Active inflammation plays a key role in causing Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD). Since inflammation is so important in how these diseases start, are diagnosed, and treated, being able to see it clearly in each patient could lead to more personalized and effective care - and may help prevent heart attacks. Right now, there's no imaging technology available to clearly see inflammation inside the coronary arteries.
The investigators hope to learn how an imaging drug; called LUMISIGHT (Pegulicianine) can help detect inflammation in blood vessels compared with saline. If the investigators find out that LUMISIGHT is active in humans, the investigators might be able to use it for detecting plaque risk in the future.

开始日期2026-02-28

申办/合作机构

The Massachusetts General Hospital

[+2]

NCT04276909

/ WithdrawnN/A

Feasibility of the LUM Imaging System for Detection of Primary Pancreatic Cancer and Peritoneal Invasion From Primary Pancreatic Cancer During Surgery

This single-site, non-randomized, open-label study to assess the initial safety and efficacy of the LUM Imaging System for detection of primary pancreatic cancer and peritoneal invasion from primary pancreatic cancer during surgery. In this feasibility study, the tumor detection algorithm will be developed for this indication.

开始日期2026-01-01

申办/合作机构

Lumicell, Inc.

NCT04440982

/ Terminated临床2期

Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Breast Cancer Patients Receiving and Not Receiving Neoadjuvant Therapy

This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.

开始日期2020-09-01

申办/合作机构

Lumicell, Inc.

[+1]

100 项与 Pegulicianine 相关的临床结果

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100 项与 Pegulicianine 相关的转化医学

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100 项与 Pegulicianine 相关的专利（医药）

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项与 Pegulicianine 相关的文献（医药）

2025-03-01·Annals of Medicine and Surgery

A new dawn in research: FDA approves pegulicianine for fluorescence-guided surgery in breast cancer patients

作者: Hussain, Muhammad Shoaib ; Sajid, Muhammad Faateh ; Muskan, Fnu ; Awan, Muhammad Haseef ; Nishat, Syeed Mahmud ; Mohammad, Afshan Tarannum ; Shah, Muhammed Aalam

Sajid, Muhammad Faateh MBBS; Hussain, Muhammad Shoaib MBBS; Shah, Muhammed Aalam MBBS; Awan, Muhammad Haseef MBBS; Muskan, Fnu MBBS; Mohammad, Afshan Tarannum MD; Nishat, Syeed Mahmud MBBS Author Information

2023-06-27·NEJM evidence

Something to Dye For: Toward Better Breast Lumpectomy Margins

Communications

作者: Shriver, Craig D. ; Turza, Lauren C.

The development of fluorescence imaging in oncology led to the possibility of using intraoperative devices to improve the precision of surgical techniques.¹ In this issue of NEJM Evidence, Smith et al.² report results from a prospective multicenter trial evaluating the ability of intravenous pegulicianine with an optical head device and software to intraoperatively identify lumpectomy margins with residual cancer and excise them immediately. Identifying these margins intraoperatively avoids the need for a second surgery, which is required when margins are positive on the final pathology.

2023-06-27·NEJM evidence

Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery

Article

作者: Dekhne, Nayana ; Stone, Kimberly ; Schlossberg, Brian ; Lee, Marie Catherine ; Hunt, Kelly K. ; Hwang, E. Shelley ; Blumencranz, Peter W. ; Lesnikoski, Beth-Anne ; Smith, Barbara L. ; Clark, Patricia ; Clark, Lynne ; Wapnir, Irene L. ; Ferrer, Jorge ; Gadd, Michele A. ; Harris, Daniel K. ; Carr, David ; Dodge, Daleela ; Valente, Stephanie ; Dyess, Donna L. ; Samiian, Laila ; Chang, Manna ; Smith, Kate Porta

BACKGROUND: Although lumpectomy and mastectomy provide equivalent survival for patients with breast cancer, local recurrence after lumpectomy increases breast cancer mortality. Positive lumpectomy margins, which imply incomplete tumor removal, are the strongest predictor of local recurrence and are identified days after surgery, necessitating a second surgery. METHODS: In this prospective trial, we assessed margin status with or without pegulicianine fluorescence-guided surgery (pFGS) for stages 0 to 3 breast cancers. To prevent surgeons from performing smaller than standard lumpectomies in anticipation of pFGS assistance, patients were randomly assigned 10:1 to pFGS or control groups, thus randomization was not designed to provide a control group for evaluating device performance. In patients undergoing pFGS, additional pFGS-guided cavity margins were excised at sites of pegulicianine signal. We evaluated three coprimary end points: the percentage of patients for whom pFGS-guided margins contained cancer, sensitivity, and specificity. RESULTS: Overall, 406 patients received 1.0 mg/kg intravenous pegulicianine followed by lumpectomy. Among 392 patients randomly assigned, 316 had invasive cancers, and 76 had in situ cancers. In 27 of 357 patients undergoing pFGS, pFGS-guided margins removed tumor left behind after standard lumpectomy, 22 from cavity orientations deemed negative on standard margin evaluation. Second surgeries were avoided by pFGS in 9 of 62 patients with positive margins. On per-margin analysis, pFGS specificity was 85.2%, and sensitivity was 49.3%. Pegulicianine administration was stopped for adverse events in six patients. Two patients had grade 3 serious adverse events related to pegulicianine. CONCLUSIONS: The use of pFGS in breast cancer surgery met prespecified thresholds for removal of residual tumor and specificity but did not meet the prespecified threshold for sensitivity. (Funded by Lumicell, Inc. and the National Institutes of Health; Clinicaltrials.gov number, NCT03686215.)

