In this project, based on the DTPA-HAS kit, investigators plan to develop a positron nuclide 68Ga labeled DTPA-HSA molecular probe in order to obtain high sensitivity, signal-to-noise ratio and high-resolution PET/CT imaging images, aiming to find the specific site of intestinal leakage while diagnosing Protein-Losing Enteropathy (PLE), and analyze the pathological mechanism of intestinal leakage in combination with pathology, so as to provide molecular imaging guidance for the treatment of PLE patients. PLE is a rare gastrointestinal protein-losing syndrome, and the radiopharmaceutical 99mTc-DTPA-HSA (99mTc-human serum albumin) approved by the State Food and Drug Administration has the diagnostic ability of protein-losing enteropathy (PLE), but due to the low resolution of SPECT/CT, the image clarity and signal-to-noise ratio need to be improved, it is a classic probe in the last century, unable to meet the existing clinical needs.

开始日期2025-05-01

申办/合作机构

北京市肿瘤防治研究所

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0 项与北京市肿瘤防治研究所相关的专利（医药）

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1,181

项与北京市肿瘤防治研究所相关的文献（医药）

2025-05-01·Pathology - Research and Practice

The m6A reader YTHDC2 restrains endometrial cancer progression through suppressing hedgehog signaling pathway

Article

作者: Li, Ning ; Zhang, Xinyan ; Ma, Hongyun ; Liu, Fei ; Gao, Man ; Si, Qin ; Wang, Tengqi ; Ma, Zhao ; Gao, Wen ; Mu, Yongping

N6-methyladenosine (m⁶A) is a prevalent RNA modification involved in different physiological and pathological processes. However, little is known about the role of m⁶A modification in endometrial cancer (EC). In this study, we explored the expression and prognosis of m⁶A-related genes in EC using public databases to screen relevantgenes. Quantitative reverse-transcription PCR and immunohistochemistry were performed to detect YTH N6-methyladenosine RNA binding protein C2 (YTHDC2) expression in EC tissues, and the relationships between YTHDC2 expression, pathological features, and prognosis were analyzed. The effect of YTHDC2 on EC cells and its mechanism of action were examined in vitro and in vivo. YTHDC2 was identified as a tumor suppressor gene in EC. Expression of YTHDC2 mRNA and protein was significantly lower in EC tissues than in normal tissues. YTHDC2 expression was related to myometrial invasion (χ²=7.523, P = 0.006), lymph node metastasis (χ²=7.203, P = 0.007), and FIGO stage (χ²=9.678, P = 0.008) in EC. It was also a prognostic factor in EC (95 %CI: 1.217-3.646, P = 0.013), and patients with EC low YTHDC2 expression had poor overall survival. YTHDC2 knockdown promoted the proliferation, migration, and invasion of EC cells, and decreased apoptosis. Upregulation of YTHDC2 showed the opposite effects. YTHDC2 inhibited the Hedgehog signaling pathway, and the Hedgehog inhibitor vismodegib partly eliminated the effects of YTHDC2 knockdown of EC cells. YTHDC2 inhibited EC progression and has the potential to be explored as an independent prognostic factor in patients with EC.

2025-05-01·Advances in Therapy

Pembrolizumab in Patients of Chinese Descent with Microsatellite Instability-high/Mismatch Repair Deficient Advanced Solid Tumors: KEYNOTE-158 Final Analysis

Article

作者: Mao, Yimin ; Wu, Xiaohua ; Zheng, Hong ; Huang, Yi ; Tang, Jie ; Luo, Suxia ; Bai, Yuxian ; Chen, Xiaojun ; Xu, Nong ; Xu, Jianming ; Zhang, Jieqing ; Mao, Yixiang ; Deng, Yanhong ; Yin, Xianli ; Gozman, Alexander ; Li, Nan ; Xu, Miaomiao ; Li, Jiayi ; Yang, Jianwei ; Zhao, Weidong ; Wang, Dong

