卡度尼利单抗(Cadonilimab) - 药物靶点：CTLA4 x PD-1_在研适应症：胃食管交界处腺癌，胃癌，宫颈癌_专利_临床

概要

基本信息

药物类型

双特异性抗体

别名

PD-1/CTLA-4 Bispecific Antibody、凯得宁单抗、卡度尼利

+ [5]

靶点

CTLA4 x PD-1

作用方式

抑制剂

作用机制

CTLA4抑制剂(细胞毒性T淋巴细胞相关抗原4抑制剂)、PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤消化系统疾病泌尿生殖系统疾病+ [7]

在研适应症

胃食管交界处腺癌胃癌宫颈癌+ [43]

非在研适应症

晚期癌症晚期食管鳞状细胞癌脂肪肉瘤+ [9]

原研机构

在研机构

+ [1]

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2022-06-28),

宫颈癌

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (美国)、优先审评 (中国)、附条件批准 (中国)、突破性疗法 (中国)

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结构/序列

Sequence Code 616719055

来源: *****

Sequence Code 616719118

来源: *****

关联

249

项与卡度尼利单抗相关的临床试验

NCT06762080

/ Recruiting临床1/2期IIT

A Phase I/II Clinical Study of an Intrathecal Combination of PD-1/CTLA-4 Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis from Solid Tumors

Leptomeningeal metastasis, characterized by tumor cells infiltrating and proliferating in the subarachnoid space, represents a distinct pattern of central nervous system involvement and is a fatal complication of malignant tumors. This study is a prospective, single-arm phase I/II clinical trial aimed at evaluating the safety and efficacy of intrathecal Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) bispecific antibodies combined with pemetrexed in treating leptomeningeal metastases from solid tumors, with the goal of identifying more effective treatment options.

开始日期2025-04-01

申办/合作机构

广州医科大学

NCT06832917

/ Not yet recruiting临床3期IIT

A Prospective Multicenter, Two-arm Parallel, Open-label, Randomised Phase III Study to Explore the Efficacy and Safety of Cadonilimab Plus Chemotherapy After Short-course Radiotherapy in Locally Advanced Rectal Cancer

The goal of this clinical trial is to learn if neoadjuvant short-course radiation (SCRT) followed by 6 cycles of cadonilimab plus mFOLFOX6 works to treat patients with locally advanced rectal cancer (LARC). It will also learn about the safety of the combined regimen. The main questions it aims to answer are:
Does the neoadjuvant SCRT plus dual immunotherapy and chemotherapy can improve pathological complete response(pCR) rate? What medical problems do participants have when receiving chemotherapy plus cadonilimab compared to chemotherapy only?
Participants will:
Receiving cadonilimab plus mFOLFOX6 or mFOLFOX6 every 2 weeks for 3 months Visit the clinic once every 2 weeks for checkups and tests

开始日期2025-03-31

申办/合作机构

深圳市人民医院

NCT06878196

/ Not yet recruitingN/AIIT

ctDNA-guided First-line Immuno-de-escalation Therapy for Stage IVB and Recurrent Cervical Cancer: A Prospective, Single-arm, Multicenter Phase II Clinical Trial

This study aims to evaluate the clinical feasibility of first-line immunochemotherapy for stage IVB and recurrent cervical cancer guided by circulating tumor DNA (ctDNA), in order to explore the optimal treatment duration or criteria for discontinuation of first-line immunotherapy in patients with stage IVB cervical cancer or recurrent cervical cancer. To ensure the quality of the study, before the study begins, the research applicant and participants jointly discuss and formulate the research plan. Necessary steps should be taken during the design and implementation stages of the study to ensure that the collected data is accurate, consistent, complete, and credible.