项与 Pegulicianine 相关的新闻（医药）

2025-12-18

·PRNewswire

Lumicell Announces Collaboration with Learn Look Locate to Empower Breast Cancer Patients through Lumpectomy Education

NEWTON, Mass., Dec. 18, 2025 /PRNewswire/ -- Lumicell, Inc., a leader in developing innovative fluorescence-guided imaging technologies for cancer detection, today announced a new collaboration with Learn Look Locate, a global breast cancer education platform dedicated to empowering patients with clear, accessible information throughout their diagnosis and treatment journey. Continue Reading Lumicell and Learn Look Locate Launch New Educational Resource for Lumpectomy Surgery Through this agreement, Lumicell and Learn Look Locate will work together to enhance awareness of advanced technologies used during breast-conserving surgery. This includes creating educational content that helps patients better understand surgical options, emerging innovations, and how technologies like LumiSystem™ may support surgeons in identifying residual cancer during lumpectomy procedures. "Our mission has always been to improve the way breast cancer surgery is performed with groundbreaking tools that enable greater precision and confidence in the operating room," said Jorge Ferrer, Chief Scientific Officer at Lumicell. "Collaborating with Learn Look Locate allows us to extend that mission directly to the patient community, providing education that empowers individuals to have informed conversations with their care teams." One of the key educational resources developed is an expert interview with Dr. Barry Rosen, MD, Breast Surgical Oncologist. "The collaboration between Lumicell and Learn Look Locate brings together two essential forces: patient education and breast surgery innovation," shared Dr. Rosen. "It's a privilege to help bridge that gap so patients can better understand the options and advancements shaping their breast cancer treatment." In the upcoming months, the collaboration will include: Co-created patient-friendly educational materials about lumpectomy and intraoperative imaging Social media and digital campaigns highlighting advancements in breast cancer surgery Physician insights and clinical perspectives to support community learning This joint effort underscores the shared commitment of Lumicell and Learn Look Locate to improve patient education, support breast cancer awareness, and highlight technological advancements shaping the future of breast-conserving surgery. Learn Look Locate founder Cynthia Jordan shared her enthusiasm for the collaboration: "Patients want clarity, compassion, and credible information. Lumicell's technology represents an important advancement in breast cancer surgery, and we're proud to help ensure patients understand what's possible in their treatment journey." About Lumicell, Inc. Lumicell is a privately held life sciences company revolutionizing the intraoperative detection of cancer with its real-time fluorescence imaging technology. Lumicell's proprietary technology is FDA-approved for use in the treatment of breast cancer and is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit and . Follow the company on Facebook, X, and LinkedIn. About Learn Look Locate Learn Look Locate is a global breast cancer education platform designed to guide, inform, and empower patients throughout their breast cancer journey. With a community of patients, physicians, and advocacy partners worldwide, Learn Look Locate provides accessible information that helps individuals navigate diagnosis, treatment, and survivorship. For more information, please visit . Media Contact: [email protected] Indications for Use LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. IMPORTANT SAFETY INFORMATION What is LUMISIGHT (pegulicianine) and Lumicell DVS? LUMISIGHT (pegulicianine) is an optical imaging agent and Lumicell DVS is a fluorescence imaging device. LUMISIGHT and Lumicell DVS, in combination, are used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure. What is the most important information to know about LUMISIGHT? Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during the use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy. The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. What additional important information should I know about LUMISIGHT and Lumicell DVS? Adjunctive Use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care lumpectomy procedure and pathology. Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in noncancerous tissue. Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity in patients who have received LUMISIGHT. Other Risks: Using the Lumicell DVS handheld probe may cause tissue damage or infection. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information . Rx only SOURCE Lumicell, Inc. 21% more press release views with Request a Demo

