普特利单抗(Pucotenlimab) - 药物靶点：PD-1_在研适应症：黑色素瘤，MSI-H 实体瘤，转移性结直肠癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Recombinant humanized anti-PD-1 monoclonal antibody(Taizhou Hanzhong Biomedical Co., Ltd.)、重组人源化抗PD-1单抗(泰州翰中生物)、AK-103

+ [3]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病心血管疾病+ [4]

在研适应症

黑色素瘤MSI-H 实体瘤转移性结直肠癌+ [14]

非在研适应症

甲状腺未分化癌EGFR 突变实体瘤局部晚期恶性实体瘤+ [5]

原研机构

在研机构

+ [3]

非在研机构

权益机构

+ [1]

最高研发阶段批准上市

首次获批日期

中国 (2022-07-19),

MSI-H 实体瘤

最高研发阶段(中国)批准上市

特殊审评附条件批准 (中国)、突破性疗法 (中国)

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结构/序列

Sequence Code 432485639H

来源: *****

Sequence Code 432485640L

来源: *****

关联

83

项与普特利单抗相关的临床试验

NCT07518979

/ Not yet recruiting临床2期IIT

Neoadjuvant Therapy With EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) for Penile Squamous Cell Carcinoma With Penile Preservation Difficulty or Regional Lymph Node Metastasis: A Single-Arm, Phase II Clinical Trial

This clinical study is a Phase II research trial focused on a new preoperative treatment for men with advanced penile squamous cell carcinoma (a type of penile cancer). The cancer may be hard to treat with penile-sparing surgery, or it may have spread to nearby lymph nodes (like groin lymph nodes).
We are testing a combination of two medicines: Becotatug vedotin (a targeted therapy that finds and kills cancer cells with high levels of a protein called EGFR) and Pucotenlimab (an immunotherapy that helps your body's immune system fight cancer). The goal is to see if this combination can shrink the tumor, make surgery more likely to remove all cancer cells, and improve treatment outcomes-while keeping side effects manageable.
Who can join?
To be eligible, you must:
Be a man 18 years or older with confirmed penile squamous cell carcinoma; Have cancer that is hard to treat with penile-sparing surgery or has spread to regional lymph nodes; Have cancer cells that test positive for EGFR (a protein most penile cancers make); Have not received prior systemic cancer treatment (or had recurrence more than 6 months after adjuvant therapy for radical resection); Have adequate organ function (e.g., healthy heart, liver, and kidney function) to tolerate treatment; Understand the study and voluntarily agree to participate by signing an informed consent form.
What will happen during the study? Screening (up to 28 days): You will have tests to confirm eligibility, including imaging scans, blood work, and EGFR testing on your tumor sample.
Preoperative treatment (4-6 cycles): You will receive intravenous infusions of Becotatug vedotin (2.0 mg/kg) and Pucotenlimab (200 mg) every 3 weeks. Every 6 weeks, you will have imaging scans to check if the tumor is shrinking.
Surgery: If the tumor responds to treatment (assessed by a team of doctors), you will undergo radical surgery to remove the cancer. If surgery is successful, you may continue Pucotenlimab as adjuvant therapy for 1 year.
Follow-up: After treatment, you will be checked every 3 months for 2 years to monitor for cancer recurrence and long-term side effects.
What are the study goals? Primary goal: To find out how many patients can have successful surgery to remove all visible cancer (R0 resection) after the combination treatment.
Secondary goals: To measure how much the tumor shrinks (objective response rate), if the cancer stage improves (downstaging rate), if surgery removes all cancer cells (pathological complete response rate), how long patients stay cancer-free (disease-free survival), and how safe the treatment is.
What are the potential risks? As with any cancer treatment, this combination may cause side effects. Common expected side effects include skin reactions (e.g., rash), digestive issues, changes in blood cell counts, liver function changes, and immune-related reactions (e.g., thyroid problems, lung inflammation). These side effects will be closely monitored by the study team, and treatments to manage them will be provided.
This study is being conducted at West China Hospital, Sichuan University. It is a single-arm trial (all participants receive the same combination treatment) and will enroll about 60 patients. The study is expected to run from April 2026 to April 2028.

开始日期2026-07-30

申办/合作机构

四川大学华西医院（四川省国际医院）

[+1]

NCT07627321

/ Not yet recruiting临床2期IIT

PRAD2: A Prospective, Single-Arm, Multi-Center, Exploratory Study of Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer

This prospective, single-arm, exploratory multicenter clinical study aims to investigate the safety and efficacy of Becotatug vedotin combined with Pucotenlimab (with or without radiotherapy), followed by Pucotenlimab maintenance therapy, in patients with driver gene-negative (e.g., EGFR, ALK, ROS1), EGFR-overexpressing non-small cell lung cancer (NSCLC).
Study Population:
The study targets patients with driver gene-negative (EGFR, ALK, ROS1, and other actionable targets) non-squamous and squamous NSCLC. All subjects (regardless of smoking history) must provide testing reports for EGFR, ALK, and ROS1. If no prior report exists, baseline biopsy or submission of archived tissue for assessment of driver gene status (via local or central laboratory) is mandatory. Additionally, eligible patients must have an immunohistochemistry (IHC)-confirmed EGFR expression level of 2+ or higher, be previously untreated with systemic therapy for stage IV NSCLC, have measurable lesions, show no active central nervous system metastases or uncontrolled autoimmune diseases, and voluntarily sign the informed consent form.
Treatment Regimen:
Subjects meeting the inclusion/exclusion criteria will receive the following treatment regimen:
Pucotenlimab (HX008): Administered from Cycle 1 to Cycle 4 at a dose of 3 mg/kg (maximum 200 mg), once every 3 weeks on Day 1 (D1). Intravenous infusion (60 ± 15 minutes; first cycle infusion duration not less than 60 minutes).
Becotatug vedotin (MRG003): Administered from Cycle 1 to Cycle 4 at a dose of 2.0 mg/kg, once every 3 weeks on D1. Administration begins at least 30 minutes after the completion of Pucotenlimab infusion. Intravenous infusion (60 ± 10 minutes; first cycle infusion duration not less than 60 minutes).
Radiotherapy: Investigators may opt to include sequential radiotherapy based on tumor size, number, location, extent of invasion, and individual patient factors. Radiotherapy options are as follows:
Target Volume: Radiotherapy commences 2 weeks (±7 days) after the completion of Cycle 4 treatment, targeting only the primary tumor or specific 1-2 metastatic lesions.
Fractionation and Dosage:
Conventional Fractionation Group: Applicable for larger target volumes (>5 cm diameter) or involvement of mediastinal lymph nodes. Total dose: 45-60 Gy; single fraction dose: 1.8-2.0 Gy; administered once daily (Qd).
Stereotactic Body Radiotherapy (SBRT) Group: Applicable for oligometastatic lesions (≤3 lesions, each ≤3 cm diameter). Total dose: 30-50 Gy delivered in 3-5 fractions; single fraction dose: 6-10 Gy.
Maintenance Therapy: Pucotenlimab (HX008) monotherapy until disease progression (defined by RECIST 1.1), investigator-assessed radiographic progression, unacceptable toxicity, withdrawal of consent, or fulfillment of criteria for discontinuation of intervention.

开始日期2026-07-15

申办/合作机构

安徽省肿瘤医院

NCT07649980

/ Not yet recruiting临床2期IIT

Becotatug Vedotin Combined With Pucotenlimab in First-Line Treatment-Failed Advanced Biliary Tract Carcinoma: A Phase II Exploratory Clinical Study

Biliary tract carcinoma (BTC), including cholangiocarcinoma and gallbladder cancer, is a highly aggressive digestive system malignancy with limited treatment options after failure of first-line standard chemotherapy.
This open-label, single-arm, Phase II exploratory study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab in patients with EGFR-positive advanced BTC who have failed first-line therapy. Participants will receive the combination regimen until the occurrence of disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator's decision to discontinue treatment, or study termination, whichever occurs first.The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.

开始日期2026-07-01

申办/合作机构

天津市肿瘤医院（天津医科大学肿瘤医院）

100 项与普特利单抗相关的临床结果

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100 项与普特利单抗相关的转化医学

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100 项与普特利单抗相关的专利（医药）

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17

项与普特利单抗相关的文献（医药）

2026-05-01·Cancer Medicine

Integration Analysis of Bayesian and Machine Learning for Heterogeneity, Biomarkers, and Optimal Combination Regimens of Pucotenlimab in Solid Tumors

Article

作者: Gao, Changqing ; He, Yingge ; Zhang, Shiyan ; Li, Liqi ; He, Shuning ; Hao, Yonghui ; Peng, Ke

ABSTRACT:

The efficacy of PD‐1 inhibitor pucotenlimab (HX008) in solid tumors exhibits heterogeneity. This study integrated data from 6 clinical trials (covering gastric/gastroesophageal junction cancer, triple‐negative breast cancer, melanoma, and dMMR/MSI‐H solid tumors) using Bayesian meta‐analysis, machine learning (optimal XGBoost AUC = 0.86), and network meta‐analysis to construct an integrated “efficacy‐prediction‐safety” framework. Bayesian analysis showed pucotenlimab significantly improved outcomes versus control (ORR OR = 4.82, 95% CrI: 3.65–6.38; PFS HR = 0.41, 0.32–0.52; OS HR = 0.37, 0.26–0.51). Subgroups revealed TNBC patients with gemcitabine/cisplatin achieved highest ORR (80.6%, 62.5%–92.6%), while mucosal melanoma showed lowest response (8.7%, 1.1%–28.0%). Combination therapy demonstrated superior efficacy to monotherapy (ORR OR: 5.91 vs. 2.35). Machine learning identified 4 efficacy biomarkers (KMT2D mutation, post‐treatment NLR decrease, PD‐L1 CPS ≥ 1, high eotaxin) and 3 irAE risk factors (baseline NLR ≥ 4, irinotecan combination, high VEGF). Network analysis recommended regimens: gemcitabine/cisplatin for TNBC (SUCRA = 95.7%), oxaliplatin/capecitabine for G/GEJ cancer (ORR = 60.0% vs. irinotecan 27.6%, HR = 0.45). The integrated model classified high‐benefit (≥ 3 points; ORR 78.2%) and low‐benefit (≤ 0 points; ORR 28.3%) groups, plus high‐risk (≤ −2 points; grade ≥ 3 irAEs 41.2%) and low‐risk (≥ 1 point; irAEs 3.5%) groups, validated by decision curve analysis. This defines precise application scenarios and provides an extensible analytical paradigm.

2026-04-01·BMJ Open

Adjuvant short-course radiotherapy combined with chemotherapy and a PD-1 inhibitor for resected mucosal melanoma: study protocol for a single-arm, prospective, phase II trial

Article

作者: Wan, Juefeng ; Chen, Yong ; Xia, Lingfang ; Zhang, Zhen ; Liu, Xin ; Zhou, Shujuan ; Xu, Yu ; Zhang, Zhiyuan ; Lv, Jiaojie ; Shen, Lijun ; Jiang, Xuebing ; Wu, Ruiyan ; Liu, Fangqi ; Wang, Yan

Introduction:

Mucosal melanoma (MM) carries a high risk of postoperative relapse and poorer survival than cutaneous disease. Prospective data from China support adjuvant temozolomide–cisplatin (TMZ/DDP) in resected MM, while radiotherapy (RT) may augment antitumour immunity and synergise with programmed death 1 (PD-1) inhibitor. We therefore designed an adjuvant regimen combining short-course RT (SCRT) with chemotherapy and PD-1 inhibitor after curative-intent resection.