开始日期2025-03-10

申办/合作机构

复旦大学附属妇产科医院

100 项与卡度尼利单抗相关的临床结果

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100 项与卡度尼利单抗相关的转化医学

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100 项与卡度尼利单抗相关的专利（医药）

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250

项与卡度尼利单抗相关的文献（医药）

2025-03-01·PESTICIDE BIOCHEMISTRY AND PHYSIOLOGY

A comparative study of the controllable release and insecticidal efficacy for two typical carrier methods on diamide insecticide delivery system

Article

作者: Liu, Bingrui ; Li, Yahui ; Liu, Xingyu ; Huang, Yucong ; Li, Shaochen ; Yang, Huiying

Using nano/microcarriers of pesticides in sustainable pest management represents a promising strategy for enhancing pesticide efficiency while mitigating environmental harm. The reported pesticide loading methods include one-step self-assembly encapsulation and two-step absorption loading, but the controllable release and insecticidal efficacy of these two methods have been infrequently evaluated. Herein, the typical diamide insecticide cyantraniliprole (CTP) was employed as the model pesticide. A hydrogen bond-driven one-step self-assembly method and a chemical deposition method were utilized to fabricate highly dispersed polylactic acid (PLA) microspheres and calcium carbonate (CaCO₃) microspheres. The resulting CTP-loaded PLA microspheres (CTP-PLA MS) and CaCO₃ microspheres (CTP-CaCO₃ MS) both exhibited high adhesion, resistance to rain erosion, and insecticidal activity under laboratory conditions. However, the functional CTP-PLA MS demonstrated superior sustained pesticide release performance, higher pesticide loading capacity, and less application amount than that of CTP-CaCO₃ MS. At the same time, the acute toxicity of CTP-PLA MS exhibited slightly reduced acute toxicity to honeybees (Apis mellifera), signifying enhanced biocompatibility. Finally, the CTP-PLA MS maintained superior insecticidal efficacy than the normal CTP in controlling O. nubilalis at a low concentration. The present study represents a promising pesticide carrier as a highly efficient, eco-friendly agent for sustained management of O. nubilalis.

2025-03-01·REPRODUCTIVE TOXICOLOGY

Hormonal mechanism and pathogenetic therapy of citalopram-induced infertility in female rats

Article

作者: Suleyman, Bahadir ; Mendil, Ali Sefa ; Altuner, Durdu ; Yilmaz, Betul Kalkan ; Suleyman, Halis ; Gumusburun, Neset ; Mammadov, Renad ; Bakan, Nuri ; Bulut, Seval ; Delibasi, Ilhan Bahri

Citalopram is a selective serotonin reuptake inhibitor (SSRI) and has been associated with reproductive dysfunction in women. In this study, the effects of citalopram on reproductive health in female rats were investigated. Albino Wistar rats was divided into six groups (each group/n = 12): healthy (HG), citalopram (CTP), cabergoline (CBR), metyrapone (MTP), cabergoline+citalopram (CBR+CTP), and metyrapone+citalopram (MTP+CTP). Initially, cabergoline 0.1 mg/kg and metyrapone 50 mg/kg were administered orally. A dose of 10 mg/kg of citalopram was given orally one hour later. For 30 days, the treatment protocol was applied once a day. Then, blood samples were taken from the tail veins of six rats from each group for prolactin and corticosterone analyses and ovaries were removed after euthanasia. The ovaries were examined for oxidants and antioxidants and histopathologically. During two months, the remaining animals were kept with male rats. The rats that did not deliver during this period were considered infertile. In terms of oxidants and antioxidants, there was no significant difference between the groups (p > 0.05). In half of the female rats, citalopram caused infertility, increased levels of prolactin and corticosterone, and damaged the ovaries histopathologically (p < 0.05). Cabergoline suppressed the elevation of prolactin by citalopram (p < 0.001) but did not prevent infertility. In contrast, metyrapone significantly prevented the citalopram-induced increase in corticosterone, infertility, and tissue damage induced by citalopram (p < 0.05). According to the results of our study, the preventive effect of drugs that suppress excessive corticosterone on citalopram-induced infertility in rats may be encouraging for further clinical studies.

2025-03-01·Med

Neoadjuvant cadonilimab plus FLOT chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma: A multicenter, phase 2 study

Article

作者: Zhu, Junmin ; Guan, Xiaoying ; Li, Long ; Huang, Zeping ; Yu, Zeyuan ; Jiang, Xiangyan ; Zhao, Xiaoning ; Long, Bo ; Mao, Jie ; Yang, Hanteng ; Yang, Xiaojun ; Yan, Hong ; Chen, Shigong ; Che, Shengfu ; Zhang, Wenjuan ; Jiang, Zebin ; Zhao, Da ; Zhou, Huinian ; Gao, Zhongti ; Wei, Dengwen ; Li, Yumin ; Jiao, Zuoyi ; Yu, Hongwei ; Luo, Changjiang ; Zhang, Gengyuan

BACKGROUND:

Treatment with cadonilimab and chemotherapy has shown promise as a first-line treatment for gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. However, its application in neoadjuvant settings has not yet been documented.