2025-12-17

·高科技与产业化

全球医学科技竞争新格局下的中美医学创新能力比较研究

点击上方“高科技与产业化”可以订阅哦摘要：本文基于 Web of Science、Medline、Nature Index、高被引科学家名单及世卫组织、FDA、NMPA、IQVIA 等最新数据，系统分析全球医学科技战略演变、基础研究格局与医药研发态势，并比较中美创新能力。研究发现：全球医学科技已升级为关乎国家安全、生物经济与供应链韧性的战略体系，病原体监测、疫苗平台、生物制造成为关键方向。基础研究进入高位稳定期，美国在规模、机构与人才上仍占主导；中国在生物科学高质量科研份额上已反超美国，但在健康科学和临床研究仍偏弱。在医药研发层面，资本与并购加速向 ADC、细胞与基因治疗、GLP-1和AI药物研发集中，新兴生物制药公司成为首创新药重要来源。中美均保持全球新药批准高位，但美国在首创机制与罕见病体系上优势明显。总体看，中国正迈向全球医学创新关键力量，但仍需补强健康科学、临床转化与平台体系建设。关键词：医学科技战略，基础研究，新药研发，高被引科学家，Nature Index，中美比较 01 全球医学科技战略进入体系化竞争新阶段全球医学与公共卫生治理正从传统医疗体系加速迈向战略性科技体系。疫情后，卫生安全与国家安全、科技竞争、产业能力和供应链韧性深度绑定，各国围绕生物防御、疾病监测、疫苗与医疗对策、健康产业政策和供应链安全系统重构，推动战略由“疾病救治”转向“技术驱动、体系化预防”。AI、mRNA、细胞与基因治疗、生物制造和大数据等成为重塑国际医学生态的核心力量，并与生物经济政策、国家实验室体系、科研资助和科技立法深度联动。医学科技正成为国家竞争力与战略能力的重要衡量指标。 1.1 全球公共卫生战略的跨维升级与科技化治理世卫组织《2025~2034年全球传统医学战略草案》[1]提出以可验证证据体系与监管标准促进传统医学与现代医学融合，并运用AI、大数据等提升透明性和可重复性；《2024年全球卫生支出报告》[2]显示，各国财政投入正从医疗服务转向监测平台、疫苗体系和数字基础设施建设，以增强卫生韧性。疫情表明政府主导资金配置更具效率，卫生投入正从被动支出升级为国家战略投资。总体来看，公共卫生治理正由卫生部门主导转向科技、财政、产业与监管协同，医学科技成为国家治理现代化与国际竞争力的重要指标。 1.2 主要国家生物防御体系由被动应急转向主动化、平台化部署新冠疫情暴露监测灵敏度不足、医疗对策可及性有限与全球协同响应不畅等系统短板，促使主要国家重塑生物防御战略。美国白宫2024年发布新版《全球卫生安全战略》（2024 GHSS）[3]，通过强化双边合作、稳定资金投入和跨部门衔接提升全球预防、检测与应对能力。美国两党生物防御委员会同期推出《国家生物防御蓝图》[4]，以“阿波罗生物防御计划”为框架，建设国家病原体监测网络，发展针对26个病毒家族的原型疫苗与国家抗原库，完善DNA合成监管、生物安全标准及战略制造体系，推动生物防御成为国家战略产业。与此同时，欧盟、日本、新加坡等也在强化病原体情报、疫苗储备和生物经济政策布局，全球生物防御正迈向制度化、产业化和长期化建设。 1.3 病原体监测、AMR治理与疫苗平台研发成为全球医学领域关键赛道 H5N1在北美奶牛扩散、猴痘暴发等事件凸显公共卫生威胁的不确定性。2024年，世卫组织更新涵盖15类耐药细菌的重点病原体目录[5]，并在 eBioMedicine 提出17种优先疫苗研发病原体清单[6]，全球疫苗布局正从“单一应对”转向广谱威胁与AMR长期体系。为突破传统疫苗周期长、成本高难题，美国ARPA-H启动APECx计划[7]，投入2.04亿美元发展预测建模与机器学习驱动的抗原设计工具，美国HHS亦投入3.06亿美元用于H5N1监测与准备[8]，mRNA候选疫苗加速推进。总体上，各国正从“疫苗储备思维”转向“疫苗平台战略”，通过常态化研发与可扩展制造体系提升未来大流行应对能力。 1.4 从卫生战略向生物经济战略跃迁：科技、立法与产业体系协同推进在全球经济结构重塑背景下，生物医药、疫苗与诊断、数字健康、生物制造正成为主要经济体推动增长、产业升级和国家安全的新支柱，生物经济治理已上升为国家战略。美国通过行政令部署“国家生物技术与生物制造倡议”， 2024年成立国家生物经济委员会[9]，统筹技术创新、产业化与基础设施建设；欧盟发布生物制造战略文件，将其作为绿色转型与战略自主的重要引擎；日本2024年更新生物经济战略[10]，计划到2030年形成约100万亿日元市场；印度则以Bio-RIDE[11]等计划促进科研、创业与制造协同发展。全球资本正从单一项目转向平台技术、数字与数据基础设施及全链条生物产业能力，相关立法、监管、伦理与财政激励同步推进，加速形成“科技—制度—产业—市场”耦合体系。医学科技与生物经济正成为未来国家竞争力与供应链韧性的关键变量。 02 全球医学基础研究格局重塑与中美竞争新态势从基础研究视角看，过去十年全球医学及相关领域持续保持高位科研产出，学科结构、国家格局、机构与人才分布正在重新塑造。高水平论文在2015~2019年快速增长后进入稳态，美国依然在规模、机构与人才上占据主导；中国在生物科学领域的高质量科研产出已与美国比肩甚至实现反超，但在健康科学领域仍存在明显差距。研究热点主要聚焦肿瘤、心血管与呼吸系统等重大疾病，代谢研究、方法学创新和药物治疗成为重要发力方向。全球顶尖科研力量高度集中于美国，哈佛大学和NIH等构成核心节点；中国科学院、中山大学、上海交通大学等机构的国际影响力快速提升，正在进入全球医学基础研究竞争前沿。 2.1 全球高水平论文产出：由高速增长转向质量与结构优化基于Web of Science核心合集数据库检索显示，2015~2024年全球医学及相关领域共发表高水平论文2,181,556 篇，年均约21.8万篇，体现持续高投入与高产出。2015年论文量为200,807篇，至2019年升至峰值228,227篇。受疫情扰动、科研节奏调整和数据库收录时滞影响，2020~2023年维持在21.9万~22.5万篇区间，整体进入“高位稳定期”，研究重点正由数量增长转向质量、影响力与结构优化。