INTRODUCTIONKEYNOTE-158 (NCT02628067) supported the US Food and Drug Administration approval of pembrolizumab for microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) advanced solid tumors. Incidence of MSI-H/dMMR tumors in patients of Chinese descent is similar to that of Western populations. Cohort L of KEYNOTE-158 evaluated pembrolizumab in patients of Chinese descent with previously treated MSI-H/dMMR tumors. We previously reported an objective response rate (ORR) of 70% in 20 patients from cohort L which supported the approval in China of pembrolizumab in patients with MSI-H/dMMR solid tumors. Here we present results of the final analysis for 30 patients with median follow-up of 18 months.METHODSEligible patients who had confirmed unresectable or metastatic MSI-H/dMMR tumors, and one or more prior lines of therapy, received 200 mg pembrolizumab Q3W (up to 35 cycles) until progression, toxicity, or withdrawal. Primary endpoint was ORR per RECIST 1.1 by central review. Secondary endpoints were duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.RESULTSThirty patients were enrolled; 7 (23%) were aged ≥ 65 years, and 20 (67%) were female. With median follow-up of 18 months, ORR was 66.7%. Median DOR was not reached (NR), with 12-month DOR rate of 85.9%. Median PFS was NR, with 18-month PFS rate of 63.0%. Median OS was NR, with 18-month OS rate of 78.8%. Treatment-related adverse events (AE) were reported in 22 (73%) patients. Grade 3-4 treatment-related AEs occurred in 7 (23%) patients. Immune-mediated AEs occurred in 11 (37%) patients of which 2 (7%) had grade 3 AEs. No grade ≥ 4 immune-mediated AEs occurred.CONCLUSIONPembrolizumab continues to provide clinically meaningful antitumor activity and durable responses with a manageable safety profile in patients of Chinese descent with MSI-H/dMMR advanced solid tumors. These results are consistent with those reported for patients in the global population and further support the use of pembrolizumab in patients of Chinese descent with MSI-H/dMMR tumors. TRIAL REGISTRATION NUMBER: NCT02628067.

2025-05-01·Annals of Oncology

Sacituzumab govitecan in advanced urothelial carcinoma: TROPiCS-04, a phase III randomized trial

Article

作者: Kovalenko, M ; Sternberg, C N ; Sierecki, M ; Sima, C S ; Powles, T ; Vulsteke, C ; Loriot, Y ; Duran, I ; Gross-Goupil, M ; Boateng, F ; Park, S H ; Goebell, P J ; Grivas, P ; Wang, L ; Tagawa, S ; Bellmunt, J ; Necchi, A ; Guo, J ; Waldes, J ; Morales-Barrera, R ; De Santis, M

BACKGROUNDSacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, demonstrated efficacy and manageable toxicity in the phase II TROPHY-U-01 study in pretreated advanced urothelial carcinoma (aUC). We report the results from final analysis of the global open-label randomized phase III TROPiCS-04 study (NCT04527991) in pretreated aUC.PATIENTS AND METHODSPatients with aUC whose disease had progressed on prior platinum-based chemotherapy and checkpoint inhibitor therapy were randomized 1 : 1 to receive SG or treatment of physician's choice (TPC; paclitaxel, docetaxel, or vinflunine). The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS) and objective response rate (ORR) by investigator and blinded independent committee review, as well as safety.RESULTSOverall, 711 patients were randomized. After a median follow-up of 9.2 months, the primary endpoint was not met [median OS for SG versus TPC: 10.3 months versus 9.0 months, hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.73-1.02, P = 0.087]. Median PFS with SG and TPC was 4.2 months and 3.6 months, respectively (HR 0.86, 95% CI 0.72-1.03); ORR (95% CI) was 23% (18% to 27%) and 14% (10% to 18%). The most common grade ≥3 treatment-related adverse event (TRAE) with SG was neutropenia (35%, including 12% with febrile neutropenia). Incidence of grade ≥3 TRAEs (67% versus 35%) and grade 5 treatment-emergent adverse events (TEAEs; 7% versus 2%) was higher with SG versus TPC. In the SG group, 16/25 grade 5 TEAEs were infections with neutropenia mostly occurring early in the treatment course of patients with multiple risk factors for febrile neutropenia. Primary prophylactic granulocyte colony-stimulating factor (G-CSF) usage with SG and TPC was 21% and 22%, respectively.CONCLUSIONSSG did not result in a significant improvement in OS or PFS compared with TPC in pretreated aUC, although SG activity was demonstrated by a higher ORR. Early toxicity-related complications with SG may have impacted efficacy outcomes.