METHODS:

This multicenter, phase 2 trial (ChiCTR2200066893) was conducted at four hospitals across China. Treatment-naive patients with locally advanced G/GEJ adenocarcinoma (cT3/4, N+, M0) and who were human epidermal growth factor receptor 2 negative received 3-cycle or 4-cycle neoadjuvant treatment of cadonilimab plus FLOT (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy, followed by gastrectomy and 4-cycle adjuvant FLOT chemotherapy. The primary endpoint was the pathological complete response (pCR) rate. Secondary endpoints included major pathological response (MPR), overall response rate (ORR), disease control rate (DCR), R0 resection rate, downstaging rate, and safety.

FINDINGS:

Between December 23, 2022, and December 15, 2023, 32 of 38 patients completed the scheduled treatment, achieving an R0 resection rate of 100% (32/32). The pCR rate was 21.1% (8/38, 90% confidence interval [CI]: 9.7-32.4), and the MPR rate was 44.7% (17/38, 90% CI: 30.9-58.5). Radiological evaluations were available for 28 of 38 patients by blinded independent central review. The ORR was 60.7% (17/28, 90% CI: 44.7-76.7), and the DCR was 100.0% (28/28, 90% CI: 100.0-100.0). Tumor downstaging occurred in 71.9% of patients (23/32), with consistent efficacy across all populations observed in the subgroup analysis. Grade 3 adverse events occurred in 31.6% of patients without severe safety issues.

CONCLUSIONS:

Neoadjuvant cadonilimab plus FLOT chemotherapy treatment exhibits promising efficacy with manageable toxicities in locally advanced G/GEJ adenocarcinoma, providing preliminary evidence for further investigation.

FUNDING:

This study was funded by Akeso Biopharma.

731

项与卡度尼利单抗相关的新闻（医药）

2025-03-21

·PRNewswire

Akeso's Cadonilimab Combined with Concurrent Chemoradiotherapy Demonstrates Promising Efficacy in Locally Advanced Cervical Cancer: Data Published at the 2025 SGO Annual Meeting

HONG KONG, March 20, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) presented promising phase III safety run-in results from the COMPASSION-18/AK104-305 study, at the 2025 Annual Meeting of the Society of Gynecologic Oncology (SGO). The study evaluates the global first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab (AK104), in combination with concurrent chemoradiotherapy (CCRT) for the treatment of locally advanced cervical cancer. Currently, CCRT is the standard of care for locally advanced cervical cancer, but approximately 30%-40% of patients experience relapse or disease progression within five years. Cadonilimab, with its unique dual-target mechanism, is designed to simultaneously inhibit the PD-1 and CTLA-4 immune checkpoint pathways. It has received approval from the National Medical Products Administration (NMPA) in China for use in patients with recurrent or metastatic cervical cancer who have failed prior platinum-based chemotherapy. The Phase III COMPASSION-16 study further confirmed that cadonilimab, when combined with platinum-based chemotherapy (with or without bevacizumab), significantly improves progression-free survival (PFS) and overall survival (OS) in patients with persistent, recurrent, or metastatic cervical cancer. Based on these compelling results, the supplemental New Drug Application (sNDA) for cadonilimab as a first-line treatment for persistent, recurrent, or metastatic cervical cancer is currently under regulatory review. At this year's SGO, data from the COMPASSION-18 study highlighted the exceptional efficacy seen in patients receiving cadonilimab in combination with CCRT during the safety run-in phase. The results demonstrate the considerable therapeutic potential of cadonilimab combined with CCRT for locally advanced cervical cancer. The study included a more challenging patient cohort, with a notably higher proportion of patients having PD-L1 CPS <1 (38.2%) and an ECOG performance status of 1 (52.9%) compared to other similar studies. Overall Response Rate (ORR): The evaluable patients achieved a remarkable ORR of 100%, with a complete response (CR) rate of 84.8% and a partial response (PR) rate of 15.2%, which significantly outperformed data from other comparable studies. The median duration of response (DoR) has yet to be reached. Progression-Free Survival (PFS): While the median PFS has not been reached, the 12-month PFS rate was 74.9%. Subgroup Analysis: Patients with PD-L1 CPS ≥1, ECOG 0, and those not infected with COVID-19 derived even greater benefit from the treatment, with 12-month PFS rates of 85%, 87.5%, and 81.3%, respectively. Safety Profile: Cadonilimab combined with CCRT exhibited a favorable safety profile, demonstrating good tolerability and manageable adverse events. Notably, there were no treatment-related deaths (TRAE) and no new safety concerns were identified. Cadonilimab is making significant progress in treating both recurrent/metastatic and locally advanced cervical cancer, establishing a comprehensive therapeutic approach. The positive results from the COMPASSION-18 study reinforce its potential in a broader patient population. As clinical development continues, cadonilimab is set to redefine cervical cancer treatment, offering long-term survival benefits to more patients. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床3期上市批准ASCO会议免疫疗法

