年 11 月，瑞克卫生物在国内首家完成了瑞加诺生注射液用于负荷超声心动图试验诊断冠心病的多中心、随机、自身对照、阳性药对照的Ⅲ期临床研究，于近日正式获得国家药品监督管理局注册批准，为瑞加诺生注射液在全球范围内首次获得负荷超声心动图的适应症，为该药物在国内负荷超声心动图的临床应用树立了新标准。三、对公司的影响瑞克卫生物主要聚焦于核心脏病学检查用药品的研发及商业化，公司持有瑞克卫生物30%的股权，公司全资子公司南京海融制药有限公司为瑞加诺生注射液的生产企业。此次2.4类改良型新药海诺生®瑞加诺生注射液新适应症的获批，有利于扩大该产品的销售，对公司未来经营发展产生积极影响。广誉远：安宫牛黄丸收到澳门中成药注册证明书证券代码：600771 证券简称：广誉远编号：临2025-022 近日，广誉远中药股份有限公司控股子公司山西广誉远国药有限公司收到澳门特别行政区政府药物监督管理局签发的《中成药注册证明书》。一、药品基本信息名称：安宫牛黄丸〔广誉远〕剂型：丸剂类别：非处方中成药注册编号：MAC-C00298 注册持有人：运通贸易行药物产品出入口及批发商号制药厂：山西广誉远国药有限公司制药厂地址：中国山西省晋中市太谷区广誉远路1号二、药品的其他相关信息山西广誉远于2025年5月7日向澳门特别行政区政府药物监督管理局递交了安宫牛黄丸〔广誉远〕药品注册申请。安宫牛黄丸是我国传统中药的经典名方，出自清代温病学家吴鞠通所著的《温病条辨》，功能主治为清热解毒，镇惊开窍。用于热病，邪入心包，高热惊厥，神昏谵语；中风昏迷及脑炎、脑膜炎、中毒性脑病、脑出血、败血症见上述证候者。广誉远安宫牛黄丸传统制作技艺入选国家级非物质文化遗产名录。根据米内网数据显示，2024年安宫牛黄丸在中国城市、县级公立医院和城市、网上药店的销售额为人民币498,242万元。三、对公司的影响本次获得澳门特别行政区政府药物监督管理局颁发的《中成药注册证明书》后，上述药品将获批在澳门地区销售，有助于公司扩展境外市场业务，提升本公司品牌及产品的市场竞争力。本次获得上述药品《中成药注册证明书》，对本公司当期业绩无重大影响。 ~ 新药临床试验 ~ 科伦药业：拟用于晚期实体瘤的ITGB6ADCSKB105新药临床试验申请获批证券代码：002422 证券简称：科伦药业公告编号：2026-001 四川科伦药业股份有限公司近日获悉，公司控股子公司四川科伦博泰生物医药股份有限公司自主研发的靶向整合素β6 (ITGB6)抗体偶联药物(ADC) SKB105(亦称 CR-003)的新药临床试验(IND)申请已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)批准，用于治疗晚期实体瘤。 2025年 12 月，科伦博泰与 Crescent Biopharma, Inc. (“Crescent”)就 SKB105/CR-003 与 SKB118 (程序性细胞死亡蛋白-1(PD-1) x 血管内皮生长因子 (VEGF)双特异性抗体，亦称 CR-001)达成战略合作，其中科伦博泰授予 Crescent 在美国、欧洲及所有其他大中华地区(包括中国内地、香港、澳门及台湾)以外市场研究、开发、生产和商业化 SKB105/CR-003的独家权利，Crescent 则授予科伦博泰在大中华地区研究、开发、生产和商业化 SKB118/CR-001 的独家权利。科伦博泰计划于近期向中国国家药品监督管理局药品审评中心递交SKB118/CR-001 的 IND 申请。一、关于SKB105(亦称 CR-003) SKB105是一款靶向 ITGB6 的差异化 ADC，以拓扑异构酶 1 抑制剂为有效载荷。ITGB6 在多种实体瘤中高表达，而在大多数正常组织中低表达或无表达，因此有降低系统毒性及脱靶风险的潜力。在药物设计上，SKB105 采用了专有 Kthiol®不可逆偶联技术，将靶向 ITGB6 的全人源免疫球蛋白 G1(IgG1)单克隆抗体与稳定且经临床验证的可裂解连接子偶联，旨在增强药物稳定性及肿瘤特异性载荷递送能力，同时减少不良反应。临床前研究显示，SKB105 在疗效、安全性和药代动力学(PK)方面均表现出良好特性。二、关于SKB118(亦称 CR-001) SKB118/CR-001是一款四价双特异性抗体，目前正开发用于治疗实体瘤。其结合了肿瘤学中两种互补且经过验证的作用机制——PD-1 和 VEGF 阻断，其中对 PD-1 检查点的抑制可恢复 T 细胞识别和摧毁肿瘤细胞的能力，而 VEGF 阻断可减少对肿瘤细胞的血液供应并抑制肿瘤生长。在临床前研究中， SKB118/CR-001 在 VEGF 存在的情况下显示出提升 PD-1 的结合和信号阻断能力的协同药理作用，并具有强大的抗肿瘤活性。SKB118/CR-001 的抗 VEGF 活性还可能使肿瘤部位的血管正常化，有望提高联合疗法(尤其与 ADC 联用)在肿瘤局部的富集与疗效。海思科：创新药HSK44459片新增适应症获药物临床试验批准证券代码：002653 证券简称：海思科公告编号：2025-137 海思科医药集团股份有限公司于近日收到国家药品监督管理局下发的《药物临床试验批准通知书》。药品名称剂型申请事项适应症受理号 HSK44459 片剂境内生产药品注册临床试验炎症性肠病（包括溃疡性结肠炎和克罗恩病） CXHL2501176 根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年10月受理的HSK44459片新增适应症临床试验申请符合药品注册的有关要求，同意本品开展临床试验。