777

项与北京市肿瘤防治研究所相关的新闻（医药）

2025-05-05

·ioncology

IGCC前瞻丨中国专家20项口头报告摘要闪耀国际舞台

IGCC 2025微专辑扫描二维码可查看更多内容编者按由国际胃癌学会（IGCA）主办的第16届国际胃癌大会（IGCC 2025）将于2025年5月7~10日在荷兰阿姆斯特丹隆重召开。作为全球胃癌研究领域具影响力的学术盛会，本届大会将汇聚来自世界各地的顶尖专家学者，聚焦胃癌诊疗前沿进展。值得关注的是，中国专家将在多个专题会场发表重要研究成果，展现我国在该领域的学术影响力。经《肿瘤瞭望消化时讯》系统梳理会议日程，现共整理出20项中国专家入选的口头报告摘要标题（中英文对照）供读者预览。若有遗漏或表述偏差，诚挚欢迎学界同仁批评指正。一、5月8日专题报告Session 1a：分期专场时间：11:45中文标题：多参数MRI与双能CT在胃癌局部区域分期中的对比研究英文标题：Multiparametric MRI versus Dual-Energy CT in Gastric Cancer Locoregional Staging专家：Qiong Li，南京医科大学第一附属医院时间：12:05中文标题：基于优化淋巴结分期的胃癌新辅助治疗后ypTNM分期细化英文标题：Refined ypTNM Staging for Gastric Cancer After Neoadjuvant Therapy Based on Optimal Lymph Node Staging专家：Baolong Li，福建医科大学附属协和医院Session 1b：肿瘤内科-免疫治疗专场时间：11:45中文标题：术前免疫治疗与dMMR/MSI-H胃癌病理反应改善相关英文标题：Preoperative immunotherapy is associated with better pathological response in dMMR/MSI-H gastric cancer专家：Hong Zeng，复旦大学附属中山医院时间：12:05中文标题：蛋白质组学分析预测胃癌新辅助放化疗免疫疗效英文标题：Proteomic Analysis Predicts Therapeutic Outcomes of Neoadjuvant Chemo-immunotherapy in Gastric Cancer Patients专家：崔昊，中国人民解放军总医院第一医学中心Session 1c：胃肠病学/内镜/早期胃癌专场时间：11:55中文标题：全腹腔镜与腹腔镜辅助远端胃癌根治术对早期胃癌患者生活质量的影响分析英文标题：Morbidity and quality of totally laparoscopic versus laparoscopy-assisted distal gastrectomy for early gastric cancer’s life专家：黄华，复旦大学附属肿瘤医院Session 2a：肿瘤内科-靶向治疗专场时间：16:40中文标题：T细胞激活增强抗HER2介导的胃癌抗体依赖性细胞毒性英文标题：T-cell activation enhances anti-HER2-mediated antibody-dependent cellular cytotoxicity in gastric cancer专家：薛子睿，复旦大学附属中山医院Session 2b：放射肿瘤学专场时间：16:30中文标题：可切除食管胃结合部腺癌新辅助斯鲁利单抗联合放化疗的Ⅱ期更新结果英文标题：Neoadjuvant Serplulimab with Concurrent Chemoradiotherapy in Resectable Esophagogastric Junction Adenocarcinoma: Phase 2 Updated Results专家：赵林，北京协和医院时间：16:40中文标题：可切除食管胃腺癌放化疗价值的Meta分析英文标题：The value of chemoradiation therapy for resectable esopho-gastric adenocarcinomas: A meta-analysis of randomized clinical trials专家：Tao Fu，中日友好医院Session 2c：胃癌手术创新专场时间：16:40中文标题：D2+CME根治术对局部进展期胃癌的肿瘤学疗效：RCT三年随访结果英文标题：The oncological efficacy of D2+CME for locally advanced gastric cancer: 3-year outcomes of a RCT专家：龚建平，华中科技大学同济医学院附属同济医院二、5月9日专题报告3x接受口头摘要全体会议：HDGC/预康复专场时间：9:40中文标题：多学科预康复改善老年虚弱胃癌患者临床结局英文标题：Supervised multimodal prehabilitation to improve the clinical outcomes of frail elderly patients with gastric cancer专家：Yuqi