A Phase II, Prospective, Single-Arm, Multicenter, Open-Label Study of Sacituzumab Tirumotecan in Combination With Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Locally Advanced Cervical Cancer

This is a phase II, prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of sacituzumab tirumotecan in combination with iparomlimab and tuvonralimab as neoadjuvant therapy in patients with locally advanced cervical cancer

开始日期2026-02-01

申办/合作机构

中山大学

[+2]

NCT07229846

/ Not yet recruiting临床2期IIT

A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation

This is an open-label, single-arm, single-center phase II clinical study, aiming to investigate the safety and efficacy of Aipalolitovorelizumab (QL1706) combined with bevacizumab plus standard chemotherapy regimen as first-line treatment for patients with MSS/pMMR metastatic colorectal cancer harboring BRAF V600E mutation.
Patients will receive intravenous administration of Aipalolitovorelizumab (QL1706) injection + bevacizumab + oxaliplatin/irinotecan/fluorouracil/calcium folinate, along with oral capecitabine. After completing the corresponding treatment cycles, patients will enter the maintenance treatment phase as determined by the researcher. In the maintenance treatment phase, a 3-week treatment regimen of Aipalolitovorelizumab (QL1706) injection combined with bevacizumab and capecitabine will be adopted, with the administration method and dosage remaining unchanged.
The primary endpoint of this study is objective response rate (ORR); the secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.

开始日期2026-02-01

申办/合作机构

哈尔滨医科大学

ChiCTR2500115120

/ Not yet recruitingN/AIIT

Prospective, Open-Label, Single-Center Clinical Study of Iparomlimab and Tuvonralimab Combined with AG Regimen plus SBRT versus Epalolitovorimab Combined with AG Regimen as First-Line Treatment for Unresectable Locally Advanced or Metastatic Pancreatic Cancer

开始日期2025-12-31

申办/合作机构-

100 项与艾帕洛利单抗相关的临床结果

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100 项与艾帕洛利单抗相关的转化医学

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100 项与艾帕洛利单抗相关的专利（医药）

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项与艾帕洛利单抗相关的文献（医药）

2026-02-01·EClinicalMedicine

Iparomlimab and tuvonralimab (QL1706) combined definitive chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma (QL1706-IIT-02): a single arm, phase 2 trial

Article

作者: Yan, Cihui ; Gao, Linrui ; Zheng, Zhunhao ; Cao, Fuliang ; Dong, Jie ; Chen, Xi ; Zhao, Gang ; Li, Zewei ; Zhang, Wencheng ; Bai, Na ; Pang, Qingsong ; Wang, Ping ; Li, Jiacheng ; Wang, Yufei ; Jiang, Shengpeng ; Zhang, Tian

Background:

Definitive chemoradiotherapy is the standard treatment for inoperable locally advanced esophageal squamous cell carcinoma (ESCC). However, the prognosis for these patients remains poor. This study aimed to evaluate iparomlimab and tuvonralimab (QL1706), a novel PD-1/CTLA-4 dual inhibitor, combined with definitive chemoradiotherapy in patients with unresectable stage III-IVA ESCC.

Methods:

This single-arm, open-label phase 2 trial was conducted at a single center in China between August 2022 and September 2023. 39 patients with unresectable stage III-IVA ESCC were included. QL1706 is composed of iparomlimab (anti-PD-1 IgG4) and tuvonralimab (anti-CTLA-4 IgG1) in a fixed 2:1 ratio. Patients received radiotherapy (50.4 Gy/28 in fractions on 5 days per week), concurrent chemotherapy (paclitaxel 135 mg/m² d1+ cisplatin 25 mg/m² d1-3, q3w, 2 cycles), and QL1706 (5 mg/kg q3w for up to 1 year [total of 18 cycles]). The primary endpoint was progression-free survival (PFS). This study is registered with ClinicalTrials.gov (NCT05490719).

Findings:

20 patients (51.3%) completed the full cycles of QL-1706. Reasons for the premature cessation of QL1706 were disease progression (n = 7), COVID-19 infection (n = 2), pneumonia (n = 2), allergic reaction (n = 2), patient refusal (n = 4), rash (n = 1), and esophageal hemorrhage (n = 1). With a median follow-up of 21.1 months, the median progression-free survival (PFS) was 14.8 (95% CI: 11.2-NA) months. The median overall survival (OS) was immature. The 1-year PFS and OS rates were 58.6% (95% CI: 44.9-76.4) and 84.6% (95% CI: 74.0-96.7). The objective response rate and median duration of response were 84.6% (95% CI: 69.5-94.1) and 12.7 months (95% CI: 8.9-NA). Exploratory biomarker analyses identified several potential predictive biomarkers: 1) immunochemistry staining revealed that PD-L1 combined positive score ≥1 correlated with prolonged PFS (HR 0.37, p = 0.036); 2) Whole-exome sequencing detected high tumor mutation burden associated with better PFS (HR 0.24, p = 0.0066), while the mutated group (TNRC18/CAMSAP3/CARMIL2/ZFHX4 gene alterations) correlated with poor PFS (HR 6.40, p = 0.0002) and OS (HR 6.45, p = 0.0020); and 3) Olink plasma proteomics identified baseline levels of TWEAK and FASLG were both positively associated with PFS and OS (p < 0.05 for all). Grade ≥3 adverse events occurred in 89.7% (35/39) of the patients, predominantly lymphopenia (31/39, 79.5%).