研发项目简介炎症性肠病（inflammatory bowel disease, IBD）包括溃疡性结肠炎（ulcerative colitis, UC）和克罗恩病（Crohn's disease, CD），是一种特发性累及胃肠道的慢性炎症性疾病,由多种病因引起，疾病特点为炎症活动及复发交替，需长程乃至终身治疗，且常需要多学科共同参与诊治，为个人及社会带来沉重的负担。除了传统的美沙拉嗪和糖皮质激素，目前我国获批可用于UC 的药物还有英夫利西单抗、维得利珠单抗、乌帕替尼等。鉴于UC病情变化大，易于合并感染、血栓、癌变风险等的复杂性，为使患者利益最大化，目前仍需更多有效且安全的药物获批上市。除了目前已有的生物制剂及小分子药物外，采用多靶点药物及联合治疗难治性CD、粪菌移植、干细胞注射治疗、探索新的治疗靶点药物等仍是当下研究的热点。更多基于新机制的有效且安全的药物的获批上市，将进一步提高CD疗效，降低并发症发生率，改善患者的预后。故两种疾病在临床上都亟需有效、安全性更优且用药方便的口服小分子靶向药物上市，为患者提供更多用药选择。 HSK44459片是公司自主研发的一个全新的具有独立知识产权的治疗炎症性肠病（包括溃疡性结肠炎和克罗恩病）的药物。临床前研究结果表明，本品靶点明确、疗效确切、安全性好，是一款极具开发潜力的小分子药物，临床应用的效益/风险比高，具有广阔的临床应用前景，有望成为炎症性肠病(包括溃疡性结肠炎和克罗恩病)的有效治疗药物，解决目前临床用药匮乏的难题。恒瑞医药：拟用于前列腺癌的HRS-4357注射液、HRS-5041片联用方案获得药物临床试验批准证券代码：600276 证券简称：恒瑞医药公告编号：临2026-003 近日，江苏恒瑞医药股份有限公司及子公司成都盛迪医药有限公司、天津恒瑞医药有限公司收到国家药品监督管理局核准签发关于HRS-4357注射液、HRS-5041片的《药物临床试验批准通知书》，将于近期开展临床试验。一、药物的基本情况药物名称 HRS-4357注射液 HRS-5041片剂型注射剂片剂事项临床试验受理号 CXHL2501123 CXHL2501127 CXHL2501128 审批结论根据《中华人民共和国药品管理法》及有关规定，经审查， 2025年10月15日受理的HRS-4357注射液和HRS-5041片符合药品注册的有关要求，同意开展临床试验。具体为：HRS-4357 联合HRS-5041用于PSMA阳性前列腺癌治疗的安全性、耐受性及初步疗效的开放、多中心、Ⅰb/Ⅱ期临床研究。二、药物的其他情况 HRS-4357注射液为公司自主研发的化学药品1类放射性治疗类创新药，在本品单药已获批适应症临床试验的基础上，新增HRS-4357联合HRS-5041用于治疗前列腺特异性膜抗原（PSMA）阳性的前列腺癌成人患者。国内外均未有同品种获批上市。截至目前，HRS-4357注射液相关项目累计研发投入约6,755万元。 HRS-5041是公司开发的新型、高效、选择性的AR PROTAC（雄激素受体-蛋白降解靶向嵌合体）小分子，拟用于治疗前列腺癌。HRS-5041对野生型及绝大多数突变体的AR蛋白有显著的降解作用，与二代AR抑制剂相比，有克服耐药的潜力。经查询，目前国内外暂无同类产品获批上市。截至目前，HRS-5041片相关项目累计研发投入约9,266万元。恒瑞医药：拟用于肥胖或超重的HRS9531注射液、HRS-5817注射液获药物临床试验批准证券代码：600276 证券简称：恒瑞医药公告编号：临2026-002 近日，江苏恒瑞医药股份有限公司子公司福建盛迪医药有限公司收到国家药品监督管理局核准签发关于HRS9531注射液、HRS-5817注射液的《药物临床试验批准通知书》，将于近期开展临床试验。一、药物的基本情况药物名称 HRS9531注射液 HRS-5817注射液剂型注射剂事项临床试验受理号 CXHL2501098、CXHL2501100、CXHL2501101、CXHL2501102、CXHL2501103、CXHL2501104、CXHL2501105、CXHL2501106、CXHL2501107 CXHL2501095 审批结论根据《中华人民共和国药品管理法》及有关规定，经审查，2025年10月14日受理的HRS9531注射液、HRS-5817注射液符合药品注册的有关要求，同意HRS9531注射液在成人肥胖或超重患者中开展与HRS-5817注射液联合治疗的临床试验。二、药物的其他情况 HRS9531注射液是以HRS9531为主要活性成分，具有全球自主知识产权的新型靶向胰高血糖素样肽-1受体（GLP-1R）和葡萄糖依赖性促胰岛素肽受体（GIPR）的双激动剂，可在体内调节糖脂代谢、抑制食欲和增强胰岛素敏感性，从而起到改善血糖和减轻体重的效果。目前全球范围内，针对减重适应症，仅有礼来的同靶点药物替尔泊肽注射液（商品名：ZEPBOUND）于2023年11月在美国获批上市, 并2024年7月在国内（商品名：穆峰达）获批上市。经查询EvaluatePharma 数据库，2024年ZEPBOUND全球销售额合计约为49.26亿美元。截至目前，HRS9531 相关项目累计研发投入约51,854万元。 HRS-5817注射液为一款自主研发的1类化学药物。临床前数据显示，HRS-5817可在肥胖动物模型中发挥减重效果，且安全性良好。经查询，目前国内外尚无同靶点的药物获批上市。截至目前，HRS-5817注射液累计研发投入约2,489万元。