Sun，青岛大学附属医院Session 3a：病理学/转化研究专场时间：11:55中文标题：FGFBP2+NK细胞作为胃癌免疫治疗预测性生物标志物的角色解析英文标题：Unraveling the Role of FGFBP2+NK Cells as Predictive Biomarkers in Gastric Adenocarcinoma Immunotherapy专家：潘宏达，复旦大学附属肿瘤医院Session 3b：人工智能与精准手术专场时间：11:45中文标题：机器学习模型预测胃癌患者术后并发症英文标题：Machine Learning Models for Predicting Postoperative Surgical Complications in Gastric Cancer Patients专家：Xiaohan Cui，山东大学齐鲁医院时间：12:05中文标题：基于多场景血管识别的AI驱动胃癌微创手术导航系统英文标题：AI-driven Surgical Navigation System based on Multi-scene Vessel Recognition for Minimally Invasive Gastric Cancer Surgery专家：Hao Chen，南方医科大学南方医院Session 3c：生活质量/支持治疗专场时间：11:55中文标题：中国胃癌手术质量与经济学评价：基于PACAGE研究分析英文标题：Surgical Quality and Economic Evaluation of Gastric Cancer Surgery in China: Analysis of PACAGE study专家：吴舟桥，北京大学肿瘤医院Session 4b：多模态治疗专场时间：16:30中文标题：AS与CAPOX在Ⅲ期胃腺癌术后化疗中的生存与安全性更新英文标题：AS versus CAPOX in postoperative chemotherapy for stage Ⅲ gastric adenocarcinoma patients: survival and safety update专家：俞鹏飞，浙江省肿瘤医院Session 4c：手术拓展-局限性Ⅳ期胃癌治疗专场时间：16:40中文标题：腹腔联合静脉化疗对比静脉紫杉醇+S-1治疗腹膜转移胃癌：DRAGON-01试验结果英文标题：Intraperitoneal+intravenous vs. intravenous paclitaxel+S-1 in gastric cancer with peritoneal metastasis: Results from DRAGON-01 trial专家：严超，上海交通大学医学院附属瑞金医院三、5月10日专题报告3x接受口头摘要全体会会议：手术专场时间：9:30中文标题：食管胃结合部腺癌纵隔淋巴结清扫的多中心队列研究中期分析英文标题：Lower mediastinal lymphadenectomy for adenocarcinoma of esophagogastric junction: interim analysis of a multicenter cohort study专家：李子禹，北京大学肿瘤医院时间：9:40中文标题：全腹腔镜与腹腔镜辅助全胃切除术疗效比较：CLASS08多中心RCT研究英文标题：The Efficacy of Totally Laparoscopic versus Laparoscopic-Assisted Total Gastrectomy: The CLASS08 Multicentre Randomized Controlled Trial专家：Qingya Li，南京医科大学第一附属医院Session 5a：肿瘤内科-新药与技术专场时间：11:55中文标题：替雷利珠单抗联合安罗替尼与XELOX一线治疗晚期胃/胃食管结合部腺癌（TALENT研究）英文标题：Tislelizumab Combined with Anlotinib and XELOX as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (TALENT)专家：Ling Ma，南京医科大学第一附属医院Session 5c：视频专场：如何应对治疗失败时间：11:45中文标题：D2+CME手术技术演示英文标题：D2+CME surgery专家：龚建平，华中科技大学同济医学院附属同济医院综上，本届IGCC大会中，中国专家在胃癌的分期诊断、免疫治疗、微创手术、多学科预康复等领域贡献多项突破性研究成果，涵盖临床分期优化、新型靶向药物联合方案、AI手术辅助系统等技术进展。特别关注领域包括：免疫治疗标志物探索（如dMMR/MSI-H分型与FGFBP2+NK细胞）、手术技术创新（如D2+CME根治术、全腹腔镜操作安全性）、多学科综合治疗（新辅助放化疗、多学科预康复模式）等。这些研究不仅展现中国在胃癌诊疗领域的国际影响力，更为全球患者带来潜在诊疗方案优化契机。期待中国专家在阿姆斯特丹的学术舞台上发出更强音！（来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床2期免疫疗法