Methods and analysis:

This investigator-initiated, single-arm, prospective, phase II study at Fudan University Shanghai Cancer Centre enrols adults (≥18 years) with histologically confirmed MM after R0/R1 resection, Eastern Cooperative Oncology Group (ECOG) performance status 0–1 and M0 disease. Patients receive six 3-week cycles of systemic therapy: pucotenlimab 200 mg IV on day 1; TMZ 200 mg/m² orally on days 1–5 and DDP 25 mg/m² IV on days 1–3. (SCRT; 25 Gy in five fractions) is delivered after the first two cycles of systemic therapy, followed by four additional cycles of systemic therapy without RT. The primary endpoint is 1-year recurrence-free survival (RFS). Secondary endpoints include locoregional RFS, distant metastasis-free survival, overall survival and safety (CTCAE V.5.0). The planned sample size is 47 (44 evaluable), providing 80% power (one-sided α of 0.10) to detect an improvement in 1-year RFS from 55% to 70%. Time-to-event endpoints will be estimated using Kaplan–Meier methods with 95% CIs.

Ethics and dissemination:

The protocol was approved by the Ethics Committee of Fudan University Shanghai Cancer Centre (approval number: 2407300-5), and all participants will provide written informed consent. Findings will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration number:

ChiCTR2400093001.

2026-01-11·[Zhonghua yan ke za zhi] Chinese journal of ophthalmology

[A case of Vogt-Koyanagi-Harada syndrome-like lesions during pucotenlimab treatment for malignant melanoma].

Article

作者: Guan, T J ; Zhu, X ; Chen, H ; Zhang, M ; Ji, M ; Guan, H J

A patient presented to the ophthalmology department with bilateral blurred vision, with a history of intravenous infusion of Pucotenlimab injection for malignant melanoma. Examinations revealed right anterior chamber inflammation, bilateral papilledema and macular edema. Optical Coherence Tomography (OCT) showed choroidal elevation in the macular area of both eyes, accompanied by multifocal exudative neurosensory detachment and pigment epithelial detachment. Indocyanine Green Angiography (ICG-A) demonstrated multifocal patchy hyperfluorescence in the posterior pole of both eyes in the early phase, weak fluorescence of horizontal choroidal folds, and hyperfluorescence in the posterior pole in the late phase. Based on the medical history, the patient was diagnosed with bilateral drug-related Vogt-Koyanagi-Harada (VKH) syndrome-like lesions. Treatment with intravitreal injection of dexamethasone sustained-release implant in the right eye combined with systemic glucocorticoid therapy resulted in improvement of ocular symptoms.