截至2025年1月5日，数据库已收录2024年论文207,541 篇。学科结构显示，研究高度聚焦重大疾病：肿瘤学约4.10万篇（19.76%）居首，心血管疾病约2.39万篇（11.51%）、呼吸系统疾病约2.22万篇（10.71%）紧随其后。胃肠病学与肝病学、重症医学、医学影像、全科医学及神经科学同样活跃，共同构成以慢性非传染性疾病与公共卫生风险为核心的研究格局。MeSH主题词分布显示，近交C57BL小鼠、肿瘤细胞系、肿瘤、动物模型、脑、信号转导、生物标志物、妊娠、磁共振成像、肿瘤微环境及 COVID-19为主要热点，体现基础机制研究与先进诊疗技术并行推进。研究类型以回顾性、前瞻性、队列与横断面研究为主，说明循证医学范式已在全球深度固化。从应用取向看，代谢研究14,924篇居首，其次为方法学12,250篇和药物治疗11,277篇，遗传、病理、治疗用途与流行病学亦保持高产出。研究对象年龄结构显示，中年人群（45~64 岁）为主要关注对象，其次为老年（≥65 岁）和成人（19~44 岁），儿童与青少年研究相对不足，提示未来儿科和早期健康干预仍需加强。总体而言，全球医学基础研究正呈现“重大疾病聚焦—机制与方法并重—中老年主导”的结构特征，并由单病种研究向机制—人群—干预一体化研究范式演进。 2.2 国家与机构格局：美国主导与中国追赶并存 2024 年全球医学及相关领域高水平论文国家排名显示，美国以83,837篇、40.77%占比稳居首位，具显著数量级领先；中国以24,971篇、12.14%居第二，明显领先英国（9.61%）、德国（6.24%）、意大利（5.58%）、加拿大（5.43%）等第二梯队国家。这表明美国仍掌握医学基础研究主导权，科研体系长期稳固；中国已进入全球核心竞争区，在规模、领域参与度与国际影响力方面实现跨越式提升，但在人均产出、学科均衡性与顶尖人才密度方面仍有提升空间。从机构分布看，高水平论文呈强集聚效应。全球排名前二十机构中，16家来自美国，其余 4 家分别来自加拿大、法国和英国，体现“北美—西欧中心化”格局。哈佛大学以10,030篇、4.88%占比领跑全球，梅奥诊所、多伦多大学、宾夕法尼亚大学、约翰霍普金斯大学、布莱根妇女医院、加州大学旧金山分校、麻省总医院、伦敦大学学院、斯坦福大学等共同构成全球医学研究核心网络。在顶级期刊层面，美国优势更为突出。2024年Cell、Nature、Science 共发表医学及相关论文1,994篇，美国贡献1,159篇（约 58%），英国 286篇、德国278篇，中国274篇（约14%）位列第四。CNS发文前二十机构几乎全部来自美国和英国，其中哈佛大学以257篇（12.89%）位居第一，霍华德・休斯医学研究所（200篇）与麻省理工学院（144 篇）紧随其后。总体来看，美国凭借规模优势、顶刊产出能力、科研平台密度与人才集聚，形成“量—质—机构—体系”全链条主导格局；中国虽已跻身全球第二，但在顶尖机构产出能力、CNS首发竞争力以及战略科研资源布局方面仍需持续强化。 2.3 高被引科学家分布：人才高度集中与中美梯度分化高被引科学家是衡量基础研究源头创新能力和全球影响力的重要指标。科睿唯安2024年名单显示，来自59个国家和地区、1200余家机构的6,636名学者（6,886人次）入选，其中ESI医学及相关八大领域共有1,746名科学家、1,838人次上榜。从国家/地区分布看，人才高度集中于少数国家：美国以892人次（48.5%）占据近半壁江山，英国199人次（10.8%）和德国94人次（5.1%）分列其后。中国共有90人次（4.9%）入选，位居全球第四，其中中国大陆63人次、中国香港21人次、中国台湾4人次、中国澳门2人次。在机构层面，头部集聚效应更为突出。2024年拥有不少于15人次高被引学者的机构共22家，其中17家位于美国、3家在英国、2家在中国。哈佛大学以80人次遥遥领先，美国国立卫生研究院（NIH）和斯坦福大学各39人次，加州大学旧金山分校、麻省理工学院、伦敦大学学院、牛津大学等紧随其后。中国科学院以20人次居国内首位，香港大学以15人次进入全球前二十，显示中国高端科研节点正在加速形成。这一格局表明：全球医学基础研究人才呈“强头部、强集中”态势，美国大学—医学中心—国家研究体系构成世界创新塔尖；同时，中美在人才规模、结构与国际影响力上仍存在量级差距。尽管如此，中国已在基础生物学领域形成增长优势，但在健康科学、临床研究人才、长期队列与成果转化体系方面仍相对不足，结构性短板依旧明显。 2.4 生物科学与健康科学：中美竞争的“强项与短板” 将医学基础研究划分为生物科学与健康科学两大板块，可更清晰识别中美科研能力差异。Nature Index显示，在生物科学领域，中国2023年的Share为23172，相比2022年的20221增长显著；美国2023年的Share为20292，相比2022年的21659有所下降。中国的总论文数为27736篇，而美国为29165篇。中国的Adjusted Share增长0.136，美国的Adjusted Share减少0.071。以上数据表明，在生物领域，尽管美国总发表论文数仍然略高于中国，但差距已大幅缩小。中国在全球高质量科研产出中的份额进一步提升，分值首次超过美国。中国科学院、北京大学、浙江大学等机构全球影响力持续提升，表明中国在基础生物学、分子机制与前沿方法等“源头创新”方向具备竞争优势。然而，健康科学领域差距仍然明显。美国2023年的Share为5019，虽然相比2022年的5367有所下降，但仍然以显著优势居全球首位；中国2023年的Share为1401，相比2022年的1289有所提升，并且明显领先于位于第三位的英国（860），但与美国在规模、影响力和体系能力上仍存在量级差距。健康科学研究的全球核心机构依旧高度集中于美国，包括哈佛大学、约翰霍普金斯大学、UCSF、密歇根大学、多伦多大学等，而中国主要高地集中在中山大学、上海交通大学。综合来看，全球医学基础研究正呈“生物科学双中心、健康科学单中心”格局：中国在生物科学“上游环节”已具备并跑甚至局部领跑能力，但在健康科学、临床研究体系、长期人群队列、转化医学平台与高被引人才集聚等“下游环节”仍较薄弱。