2025-04-30

·肿瘤界

北京大学肿瘤医院10项研究成果亮相2025 ASCO年会

前言美国临床肿瘤学会（ASCO）年会作为规模最大、最具影响力的国际临床肿瘤学会议之一，引领着癌症诊疗的前沿方向。2025年ASCO年会于5月30日至6月3日在芝加哥召开，中国共有七十余项研究入选。北京大学肿瘤医院表现亮眼，共10项研究入选本届年会，包括4项口头报告（Oral Abstract Session）、5项快速口头报告（Rapid Oral Abstract Session）及1项临床科学研讨会（Clinical Science Symposium），研究领域覆盖消化道肿瘤、黑色素瘤与肉瘤、泌尿生殖系统肿瘤、中西医结合等关键领域。成/果/报/告Achievement Report消化肿瘤方向讲者：沈琳摘要号：LBA4012报告类型：Rapid Oral Abstract SessionDisitamab vedotin (DV) plus toripalimab (Tor) and chemotherapy (C)/trastuzumab (Tra) as first-line (1L) treatment of patients (pts) with HER2-expressing locally advanced or metastatic (la/m) gastric cancer.维迪西妥单抗联合特瑞普利单抗和化疗/曲妥珠单抗作为局部晚期或转移性HER2表达胃癌患者的一线（1L）治疗讲者：龚继芳摘要号：4010报告类型：Clinical Science SymposiumEfficacy and safety of cafelkibart (LM-108), an anti-CCR8 monoclonal antibody, in combination with anti-PD-1 therapy in patients with pancreatic cancer: Results from phase 1/2 studies抗 CCR8 单克隆抗体 cafelkibart (LM-108) 与抗 PD-1 疗法联合治疗胰腺癌患者的疗效和安全性：I/II期研究结果讲者：周军摘要号：4016报告类型：Rapid Oral Abstract SessionCosiporfin sodium (DVDMS)-mediated photodynamic therapy (PDT) versus treatment of physician's choice (TPC) in patients (pts) with advanced esophageal cancer (aEC): A phase III, randomized, open-label, multicenter trial.华卟啉钠介导的光动力疗法（PDT）对比医师选择治疗（TPC）治疗晚期食管癌患者：一项III期、随机、开放标签、多中心试验讲者：齐长松摘要号：4003报告类型：Oral Abstract SessionClaudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01).Claudin18.2特异性CAR T细胞（Satri-cel）对比医生选择的治疗方案应用于既往接受过治疗的晚期GC/GEJC患者：随机、开放标签、II期CT041-ST-01试验的主要结果讲者：张盼盼摘要号：2500报告类型：Oral Abstract SessionAssessment of efficacy of LBL-024, a novel and uniquely designed bispecific antibody against PD-L1 and 4-1BB, combined with etoposide/platinum-based chemotherapy in treatment-naive advanced extrapulmonary neuroendocrine carcinoma (EP-NEC): A multicenter phase Ib/II trial.新型结构PD-L1/4-1BB双特异性抗体LBL-024联合依托泊苷/铂类化疗治疗初治晚期肺外神经内分泌癌（EP-NEC）的疗效评估：一项多中心Ib/II期临床试验讲者：彭浩欣摘要号：4015报告类型：Rapid Oral Abstract SessionDecoding the response and resistant features to the Claudin18.2-specific CAR-T cell CT041 in gastric cancer: A multi-omics exploratory biomarker analysis of the phase 1 clinical trial.揭秘胃癌中Claudin18.2特异性CAR-T细胞CT041的应答和耐药性特征：I期临床试验的多组学探索性生物标志物分析黑色素瘤方向讲者：郭军摘要号：2502报告类型：Oral Abstract SessionEfficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in patients (pts) with immunotherapy-treated, advanced acral and mucosal melanoma.首创新药PD-1/IL-2α偏倚型双特异性抗体融合蛋白IBI363应用于免疫治疗后的晚期肢端型与黏膜型黑色素瘤患者的疗效与安全性结果讲者：毛丽丽摘要号：9512报告类型：Oral Abstract SessionNeoadjuvant camrelizumab plus apatinib and temozolomide for resectable stage II/III acral melanoma: The CAP 03-NEO trial.新辅助卡瑞利珠单抗联合阿帕替尼和替莫唑胺治疗可切除的 II/III 期肢端黑色素瘤：CAP 03-NEO 试验泌尿系统肿瘤方向讲者：盛锡楠摘要号：4519报告类型：Rapid Oral Abstract Session9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naïve patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a phase 1b/2 study.9MW2821，一种新型的 Nectin-4 抗体药物偶联物（ADC），与特瑞普利单抗联合用于初治的局部晚期或转移性尿路上皮癌（la/mUC）患者：一项 Ib/II 期研究的结果中西医结合肿瘤方向讲者：许轶琛摘要号：12012报告类型：Rapid Oral Abstract SessionEfficacy of treatment with traditional Chinese medicine (Renshen Yangrong Tang granules) for cancer-related fatigue in patients with platinumbased chemotherapy: A randomized, double-blinded, placebo-controlled, multicenter trial.中药（人参养荣汤颗粒）治疗铂类化疗患者癌因性疲劳的疗效：一项随机、双盲、安慰剂对照、多中心试验备注：如有遗漏或任何问题，请给我们留言~声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：北京大学肿瘤医院临床试验机构编辑：南星