327

项与普特利单抗相关的新闻（医药）

2026-06-28

·肿瘤界

ICI视界 | 2026 CSCO胃肠肿瘤免疫治疗推荐方案速查

点击蓝字关注我们 ICI 视界本期“ICI视界”专栏聚焦胃癌与结直肠癌，依据《CSCO免疫检查点抑制剂临床应用指南2026》，将推荐治疗方案按分子分型（HER2表达状态、dMMR/MSI-H等）、疾病分期（非转移性/转移性）、治疗场景（一线/二线/三线/新辅助）及推荐级别（Ⅰ/Ⅱ/Ⅲ级）进行分层整理，旨在为临床医生提供一份可快速检索、便捷查阅的胃肠肿瘤免疫治疗推荐方案工具型内容，助力精准决策。 01 胃癌晚期一线治疗（HER2中/低或不表达） _ 治疗方案 Ⅰ级推荐 FOLFOX/XELOX+纳武利尤单抗（PD-L1 CPS≥5）（1A类） XELOX+信迪利单抗（PD-L1 CPS≥5）（1A类，医保） XELOX/FP+替雷利珠单抗（PD-L1 TAP≥5%）（1A类，医保） XELOX/FP+帕博利珠单抗（PD-L1 CPS≥5）（1A类） XELOX+舒格利单抗（PD-L1 CPS≥5）（1A类） XELOX+瑞拉芙普α注射液（PD-L1 CPS≥1）（1A类）无论PD-L1表达状态：XELOX联合卡度尼利单抗（1A类） Ⅱ级推荐 FOLFOX/XELOX+纳武利尤单抗（PD-L1 CPS＜5或检测不可及）（1B类） XELOX+信迪利单抗（1B类，医保） XELOX/FP+替雷利珠单抗（PD-L1 TAP＜5%或检测不可及）（1B类，医保） XELOX/FP+帕博利珠单抗（PD-L1 CPS＜5或检测不可及）（1B类） Ⅲ级推荐 SOX联合纳武利尤单抗（2A类）帕博利珠单抗（PD-L1 CPS≥10）（2B类）晚期一线治疗（HER2高表达） _ 治疗方案 Ⅰ级推荐帕博利珠单抗+曲妥珠单抗+XELOX/FP（PD-L1 CPS≥1）（1A类） Ⅱ级推荐替雷利珠单抗+泽尼达妥单抗+XELOX/FP（1A类）晚期一线治疗（dMMR/MSI-H，无论HER2状态） _ 治疗方案 Ⅰ级推荐纳武利尤单抗+伊匹木单抗（2B类） Ⅱ级推荐帕博利珠单抗（2B类） Ⅲ级推荐帕博利珠单抗+顺铂/氟尿嘧啶（2B类）纳武利尤单抗+FOLFOX/XELOX（2B类）其他ICI（3类）晚期一线治疗（产AFP胃癌） _ 治疗方案 Ⅰ级推荐 / Ⅱ级推荐 SOX+卡瑞利珠单抗+阿帕替尼（2B类）晚期二线治疗（dMMR/MSI-H，无论HER2状态） _ 治疗方案 Ⅰ级推荐帕博利珠单抗（既往未应用PD-1/PD-L1单抗）（2B类）恩沃利单抗（既往未应用PD-1/PD-L1单抗）（2A类）替雷利珠单抗（既往未应用PD-1/PD-L1单抗）（2A类）斯鲁利单抗（既往未应用PD-1/PD-L1单抗）（2A类）晚期三线及以上治疗 _ 治疗方案 Ⅰ级推荐纳武利尤单抗（既往未应用PD-1/PD-L1单抗）（1A类）新辅助治疗 _ 治疗方案 Ⅰ级推荐 / Ⅱ级推荐 dMMR/MSI-H型：新辅助PD-1单抗联合CTLA-4单抗（2B类） Ⅲ级推荐 dMMR/MSI-H型：新辅助PD-1单抗联合化疗（2B类） HER2高表达型（cT3~4bNanyM0或TanyN+M0，cⅢ~ⅣA期），新辅助XELOX+曲妥珠单抗+阿替利珠单抗（2A类） 02 非转移性结直肠癌（M₀） dMMR/MSI-H患者（可根治切除） _ 治疗方案 Ⅰ级推荐 cT4或N₊：先行信迪利单抗+伊匹木单抗N01治疗，然后根治性手术（2A类） Ⅱ级推荐 cT4b：先行纳武利尤单抗+伊匹木单抗，或单药PD-1单抗治疗，然后根治性手术（2B类） Ⅲ级推荐非cT4b，但有器官保留/功能保护需求：PD-1单抗±CTLA-4单抗（2B类）已接受根治性手术的Ⅲ期患者：FOLFOX联合阿替利珠单抗辅助治疗（1B类） dMMR/MSI-H患者（不可根治切除[指T4b、M0患者，即使采用联合脏器切除也无法达到根治目的]） _ 治疗方案 Ⅰ级推荐纳武利尤单抗±伊匹木单抗（2A类）帕博利珠单抗（2A类） Ⅱ级推荐恩沃利单抗、斯鲁利单抗、替雷利珠单抗或普特利单抗（2B类） pMMR/MSS或MSI-L患者（cT3，任何N且MRF⁻；cT1~2，N+[保留肛门括约肌无困难]） _ 治疗方案 Ⅰ级推荐 / Ⅱ级推荐 / Ⅲ级推荐放/化疗+化疗联合免疫（再次评估）+直肠癌根治术（1B类） pMMR/MSS或MSI-L患者（cT3，任何N且MRF⁻；cT1~2，N+[保留肛门括约肌有困难]） _ 治疗方案 Ⅰ级推荐 / Ⅱ级推荐放/化疗+化疗联合免疫（再次评估）+直肠癌根治术（1B类） pMMR/MSS或MSI-L患者（cT3，任何N伴MRF⁺；cT4，任何N[距肛10cm以内]） _ 治疗方案 Ⅰ级推荐 / Ⅱ级推荐放/化疗+化疗联合免疫（再次评估）+直肠癌根治术（1B类） 02 转移性结直肠癌（M₁） dMMR/MSI-H患者（转化治疗[转移灶潜在可切除]） _ 治疗方案 Ⅰ级推荐纳武利尤单抗±伊匹木单抗（1A类）帕博利珠单抗（1A类） dMMR/MSI-H患者（姑息一线治疗） _ 治疗方案 Ⅰ级推荐纳武利尤单抗±伊匹木单抗（1A类）帕博利珠单抗（1A类） dMMR/MSI-H患者（姑息二线治疗和三线治疗[既往未使用过免疫检查点抑制剂]） _ 治疗方案 Ⅰ级推荐 / Ⅱ级推荐恩沃利单抗、斯鲁利单抗、替雷利珠单抗或普特利单抗（2A类）帕博利珠单抗和纳武利尤单抗（2A类） Ⅲ级推荐纳武利尤单抗+伊匹木单抗（2A类） pMMR/MSS或MSI-L患者（姑息三线治疗） _ 治疗方案 Ⅰ级推荐 / Ⅱ级推荐 / Ⅲ级推荐 PD-1抑制剂±CTLA-4抑制剂（携带POLE/POLD1致病突变）（3类）推荐阅读 ICI视界 | 免疫检查点抑制剂作用机制与国内上市药物适应证汇总 ICI视界 | 2026 CSCO肺癌免疫治疗推荐方案速查声明：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：中国临床肿瘤学会(CSCO)免疫检查点抑制剂临床应用指南2026 编辑：Lagertha 审核：阿希雅