康弘药业：拟用于糖尿病黄斑水肿的KH631眼用注射液收到药物临床试验批准证券代码：002773 证券简称：康弘药业公告编号：2026-001 近日，成都康弘药业集团股份有限公司子公司成都弘基生物科技有限公司收到国家药品监督管理局签发的《药物临床试验批准通知书》。一、药品基本信息药品名称：KH631眼用注射液剂型：注射剂适应症：本品适用于治疗糖尿病黄斑水肿（DME）注册分类：治疗用生物制品1类受理号：CXSL2500874、CXSL2500875 审批结论：同意开展本品适用于治疗糖尿病黄斑水肿（DME）的临床试验。二、产品简介 KH631眼用注射液是弘基生物自主研发的基因治疗创新产品，属于治疗用生物制品1类，分别于2022年11月15日获得中国药品监督管理局药物临床试验批准通知书，美国时间2022年11月22日收到U.S.Food and Drug Administration（美国食品药品管理局）的准许在美国开展临床试验的邮件，同意开展新生血管性（湿性）年龄相关性黄斑变性（nAMD）的临床试验。该产品以具有自主知识产权的腺相关病毒(AAV)递送系统为基础，在组织特异性、免疫原性、表达可控性和感染效率上具有特色，并在临床前疾病模型中显示出持续疗效。康希诺：24价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素）获得药物临床试验批准证券代码：688185 证券简称：康希诺公告编号：2026-001 康希诺生物股份公司于近日收到国家药品监督管理局核准签发的关于24价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素）（PCV24）的《药物临床试验批准通知书》。一、通知书基本情况产品名称：24 价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素）注册分类：预防用生物制品1.4 类申请事项：境内生产药品注册临床试验申请人：康希诺生物股份公司、康希诺（上海）生物科技有限公司通知书编号：2026LP00022 审批结论：根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》及有关规定，经审查，PCV24 符合药品注册的有关要求，同意开展预防由本品所含 24 种肺炎球菌血清型引起的感染性疾病的临床试验。二、产品相关情况肺炎球菌性疾病是由肺炎链球菌引起的全球严重公共卫生问题之一。全球流行病学数据显示，肺炎链球菌作为重要的呼吸道致病菌，目前确定的血清型已超过100 种，所有血清型均可致病。肺炎球菌性疾病亦是引起中国婴幼儿和老年人发病和死亡的重要病因。世界卫生组织（WHO）已将肺炎球菌性疾病列为需“极高度优先”使用疫苗预防的疾病。公司PCV24 覆盖当前肺炎球菌主要流行血清型，采用多糖抗原与蛋白载体共价结合的方式，以及双载体技术，拟适用于2 月龄（最小 6 周）及以上人群接种，以预防由 24 种肺炎球菌血清型引起的感染性疾病。该产品完成了 24 种血清型纯化多糖、多糖蛋白结合物原液生产工艺、成品处方的开发与确认。截止本公告披露日，24 价肺炎球菌多糖结合疫苗在国内外均无上市产品。亿帆医药：在研产品F-652国内新增适应症移植物抗宿主病获得临床试验批准证券代码：002019 证券简称：亿帆医药公告编号：2026-003 亿帆医药股份有限公司控股子公司亿一生物医药开发（上海）有限公司、亿一生物制药（北京）有限公司（上述子公司以下合称“亿一生物”）于近日收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，同意亿一生物就在研产品注射用重组人白介素22-Fc融合蛋白（F-652）开展治疗移植物抗宿主病（GVHD）II期临床试验。一、基本情况产品名称：注射用重组人白介素22-Fc 融合蛋白申请的适应症：移植物抗宿主病剂型：注射用冻干粉针剂受理号：CXSL2500929 通知书编号：2025LP03614 申请类型：新药注册分类：治疗用生物制品1 类申请人：亿一生物医药开发（上海）有限公司、亿一生物制药（北京）有限公司审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 10 月 27 日受理的注射用重组人白介素 22-Fc 融合蛋白临床试验申请符合药品注册的有关要求，同意开展临床试验。二、F-652 的其他相关情况 F-652是一款通过基因工程技术在 CHO 细胞中表达的重组人白细胞介素 22-Fc（IgG2）融合蛋白，由公司依托自主知识产权 Di-KineTM 双分子技术平台研发，为全球首创（1 类创新）生物药。其活性机理上模拟人体天然白介素 22，而融合的 Fc 片段可显著延长药物半衰期，进而大幅提升临床疗效。移植物抗宿主病（GVHD）是异基因造血干细胞移植（HCT）的主要并发症，由异体供者移植物中 T 细胞攻击受者组织引起，导致高死亡率，是移植相关死亡主因。目前针对急性中重度 GVHD 的标准治疗方案为每日给予全身性皮质类固醇，然而，该疗法缺乏靶向特异性，约 50% 患者接受糖皮质治疗后无法获得持续的完全缓解，且可能引发多种潜在致命性副作用。现有治疗策略，无论是一线疗法还是联合治疗方案，在降低发生率和死亡率方面，还存在巨大的、未被满足的临床治疗需求。截至本报告披露日，F-652 共进行了 7 项临床试验，其中 4 项为 I 期临床试验，3 项为 IIa 期临床试验。