更新于：2024-11-01

Corticobasal degeneration

皮质基底节变性

更新于：2024-11-01

基本信息

别名

Cortical Basal Ganglionic Degeneration、Cortical basal ganglionic degeneration、Cortico basal Degeneration

+ [14]

简介

Rare progressive neurological disorder characterized by Parkinsonism, cortical atrophy of multiple areas of the brain including the cerebral cortex and the basal ganglia, cognitive dysfunction and eye movement abnormalities.

关联

项与皮质基底节变性相关的药物

Flortaucipir F-18

靶点

TAU

作用机制

TAU调节剂

在研机构

Eli Lilly Nederland BV [+1]

原研机构

Siemens Healthineers AG

在研适应症

造影剂 [+3]

非在研适应症

失语 [+8]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2020-05-28

Fasudil mesylate

甲磺酸法舒地尔

靶点

ROCK1 x VDCCs

作用机制

ROCK1抑制剂 [+1]

在研机构

Raya Therapeutic Inc. [+2]

原研机构

Annovis Bio, Inc.

在研适应症

脑缺血 [+2]

非在研适应症

皮质基底节变性 [+2]

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2012-05-15

ARC-100

靶点

Tubulin

作用机制

微管蛋白抑制剂

在研机构

Tapestry Pharmaceuticals, Inc. [+1]

原研机构

Cortice Biosciences, Inc.

在研适应症

胶质母细胞瘤 [+2]

非在研适应症

阿尔茨海默症 [+15]

最高研发阶段临床2期

首次获批国家/地区-

首次获批日期1800-01-20

项与皮质基底节变性相关的临床试验

NCT06613204 / Not yet recruitingN/AIIT

STELLA-FTD: Examination of a Behavior Change Intervention for FTD Family Care Partners

The purpose of this nationwide study is to test STELLA-FTD (Support via Telehealth: Living and Learning with Advancing Alzheimer's Disease)-FTD, an intervention to specifically address the needs of family Care Partners of persons with frontotemporal degeneration (FTD). STELLA-FTD is a multicomponent video-conference based intervention designed to facilitate effective use of community and peer resources to foster effective management of behavioral and psychological symptoms of dementia. The study is recruiting families from across the US.

开始日期2025-03-01

申办/合作机构

Oregon Health & Science University

NCT06647641 / Not yet recruitingN/AIIT

The CurePSP Genetics Program

This study is an observational, prospective genetic study. It aims to obtain DNA for research and testing from patients with PSP, CBS, MSA, and related neurological conditions and their families.
Up to 1,000 adults who have been clinically diagnosed with PSP, CBS, MSA, or related neurological conditions will be enrolled. The study intervention involves sequencing of participant blood samples using non-CLIA-approved whole genome sequencing at the National Institutes of Health. Pathogenic variants that are deemed possibly related to these conditions will be confirmed using CLIA-approved testing. The study involves minimal risk to participants.

开始日期2024-10-08

申办/合作机构

The General Hospital Corp.

[+1]

NCT06596746 / RecruitingN/AIIT

Neurodegenerative Diseases Progression Markers (MARKERS-NDD): a Real-world Data Longitudinal Prospective Study

MARKERS-NDD is a prospective, observational, longitudinal study, which aims to collect data from patients affected by neurodegenerative diseases (NDD) followed longitudinally for routine examinations performed as part of normal clinical practice. Data collected from clinical evaluations, movement analysis, brain imaging, neuropsychological and electroencephalographic assessments, blood chemistry tests will be analysed to carry out statistical investigations and predictive analyses, also using artificial intelligence systems, which allow the identification of new early markers of diagnosis and prognosis of neurodegenerative diseases.