2025-03-21

·康方生物

SGO 2025丨康方生物卡度尼利联合同步放化疗治疗局部晚期宫颈癌疗效优异

近日，康方生物（9926.HK）在2025年美国妇科肿瘤学会（SGO）年会上发布了其独立自主研发的全球首创PD-1/CTLA-4双特异性抗体卡度尼利（AK104）联合同步放化疗（CCRT）治疗局部晚期宫颈癌的Ⅲ期临床研究COMPASSION-18/AK104-305的安全性导入阶段优异数据。这一重要进展不仅再次证明了卡度尼利在更广泛宫颈癌患者群体中的治疗价值，更彰显了其在宫颈癌治疗领域的卓越疗效和广阔应用前景。作为局部晚期宫颈癌的标准治疗方案，CCRT仍面临30%-40%患者在5年内复发或进展的治疗困境。卡度尼利具有独特的双靶点机制，能够同时阻断PD-1和CTLA-4免疫检查点通路，在宫颈癌治疗中已经展现出巨大的临床价值。目前，卡度尼利已获得中国国家药品监督管理局（NMPA）批准用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者。III 期临床研究COMPASSION-16研究也已证实，卡度尼利联合含铂化疗（无论是否联合贝伐珠单抗）可显著延长一线持续性、复发性或转移性宫颈癌患者的无进展生存期（PFS）和总生存期（OS）。基于这一显著疗效，卡度尼利方案一线治疗持续、复发或转移性宫颈癌的新药上市申请（sNDA）已处于审评审批阶段。在本届SGO报道了COMPASSION-18研究中，在安全性导入阶段接受卡度尼利联合CCRT治疗的患者展现出的卓越的疗效，展示了卡度尼利联合CCRT在局部晚期宫颈癌中的巨大的治疗潜力。研究纳入了更具挑战性的患者群体，其中PD-L1 CPS＜1（38.2%）和ECOG评分为1（52.9%）的患者比例显著高于同类研究。可评估患者的最佳总缓解率（ORR）达到100%，其中完全缓解（CR）率高达84.8%，部分缓解（PR）率为15.2%，远优于同类型研究数据；中位缓解持续时间（DoR）尚未达到。无进展生存期（PFS）未达到，12个月无进展生存率达74.9%。亚组分析显示，PD-L1 CPS≥1、ECOG评分为0、未感染COVID-19的患者从该治疗方案中的获益趋势更明显，12个月PFS率分别为85%、87.5%和81.3%。卡度尼利联合CCRT展现出良好的耐受性，临床安全可控，未出现因TRAE导致的死亡事件，未出现新的安全性信号。从复发/转移性宫颈癌到局部晚期宫颈癌，卡度尼利在宫颈癌治疗领域的突破性成果不断涌现。COMPASSION-18研究的积极数据进一步验证了卡度尼利在更广泛患者群体中的治疗潜力。随着临床开发的深入推进，卡度尼利正在逐渐重塑宫颈癌治疗格局，为更多患者带来长期生存获益。说明：本文作为康方生物的新闻发布，用于披露公司最新进展，并非产品推广广告，不构成康方生物的信息披露或投资建议。关于开坦尼®（卡度尼利单抗注射液）开坦尼®是康方生物自主研发的全球首创PD-1/CTLA-4双特异性肿瘤免疫治疗药物，2022年6月获得国家药品监督管理局的批准，用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。2024年9月，开坦尼®联合方案用于局部晚期不可切除或转移性胃或胃食管结合部（G/GEJ）腺癌患者一线治疗适应症获批上市。开坦尼®加含铂化疗联合/不联合贝伐珠单抗一线治疗持续、复发或转移性宫颈癌的新药上市申请正在审评审批阶段。开坦尼®是世界上第一个肿瘤免疫治疗双抗新药，也是中国的第一个双特异性抗体新药。开坦尼®既往接受含铂化疗失败的复发或转移性宫颈癌适应症于2024年11月被纳入2024年国家医保目录。