ASCO会议临床结果细胞疗法免疫疗法临床研究

2025-04-30

·药智网

中药巨头杀入百亿赛道

在创新药热潮下，中药巨头们也开始拓展新赛道。近日，云南白药发布公告，其子公司云核医药于近日收到药监局下发的《药物临床试验批准通知书》，同意其INR102注射液用于前列腺癌的临床试验申请。这已是云南白药第二个获批临床的核药。除了云南白药，康缘药业、步长制药、天士力、片仔癀、白云山也在“跨界创新”，布局了前沿化学、生物创新药。中药巨头们下了一盘什么棋？1杀入百亿核药赛道云南白药是一家百年老字号品牌，其核心产品“云南白药”属于国家级保密配方。这一秘方长期为云南白药提供充足现金流，并使其业绩穿越周期，实现连续多年增长。2024年云南白药营收400.33亿元，同比增长2.36%，创出历史新高。图1 近年云南白药营收图片来源：同花顺财经但近几年，随着市场饱和度提升，加之消费疲软，云南白药业绩增速缓慢，而且净利曾在2021年大幅下降，至今未回到2020年的高点。充足的现金流，但有限的增长，于是云南白药将眼光瞄向了“高投入、高风险、高回报”的创新药，以期找到下一个业绩增长密码。而在创新药众多新兴赛道中，云南白药选择了核药，可以说眼光独到。核药通常又称放射性药品，在恶性肿瘤、心脑血管疾病、中枢神经系统疾病等诊断与治疗领域广泛应用。但是在早期的发展中，核药主要作为重要的癌症诊断药物被开发使用。直到诺华两款放射性核素偶联药物（RDC）Lutathera和Pluvicto的获批，尤其是2022年Pluvicto的获批，点燃了核药研发热情，吸引礼来、罗氏、阿斯利康、默沙东、赛诺菲等制药巨头布局。根据BBC Research的数据显示，RDC的全球市场规模预计将在2026年达到175亿美元。Pluvicto是首款靶向PSMA的核药，能够精准辐射前列腺癌，具备替代全身放疗的潜力。该药最早于2022年3月获FDA批准，用于治疗接受过ARPI和紫杉类化疗的PSMA阳性转移性去势抵抗性前列腺癌（mCRPC）成年患者。2024年该药销售额13.92亿美元，成功解锁核药赛道首个“重磅炸弹”成就。而云南白药也是在这一时期选择将核药作为“创新药转型”战略的核心方向之一。2022年9月，云南白药豪掷2000万元，从北京大学第一医院、北京市肿瘤防治研究所引进了前列腺特异性膜抗原（PSMA）靶向核药相关专利，启动核药研发。2023年7月，云南白药成立云核医药全资子公司，致力于推动创新核药的研发与商业化。云核医药计划在天津建设6000平方米的核药研发中心，作为推动核药研发的重要基地。2024年1月初，云核医药取得核药研发中心天津项目环境影响报告表批复，并正式启动工程建设。2024年5月，INR101获得临床试验默示许可。这是云南白药研发的首个诊断性核药，适用于前列腺癌患者PSMA阳性病灶的PET成像。11月完成I/IIa期临床总结报告，结果显示产品具备优异的稳定性和安全性。药智数据显示，目前该药临床Ⅲ期进行中。图2 INR101研发进展图片来源：药智数据2025年4月，INR102的临床试验申请获得NMPA批准，同意开展前列腺癌的临床试验。这是云南白药首个创新治疗核药产品，拟用于治疗已经接受过雄激素受体通路抑制剂和紫杉烷类药物化疗的前列腺特异性膜抗原（PSMA）阳性的转移性去势抵抗性前列腺癌（mCRPC）成人患者。云南白药公告显示，该产品已投入研发费用约人民币2332.5万元。相较于生物技术公司，云南白药在资源整合、长期投入的稳定性等方面具有优势，自2022年进入核药赛道，3年时间，快速完成团队搭建，通过外部合作+自研，已成功将两个产品推入临床研究阶段，未来有望成为核药领域的佼佼者。同时，使云南白药突破传统业务天花板，形成“中药+创新药”双轮驱动模式。2中药巨头集体跨界创新除了云南白药，其他中药巨头在近几年的创新药热潮下，也纷纷开启了“跨界创新”。