开始日期2024-09-09

申办/合作机构

IRCCS San Raffaele Roma Srl

[+2]

100 项与皮质基底节变性相关的临床结果

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100 项与皮质基底节变性相关的转化医学

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0 项与皮质基底节变性相关的专利（医药）

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2,701

项与皮质基底节变性相关的文献（医药）

2025-02-01·Neurology Clinical Practice

Frontotemporal Dementia Differential Diagnosis in Clinical Practice

Article

作者: Krishnadas, Natasha ; Chew, Marcia ; Islam, Fariha ; Rogers, Kirrily A. ; Christensen, Maja ; Brodtmann, Amy ; Darby, David G. ; Sutherland, Antony ; Kyndt, Christopher

Background and ObjectivesMany neurodegenerative syndromes present with impairment of frontal networks, especially frontoinsular networks affecting social and emotional cognition. People presenting with frontal network impairments may be considered for a frontotemporal dementia (FTD) diagnosis. We sought to examine the diagnostic mix of patients referred with frontal network impairments to a single cognitive neurology service.MethodsA retrospective review was conducted of all patients seen between January 2010 and December 2019 at the Eastern Cognitive Disorders Clinic, a quaternary cognitive neurology clinic in Melbourne, Australia. Patients were included if they met the following criteria: (1) were referred for suspected FTD or with a preexisting diagnosis of a FTD syndrome, (2) were referred for 'frontal behaviors' (i.e., disinhibition, disorganization, poor judgment, loss of empathy, apathy) and/or had an informant report of behavior change, and (3) had available referral documents and clinical consensus diagnosis. Referral diagnosis was compared against final diagnosis adjudicated by a consensus multidisciplinary team. Case details including age of symptom onset, Cambridge Behavioural Inventory-Revised scores, psychiatric history, and Charlson Comorbidity Index were compared against the final diagnosis.ResultsIn total, 161 patients aged 42-82 years (mean = 64.5, SD = 9.0; 74.5% men) met inclusion criteria. The commonest final diagnosis was a FTD syndrome (44.6%: 26.7% behavioral variant FTD (bvFTD), 9.3% progressive supranuclear palsy, 6.2% semantic dementia, 1.2% corticobasal syndrome, and 1.2% FTD/motor neuron disease). A primary psychiatric disorder (PPD) was the next commonest diagnosis (15.5%), followed by vascular cognitive impairment (VCI, 10.6%), Alzheimer disease (AD, 9.9%), and other neurologic diagnoses (6.2%). A final diagnosis of bvFTD was associated with higher rates of medical comorbidities and more eating behavior abnormalities compared with a diagnosis of PPD. Screening cognitive tests and preexisting psychiatric history did not distinguish these 2 groups.DiscussionA broad spectrum of neurologic and psychiatric disorders may present with impairments to frontal networks. Almost half of patients referred had a final FTD syndrome diagnosis, with bvFTD the commonest final diagnosis. People with PPD, VCI, and AD present with similar clinical profiles but are distinguishable using MRI and FDG-PET imaging. Medical and psychiatric comorbidities are common in people with bvFTD.

2025-02-01·Neurology Clinical Practice

Corticobasal Syndrome

Article

作者: Lenka, Abhishek ; Jankovic, Joseph

Background and ObjectivesCorticobasal syndrome (CBS) is a complex of symptoms and signs comprising limb rigidity, bradykinesia, dystonia, myoclonus, apraxia, cortical sensory loss, and a variety of cognitive and language impairments. CBS is commonly seen in tauopathies. Striking asymmetry in clinical and imaging findings in CBS raises questions about potential triggers initiating neurodegeneration. The objective of this study was to investigate potential central or peripheral triggers preceding CBS symptoms.MethodsIn this retrospective observational study, we reviewed medical records of patients with CBS at our Parkinson's Disease Center and Movement Disorders Clinic, focusing on evidence of possible central or peripheral "trigger" occurring within a year before the onset of CBS. We also reviewed records of patients with Parkinson disease (PD) for comparison.ResultsOf the 72 patients with CBS, 15 (20.8%) reported potential focal triggers before the onset of CBS-related neurologic symptoms. By contrast, only 1 of 72 patients with PD (1.4%) had a documented trigger before the onset of PD-related symptoms (p < 0.001). Of potential triggers, 13 were peripheral (related to hand or shoulder surgeries or trauma) and 2 were central (stroke and head trauma). Patients with CBS with triggers were younger, had earlier symptom onset, comprised a higher proportion of men, and had a higher likelihood of limb onset of symptoms than those without.DiscussionOur finding of relatively high frequency of focal triggers in CBS compared with PD suggests potential central or peripheral triggers initiating neurodegeneration, possibly explaining asymmetric clinical and imaging features in CBS. Further research is necessary to validate and explore this observation's implications for CBS pathogenesis.