开坦尼®已针对胃癌、肺癌、肝癌、宫颈癌、胰腺癌等16种恶性肿瘤疾病开展了23项以上的临床研究。开坦尼®是一种全新机制的肿瘤免疫治疗药物，可以同时靶向PD-1和CTLA-4发挥协同抗肿瘤的作用，具有优异的抗肿瘤疗效，相比联合疗法的毒性显著降低，安全可耐受。多项临床研究显示，开坦尼®针对多种肿瘤疾病的PD-L1表达阳性和阴性患者均具有优异的抗肿瘤疗效，临床差异化价值凸显。目前，开坦尼®已被16项临床治疗指南和共识重磅推荐，覆盖胃癌、妇科肿瘤、肝癌、食管癌、鼻咽癌等多个适应症。关于康方生物康方生物（9926.HK）是一家集研究、开发、生产及商业化全球首创或同类最佳创新生物新药于一体的领先企业。自2012年成立以来，公司始终以患者为中心，以临床价值为导向，打造了独有的端对端康方全方位新药研究开发平台，建立了以Tetrabody双特异性抗体开发技术、抗体偶联（ADC）技术、mRNA技术及细胞治疗技术为核心的研发创新体系，国际化标准的GMP生产体系和运作模式先进的商业化体系，成为了在全球范围内具有竞争力的生物医药创新公司。公司已开发了50个以上用于治疗肿瘤、自身免疫、炎症、代谢疾病等重大疾病的创新候选药物，23个候选药已进入临床（包括11个双抗/多抗/双抗ADC），6个新药已在商业化销售，5个新药多个适应症的上市申请处于审评审批阶段。康方生物是全球迄今唯一拥有2个肿瘤免疫双抗新药的制药公司：2022年6月，公司全球首创的PD-1/CTLA-4双抗开坦尼®获批上市，是全球首个获批的肿瘤免疫治疗双抗新药，也是中国第一个双特异性抗体新药。目前开坦尼®一线治疗胃癌和治疗复发/转移性宫颈癌适应症已获批，一线治疗宫颈癌sNDA已受理，另有8个注册III期临床开展中。2024年5月，公司另一全球首创双抗新药依达方®获批上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，是全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依达方®在与全球“药王”帕博利珠单抗的随机、双盲、对照一线治疗PD-L1阳性NSCLC的“头对头”III期临床研究中获得显著阳性结果，依达方®可降低患者疾病进展/死亡风险达49%，依沃西成为全球迄今唯一在头对头III期临床研究中证明疗效显著优于“药王”帕博利珠单抗的药物。基于该研究结果，依沃西同适应症的sNDA获CDE受理，并获优先审评，将有望成为一线肺癌治疗新的标准治疗方案，为患者提供全新更优的“去化疗”选择。目前依达方®有11项注册性III期临床正在开展，包括3项国际多中心注册性III期临床研究。2024年12月，开坦尼®、依达方®均通过医保谈判被纳入国家新版医保目录。国际市场开发是康方生物核心发展战略，继2015年开中国先河将自主研发的CTLA-4单抗权益许可给默沙东公司之后，2022年12月，公司再次创造中国记录，以50亿美金+2位数百分比销售提成的方案，将依达方®部分海外权益许可给美国Summit公司，该合作创下了彼时中国新药对外许可的最高交易金额记录。2025年2月，Summit 与美国辉瑞（Pfizer）公司达成临床试验合作，共同推进依达方®联合辉瑞多款抗体偶联药物（ADCs）在多种实体瘤中的联合治疗疗法。2024年9月，公司自主研发的伊喜宁®（伊努西单抗，PCSK9）治疗高胆固醇血症两项适应症获批，成为非肿瘤领域的首个获批产品。康方生物期望通过高效及突破性的研发创新，开发国际首创及同类药物最佳疗法的新药，为全球患者提供更优疾病解决方案，成为全球领先的生物制药企业。