“上游强—下游弱”意味着中国基础研究创新势能尚未充分转化为临床与产业竞争力。未来竞争焦点将从规模与发表转向体系能力、转化效率与产业牵引力，实现从“0到1”“1到100”的跨越。 03 全球医药研发态势演变与中美新药竞争格局全球医药研发正由“数量扩张”转向“质量与结构优化”，竞争重心由单品研发转向平台技术与体系能力。资本、并购与研发资源加速集中于ADC、细胞与基因治疗、GLP-1受体激动剂和AI赋能药物研发等高价值赛道。尽管全球临床试验总量放缓，肿瘤、免疫、肥胖和罕见病仍保持高景气，新兴生物制药公司在突破性创新中的作用更突出。新活性物质上市数量已恢复至疫情前水平，中美均维持全球最高批准规模，但结构存在差异：中国NAS上市与本土创新占比快速提升，美国在首创新药、罕见病用药及生物仿制药体系方面继续占优。总体来看，全球医药研发竞争正进入“技术平台—临床资源—监管激励”协同驱动的新阶段。 3.1 全球医药研发现状与演进特征 3.1.1 资金与资本流向：从广撒网走向平台化和结构优化 IQVIA《2024年全年医药研发全景展望》显示[12]，2023年全球医药研发资金回升，生物制药融资由610亿美元增至720亿美元，虽低于疫情高峰，但显示资本正从“广撒网”转向更聚焦的平台化投入。并购活动进入高位周期，总规模达1,400亿美元，其中ADC占重大交易近半，成为全球肿瘤研发核心赛道；与人工智能相关交易同比翻倍，AI正加速融入靶点发现、分子设计与临床开发。中国企业活跃度持续提升，全球资本网络影响力增强。同时，大型制药公司研发支出增至1,610亿美元，占净销售额23.4%，创历史新高，体现头部企业通过强化平台技术与前沿管线布局巩固创新主导地位。 3.1.2 临床试验布局：整体放缓与重点领域高活跃度并存全球临床试验进入“增速放缓、结构调整”阶段。2023年试验启动量同比下降15%，较 2021年累计下降22%，主要因COVID-19相关试验减少及大型药企、新兴生物制药公司收缩项目布局。尽管数量回调，研发成功率却提升至10.8%，Ⅰ期、Ⅲ期成功率分别升至48%和66%，显示试验筛选更审慎、质量改善。Ⅰ—Ⅱ期仍是药物流失高风险区，Ⅲ期增速持续承压，高成本、长周期成为行业效率瓶颈。在区域格局上，中国企业试验占全球比例已由约3%升至28%，并加速参与国际多中心试验，全球影响力上升。疾病与技术方向则呈集中化趋势：肿瘤、免疫、代谢/内分泌、神经疾病占比达79%，其中细胞与基因治疗、ADC、多特异性抗体等新机制试验快速增长；肥胖试验同比增长68%，成为新热点。相较之下，新冠及抗菌药物试验持续下降，AMR 领域投入不足问题仍待解决。整体而言，全球临床研发正从规模扩张转向质量、效率与战略重点竞争。 3.1.3 新活性物质上市：创新主体与治疗谱系双重重构全球新活性物质（NAS）上市逐步摆脱疫情影响并回归常态增长。2023年全球上市69种NAS，较2022年增长10%，过去五年累计达362种。研发资源正加速向肿瘤学、神经科学与免疫学集中，其NAS占比已由43%提升至56%，凸显重大未满足医疗需求的战略牵引力。首创新药持续涌现，包括6种细胞与基因治疗产品，以及多款基于新机制的新药，推动临床治疗边界外延。创新主体发生结构性变化，新兴生物制药公司（EBP）成为全球创新主力。2023年EBP研发的新药占全部上市品种的 53%，在美国上市的新型肿瘤药物中63%源自EBP，显示其中小型研发力量在突破性疗法领域的创新优势。上市地域差异进一步放大全球“创新可及性鸿沟”。过去五年，美国上市267种NAS，显著领先欧洲（182 种）与中国（192 种）[13]。其中42%的美国上市新药尚未在欧洲上市，而欧洲仅6%未在美国上市，体现美国患者新药可及性相对更高。中国NAS上市数量全球第二，反映其生物医药产业快速成长及监管优化带来的结构性机遇。 3.2 中美新药批准格局与结构性差异 3.2.1 中国：新药批准显著提速，创新活跃度持续增强从监管看，中国新药审评审批已进入“提速放行—结构优化”阶段。2024年国家药监局共批准93款新药上市，明显高于 2023 年（82 款）和2022年（49款），也超过2019~2021年间约50~83款的水平，呈稳步上升态势。从类型结构看，93款新药包括47款化学药、37款生物药和9款中药，覆盖小分子、多肽、核酸、单抗、双抗、ADC、细胞治疗等多种技术路线。其中国产自主研发药物43款，占比约46%，反映本土企业在药物发现、临床开发和上市转化方面的能力持续提升。从疾病谱看，肿瘤仍是创新药获批最集中的领域。2024年共批准31款肿瘤新药，占全部新药的37%，其中非小细胞肺癌（NSCLC）相关品种11款[14]，显示我国在肺癌靶向治疗与免疫治疗布局持续活跃，创新药形成围绕重大疾病、成熟靶点和临床需求集中的产业特征。 3.2.2 美国：批准节奏稳定，突出首创机制与罕见病导向美国 FDA 近五年保持稳定高位的新药批准节奏，2019~2024年年度批准量基本维持在约50款，体现成熟监管体系的稳定输出能力。2024年批准的50款新药中，34款（68%）率先在美国上市，33款（66%）使用突破性、加速审批等快速通道，表明FDA在重要创新产品上具有较强审评灵活性与响应效率。从创新属性看，24款（48%）被认定为首创新药，覆盖肿瘤、精神神经、代谢性肝病、罕见病及心血管等领域，典型代表包括 Anktiva、Cobenfy、Lumisight、Nemluvio、revumenib、Rezdiffra 与 Tryvio，显示美国在新机制药物与复杂疾病治疗方面持续领先。疾病覆盖布局广泛，涵盖癌症、感染性疾病、神经退行性疾病、心肾代谢疾病及成瘾治疗等关键公共健康领域。在未被满足医疗需求方面，美国监管支持力度更突出。2024年新药中26款（52%）用于罕见病，涉及多类遗传代谢病、自身免疫疾病和罕见肿瘤，反映政策、资本与审评资源的长期倾斜。此外，FDA当年批准18款生物仿制药和9款可互换生物仿制药，创历史新高，自2015年以来累计已超60款[15]，有助于提高药物可及性、降低费用并强化市场竞争力。 