2024-12-01·eNeurologicalSci

Dynamic aphasia as an early sign of corticobasal degeneration: Clinico-radio-pathological correlation

Article

作者: Arakawa, Akira ; Takeda, Katsuhiko ; Tokumaru, Aya Midori ; Kurihara, Masanori ; Eguchi, Hiroto ; Hasegawa, Masato ; Shimo, Yasushi ; Murayama, Shigeo ; Matsubara, Tomoyasu ; Saito, Yuko ; Kanemaru, Kazutomi ; Iwata, Atsushi

A 72-year-old man presented with a 6-month history of decreased voluntary speech. Sparse speech and decreased word fluency were observed. Articulation, naming, comprehension, and repetition were preserved. Agrammatism and paraphasia were not observed. These characteristics matched those reported as dynamic aphasia. Other findings were mild behavioral symptoms, recent memory impairment, and right hemiparkinsonism. The patient's voluntary speech continued to reduce and behavioral symptoms progressed. Brain MRI including voxel-based morphometric analysis showed left-dominant white matter volume reduction in the frontal lobe including those between the left supplementary motor area (SMA)/preSMA and the frontal operculum, likely involving the frontal aslant tract (FAT). The patient became completely mute after two years from disease onset and died of aspiration pneumonia. The neuropathological diagnosis was corticobasal degeneration (CBD). This case suggests that dynamic aphasia may be the initial sign of CBD and that early involvement of left FAT may be responsible for this feature.

项与皮质基底节变性相关的新闻（医药）

2024-09-10

·PRNewswire

CurePSP Receives $200,000 Contribution from the Rainwater Charitable Foundation in Partnership to Support Grant Program for Early-Career Scientists

NEW YORK, Sept. 10, 2024 /PRNewswire/ -- CurePSP is pleased to announce receipt of a $200,000 contribution from the Rainwater Charitable Foundation (RCF), one of the largest independent funders of primary tauopathy research, enabling field-advancing programs and delivering crucial resources to a diverse set of collaborative researchers to support the organization's Pathway and Pipeline Grant Program. The CurePSP Pathway and Pipeline Program provides seed funding of up to $100,000 to junior investigators studying progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) or closely related tauopathies. The goal of the grant program is to provide support for investigators who have innovative ideas that need proof of concept or pilot studies to qualify for larger funding sources. CurePSP has funded over $20 million in research from 1997 to present, including over 200 research grants. "The RCF is excited to support promising early-career researchers who are exploring novel scientific approaches to address life-altering neurodegenerative diseases," said Glenn Harris, RCF director of research partnerships, business development and the drug discovery lead. "We look forward to tracking their scientific impact through the Pathway and Pipeline Grant Program and continuing to enable research that may ultimately lead to cures for these tauopathies." CurePSP Executive Director and Chief Science Officer Kristophe Diaz states that the Rainwater Charitable Foundation's contribution to this program is "a natural evolution of our shared focus, goals and our long-term partnership. This support accelerates our impact and builds an even stronger community of early-career neuroscientists needed to better diagnose and eventually solve for PSP and CBD." The Pathway and Pipeline Grant Program is currently accepting applications through October 3, 2024. The program supports early-career investigators studying the fundamental neurobiology of PSP or CBD ("Pathway") or translational projects focusing on new therapeutics and biomarkers for PSP and CBD ("Pipeline"). Learn more about the program here. About the Rainwater Charitable Foundation's Medical Research The Rainwater Charitable Foundation (RCF) was created in the early 1990s by renowned private equity investor and philanthropist Richard E. Rainwater. When Richard was diagnosed with a rare neurodegenerative disease and primary tauopathy called progressive supranuclear palsy (PSP), the RCF expanded its mission to accelerate the development of new diagnostics and treatments for tau-related neurodegenerative disorders. The RCF Medical Research Team supports this focus by managing the Tau Consortium, the Rainwater Prize Program and the Tauopathy Challenge Workshop. With over $140 million invested in medical research to date, the RCF has helped to advance eight treatments into human trials. The RCF supports a range of programs, including a focus on family economic security, medical research and other worthy causes. For more information, please visit rainwatercharitablefoundation.org. About CurePSP CurePSP is the leading nonprofit organization dedicated to the awareness, care and cure for three neurodegenerative diseases: progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and multiple system atrophy (MSA). As a catalyst for new treatments and a cure, CurePSP establishes important partnerships and funds critical research internationally. Through its advocacy and support efforts, CurePSP enhances education, care delivery and quality of life for people living with PSP, CBD and MSA and their families. Science, community and hope are at the heart of CurePSP's mission and all its services. CurePSP is a registered 501(c)(3) charity within the United States (EIN: 52-1704978). For more information, please visit . Contact: Kristophe Diaz, PhD Executive Director and Chief Science Officer 646-725-1453 [email protected] SOURCE CurePSP, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-09-09