临床3期临床结果

2025-03-17

·PRNewswire

Akeso's Penpulimab Receives NMPA Approval for First-Line Treatment of Nasopharyngeal Cancer

HONG KONG, March 16, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) announced that its innovative, self-developed anti-PD-1 monoclonal antibody, penpulimab, has been officially approved by the National Medical Products Administration (NMPA) for the first-line treatment of recurrent or metastatic nasopharyngeal cancer (NPC) in combination with chemotherapy. Previously, penpulimab was approved for use as a third-line treatment for advanced NPC. With this new approval, penpulimab now provides comprehensive treatment coverage across all stages of NPC, offering patients a continuous immunotherapy option from first-line to third-line therapy. This marks the fourth approved indication for penpulimab. In addition to the two NPC indications, penpulimab is also approved for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) when combined with chemotherapy, as well as for monotherapy in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have previously received at least two lines of systemic chemotherapy. Furthermore, a supplemental New Drug Application (sNDA) for penpulimab in combination with anlotinib for first-line treatment of advanced hepatocellular carcinoma (HCC) is currently under review. Professor Hu Chaosu, one of the principal investigators of penpulimab at Fudan University Shanghai Cancer Center, said: "In China, there remains a significant unmet clinical need for NPC. As the only IgG1 subtype anti-PD-1 monoclonal antibody globally, penpulimab has demonstrated robust efficacy in clinical studies, enhancing the effectiveness of immunotherapy for NPC. The approval for first-line treatment marks a major milestone, as it provides a comprehensive treatment regimen for clinicians and patients, benefiting a large population of NPC patients in China, from first-line to third-line therapy." Professor Chen Xiaozhong, one of the principal investigators of penpulimab at Zhejiang Cancer Hospital, said: "Nasopharyngeal cancer (NPC) is a highly prevalent malignancy in certain regions, and patients with recurrent or metastatic NPC typically face a poor prognosis. Penpulimab has demonstrated a significantly high response rate and prolonged survival benefits in both first-line treatment of NPC and in patients with metastatic NPC who have failed multiple lines of prior therapy. Additionally, it has shown a favorable safety profile, with a low incidence of immune-related adverse events. " Dr. Xia Yu, Founder, Chairwoman, CEO, and President of Akeso, said: "We want to extend our sincere gratitude to all the researchers, clinical trial participants, and NPC patients who have contributed to this milestone. With its differentiated design, penpulimab has gained widespread recognition among clinicians and patients for its efficacy and safety in treating diseases like non-small cell lung cancer (NSCLC), Hodgkin lymphoma, and nasopharyngeal cancer. The approval for first-line treatment of advanced NPC will allow more patients in China to benefit from this new PD-1 monoclonal antibody, further improving survival outcomes." "As key drugs like cadonilimab, ivonescimab, and penpulimab receive approval for a wide range of indications, Akeso's commitment to innovation and excellence in drug development—from discovery to clinical application—is clearly demonstrated. These advancements are not only improving patient outcomes but also reaffirming our dedication to transforming global healthcare. Moving forward, Akeso will continue to pioneer breakthrough therapies with the potential to set new standards of care, driving positive change in treatment paradigms and improving the lives of patients worldwide." SOURCE Akeso, 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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KEGG	Wiki	ATC	Drug Bank
D12190	-	-	-

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适应症	国家/地区	公司	日期
胃食管交界处腺癌	中国	康方药业有限公司	2024-09-26
胃癌	中国	康方药业有限公司	2024-09-26
宫颈癌	中国	康方药业有限公司	2022-06-28