3.2.3 中美对比：数量追平、结构分化与体系能力差异并存总体看，中美均位于全球新药批准最活跃国家之列，但在数量趋势、结构和体系能力方面存在显著差异：一是数量趋势上，中国新药批准增长更快，呈阶梯式上升，与审评改革成效、产业扩容和研发投入提升密切相关；美国批准数量在高位区间小幅波动，体现成熟审评体系与稳态研发生态。二是结构与技术路径上，中国创新明显集中于肿瘤尤其是NSCLC等优势赛道；美国布局更均衡，在肿瘤、免疫、罕见病、神经和代谢疾病等领域均具主导优势，首创新药占比更高。三是体系能力上，中国在新药批准数量、本土创新占比和NAS上市数量上快速追赶，全球影响力显著提升；但美国凭借高密度临床研究网络、成熟多中心试验体系、长期队列资源、完备监管工具和强劲创新资本结构，仍保持“发现—开发—审评—可及性”全链条竞争优势。总体而言，中国正在加速成长为全球医药创新重要力量，但在临床研究体系、创新驱动机制、机构集聚度和全球可及性方面仍有提升空间，未来竞争焦点将更多转向体系能力、首创突破和临床转化效率。总体而言，中国正在加速形成全球医药创新重要力量，但与美国相比，在临床研究体系、创新驱动机制、机构集聚度与全球可及性仍存在提升空间。未来竞争焦点将从数量扩张转向体系能力、首创突破与临床转化效率。 04 全结语与趋势展望纵观全球医学科技战略、基础研究格局与医药研发态势，医学科技正由传统卫生子系统跃迁为重塑国际竞争格局、生物安全格局和未来产业形态的关键变量。中国要在新一轮医学科技和生物医药竞争中实现从“量的追平”到“质的跨越”，既要巩固源头创新优势，也要打通基础研究—临床转化—产业应用的全链条。 4.1 医学科技战略：从应急驱动走向体系化布局全球医学科技正从疫情应急驱动的阶段性投入，转向以生物防御体系、生物经济战略和科技治理体系为核心的长期布局。病原体监测、AMR治理、疫苗平台、生物安全与生物制造被纳入国家安全与产业安全整体框架，竞争焦点正在从单点技术突破转向“科技—制度—产业—市场”一体化体系能力。对中国而言，关键在于将医学科技布局与国家生物安全、生物经济和高水平对外开放统筹谋划，在国家实验室体系、重大科技基础设施以及数据与算力平台等层面形成协同。 4.2 基础研究格局：巩固生物科学“上游优势”，补齐健康科学“下游短板” 在基础研究层面，中国已在生物科学领域实现对美国的份额反超，基础生物学、分子机制和前沿方法等源头创新能力显著提升；但在健康科学、临床医学与公共卫生等“下游环节”，与美国在论文产出、高被引人才、临床研究体系和顶尖机构集聚度方面仍存在差距。未来需在继续加强基础生物学与交叉前沿布局的同时，面向重大慢病、精神心理、神经退行性疾病和老龄化相关疾病，加强真实世界研究、多中心队列建设和转化医学平台布局，推动基础研究优势向健康科学与临床应用系统性转化。 4.3 医药研发态势：抓住技术平台窗口期，提升“从0到1”到“从1到100”的整体效率全球医药研发正由“管线竞争”转向“平台竞争”，ADC、细胞与基因治疗、GLP-1受体激动剂和AI赋能药物研发成为技术高地。临床试验活动整体放缓但结构优化，新兴生物制药公司在首创新药与突破性疗法中的作用日益凸显，监管体系通过加速审评和生物仿制药制度重塑创新与可及性的平衡。对于中国而言，在新药数量和NAS上市等指标上已实现快速追赶，下一步关键在于：一是围绕若干关键技术平台形成持续投入和长期布局，避免“赛道拥挤—同质竞争”；二是完善临床试验与真实世界证据体系，提高III期及上市后阶段的效率与质量；三是加强监管科学能力建设，形成兼顾安全、效率与可及性的制度优势。 4.4 面向未来的中国路径：从“参与者”跃升为“关键力量” 综合来看，中国在全球医学领域已从“参与者”跃升为“关键力量”，在部分基础研究和新药上市指标上与发达国家并跑甚至局部领跑。但要真正从“追赶者”走向与美国等国家共同塑造规则、议程和标准的“并行塑造者”，仍需在三方面持续发力：一是强化战略统筹与顶层设计，将医学科技、健康中国、生物安全和生物经济纳入统一国家战略框架，提升政策一致性、连续性和可预期性；二是围绕“基础研究—临床转化—产业应用”全链条优化资源配置，协同推进学科布局、人才培养、平台建设和产业政策，打造若干具有全球影响力的医学科技创新集群；三是主动融入并塑造全球规则体系，在病原体监测、疫苗与药物研发规范、数据与伦理标准、药品监管合作等领域提升国际参与度与话语权。参考文献 1 WHO. 2025—2034 年全球传统医学战略（草案）[EB/OL]. Geneva: World Health Organization, 2024. Accessed: 2025-02 10. https://apps.who.int/gb/ebwha/pdf_files/EB156/B156_16-ch. pdf?utm_source. 2 WHO. 世卫组织新报告显示各国政府不再优先考虑卫生支出[EB/OL]. 2024-12-12. Accessed: 2025-02-10. https:// www.who.int/zh/news/item/12-12-2024-new-who-report-reveals-governments-deprioritizing-health-spending?utm_source. 3 The White House. FACT SHEET: Biden-Harris Administration Releases Strategy to Strengthen Global Health Security[EB/OL]. 2024-04-16. Accessed: 2025-02-10. https://www.whitehouse. gov/briefing-room/statements-releases/2024/04/16/fact-sheet biden-%e2%81%a0harris-administration-releases-strategy-to strengthen-global-health-security. 