已经完成 6 项临床试验，分别为在美国开展的治疗急性移植物抗宿主病（GVHD）、酒精性肝炎（AH）和在中国开展的治疗慢加急性肝衰竭（ACLF）三个适应症的 IIa 期临床试验，以及在澳大利亚、中国和美国分别开展的三个 I 期临床试验。结果表明 F-652 具有良好的安全性、耐受性和初步有效性。另外，一项在中国健康受试者中开展的，旨在探索更高剂量耐受性和安全性的I 期临床试验正在进行中。已完成的急性移植物抗宿主病（aGVHD）、酒精性肝炎（AH）和慢加急性肝衰竭（ACLF）三项 IIa 期临床试验的结果表明，F-652 在抗中重度组织炎症、修复器官损伤等方面具有突出的疗效。2019 年 10 月 F-652 被 FDA 授予治疗 aGVHD 的孤儿药资格；AH 临床试验结果也在国际知名肝病杂志《Hepatology》上刊发.。除亿一生物发起的临床研究外，F-652 还由纽约纪念斯隆凯特琳癌症中心开展了一系列针对多次治疗失败的难治性胃肠道GVHD 的单一患者使用研究（SPU）。研究者发起研究（IIT）数据显示，F-652 治疗胃肠道 GVHD 安全且耐受良好，多名患者在接受 F-652 治疗后获得缓解。 ST人福：拟用于晚期实体瘤的HW221043片获得药物临床试验批准证券代码：600079 证券简称：ST人福编号：临2026-001 人福医药集团股份公司全资子公司湖北生物医药产业技术研究院有限公司近日收到国家药品监督管理局核准签发的HW221043片的《药物临床试验批准通知书》。名称：HW221043片剂型：片剂申请事项：境内生产药品注册临床试验注册分类：化学药品1类申请人：湖北生物医药产业技术研究院有限公司审批结论：经审查，2025年10月29日受理的HW221043片符合药品注册的有关要求，同意本品单药在晚期实体瘤患者中开展临床试验。 HW221043片拟用于晚期实体瘤的治疗，是由公司自主研发的新分子实体化合物，目前国内外暂无同类药物获批上市。截至目前，HW221043 片累计研发投入约为 2,400 万元人民币。哈哈第2部分 The second story 白 1 报告分享报告今日报告：《2025 FDA approvals》在公众号内回复“7777”获得报告原文（有效期7天）如需下载历史分享报告和更多报告，请扫以下二维码加入社群：哈哈第3部分 The third story 白 1 书籍介绍 Humanitarian Myths and Hubris——A Critical Self-Portrait from Médecins Sans Frontières 人道主义的迷思与傲慢 ——无国界医生的自我批判这本书是一本由多位实践者、学者共同撰写的著作，核心是对当代人道主义行动进行深刻反思——而反思的镜子，正是无国界医生组织自己。无国界医生（MSF）成立于1971年，初衷是为战乱危机中最脆弱的人群提供医疗救护。从最初几十人的队伍，它已壮大成一个拥有超过6.7万名成员、年度预算超20亿欧元的庞大运动。然而，在当今急速变化的世界里，许多创立时的基本原则和赖以维系的“神话”，正受到前所未有的质疑和冲击。书中指出，新冠疫情后的时代，一些原有的趋势反而被加强或加速，持续挑战着包括MSF在内的人道组织： 1、国家的限制与敌意：许多国家的政策日趋收紧甚至充满敌意，给人道工作设置重重障碍。 2、反恐语境下的非国家行为体：在反恐框架下，与非国家武装行为体打交道变得异常复杂和危险。 3、国际人道法被践踏：国际人道法的尊严常遭无视，人道空间被不断压缩。与此同时，MSF自身也必须直面一系列核心议题： 1、如何真正打击组织内部存在的歧视问题。 2、如何在干预国家中，界定自身与当地抗议运动的关系。 3、如何应对气候变化和全球卫生安全带来的全新挑战。 4、如何在全球数字监控时代，切实保护患者的个人数据安全。这本书的独特之处在于，它并非来自外界的批评，而是MSF及其相关领域的内部从业者与思想者的“自我画像”。它不回避矛盾、不美化现实，坦诚地剖析光荣与困境。说到底，这是一本写给所有关心或从事人道工作的人的重要读物。它想告诉读者：在人道主义的光环之下，是错综复杂的现实、是必须审视的傲慢、是亟待打破的迷思，以及一条充满荆棘却必须前行的改革之路。作者：Duncan McLean, Françoise Duroch (Editor), Amy Mavor (Editor) 出版：2026.1.22 哈哈第4部分 The fourth story 白 1 猜猜看问题微塑料对爸爸的伤害如何遗传给下一代？大家猜猜看答案是什么可直接下方留言或者后台回复明天揭晓答案哦上期答案《Science Translational Medicine》：斯坦福医学院研究者首次揭示了mRNA 疫苗罕见诱发心肌炎的机制：疫苗激活免疫细胞释放CXCL10 与IFN-γ，形成炎症级联反应，损伤心肌细胞。研究发现，大豆中的天然类雌激素——大豆异黄酮（genistein）可有效阻断这一过程，通过抑制免疫蛋白酶体和炎症信号通路，减轻心肌损伤，同时不影响疫苗产生的免疫保护。在动物与体外模型中均验证其保护效果。这一发现为降低疫苗相关心脏风险、提升mRNA 疫苗安全性提供了全新方向，尤其适用于年轻男性等高风险人群。问题请见上期文章：医周政见 l 国家卫健委：印发第四批鼓励仿制药品目录－第448期已完成的项目星际微光已完成的项目（截至2023.9，仍在继续......）圆满中秋 | 星际微光七年完成100个咨询项目咨询、调研、PR、投资、融资、营销、技术转化项目需求请扫码联系我们： Copyright © 2016-2025 Interstellar Firefly Ltd. All rights reserved 星际微光（北京）咨询顾问有限公司版权所有点击“阅读原文”，看看：”疫苗啤酒“的禁忌实验