康缘药业：押注GLP-1康缘药业杀入了多个市场潜力巨大的赛道，其中已有多款化药、生物药1类项目进入临床试验，包括WXSH0493片（高尿酸血症）、KYS202004A（银屑病）、KYS202002A（系统性红斑狼疮）等。而在2024年，康缘药业又斥资2.7亿元收购中新医药，“跨界”布局GLP-1药物。据公告，中新医药有4个临床阶段的创新药，包括两款GLP-1产品：长效GLP-1/GIP/GCG三重受体激动剂ZX-2021，和长效GLP-1/GIP双重受体激动剂ZX-2010。前者正在进行肥胖和超重适应症的Ⅱ期临床研究，后者正在针对2型糖尿病、超重或肥胖两个适应症开展I期临床研究。图3 康缘药业创新药管线图片来源：药智数据步长制药：抗体领域崭露头角步长制药则在生物药领域小有成就，控股子公司泸州步长开发的1类生物药注射用艾帕依泊汀α已提交上市申请。据悉，这是人促红细胞生成素（EPO）和人免疫球蛋白G2（IgG2）Fc片段组成的重组融合蛋白，适用于治疗正在接受促红细胞生成素治疗的成人透析患者因慢性肾脏病（CKD）引起的贫血。此外，泸州步长还有两款双特异性抗体已进入临床阶段：BC-004和BC008-1A。BC004是一款抗HER2/CD3双功能特异性抗体，是步长制药首个申报IND的双抗，不过近期没有研发进展消息传出。BC008-1A是一款特异性靶向PD-1和TIGIT的双抗药物，在前期研究中显示出良好的治疗效果和安全性，现已获国家药监局批准，在复发CNS WHO 4级脑胶质瘤患者中开展I期注册临床试验。天士力：细胞领域佼佼者天士力在生物药领域也多有布局，且在细胞治疗领域已处于领先地位。今年3月，其自主研发的同种异体脂肪间充质基质细胞注射液（NR-20201）获得NMPA批准该药物用于治疗急性缺血性脑卒中。而此前NR-20201已在美国获批开展临床试验。不久后，天士力与首都医科大学附属北京神经外科研究所联合开发的‌P134细胞注射液‌获批IND，拟用于治疗‌复发胶质母细胞瘤（GBM）‌。这是我国首款针对CD44/CD133双靶点的自体CAR-T疗法。另外，与云南白药齐名的片仔癀已有多个化学1类创新药获批临床，包括PZH2111片、PZH2113胶囊等。图4 片仔癀创新药管线图片来源：药智数据以岭药业、白云山也都有多个创新药进入临床。这些中药企业已成为化学、生物创新药领域不可忽视的力量。3结语中药虽好，但化药、生物药创新药的高回报正吸引着更多老牌药企布局。凭借稳定而充沛的现金流和积累多年的资源整合能力，云南白药、康缘药业、步长制药等中药巨头有望破界在化药、生物药领域开拓“第二增长曲线”。参考资料：1.云南国资：云南白药加速推进核药领域布局2.E药经理人：江苏中药研发一哥杀进GLP-1！“出走”背后，困局难破？3.步长制药：步长制药关于控股子公司取得药品注册受理通知书的公告4.步长制药：四川泸州步长生物制药BC008-1A注射液正式开展Ⅰ期临床试验5.天士力大健康招聘：全球首款间充质基质细胞药物获批中美IND，助力中国引领细胞治疗国际标准制定6.基因治疗圈：“双靶点围剿脑癌之王！天士力CAR-T疗法P134获批临床”7.药智数据声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

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重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞） ( CTLA4 x PDL1 )	转移性微卫星稳定结直肠癌更多	临床2期
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