4 Bipartisan Commission on Biodefense. The National Blueprint for Biodefense[EB/OL]. 2024. Accessed: 2025-02-10. https:// biodefensecommission.org/reports/the-national-blueprint-for biodefense/. 5 WHO. 世卫组织更新对人类健康威胁最大的耐药细菌名单[EB/OL]. 2024-05-17. Accessed: 2025-02-10. https://www. who.int/zh/news/item/17-05-2024-who-updates-list-of drug-resistant-bacteria-most-threatening-to-human-health. 6 WHO. 世卫组织研究列出急需新疫苗的主要地方性病原体[EB/OL]. 2024-11-05. Accessed: 2025-02-10. https://www. who.int/zh/news/item/05-11-2024-who-study-lists-topendemic-pathogens-for-which-new-vaccines-are-urgently needed. 7 ARPA-H. ARPA-H announces awards to develop computational platform for multi-virus vaccine design[EB/OL]. 2024-09-25. Accessed: 2025-02-10. https://arpa-h.gov/news-and-events/ arpa-h-announces-awards-develop-computational-platform multi-virus-vaccine-design. 8 HHS. HHS awards $306 million in Avian Flu monitoring and preparedness funding[EB/OL]. [2025-01-03]. https://www.hhs. gov/about/news/2025/01/03/hhs-awards-306-million-avian flu-monitoring-and-preparedness-funding.html. 9 THE WHITE HOUSE. FACT SHEET: The United States Announces New Investments and Resources to Advance President Biden’s National Biotechnology and Biomanufacturing Initiative. https://www.whitehouse.gov/briefing-room/statements releases/2022/09/14/fact-sheet-the-united-states-announces new-investments-and-resources-to-advance-president-bidens national-biotechnology-and-biomanufacturing-initiative/. 10 Japan Bioindustry Association. Japan’s Bioeconomy Strategy 2024[EB/OL]. 2024. Accessed: 2025-02-10. https://gtb.jba.or.jp/ en/japans-bioeconomy-strategy-2024/?utm_source. 11 知乎专栏. 生物制造如何改变全球产业格局？[EB/OL]. 2024-09-10. Accessed: 2025-02-10. https://zhuanlan. zhihu.com/p/721855396?utm_source. 12 IQVIA. 全球医药研发趋势2024：活动、生产率与赋能因素[EB/OL]. 2024. Accessed: 2025-02-10. https://www.iqvia.com/-/ media/iqvia/pdfs/china/viewpoints/view-point-issue-72.pdf. 13 IQVIA Institute. Global trends in R&D 2024: Activity, productivity and enablers[EB/OL]. 2024. Accessed: 2025-02-10. https://www. iqvia.com/insights/the-iqvia-institute/reports-and-publications/ reports/global-trends-in-r-and-d-2024-activity-productivity and-enablers. 14 93款上市，2024年我国批准上市新药显著上涨 [EB/OL]. 2025-01-05. https://news.qq.com/rain/ a/20250105A06IJJ00?utm_source. 15 FDA. Novel Drug Approvals 2024—Annual Report[EB/ OL]. 2025. Accessed: 2025-02-10. https://www.fda.gov/ media/184967/download?attachment 更多内容请订阅《高科技与产业化》杂志地址：北京市海淀区中关村北四环西路33号（100190）电话：010-62539166 邮箱:hitech@mail.las.ac.cn 网址：http://www.hitech.ac.cn 全年12期，128元/期，全年订价1536元邮发代号：82-741 刊号：ISSN1006-222X CN11-3556/N