2026-06-16

·有驾

「Gemini完善版」AACR 2026年会涉及中国生物技术/制药公司药物的摘要汇总

使用Gemini直接在网页上汇总了来自中国生物科技与生物制药企业（含合作或中国研究机构主导使用国产管线）的临床试验结果与进展报告，结果看起来更加全面。按企业与药物管线分类如下：恒瑞医药 (Hengrui Pharmaceuticals) Adebrelimab (阿得贝利单抗 / PD-L1)：Abstract CT014：联合化疗在可切除II-III期非小细胞肺癌（NSCLC）围手术期的III期EFS中期分析及MRD分析。Abstract CT038：联合risvutatug rezetecan治疗既往接受过治疗且无可用靶向基因突变的晚期非鳞状NSCLC的I期研究初步结果。Abstract CT239：联合化疗在未经治疗的局部晚期头颈部鳞状细胞癌新辅助治疗中的单臂II期研究疗效与生物标志物分析。SHR-A1811 (HER2 ADC)：Abstract CT301探讨其单药或联合adebrelimab作为晚期HER2突变NSCLC一线治疗的Ib/II期队列结果。Dalpiciclib (达尔西利 / CDK4/6)：Abstract CT151探讨其联合mFOLFOX6治疗经治转移性结直肠癌的Simon两阶段II期研究结果。HRS-6209 (高选择性CDK4抑制剂)：Abstract CT117公布在晚期实体瘤患者中的I期研究。百济神州 (BeiGene) Tislelizumab (替雷利珠单抗 / PD-1)：Abstract CT007：联合研究药物作为复发和/或转移性头颈部鳞状细胞癌（R/M HNSCC）一线治疗的II期研究。Abstract CT085：联合吉西他滨、顺铂和白蛋白结合型紫杉醇（GENTIS方案）治疗晚期胆道癌的Ib/II期试验。Abstract CT122：联合个性化mRNA新抗原疫苗EVM16治疗晚期实体瘤的首次人体（FIH）研究。BGB-24714 (SMAC类似物)：公布其在实体瘤患者首次人体研究中的单药/联合化疗I期进展Abstract CT120及药效学特征Abstract CT121。君实生物 (Junshi Biosciences) JS207 (PD-1/VEGF 双抗)：Abstract CT152：联合化疗治疗转移性结直肠癌的安全性和疗效II期初步结果。Abstract CT159：联合JS007（anti-CTLA4）治疗晚期肝细胞癌的多中心II期随机研究。JS212 (EGFR/HER3 双抗ADC)：Abstract CT128公布治疗晚期实体瘤的首次人体I/II期初步结果。Toripalimab (特瑞普利单抗 / PD-1)：Abstract CT082探讨联合nadunolimab治疗化疗难治性转移性微卫星稳定（MSS）结直肠癌的Ib/II期研究。信达生物 (Innovent Biologics) Sintilimab (信迪利单抗 / PD-1)：Abstract CT150：联合顺铂和白蛋白结合型紫杉醇诱导治疗局部晚期临界可切除食管鳞癌的单臂前瞻性II期研究。Abstract CT160：联合索凡替尼和卡培他滨治疗经治转移性小肠腺癌和阑尾癌的Ib/II期更新分析。Abstract CT183：联合新型RNA溶瘤病毒IVX037治疗晚期MSS结直肠癌的Ib期临床评估。康方生物 (Akeso) Ivonescimab (依沃西单抗 / PD-1/VEGF)：Abstract CT277：治疗转移性内分泌难治性HR+/HER2-或三阴性浸润性小叶癌的II期试验（IvoLoC Trial）。Abstract CT281：治疗既往接受过治疗的胸腺癌的II期试验。Cadonilimab (卡度尼利单抗 / PD-1/CTLA-4)：Abstract CT145联合化疗一线治疗晚期胰腺导管腺癌的多中心开放标签II期研究（COMPASSION-26）。和黄医药 (HUTCHMED) Fruquintinib (呋喹替尼)：Abstract CT048（联合IMT-009）及Abstract CT083（联合ADG126及K药）在转移性MSS结直肠癌中的联合用药研究。Surufatinib (索凡替尼)：Abstract CT146（单药或联合AG方案一线治疗晚期胰腺癌）及Abstract CT160（联合信迪利单抗治疗小肠/阑尾癌）。Savolitinib (赛沃替尼)：Abstract CT247联合度伐利尤单抗治疗伴有MET异常的EGFR野生型晚期NSCLC的II期SOUND试验。贝达药业 (Betta Pharmaceuticals) / 葆元医药 (AnHeart) Dirozalkib (ALK抑制剂)：Abstract CT299及Abstract CT243分别报告其在晚期ALK阳性NSCLC中的多中心随机开放标签III期及II期试验结果。BPI-572270 (RAS多靶点抑制剂)：Abstract CT284报告治疗RAS突变晚期实体瘤的首次人体I/II期研究。Taletrectinib (ROS1抑制剂)：Abstract CT300及Abstract CT244公布其在TKI初治与经治ROS1阳性NSCLC患者中的TRUST-I和TRUST-II更新数据。再鼎医药 (Zai Lab) ZL-1310 (DLL3 ADC)：Abstract CT189报告其在神经内分泌癌及其他实体瘤中的Ib/II期初步结果；Abstract CT193报告其在伴有基线脑转移的广泛期小细胞肺癌患者中的颅内活性分析。映恩生物 (DualityBio) DB-1324 (CDH17 ADC)：Abstract CT086晚期胃肠道肿瘤的首次人体I/II期研究。DB-1317 (ADAM9 ADC)：Abstract CT092晚期实体瘤的首次人体Ia/Ib期研究。德昇济医药 (D3 Bio) Elisrasib / D3S-001 (KRAS G12C抑制剂)：Abstract CT303单药或联合西妥昔单抗治疗既往经治的转移性结直肠癌和胰腺癌I/II期安全性和疗效。D3S-002 (ERK1/2抑制剂)：Abstract CT060治疗具有MAPK通路突变的晚期实体瘤的首次人体I期研究。天演药业 (Adagene) Muzastotug / ADG126 (Masked Anti-CTLA-4)：Abstract CT054联合治疗不可切除局部晚期或转移性肝细胞癌的Ib/II期Morpheus肝脏研究结果；Abstract CT083联合帕博利珠单抗及呋喹替尼治疗晚期MSS结直肠癌的Ib期评估。其他中国企业管线与合作/自研疗法石药集团 (CSPC) - SYS6010 (EGFR ADC)：Abstract CT036治疗晚期鼻咽癌的首次人体研究结果。翰森制药 (Hansoh) - HS-10504：Abstract CT302治疗EGFR突变阳性局部晚期或转移性NSCLC的首次人体I期初步结果。艾博生物 (Abogen) - ABO2203 (mRNA)：Abstract CT032治疗复发/难治性B细胞非霍奇金淋巴瘤的首次人体初步结果。乐普生物 (Lepu) - Pucotenlimab (普特利单抗)：Abstract CT180联合标准化疗作为中高危横纹肌肉瘤患儿术前治疗的I/II期安全性与疗效。科望医药 (Elpiscience) - ES014 (CD39/TGF-β 双抗)：Abstract CT127单药治疗晚期实体瘤的首次人体研究。细胞疗法/创新制剂：Abstract CT027/Abstract CT078：北京大学肿瘤医院主导的LACO-Stim装甲靶向间皮素（Mesothelin）及CD70靶向（UCL70802）的CAR-T疗法实体瘤试验。Abstract CT195：针对亚洲患者的快速制造FAST-TIL治疗晚期黑色素瘤I期临床随访数据。Abstract CT291：IL-12前体药物KGX101在晚期黑色素瘤中的首次人体研究（北京大学肿瘤医院主导）。Abstract CT115：LYC001（靶向淋巴结的IL-2免疫疗法）I期初步安全性数据。