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌IIIB期	临床3期	中国	中山康方生物医药有限公司	2024-11-12
晚期胃食管交界处腺癌	临床3期	中国	中山康方生物医药有限公司	2024-06-19
局部晚期非小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2023-11-14
鳞状非小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2023-11-14
晚期鼻咽癌	临床3期	中国	康方药业有限公司	2023-08-01
鼻咽癌	临床3期	中国	康方药业有限公司	2023-08-01
肝细胞癌	临床3期	中国	中山康方生物医药有限公司	2022-12-14
局部晚期宫颈癌	临床3期	中国	中山康方生物医药有限公司	2022-06-08
局部晚期胃食管交界处腺癌	临床3期	中国	中山康方生物医药有限公司	2021-09-17
局部晚期不可切除的胃腺癌	临床3期	中国	中山康方生物医药有限公司	2021-09-17

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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


NCT05792735 (NeoCaCRT, ASCO_GI2025) 人工标引	临床2期	局部晚期直肠癌新辅助 Proficient DNA Mismatch Repair (pMMR) \| Microsatellite Stable (MSS)	27	SCRT + Cadonilimab + mFOLFOX6	餘鹹襯網獵鏇憲簾觸蓋(獵觸淵築範願襯鹽衊鑰) = 遞艱獵鏇範願觸衊糧夢積膚鏇觸選獵積餘獵鹹 (網積衊鑰積艱繭網憲壓, 19.4 ~ 57.6) 更多	积极	2025-01-23
NCT05522894 (AK104-IIT-014, ASCO_GI2025) 人工标引	临床2期	晚期食管鳞状细胞癌维持 \| 一线	43	Cadonilimab + Paclitaxel + Cisplatin	鹹簾獵遞構鹹網構夢淵(糧鹹鏇顧廠憲鑰範廠鑰) = 範製壓醖鏇鏇鬱繭構繭構鏇顧顧鹹衊範鑰壓簾 (廠繭構鬱壓淵膚範鏇衊, 66.1 ~ 91.1) 更多	积极	2025-01-23
NCT05522894 (AK104-IIT-014, ASCO_GI2025) 人工标引	临床2期	晚期食管鳞状细胞癌维持 \| 一线	43	Cadonilimab + Paclitaxel + Cisplatin (PD-L1 CPS≥10)	鹹簾獵遞構鹹網構夢淵(糧鹹鏇顧廠憲鑰範廠鑰) = 齋鬱繭膚製糧齋簾願顧構鏇顧顧鹹衊範鑰壓簾 (廠繭構鬱壓淵膚範鏇衊, 77.1 ~ 100.0) 更多	积极	2025-01-23
NCT05839470 (SYLT-026, ASCO_GI2025) 人工标引	临床2期	转移性微卫星稳定结直肠癌一线 Microsatellite Stable (MSS)	20	FOLFOXIRI + Bevacizumab + Cadonilimab	淵簾構鬱憲窪鏇簾鑰鑰(淵遞簾夢網鑰鑰鹹繭醖) = 齋鹽積顧觸獵齋艱襯窪繭願繭窪艱築鏇簾廠構 (顧鹽鏇窪鹽顧簾願鑰網 ) 更多	积极	2025-01-23
NCT05008783 (Pubmed) 人工标引	临床3期	HER2阴性胃癌 \| HER2阴性胃食管结合部腺癌一线 HER2 Negative	610	Cadonilimab + Chemotherapy	獵壓鹹簾顧齋糧獵鹽簾(窪築憲願窪製艱窪獵構) = 構鹹築鹽網憲願衊鹽齋範糧鏇選廠構構襯構襯 (鏇鏇憲艱選遞願艱憲鹽 ) 达到更多	积极	2025-01-22