疫苗细胞疗法并购基因疗法信使RNA

2025-04-28

·PRNewswire

Lumicell Announces Promising Feasibility Trial Findings Using Pegulicianine in Gastrointestinal Cancer Patients

Pioneering real-time detection of cancer brings promise to enabling a more complete resection in gastrointestinal cancer surgery NEWTON, Mass., April 28, 2025 /PRNewswire/ -- Lumicell, Inc., a leader in developing innovative fluorescence-guided imaging technologies for cancer detection, today announced the release of early clinical trial findings from the ex vivo feasibility study for molecular imaging in gastric cancer. Today, Andrew T. Chan, MD, MPH, and David A. Drew, Ph.D. of the Clinical and Translational Epidemiology Unit and Division of Gastroenterology at Massachusetts General Hospital, presented during the session "Advances in the Detection and Treatment of Gastrointestinal Cancers" as a part of the Stand Up To Cancer (SU2C) Gastric Cancer Open Scientific Session at this year's American Association for Cancer Research (AACR) Annual Meeting. Dr. Drew presented compelling new findings highlighting the potential of cathepsin activity as a biomarker for gastric cancer, confirmed through single-cell analysis in patient samples and molecular profiling in genetically engineered mouse models. These findings support the use of pegulicianine-fluorescence imaging in detecting early-stage and neoadjuvant-treated gastric tumors. In collaboration with Lumicell, Dr. Drew and Dr. Chan led the first clinical trial of pegulicianine in gastrointestinal cancer patients ( NCT02584244). In this study, patients with diffuse and intestinal-type gastric cancers received intravenous pegulicianine prior to undergoing curative-intent surgical resection. Post-surgical specimens imaged ex vivo demonstrated strong, tumor-specific fluorescence signals, correlating with pathologically confirmed cancerous tissue. Importantly, pegulicianine was well tolerated by all study participants. "Most gastric cancers are diagnosed at a locally advanced stage, with five-year survival rates below 30%," said Dr. Chan. "Current screening approaches, such as random biopsies during upper endoscopy, lack sensitivity. These findings represent a shift toward enabling early and more accurate detection." Dr. Drew added, "We are thrilled to share these feasibility results. This work is propelling us toward real-time, in vivo endoscopic imaging, which could improve early detection strategies of gastric and gastroesophageal cancers in the at-risk patient population." The next stage of this research is in progress, involving an in vivo clinical trial of pegulicianine and Lumicell's newly developed endoscopic imaging system. About Lumicell Inc. Lumicell is a privately held company focused on developing innovative fluorescence-guided imaging technologies for the detection of cancerous tissue during surgery. The company's lead products are used to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, as an adjunct to the Standard of Care. Lumicell's proprietary, pan-oncologic optical imaging agent is also being explored for further development across a wide variety of solid tumor indications. For more information, please visit and follow the company on Facebook, X, and LinkedIn. This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this press release reflect Lumicell's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions, and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the regulatory process to approve pharmaceutical drugs or medical devices. Indication expansion involving gastrointestinal cancers require additional studies and FDA approval. MKT00357rA Media Inquiries – [email protected] SOURCE Lumicell, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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100 项与 Pegulicianine 相关的药物交易

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适应症	国家/地区	公司	日期
乳腺癌	美国	Lumicell, Inc.	2024-04-17

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适应症	最高研发状态	国家/地区	公司	日期
浸润性乳腺癌	临床3期	美国	Lumicell, Inc.	2019-11-04
前列腺腺癌	临床2期	美国	Lumicell, Inc.	2019-03-20
局部晚期前列腺癌	临床2期	美国	Lumicell, Inc.	2019-03-20
腹膜继发性恶性肿瘤	临床2期	美国	Lumicell, Inc.	2019-03-18
结直肠癌	临床2期	美国	Lumicell, Inc.	2016-08-04
早期胃癌	临床2期	美国	Lumicell, Inc.	2016-08-04
食管癌	临床2期	美国	Lumicell, Inc.	2016-08-04
胰腺癌	临床2期	美国	Lumicell, Inc.	2016-08-04
脑转移瘤	临床阶段不明	美国	Lumicell, Inc.	2019-05-03
胶质母细胞瘤	临床阶段不明	美国	Lumicell, Inc.	2019-05-03

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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


NCT03686215 (CL0007, FDA_CDER) 人工标引	临床3期	乳腺癌	357	LUMISIGHT	繭築夢鹹顧憲簾齋網簾(願鬱網壓醖鑰築鑰選簾) = 蓋顧醖簾遞糧網選衊觸築繭醖鑰艱鹹選顧壓觸 (遞窪築鑰鏇餘築夢衊遞, 5.0 ~ 10.8) 更多	积极	2024-04-17
NCT03686215 (pivotal study \| CL0007 \| INSITE, CTgov)	临床3期	乳腺癌 \| 浸润性乳腺癌	406	Study Device Arm (Device Intervention: LUM Imaging System Used During Surgery)	壓餘積鏇鑰積膚鹹壓醖 = 蓋廠醖構廠蓋願網糧壓構餘顧窪積網醖鹹壓簾 (選鏇簾艱鏇壓衊網蓋憲, 積鏇構築廠觸憲願積膚 ~ 膚壓艱觸顧構蓋糧範顧) 更多	-	2023-08-24
				LUM015 (Standard of Care Arm)	窪願夢選遞鑰窪壓夢膚(鹽遞鹹糧觸糧網衊鑰選) = 鹹壓積鏇選鏇衊繭選觸艱壓廠鏇餘艱憲憲憲鹹 (鑰廠憲選網簾餘網構範, 鬱夢壓繭醖齋範鹹衊蓋 ~ 製糧鹹鏇網淵觸廠齋齋) 更多
NCT02438358 (CTgov)	临床1/2期	乳腺癌	60	LUM015 (Phase A No LUM015)	壓範製構顧廠網齋膚夢(膚壓餘憲網構鑰襯鹹糧) = 觸鑰夢鑰壓淵繭窪範壓顧範鬱齋獵壓憲構艱鬱 (獵艱齋壓獵膚選鹹獵鏇, 0.7)	-	2023-01-05
				LUM015 (Phase A 0.5 mg/kg)	壓範製構顧廠網齋膚夢(膚壓餘憲網構鑰襯鹹糧) = 網築構顧顧醖鏇廠衊壓顧範鬱齋獵壓憲構艱鬱 (獵艱齋壓獵膚選鹹獵鏇, 2.0)
NCT01626066 (ASCO2014)	临床1期	肿瘤	9	LUM015 0.25 mg/kg	糧淵願網願範醖襯網鑰(網遞鹹顧憲醖廠構窪選) = 壓選窪壓鑰鹹鑰遞糧網顧顧選鏇餘鹹範構觸廠 (鬱網襯艱繭製壓鑰膚獵 )	-	2014-05-20
				LUM015 0.5 mg/kg	糧淵願網願範醖襯網鑰(網遞鹹顧憲醖廠構窪選) = 糧醖鏇繭鏇範築願餘繭顧顧選鏇餘鹹範構觸廠 (鬱網襯艱繭製壓鑰膚獵 )