2026-06-16

·百度百家

「Gemini完善版」AACR 2026年会涉及中国生物技术/制药公司药物的摘要汇总

使用Gemini直接在网页上汇总了来自中国生物科技与生物制药企业（含合作或中国研究机构主导使用国产管线）的临床试验结果与进展报告，结果看起来更加全面。按企业与药物管线分类如下：恒瑞医药 (Hengrui Pharmaceuticals) Adebrelimab (阿得贝利单抗 / PD-L1)：Abstract CT014：联合化疗在可切除II-III期非小细胞肺癌（NSCLC）围手术期的III期EFS中期分析及MRD分析。Abstract CT038：联合risvutatug rezetecan治疗既往接受过治疗且无可用靶向基因突变的晚期非鳞状NSCLC的I期研究初步结果。Abstract CT239：联合化疗在未经治疗的局部晚期头颈部鳞状细胞癌新辅助治疗中的单臂II期研究疗效与生物标志物分析。SHR-A1811 (HER2 ADC)：Abstract CT301探讨其单药或联合adebrelimab作为晚期HER2突变NSCLC一线治疗的Ib/II期队列结果。Dalpiciclib (达尔西利 / CDK4/6)：Abstract CT151探讨其联合mFOLFOX6治疗经治转移性结直肠癌的Simon两阶段II期研究结果。HRS-6209 (高选择性CDK4抑制剂)：Abstract CT117公布在晚期实体瘤患者中的I期研究。百济神州 (BeiGene) Tislelizumab (替雷利珠单抗 / PD-1)：Abstract CT007：联合研究药物作为复发和/或转移性头颈部鳞状细胞癌（R/M HNSCC）一线治疗的II期研究。Abstract CT085：联合吉西他滨、顺铂和白蛋白结合型紫杉醇（GENTIS方案）治疗晚期胆道癌的Ib/II期试验。Abstract CT122：联合个性化mRNA新抗原疫苗EVM16治疗晚期实体瘤的首次人体（FIH）研究。BGB-24714 (SMAC类似物)：公布其在实体瘤患者首次人体研究中的单药/联合化疗I期进展Abstract CT120及药效学特征Abstract CT121。君实生物 (Junshi Biosciences) JS207 (PD-1/VEGF 双抗)：Abstract CT152：联合化疗治疗转移性结直肠癌的安全性和疗效II期初步结果。Abstract CT159：联合JS007（anti-CTLA4）治疗晚期肝细胞癌的多中心II期随机研究。JS212 (EGFR/HER3 双抗ADC)：Abstract CT128公布治疗晚期实体瘤的首次人体I/II期初步结果。Toripalimab (特瑞普利单抗 / PD-1)：Abstract CT082探讨联合nadunolimab治疗化疗难治性转移性微卫星稳定（MSS）结直肠癌的Ib/II期研究。信达生物 (Innovent Biologics) Sintilimab (信迪利单抗 / PD-1)：Abstract CT150：联合顺铂和白蛋白结合型紫杉醇诱导治疗局部晚期临界可切除食管鳞癌的单臂前瞻性II期研究。Abstract CT160：联合索凡替尼和卡培他滨治疗经治转移性小肠腺癌和阑尾癌的Ib/II期更新分析。Abstract CT183：联合新型RNA溶瘤病毒IVX037治疗晚期MSS结直肠癌的Ib期临床评估。康方生物 (Akeso) Ivonescimab (依沃西单抗 / PD-1/VEGF)：Abstract CT277：治疗转移性内分泌难治性HR+/HER2-或三阴性浸润性小叶癌的II期试验（IvoLoC Trial）。Abstract CT281：治疗既往接受过治疗的胸腺癌的II期试验。Cadonilimab (卡度尼利单抗 / PD-1/CTLA-4)：Abstract CT145联合化疗一线治疗晚期胰腺导管腺癌的多中心开放标签II期研究（COMPASSION-26）。和黄医药 (HUTCHMED) Fruquintinib (呋喹替尼)：Abstract CT048（联合IMT-009）及Abstract CT083（联合ADG126及K药）在转移性MSS结直肠癌中的联合用药研究。Surufatinib (索凡替尼)：Abstract CT146（单药或联合AG方案一线治疗晚期胰腺癌）及Abstract CT160（联合信迪利单抗治疗小肠/阑尾癌）。Savolitinib (赛沃替尼)：Abstract CT247联合度伐利尤单抗治疗伴有MET异常的EGFR野生型晚期NSCLC的II期SOUND试验。贝达药业 (Betta Pharmaceuticals) / 葆元医药 (AnHeart) Dirozalkib (ALK抑制剂)：Abstract CT299及Abstract CT243分别报告其在晚期ALK阳性NSCLC中的多中心随机开放标签III期及II期试验结果。BPI-572270 (RAS多靶点抑制剂)：Abstract CT284报告治疗RAS突变晚期实体瘤的首次人体I/II期研究。Taletrectinib (ROS1抑制剂)：Abstract CT300及Abstract CT244公布其在TKI初治与经治ROS1阳性NSCLC患者中的TRUST-I和TRUST-II更新数据。再鼎医药 (Zai Lab) ZL-1310 (DLL3 ADC)：Abstract CT189报告其在神经内分泌癌及其他实体瘤中的Ib/II期初步结果；Abstract CT193报告其在伴有基线脑转移的广泛期小细胞肺癌患者中的颅内活性分析。映恩生物 (DualityBio) DB-1324 (CDH17 ADC)：Abstract CT086晚期胃肠道肿瘤的首次人体I/II期研究。DB-1317 (ADAM9 ADC)：Abstract CT092晚期实体瘤的首次人体Ia/Ib期研究。德昇济医药 (D3 Bio) Elisrasib / D3S-001 (KRAS G12C抑制剂)：Abstract CT303单药或联合西妥昔单抗治疗既往经治的转移性结直肠癌和胰腺癌I/II期安全性和疗效。D3S-002 (ERK1/2抑制剂)：Abstract CT060治疗具有MAPK通路突变的晚期实体瘤的首次人体I期研究。天演药业 (Adagene) Muzastotug / ADG126 (Masked Anti-CTLA-4)：Abstract CT054联合治疗不可切除局部晚期或转移性肝细胞癌的Ib/II期Morpheus肝脏研究结果；Abstract CT083联合帕博利珠单抗及呋喹替尼治疗晚期MSS结直肠癌的Ib期评估。其他中国企业管线与合作/自研疗法石药集团 (CSPC) - SYS6010 (EGFR ADC)：Abstract CT036治疗晚期鼻咽癌的首次人体研究结果。翰森制药 (Hansoh) - HS-10504：Abstract CT302治疗EGFR突变阳性局部晚期或转移性NSCLC的首次人体I期初步结果。艾博生物 (Abogen) - ABO2203 (mRNA)：Abstract CT032治疗复发/难治性B细胞非霍奇金淋巴瘤的首次人体初步结果。乐普生物 (Lepu) - Pucotenlimab (普特利单抗)：Abstract CT180联合标准化疗作为中高危横纹肌肉瘤患儿术前治疗的I/II期安全性与疗效。科望医药 (Elpiscience) - ES014 (CD39/TGF-β 双抗)：Abstract CT127单药治疗晚期实体瘤的首次人体研究。细胞疗法/创新制剂：Abstract CT027/Abstract CT078：北京大学肿瘤医院主导的LACO-Stim装甲靶向间皮素（Mesothelin）及CD70靶向（UCL70802）的CAR-T疗法实体瘤试验。Abstract CT195：针对亚洲患者的快速制造FAST-TIL治疗晚期黑色素瘤I期临床随访数据。Abstract CT291：IL-12前体药物KGX101在晚期黑色素瘤中的首次人体研究（北京大学肿瘤医院主导）。Abstract CT115：LYC001（靶向淋巴结的IL-2免疫疗法）I期初步安全性数据。