·药渡Daily

【药渡药闻报告-创新药篇】-2024年第34期/总第155期

全球药物批准/研发动态 01 全球新药批准情况根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）全球（不含中国）共有10个新药获批上市。其中，NDA批准1个，BLA批准2个，疫苗批准1个，新适应症批准5个，新制剂批准1个。与上个统计周期相比，本次增加3个批准新药。 8月26日，Vericel Corporation宣布，FDA已批准了补充生物制品许可申请，扩大了MACI（猪胶原膜上自体培养的软骨细胞）标签，包括关节镜下输送MACI，用于修复有症状的膝关节单层或多发全层软骨缺损，伴或不伴骨骼受累。MACI植入物由接种在可吸收I/III型胶原膜上的自体培养软骨细胞组成。自体培养的软骨细胞是从患者自身的软骨中获得的人类来源的细胞，用于制造MACI。MACI Arthro器械为医生提供了一种侵入性较小的选择，可以为患者进行经过临床验证的治疗，更有利于患者的治疗。 8月26日，REGN宣布EC已批准Ordspono™（Odronextamab）用于治疗经过两种或多种全身治疗的复发或难治性（R/R）滤泡性淋巴瘤（FL）或R/R弥漫性大B细胞淋巴瘤（DLBCL）成年患者。Ordspono是一种双特异性抗体，通过将淋巴瘤细胞与杀伤性T细胞连接起来发挥作用，在临床试验中，Ordspono表现出显著的完全缓解率，并且在弥漫性大B细胞淋巴瘤中表现出令人信服的疗效结果。全球（不含中国）新药批准情况（部分） 02 全球新药申报进展根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）全球（不含中国）共有4个新药申报上市。其中，NDA申报2个，BLA申报1个。与上次统计周期相比，本次减少1个NDA/BLA申报。 8月27日，Soleno宣布FDA已接受提交Diazoxide Choline的新药申请，用于治疗4岁及以上食欲亢进症患者的Prader-Willi综合征。Diazoxide Choline是一种新型的专有缓释剂型，含有二氮嗪胆碱，每天给药一次。在PWS III期临床开发计划中，Diazoxide Choline在解决食欲亢进以及其他几种症状（如攻击性/破坏性行为等）方面显示出前景。 NDA/BLA申报根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）全球（不含中国）共有6个药物获监管机构特殊资格认定。其中，化学药6个。与上次统计周期相比，本次减少2个获监管机构特殊资格认定的药物。 8月26日，BeiGene宣布FDA已授予BGB-16673快速通道资格。BGB-16673是一种口服在研布鲁顿酪氨酸激酶（BTK），靶向嵌合降解激活化合物（CDAC），适用于既往接受过至少两种既往治疗治疗的复发或难治性（R/R）慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）成人患者。BGB-16673是目前最先进的BTK降解剂，非常适合成为BTKi后病情恶化且选择有限的患者的重要疗法。 8月28日，AC宣布其合作伙伴LMI已获得FDA对三种神经退行性疾病的Tau正电子发射断层扫描（PET）诊断[18F]PI-2620的快速通道指定。[18F]PI-2620已获准用于阿尔茨海默病、进行性核上性麻痹和皮质基底节变性的临床开发。PI-2620目前正在进行多项临床研究，作为检测人脑中Tau沉积物的靶向放射性药物。PI-2620还显示出对进行性核上性麻痹（PSP）和皮质基底节综合征（CBS）等非AD tau蛋白病的希望。特殊资格认定情况（部分） 03 全球新药研发进展根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）全球（不含中国）新药临床研发状态更新共计24条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及皮肤病等共计9个领域。其中，肿瘤领域临床进展更新居各领域之首，为7条：涉及化学药2条，生物药4条，疫苗1条。