2025-12-31

·生物谷

COVID-19 疫苗为何会引起心肌炎？Science 子刊找到元凶！证实 CXCL10-IFN-γ 轴，大豆异黄酮可防护

斯坦福医学院的研究人员揭示了基于mRNA的COVID-19疫苗在某些年轻男性和青少年中引起心脏损伤的生物学过程，并提出了一条可能降低其发生风险的途径。 mRNA 新冠疫苗在全球数十亿次接种中展现了卓越的安全性和抗疫价值，但少数年轻男性和青少年接种后出现的心肌炎风险，始终是公众关注的焦点。近日，斯坦福医学院 Joseph Wu 团队在《科学・转化医学》发表重磅研究，首次完整揭示了这一罕见不良反应的核心机制：疫苗会激活免疫细胞产生 CXCL10 和 IFN-γ 两种细胞因子，形成炎症级联反应损伤心肌；而大豆中的天然成分大豆异黄酮（genistein），能有效阻断这一过程，为降低疫苗相关心脏风险提供了全新思路。 “mRNA 疫苗彻底改变了新冠大流行的走向，没有它们，会有更多人患病、重症甚至死亡。” 斯坦福心血管研究所所长 Joseph Wu 博士强调。作为快速应对变异毒株的革命性技术，mRNA 疫苗的安全性已得到充分验证，但与所有医疗干预一样，仍存在罕见不良反应。疫苗相关心肌炎的症状多为胸痛、呼吸短促、心悸，通常在接种后 1-3 天内出现，不伴随病毒感染，且血液中心肌肌钙蛋白（心肌损伤的核心标志物）水平会升高。数据显示，这种情况在首剂后发生率约为每百万剂 7.2 例，第二剂后升至 31.3 例，30 岁以下男性风险最高，达每百万剂 59.7 例。幸运的是，多数患者预后良好，心脏功能可快速恢复，但严重病例可能导致住院甚至死亡，而新冠感染引发心肌炎的风险更是疫苗的 10 倍。为破解疫苗相关心肌炎的成因，研究团队整合了人类血浆数据分析、体外细胞实验和小鼠模型验证。他们发现，这一过程源于一套两步式免疫反应：首先，mRNA 疫苗会激活巨噬细胞，使其大量分泌细胞因子 CXCL10；随后，CXCL10 会招募并激活 T 细胞，促使其释放另一关键细胞因子 IFN-γ。这两种细胞因子协同作用，构成了损伤心肌的 “致命组合”——它们不仅会直接破坏心肌细胞的收缩功能、诱发心律失常，还会诱导心肌细胞表达炎症基因，同时增强血管内皮细胞对中性粒细胞、巨噬细胞的粘附能力，导致免疫细胞浸润心脏，造成二次炎症损伤。在小鼠模型中，接种 mRNA 疫苗后，血清中 CXCL10 和 IFN-γ 水平显著升高，心肌肌钙蛋白释放增加，中性粒细胞和巨噬细胞大量浸润心脏组织；而通过中和抗体阻断这两种细胞因子后，心肌损伤明显减轻，且疫苗诱导的抗新冠刺突蛋白抗体水平未受影响，证明这一干预能在保留免疫保护的同时降低心脏风险。进一步的体外实验显示，用富含 CXCL10 和 IFN-γ 的培养液处理人类诱导多能干细胞衍生的心肌细胞（iPSC-CMs）和心脏类器官，会导致心肌细胞收缩速度减慢、舒张功能受损，甚至出现心律失常样事件，而这些损伤均可被细胞因子抑制剂逆转。基于疫苗相关心肌炎在男性中高发的现象，研究团队联想到雌激素的抗炎特性，进而测试了大豆异黄酮的防护效果——这种源自大豆的天然类雌激素，此前已被证实具有心血管保护作用。实验结果令人振奋：提前用大豆异黄酮预处理心肌细胞、心脏类器官或小鼠，能有效阻断 CXCL10 和 IFN-γ 引发的炎症反应，减少心肌细胞损伤标志物释放，改善心肌收缩功能；在接种 mRNA 疫苗的小鼠中，口服大豆异黄酮还能降低血清中两种细胞因子的水平，减少中性粒细胞和巨噬细胞向心脏浸润，同时不影响疫苗诱导的抗体产生。机制研究表明，大豆异黄酮的保护作用并非直接抑制细胞因子，而是通过阻断下游免疫蛋白酶体激活，减少心肌结构蛋白的降解，同时抑制 STAT1 等炎症信号通路，从源头减轻细胞因子介导的心肌损伤。“大豆异黄酮作为天然膳食成分，口服安全性高，不会因日常食用过量产生风险。”Joseph Wu 博士解释道。这一发现为高风险人群（如年轻男性）提供了潜在的预防方案，也为优化 mRNA 疫苗安全性开辟了新路径。研究还指出，CXCL10-IFN-γ 介导的炎症反应可能是 mRNA 疫苗的一类效应——IFN-γ 本是机体抵御病毒的关键武器，但过量释放时会对心肌造成毒性。除心脏外，这种炎症信号还可能影响肺、肝、肾等器官，而大豆异黄酮或许能同时逆转这些全身性炎症变化。未来，随着 mRNA 技术向癌症治疗、其他传染病疫苗等领域拓展，这一机制和防护策略，将为各类 mRNA 疗法的安全性优化提供重要参考。 “我们的研究既解答了公众对疫苗安全性的疑问，也提供了切实可行的防护方向。”Joseph Wu 团队表示，下一步将进一步探索大豆异黄酮的最佳使用剂量和时机，同时研究其他天然成分的防护潜力，让 mRNA 技术在更安全的前提下，持续为人类健康保驾护航。（生物谷Bioon.com）参考文献： Xu Cao et al, Inhibition of CXCL10 and IFN-γ ameliorates myocarditis in preclinical models of SARS-CoV-2 mRNA vaccination, Science Translational Medicine (2025). DOI: 10.1126/scitranslmed.adq0143.