100 项与普特利单抗相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
黑色素瘤	中国	乐普生物科技股份有限公司	2022-09-20
MSI-H 实体瘤	中国	乐普生物科技股份有限公司	2022-07-19

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
鼻咽癌	临床3期	中国	上海美雅珂生物技术有限责任公司	2025-05-06
转移性结直肠癌	临床3期	中国	泰州翰中生物医药有限公司	2023-02-28
错配修复缺陷或微卫星高度不稳定性结直肠癌	临床3期	中国	乐普生物科技股份有限公司	2023-02-28
错配修复缺陷或微卫星高度不稳定性结直肠癌	临床3期	中国	鼎康（武汉）生物医药有限公司	2023-02-28
栓塞	临床3期	中国	乐普生物科技股份有限公司	2023-02-03
栓塞	临床3期	中国	鼎康（武汉）生物医药有限公司	2023-02-03
转移性黑色素瘤	临床3期	中国	泰州翰中生物医药有限公司	2022-12-31
胃食管交界处腺癌	临床3期	中国	乐普生物科技股份有限公司	2022-03-25
胃腺癌	临床3期	中国	乐普生物科技股份有限公司	2022-03-25
转移性非鳞状非小细胞肺癌	临床3期	中国	泰州翰中生物医药有限公司	2020-09-25

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适应症

分期

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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