近日，在WCLC 2024大会上，恒瑞公布了TROP2 ADC药物SHR-1921治疗晚期小细胞肺癌（SCLC）I期研究的口头报告。结果显示，在17名患者中，治疗相关不良反应（TRAE）(≥grade 3) 为35.3%，ORR为33.3%，中位PFS为3.8个月，中位OS尚未达到。SHR-A1921在重度经治的广泛期SCLC患者中表现出有潜力的临床疗效和可控的安全性。 8月29日，多玛医药双抗ADC产品DM005正式获得FDA IND批准，即将开启临床I期研究。在前期的临床前研究中，DM005展现出强大的抗肿瘤活性和良好的安全性。动物实验结果显示，DM005能够显著抑制多种实体瘤的生长，且耐受性良好，未见显著毒性反应。即将开展的全球临床I期研究将招募多种类型实体瘤患者，包括非小细胞肺癌、头颈癌等，旨在评估DM005单一疗法在晚期实体瘤患者中的安全性、初步疗效和药代动力学特性。全球新药研发进展详情（部分） 04 全球医药交易事件本次统计周期（2024.08.24-08.0）全球（含中国）医药交易时间共计25起，涉及药物权益转让、公司并购等多起交易事件。全球医药交易时间汇总表（部分）国内药物批准/研发动态 01 国内新药批准情况根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内共有3个新药获NMPA批准上市。其中，BLA批准3个3。与上次统计周期相比，本次减少4个NMPA批准新药。 8月21日，劲方医药宣布国家药品监督管理局通过优先审评程序批准KRAS G12C抑制剂达伯特®（氟泽雷塞片，GFH925/IBI351）上市；本品单药疗法适用于至少接受过一种系统性治疗的KRAS G12C突变型晚期非小细胞肺癌（NSCLC）成人患者。研究结果显示，氟泽雷塞总体耐受性良好。IRRC确认的客观缓解率达49.1% (95% CI: 39.7-58.6)；疾病控制率达90.5% (95%CI: 83.7, 95.2)。中位缓解持续时间（DoR）未达到。 8月27日，智翔金泰宣布，公司自主研发的1类新药赛立奇单抗注射液正式获得NMPA核准签发的《药品注册证书》，正式获批上市，用于中、重度斑块状银屑病的治疗。赛立奇单抗注射液可通过抗体特异性结合血清中的IL-17A细胞因子，阻断IL-17A与IL-17RA的结合，抑制炎症的发生和发展。研究表明，赛立奇单抗注射液对中、重度斑块状银屑病表现出优异的疗效以及良好的安全性和耐受性。国内新药批准情况（部分） 02 国内新药临床默示许可进展根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内共有32个新药获临床默示许可，涉及46个受理号。其中，化学药17个，治疗用生物制品15个。与上次统计周期相比，本次减少28个临床默示许可获批受理号。本周国内新药临床默示许可进展（部分） 03 国内新药申报进展根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内共有10个新药申报上市，涉及17个受理号。其中，化药6个，治疗用生物制品3个，预防用生物制品1个。与上个统计周期相比，本次增加9个新药申报上市受理号。国内新药申报上市情况根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内共有38个新药申报临床，涉及60个受理号。其中，化学药22个，治疗用生物制品14个，预防用生物制品2个。与上次统计周期相比，本次增加30个临床申报受理号。国内新药临床申报情况（部分）根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内共有1个药物获NMPA特殊资格认定。其中，生物药1个。与上次统计周期相比，本次减少1个获监管机构特殊资格认定的药物。 8月29日，CDE官网最新公示，由中生复诺健生物申报的重组人IL12/15-PDL1B单纯疱疹I型溶瘤病毒注射液（Vero细胞）拟纳入突破性治疗品种，适应症为：经标准治疗失败的晚期肝细胞癌（HCC）。VG161是一款新型抗肿瘤免疫增强型I型单纯疱疹溶瘤病毒，同时携带IL12、IL15/15RA（IL15和IL15受体α亚基）和PD-L1阻断肽（PDL1B）的基因。