NCT05008783 (Pubmed) 人工标引	临床3期	HER2阴性胃癌 \| HER2阴性胃食管结合部腺癌一线 HER2 Negative	610	Placebo + Chemotherapy	獵壓鹹簾顧齋糧獵鹽簾(窪築憲願窪製艱窪獵構) = 鹽齋築鑰選鬱蓋艱鑰構範糧鏇選廠構構襯構襯 (鏇鏇憲艱選遞願艱憲鹽 ) 达到更多	积极	2025-01-22
NCT05430906 (AK104-IIT-003, ESMO_IO2024) 人工标引	临床2期	卵巢癌新辅助	28	Cadonilimab + Platinum-Taxane Chemotherapy	獵膚艱網蓋鹹鬱憲廠網(獵襯醖築憲廠廠鏇觸壓) = 餘鹽築製淵積範鏇製遞齋餘衊遞窪鑰糧夢願餘 (遞醖糧繭廠醖壓鹽膚艱 ) 更多	积极	2024-12-12
ESMO_IO2024 人工标引	N/A	转移性非小细胞肺癌二线 \| 末线 \| 三线	21	Cadonilimab (AK104) + Single-agent Chemotherapy	鹹蓋艱鹹選網鹹糧壓網(糧鏇網鹽築積鹽選鬱憲) = 鬱製製夢築襯網夢壓衊鏇顧餘鬱淵鏇簾膚構糧 (顧醖淵範壓鹹衊觸選鏇 ) 更多	积极	2024-12-12
NCT05815290 (ESMO_IO2024) 人工标引	临床2期	错配修复缺陷或微卫星高度不稳定性结直肠癌新辅助 MSI-High \| Deficient DNA Mismatch Repair (dMMR)	34	Cadonilimab (AK104) 10mg/kg	鏇壓壓選淵衊願衊憲遞(構憲繭糧蓋壓餘淵膚齋) = 艱繭築餘夢衊壓蓋製襯顧選襯蓋製襯壓願鹽繭 (繭顧餘襯範夢襯鹽鏇夢 ) 更多	积极	2024-12-12
ESMO_IO2024 人工标引	临床2期	晚期胃癌 \| 晚期胃食管交界处腺癌一线	19	Cadonilimab+SOX (HER2-negative)	鹽醖窪範淵夢網構壓壓(製廠築願廠積醖鑰襯構) = 觸範鏇選繭餘淵鹽襯憲蓋壓鹽襯艱積範憲壓蓋 (選觸夢簾鹹築構構鏇艱 ) 更多	积极	2024-12-12
ESMO_IO2024 人工标引	临床2期	晚期胃癌 \| 晚期胃食管交界处腺癌一线	19	Cadonilimab+Trastuzumab+SOX (HER2-positive)	鹽醖窪範淵夢網構壓壓(製廠築願廠積醖鑰襯構) = 衊鹽廠蓋壓觸選積窪艱蓋壓鹽襯艱積範憲壓蓋 (選觸夢簾鹹築構構鏇艱 ) 更多	积极	2024-12-12
ESMO_IO2024 \| NEWS 人工标引	N/A	转移性胃食管结合部腺癌 \| 转移性胃腺癌一线	31	Cadonilimab plus chemotherapy (SOX, XELOX or FOLFOX)	窪範簾膚齋選壓鬱範鑰(範淵襯蓋廠鑰構鏇蓋觸) = 鹽襯範鏇鬱網壓夢網選願鹹夢觸構窪簾糧網淵 (選簾膚鏇積糧衊壓襯網 ) 更多	积极	2024-12-12
ESMO_IO2024 \| NEWS 人工标引	N/A	转移性胃食管结合部腺癌 \| 转移性胃腺癌一线	31	Cadonilimab plus chemotherapy (SOX, XELOX or FOLFOX) (PD-L1 CPS＜1)	窪範簾膚齋選壓鬱範鑰(範淵襯蓋廠鑰構鏇蓋觸) = 窪積鏇淵憲醖齋簾醖夢願鹹夢觸構窪簾糧網淵 (選簾膚鏇積糧衊壓襯網 ) 更多	积极	2024-12-12
NCT05790200 (ESMO_ASIA2024) 人工标引	临床2期	鼻咽癌	15	AK104 10 mg/kg + Chemotherapy	製艱繭窪襯襯鏇夢醖鑰(獵襯餘願願繭蓋齋蓋襯) = 顧獵夢夢糧廠鬱積簾製繭製淵夢選壓齋衊衊鏇 (網遞製遞鑰蓋夢鬱鹽鑰 ) 更多	积极	2024-12-07