疫苗信使RNA临床结果

2025-12-27

·Science Daily

Stanford scientists uncover why mRNA COVID vaccines can trigger heart inflammation

Stanford scientists have uncovered how mRNA COVID-19 vaccines can very rarely trigger heart inflammation in young men — and how that risk might be reduced. They found that the vaccines can spark a two-step immune reaction that floods the body with inflammatory signals, drawing aggressive immune cells into the heart and causing temporary injury.Researchers at Stanford Medicine have identified the biological steps that explain how mRNA-based COVID-19 vaccines can, in rare cases, lead to heart inflammation in some adolescent and young adult males. Their work also points to a potential strategy for lowering that risk. By combining modern laboratory techniques with previously published data from vaccinated individuals, the team uncovered a two-stage immune response. In this process, the vaccine activates one type of immune cell, which then stimulates another. Together, these immune reactions drive inflammation that can damage heart muscle cells and set off additional inflammatory effects. Vaccines Remain Highly Safe and Effective The findings come despite the fact that mRNA COVID-19 vaccines have been given billions of times worldwide and continue to show an excellent safety record, said Joseph Wu, MD, PhD, director of the Stanford Cardiovascular Institute. "The mRNA vaccines have done a tremendous job mitigating the COVID pandemic," said Wu, the Simon H. Stertzer, MD, Professor and a professor of medicine and of radiology. "Without these vaccines, more people would have gotten sick, more people would have had severe effects and more people would have died." mRNA vaccines are considered a major advance because they can be developed quickly, adjusted as viruses change, and tailored to target very different pathogens. Still, as with any medical intervention, reactions are not identical for everyone. Understanding Vaccine-Associated Myocarditis One uncommon but documented side effect of mRNA COVID-19 vaccines is myocarditis, which refers to inflammation of the heart muscle. Symptoms can include chest pain, shortness of breath, fever and heart palpitations. These symptoms occur without a viral infection and typically appear within one to three days after vaccination. Most affected individuals show elevated levels of cardiac troponin in their blood, a widely used marker of heart muscle injury. (Cardiac troponin is normally found exclusively in the heart muscle. When found circulating in blood, it indicates damage to heart muscle cells.) The condition occurs in roughly one out of every 140,000 people after a first vaccine dose and increases to about one in 32,000 after a second dose. Rates are highest among males age 30 and younger, where it affects about one in 16,750 vaccine recipients. Outcomes Are Usually Mild and Temporary Wu emphasized that the majority of myocarditis cases linked to vaccination resolve quickly, with heart function either fully preserved or restored. "It's not a heart attack in the traditional sense," he said. "There's no blockage of blood vessels as found in most common heart attacks. When symptoms are mild and the inflammation hasn't caused structural damage to the heart, we just observe these patients to make sure they recover." In rare instances, however, severe inflammation can cause serious injury, leading to hospitalization, intensive care treatment or death. "But COVID's worse," Wu said. He noted that a COVID-19 infection is about 10 times more likely to cause myocarditis than an mRNA-based COVID-19 vaccine, in addition to the many other risks posed by the disease. A Closer Look at the Immune Response Wu is a senior author of the study, publisded Dec. 10 in Science Translational Medicine, along with Masataka Nishiga, MD, PhD, a former Stanford postdoctoral scholar now at The Ohio State University. The study's lead author is Xu Cao, PhD, also a postdoctoral scholar at Stanford. "Medical scientists are quite aware that COVID itself can cause myocarditis," Wu said. "To a lesser extent, so can the mRNA vaccines. The question is, why?" Suspects Identified To answer that question, the team analyzed blood samples from vaccinated individuals, including