该在研溶瘤病毒产品实现了一个病毒表达4个具有协同性抗肿瘤免疫刺激作用的基因，可实现溶瘤活性与免疫刺激的协同，并能将抗病毒免疫反应转化为特异性的抗肿瘤免疫反应。数据展示：VG161单药治疗在这些HCC患者中获得了显著的临床获益，相比对照组总生存期（OS）显著延长。国内监管机构特殊资格认定药物 04 国内新药研发进展根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内新药临床研发状态更新共计5条，涉及肿瘤、遗传和代谢病、呼吸系统疾病和皮肤病共计4个领域。其中，化学药3条，生物药2条。与上次统计周期相比，本次减少1条国内新药临床研发状态更新。 8月26日，爱科百发CEO邬征博士在第8届IPF峰会上发表了主题报告“Development of Next Generation Broadly Active IPF Drug AK3280”，报告了新一代抗纤维化药物AK3280的临床前和临床研究进展，特别是在特发性肺纤维化受试者中开展的2期随机双盲多中心临床研究，并宣布这项研究已完成全部受试者入组。该研究旨在评估AK3280在特发性肺纤维化受试者中的安全性，耐受性和药效。 AK3280是在已上市产品吡非尼酮的基础上优化而成的新一代广谱抗纤维化分子，能够调节多种与纤维化病理过程密切相关的通路和生物标记物，包括转化生长因子（TGF-β）和溶血磷脂酸（LPA）等诱导的纤维化相关基因和蛋白的表达，降低细胞增殖，抑制细胞外基质的合成和聚集。AK3280相较吡非尼酮有安全性和耐受性优势，且潜在药效更强。国内新药研发进展 05 国内新药研发领域政策法规动态关于公开征求《预防用mRNA疫苗非临床研究技术指导原则（征求意见稿）》意见的通知为规范和指导预防用mRNA疫苗的非临床研究，我中心在前期调研的基础上，结合国内外相关指导原则和技术要求，以及当前技术发展和科学认知，撰写了《预防用mRNA疫苗非临床研究技术指导原则（征求意见稿）》。我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见并及时反馈给我们，以便后续完善。征求意见时限为自发布之日起1个月。 06 国内新药研发领域热点新闻乐普生物已到“最佳击球区” 根据最新半年报数据，2024年上半年，乐普生物总营收1.33亿元。主要收入来自PD-1普特利单抗，上半年录得9480万元收入，较去年同期增加一倍。研发开支2.17亿元，减少6.6%；现金及现金等价物5.14亿元，增加20.6%。乐普生物自今年2季度以来，市值经历了过山车起伏，振幅数以倍计，让人有些摸不着头脑。作为国内可算作头部ADC的Biotech，乐普生物的研发管线里其实还有许多惊喜，而且很多潜在重磅项目均还待字闺中，有很高的“出海”价值。但却迟迟得不到资本市场的看好，这是为何？更多资讯，请阅读原文康方半年报：首款自研ADC浮出水面 8月28日，康方生物公布2024年中期业绩。上半年，康方药业仍然保持高质量发展，实现营收共计10.25亿元，主要为产品收入和许可费收入。创新产品收入同比增长24%达到了9.4亿元，主要归因为商业化产品——PD-1/CTLA-4双抗卡度尼利的销售放量，以及PD-1/VEGF双抗于5月底正式获批带来的贡献。半年报中的另一亮点还在于，康方公布了其首款自研ADC候选药物AK138D1——日前已经向CDE递交IND申请，用于治疗晚期恶性肿瘤。更多资讯，请阅读原文梭哈自免赛道后，三生国健创下历史最佳业绩近日，三生国健发布2024年半年度报告。2024年上半年实现收入5.97亿元，同比增长24.9%；归母净利润1.3亿元，同比增长36.7%；扣非净利润1.26亿元，同比增长50.81%。这是三生国健自2019年以来，首次重回巅峰，并创下历史半年最高营收纪录。自2022年决定剥离肿瘤管线开始，三生国健全力梭哈自免赛道，到如今轻装上阵，多款创新管线步入收获期，有望在即将爆发的中国自免赛道取得先机。更多资讯，请阅读原文咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“0909创新药周报”，即可下载。