NCT07381699 (ASCO2026)	临床2期	鼻咽癌一线	36	Becotatug vedotin + Pucotenlimab	壓壓艱糧構餘選襯構憲(壓顧鬱壓獵壓糧齋觸窪) = 築衊夢遞餘齋鑰製鹹範願獵顧艱壓觸窪鹽窪餘 (鑰鑰鬱簾網衊簾獵觸遞 ) 更多	积极	2026-05-29
NCT06456892 (AACR2026)	临床1/2期	横纹肌肉瘤新辅助	42	Pucotenlimab combined with standard chemotherapy regimens (intermediate or high-risk rhabdomyosarcoma)	膚鏇醖憲獵顧蓋顧艱簾(淵夢憲鏇觸衊膚鏇築鬱) = 齋艱蓋蓋廠願獵膚獵鹹範構糧顧範醖夢鑰獵蓋 (顧襯鏇願衊簾積繭築觸 ) 更多	积极	2026-04-21
NCT05688605 (HX008/MRG003-C001, ESMO2025) 人工标引	临床2期	转移性头颈部鳞状细胞癌 \| 复发性头颈部鳞状细胞癌一线	37	Becotatug vedotin 2.0 mg/kg + pucotenlimab	築鬱鹹繭淵遞簾網簾願(構築積鑰壓鏇膚膚獵膚) = 膚築淵糧艱繭築膚網餘蓋獵淵襯獵鹹鑰積艱構 (醖膚醖夢鏇範遞簾醖壓 ) 更多	积极	2025-10-17
NCT05688605 (HX008/MRG003-C001, ESMO2025) 人工标引	临床2期	转移性头颈部鳞状细胞癌 \| 复发性头颈部鳞状细胞癌一线	37	Becotatug vedotin 2.3 mg/kg + pucotenlimab	築鬱鹹繭淵遞簾網簾願(構築積鑰壓鏇膚膚獵膚) = 築廠齋網鹹築淵鑰蓋構蓋獵淵襯獵鹹鑰積艱構 (醖膚醖夢鏇範遞簾醖壓 ) 更多	积极	2025-10-17
NCT05688605 (HX008/MRG003-C001, ESMO2025) 人工标引	临床2期	复发性鼻咽癌二线	30	becotatug vedotin (HX008)pucotenlimab (MRG003)	廠膚網襯鏇餘壓鬱鬱蓋(憲衊糧壓願範製醖願廠) = 鏇淵淵襯窪構積觸醖遞襯醖淵選繭製窪顧願繭 (構襯遞窪網網壓衊繭築 ) 更多	积极	2025-10-17
NCT06456892 (ASCO2025)	临床1/2期	小儿横纹肌肉瘤新辅助	15	Pucotenlimab + Standard Chemotherapy	窪繭選簾蓋壓襯艱簾艱(憲觸糧網遞襯醖範範鏇) = 夢艱製餘願顧顧願構築構繭繭鏇範鹹積製獵糧 (壓餘膚膚鬱衊膚衊壓遞 ) 更多	积极	2025-05-30
NCT03704246 (phase II, ASCO2025)	临床2期	局部晚期恶性实体瘤 \| 晚期恶性实体瘤二线	100	Pucotenlimab 200 mg Q3W	製醖夢繭廠觸襯壓積積(齋醖製簾衊願鑰鏇憲壓) = 齋製糧範網鏇範蓋齋網願衊膚繭鬱範積築網窪 (簾積鬱夢壓齋鏇醖顧顧, 39.8 ~ 60.2) 更多	积极	2025-05-30
NCT05688605 (HX008/MRG003-C001, ESMO_ASIA2024) 人工标引	临床2期	鼻咽癌	30	Pucotenlimab (HX008) 3.0 mg/kg + EGFR-ADC (MRG003) 2.0 mg/kg	鑰鹹簾繭鹹糧齋夢選鏇(糧鏇壓鏇壓繭觸糧構願) = 齋觸範衊夢壓糧窪膚夢遞觸艱獵衊選淵膚積醖 (構餘構鬱簾艱鏇鑰憲鏇, 59.7 ~ 73.7) 更多	积极	2024-12-07
NCT04508803 (CHANGEABLE, ASCO2024) 人工标引	临床2期	转移性乳腺癌 BRCA2 Mutation (Germline)	37	Niraparib 200 mg qd + HX008 200 mg q3w	醖餘網膚憲網艱顧製鑰(鏇簾獵鏇齋選製鏇遞夢) = 簾鏇願選觸艱夢製遞廠衊膚觸獵願艱獵憲顧鹽 (網膚範艱網鹹鏇醖選壓 ) 更多	积极	2024-05-24
NCT04508803 (CHANGEABLE, ASCO2024) 人工标引	临床2期	转移性乳腺癌 BRCA2 Mutation (Germline)	37	HX008+niraparib+pyrotinib	醖餘網膚憲網艱顧製鑰(鏇簾獵鏇齋選製鏇遞夢) = 選夢憲醖築鹹製簾淵願衊膚觸獵願艱獵憲顧鹽 (網膚範艱網鹹鏇醖選壓 ) 更多	积极	2024-05-24
NCT05688605 (Phase I/II study, ASCO2024) 人工标引	临床1/2期	EGFR 突变实体瘤 EGFR-positive	33	Pucotenlimab(HX008) + MRG003	顧範顧範鬱簾積鏇夢糧(簾構壓廠艱遞選築壓壓) = 簾遞遞鏇蓋鹹積鏇製糧淵窪繭夢憲獵顧網製糧 (積簾選壓襯糧鑰蓋醖膚 ) 更多	积极	2024-05-24
NCT04750083 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	非鳞状非小细胞肺癌一线 EGFR mutation \| ALK mutation	43	Pucotenlimab 200mg+pemetrexed+platinum	襯選獵窪製鹹艱糧選顧(鏇選鹽淵製築製簾鏇積) = 網鏇糧窪壓壓鹽蓋鏇醖憲範鹹夢獵築鏇願鹽淵 (廠衊簾淵餘繭夢積製積, 38.9 ~ 59.2) 更多	积极	2023-10-23