some who developed myocarditis. When they compared these samples with those from people who did not develop heart inflammation, two proteins stood out. "Two proteins, named CXCL10 and IFN-gamma, popped up. We think these two are the major drivers of myocarditis," Wu said. Both CXCL10 and IFN-gamma are cytokines, signaling molecules that immune cells use to communicate and coordinate their activity. How Immune Cells Interact After Vaccination The researchers grew human immune cells called macrophages in laboratory dishes and exposed them to mRNA vaccines. Macrophages act as early responders in immune defense. After exposure, the macrophages released multiple cytokines, with especially high levels of CXCL10. Their behavior closely matched immune responses previously documented in vaccinated people. When T cells were added to the system, either directly or by exposing them to fluid from the macrophage cultures, the T cells began producing large amounts of IFN-gamma. In contrast, T cells exposed to the vaccine alone did not show this spike. These findings showed that macrophages primarily produce CXCL10, while T cells are the main source of IFN-gamma following vaccination. How the Cytokines Affect the Heart To determine whether these cytokines directly harm the heart, the team vaccinated young male mice and observed increased cardiac troponin levels, indicating heart muscle injury. They also found that immune cells, including macrophages and neutrophils, had entered heart tissue. Neutrophils are short-lived immune cells that respond aggressively to threats and are a major component of pus. Similar immune cell infiltration is seen in people who develop myocarditis after vaccination. Blocking CXCL10 and IFN-gamma reduced the number of these immune cells entering the heart and limited damage to healthy tissue. The researchers also detected increased levels of adhesion molecules in heart blood vessels. These molecules help immune cells latch onto vessel walls, making it easier for them to move into heart tissue. Together, these findings confirmed that CXCL10 and IFN-gamma directly contribute to heart injury. Blocking them preserved much of the immune response to vaccination while lowering signs of heart damage. Testing Human Heart Tissue Models Wu's lab specializes in converting human skin or blood cells into stem-like cells that can become heart muscle cells, immune cells and blood vessel cells. These cells can be assembled into small, beating clusters that mimic aspects of heart function. When these cardiac spheroids were exposed to CXCL10 and IFN-gamma collected from vaccinated immune cells, markers of heart stress rose sharply. Using inhibitors to block the cytokines reduced this damage. Measures of heart function, including contraction strength and beating rhythm, were impaired by the cytokines but improved once the signaling was blocked. Saved by a Soybean Wu suspected that a widely available dietary compound might help protect the heart. Since myocarditis is more common in males and estrogen has anti-inflammatory effects, he revisited genistein, a soy-derived compound his team had studied previously. In a 2022 study published in Cell, the researchers showed that genistein has anti-inflammatory properties and can counter marijuana-related damage to blood vessels and heart tissue. "Genistein is only weakly absorbed when taken orally," Wu said. "Nobody ever overdosed on tofu." Testing Genistein's Protective Effects The team repeated their experiments while pre-treating cells, cardiac spheroids and mice (the latter by oral administration of large quantities) with genistein. This treatment reduced much of the heart damage caused by either mRNA vaccination or the CXCL10 and IFN-gamma combination. The form of genistein used in the study was more purified and concentrated than supplements commonly sold in stores. "It's reasonable to believe that the mRNA-vaccine-induced inflammatory response may extend to other organs," Wu said. "We and others have seen some evidence of this in lung, liver and kidney. It's possible that genistein may also reverse these changes." Broader Implications Beyond COVID Vaccines Heightened cytokine signaling may be a broader feature of mRNA vaccines. IFN-gamma, in particular, plays