上市批准临床3期临床结果申请上市快速通道

2024-08-28

·PRNewswire

Life Molecular Imaging Receives FDA Fast Track Designation for [18F]PI-2620 in Tau PET Imaging Across Three Neurodegenerative Conditions

Fast Track Designation Granted for use in patients being evaluated for Alzheimer's Disease, Progressive Supranuclear Palsy, or Corticobasal Degeneration BOSTON, Aug. 28, 2024 /PRNewswire/ -- Life Molecular Imaging (LMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to [18F]PI-2620 Injection, an investigational PET imaging agent targeting tau neurofibrillary tangles. The Fast Track Designation has been granted for clinical development in Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). The FDA's Fast Track program is designed to accelerate the development and review of drugs that address serious conditions and fulfill unmet medical needs. This designation underscores the significant potential of [18F]PI-2620 to improve diagnosis of these three devastating neurodegenerative diseases. [18F]PI-2620 is a next-generation, F18-labeled PET imaging agent currently in Phase 3 clinical development for detecting tau pathology in Alzheimer's disease. The compound is also being investigated in other neurodegenerative diseases and settings by many academic researchers and in drug development trials. Tau proteins are a hallmark of several neurodegenerative disorders including AD, PSP, CBD, and frontotemporal lobar dementia (FTLD). The ability to accurately image tau pathology could significantly enhance disease diagnosis and patient care. "Receiving Fast Track Designation from the FDA is a major milestone that highlights the promise of [18F]PI-2620 in addressing the critical need for effective diagnostic tools in Alzheimer's disease, progressive supranuclear palsy, and corticobasal degeneration," said Andrew Stephens, Chief Medical Officer at LMI. "This designation not only validates our approach but also facilitates closer collaboration with the FDA to expedite the development of [18F]PI-2620. We are committed to advancing this important imaging agent with the potential to make a meaningful difference for patients who need accurate and accessible Tau PET imaging." About [18F]PI-2620 [18F]PI-2620 is an investigational PET imaging agent that was discovered and developed as part of a research collaboration between AC Immune and LMI. LMI has the exclusive, worldwide license for research, development and commercialization of Tau PET tracers generated within the discovery program. [18F]PI-2620 has demonstrated robust brain uptake and fast wash-out in non-target regions and excellent reproducibility between test and retest scans. The absence of significant off-target binding enables [18F]PI-2620 to detect and quantify early tau deposition in the brain. [18F]PI-2620 is currently under investigation in several clinical studies as a targeted radiopharmaceutical for the detection of tau deposits in the human brain including a Phase 3 image-to-autopsy study. [18F]PI-2620 also shows promise for detection of tau in non-AD tauopathies like progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD). About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI) is an international pharma company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit . About Life Healthcare Group Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: . For media queries Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging Tel: +1.484.735.2840 SOURCE Life Molecular Imaging

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