a critical role in defending the body against foreign DNA and RNA, including viral genetic material. "Your body needs these cytokines to ward off viruses. It's essential to immune response but can become toxic in large amounts," Wu said. Excessive IFN-gamma can lead to myocarditis-like symptoms and breakdown of heart muscle proteins. This risk is not limited to COVID vaccines alone. "Other vaccines can cause myocarditis and inflammatory problems, but the symptoms tend to be more diffuse," Wu said. "Plus, mRNA-based COVID-19 vaccines' risks have received intense public scrutiny and media coverage. If you get chest pains from a COVID vaccine you go to the hospital to get checked out, and if the serum troponin is positive, then you get diagnosed with myocarditis. If you get achy muscles or joints from a flu vaccine, you just blow it off." Funding and Support The study was supported by the National Institutes of Health (grants R01 HL113006, R01 HL141371, R01 HL141851, R01 HL163680 and R01 HL176822) and the Gootter-Jensen Foundation.

疫苗信使RNA免疫疗法临床结果

100 项与染料木素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11680	染料木素	-	DB01645

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
代谢性骨病	临床3期	-	University of Messina	2003-01-01
心血管疾病	临床3期	-	University of Messina	2003-01-01
结缔组织病相关间质性肺疾病	临床2期	美国	Memorial Sloan Kettering Cancer Center	2026-01-06
非小细胞肺癌Ⅰ期	临床2期	美国	Memorial Sloan Kettering Cancer Center	2026-01-06
儿童肥胖	临床2期	-	Western University	2025-08-01
射血分数降低的心力衰竭	临床2期	加拿大	Greenstone Biosciences, Inc.	2024-09-27
转甲状腺素蛋白淀粉样变性心肌病	临床2期	加拿大	Greenstone Biosciences, Inc.	2024-09-27
心脏衰竭	临床2期	斯洛文尼亚	Greenstone Biosciences, Inc.	2024-07-01
肺损伤	临床2期	美国	Humanetics Corp.	2022-04-27
新冠肺炎后遗症	临床2期	美国	Humanetics Corp.	2020-11-11

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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


NCT01489813 (CTgov)	临床2期	非肌层浸润性膀胱肿瘤	36	sugar pill (Sugar Pill)	築製繭築製簾窪廠糧醖(積鬱衊築遞構衊鑰壓鑰) = 簾糧憲壓廠簾鹽齋觸網範蓋醖構觸繭簾廠廠築 (膚壓築鑰壓鏇鏇觸範窪, 築膚選齋衊廠觸糧選構 ~ 糧積積網築繭衊餘繭繭) 更多	-	2024-07-25
				Genistein (Genistein Supplement)	築製繭築製簾窪廠糧醖(積鬱衊築遞構衊鑰壓鑰) = 鹹繭膚範觸獵壓範淵襯範蓋醖構觸繭簾廠廠築 (膚壓築鑰壓鏇鏇觸範窪, 糧窪廠廠繭築網壓糧構 ~ 廠遞選遞鑰鏇簾鹽構鹽) 更多
NCT02624388 (UVA-Gen001, CTgov)	临床2期	霍奇金淋巴瘤 \| 肾母细胞瘤 \| 儿童恶性实体瘤 ... 更多	4	Placebo+Genistein (Arm A: Genistein Followed by Placebo)	廠鹹繭選選齋壓壓鑰艱(齋構顧衊積壓獵衊簾鏇) = 壓鏇襯鏇鬱鏇蓋醖淵鏇窪蓋選襯選築鑰艱鏇遞 (夢範積選衊顧壓壓蓋糧, 1.26) 更多	-	2024-05-06
				Placebo+Genistein (Arm B: Placebo Followed by Genistein)	廠鹹繭選選齋壓壓鑰艱(齋構顧衊積壓獵衊簾鏇) = 繭鬱繭繭遞獵鹹衊艱願窪蓋選襯選築鑰艱鏇遞 (夢範積選衊顧壓壓蓋糧, 2.08) 更多
NCT04650555 (CTgov)	临床1期	急性放射综合征	34	BIO 300 Oral Powder (Single Ascending Dose Cohort 1)	積醖蓋觸醖艱鏇簾淵鹽(鹹獵遞選壓壓鑰壓齋簾) = 窪顧淵鏇鏇齋觸鬱簾選廠襯蓋餘窪夢淵醖觸鹹 (壓顧願憲蓋繭製醖網鬱, 9.3) 更多	-	2024-05-03
				BIO 300 Oral Powder (Single Ascending Dose Cohort 2)	鹹憲糧製夢淵鹽繭餘顧 = 鬱衊夢醖襯製遞顧積遞夢廠壓構鬱選觸積艱觸 (壓餘廠網醖憲膚夢糧衊, 淵夢糧醖憲構鏇製齋鏇 ~ 鏇膚鬱鬱簾鬱憲鹹鏇簾) 更多
NCT02567799 (NSCLC, CTgov)	临床1/2期	非小细胞肺癌 II期 \| 非小细胞肺癌	21	BIO (BIO 300 Oral Suspension (500 mg/Day))	窪獵淵獵艱積夢窪積襯 = 築襯廠鑰獵選築淵構膚窪製淵憲選衊淵鹽夢範 (衊觸廠願網遞糧獵網艱, 壓廠鹽鬱築願壓壓構積 ~ 鏇鏇鏇選遞範繭膚積構) 更多	-	2023-12-20
				BIO (BIO 300 Oral Suspension (1000 mg/Day))	窪獵淵獵艱積夢窪積襯 = 夢觸鏇衊簾壓窪艱夢廠窪製淵憲選衊淵鹽夢範 (衊觸廠願網遞糧獵網艱, 繭鬱鹹選繭窪鹽膚膚構 ~ 鹽壓顧襯簾積夢廠壓積) 更多
NCT02567799 (Biospace) 人工标引	临床1/2期	非小细胞肺癌	21	BIO 300	鏇醖構築齋衊製鹹遞鑰(構壓淵夢蓋鏇範壓鹽鏇) = 顧構齋淵積範艱網選選築鬱襯網構壓壓鑰範鹽 (築顧蓋製鹽襯淵觸製築 ) 更多	积极	2023-09-19
NCT04650555 (Pubmed \| Clin Pharmacol Drug Dev) 人工标引	临床1期	-	34	Genistein	窪鏇醖窪衊廠獵淵膚淵(壓鏇構衊繭鏇衊壓築鏇) = mild to moderate gastrointestinal events, and no dose-limiting toxicities were reported. 遞獵餘餘衊憲淵鹹廠選 (獵簾醖憲艱獵構顧襯襯 )	积极	2022-10-27
NCT02766478 (GeniPro, CTgov)	临床2期	前列腺癌 \| 代谢性疾病	10	Genistein (Genistein)	鏇壓築積願膚構築鬱衊(築膚糧獵夢獵獵艱願齋) = 醖艱積衊鏇鑰壓憲餘構餘窪積夢鹽繭鑰餘淵蓋 (膚壓鏇夢醖製衊願鬱築, 簾鏇願餘網壓鏇構構構 ~ 餘網鹽醖獵夢願選製繭) 更多	-	2022-09-27
				Placebo (Placebo)	鏇壓築積願膚構築鬱衊(築膚糧獵夢獵獵艱願齋) = 衊壓選窪觸獵齋繭鹹獵餘窪積夢鹽繭鑰餘淵蓋 (膚壓鏇夢醖製衊願鬱築, 鬱獵衊鑰齋鹹壓選鏇選 ~ 艱壓壓鏇繭積夢範選鏇) 更多
NCT04650555 (BusinessWire) 人工标引	临床1期	-	34	BIO 300	遞醖製構餘遞鬱選觸壓(廠鏇獵獵顧齋構憲壓築) = increase survival in persons exposed to lethal levels of radiation 膚餘鏇鏇繭衊淵範壓鹽 (膚願簾鬱糧窪夢製獵糧 )	积极	2021-09-22
NCT01985763 (Pubmed \| Cancer Chemother Pharmacol) 人工标引	临床1/2期	转移性结直肠癌	13	FOLFOX+Bevacizumab+Genistein	糧鏇願觸繭築窪製壓壓(憲願憲鬱糧構顧鏇獵壓) = 1patirent (grade 3 hypertension) 觸積糧構憲獵獵廠鑰淵 (窪選願壓壓構範網淵範 ) 更多	积极	2019-09-01
NCT01985763 (CTgov)	临床1/2期	直肠癌 \| 结肠癌 \| 转移性结直肠癌	13	Genistein	範餘夢遞製憲鹽壓構顧 = 選鏇構糧醖衊構繭願壓構願簾鬱願範夢糧鹹鹽 (積淵夢衊觸鹽鏇構醖鏇, 顧廠遞蓋糧製鏇築製膚 ~ 衊繭餘構顧廠憲壓膚選) 更多	-	2019-05-10