Interpretation:

QL1706 combined with chemoradiotherapy demonstrated potential antitumor activity and manageable toxicity, supporting further investigation.

Funding:

National Natural Science Foundation of China, State Key Laboratory of Druggability Evaluation and Systematic Translational Medicine, Tianjin Key Medical Discipline Construction Project, and Tianjin Key Medical Discipline (Specialty) Construction Project.

2026-01-02·CANCER INVESTIGATION

Efficacy and Safety of Different Dosages of Anlotinib Combined with PD-1 Monoclonal Antibody in the Treatment of Advanced Non-Small Cell Lung Cancer

Article

作者: Jiang, Juan ; Chen, Shixue ; Ran, Guanghan ; Ran, Shuanghua ; Xiao, Yin

OBJECTIVE:

This study investigates the efficacy and safety of anlotinib in combination with PD-1 monoclonal antibody across different dosing regimens for advanced non-small cell lung cancer (NSCLC). It aims to determine whether a medium dosage provides the best therapeutic outcomes.

METHODS:

A retrospective analysis was conducted on 100 NSCLC patients treated between July 2018 and December 2022. Patients were divided into three groups based on anlotinib dose: low (8 mg/d, n = 38), medium (10 mg/day, n = 34), and high (12 mg/d, n = 28), all receiving 200 mg of PD-1 antibody every 21 days. The primary endpoint was overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and quality of life (QoL) assessed via the EORTC QLQ-C30 questionnaire.

RESULTS:

Median OS was significantly higher in the medium-dose group (21.3 months) compared to the low-dose group (10.2 months; p = 0.01). The high-dose group achieved a median OS of 18.2 months (p = 0.10 vs. medium). ORRs were 26%, 54%, and 42%, and DCRs were 66%, 82%, and 80% for low, medium, and high groups, respectively. QoL scores in the medium group were significantly improved in physical, emotional, and social domains (p < 0.05). Adverse events of grade ≥3 occurred in 18%, 19%, and 29% of patients in the low, medium, and high-dose groups, respectively. Immune-related side effects, such as thyroid dysfunction, increased with dosage (p = 0.018).

CONCLUSION:

Medium-dose anlotinib combined with PD-1 therapy delivers superior survival and QoL outcomes with manageable toxicity. These results underscore its potential as an optimal treatment strategy for advanced NSCLC.

2026-01-01·Journal for ImmunoTherapy of Cancer

Caninized PD-1 monoclonal antibody in oral malignant melanoma: efficacy and exploratory biomarker analysis

Article

作者: Mizoguchi, Hiroki ; Motegi, Tomoki ; Hagimori, Kenji ; Kato, Masahiro ; Mizuno, Takuya ; Igase, Masaya ; Shiga, Toshinori ; Sakurai, Masashi ; Yamamoto, Hiroka ; Tsukui, Toshihiro ; Itamoto, Kazuhito ; Inanaga, Sakuya ; Kobayashi, Tetsuya

Background:

Canine oral malignant melanoma (OMM) is a highly aggressive tumor, with several available treatment options, though few achieve durable response or complete remission. Because of its biological similarity to human mucosal melanoma, canine OMM represents a valuable spontaneous model for translational immunotherapy studies. Anti-programmed cell death protein 1 (PD-1) antibody therapy has shown promise in canine OMM; however, predictive biomarkers for treatment response and survival have not been identified.

Methods:

We conducted a multicenter, prospective, investigator-initiated clinical trial to evaluate the safety and efficacy of a caninized anti-canine PD-1 monoclonal antibody (ca-4F12-E6) in 150 dogs with advanced OMM. The dogs were administered 3 mg/kg ca-4F12-E6 intravenously every 2 weeks. Treatment response was assessed using cRECIST V.1.0. Biomarker analyses included peripheral blood parameters, cytokine/chemokines, peripheral lymphocyte subsets, microsatellite instability (MSI), immunohistochemistry for immune cell and mismatch repair protein markers, and RNA sequencing of the tumor tissue. Associations with clinical outcomes were determined by logistic regression and Cox proportional hazards models.

Results:

The overall response rate was 14.7%, with a best overall response rate of 16.7%. Treatment-related adverse events occurred in 40.0% of the dogs, which were primarily grade 1–3. Increased baseline white blood cell, neutrophil count, and C reactive protein levels were significantly associated with poor response, shorter progression-free survival, and reduced overall survival (OS). MSI-high tumors were associated with significantly prolonged OS compared with MSI-low/microsatellite stable tumors. Transcriptome analysis revealed differentially expressed genes and enriched immune-related pathways in responders, though limited by sample size.

Conclusion:

ca-4F12-E6 exhibited durable antitumor activity with manageable safety profile in dogs with OMM. Baseline systemic inflammatory markers and MSI status may serve as predictive biomarkers for clinical outcomes. The results support the use of canine OMM as a comparative model for human immuno-oncology and biomarker discovery.

107

项与艾帕洛利单抗相关的新闻（医药）

2026-02-17

·ioncology

肝癌编年史·公元2025纪事丨周俭院士邀您回顾2025年中国肝癌诊疗变革

编者按肝癌，曾是人类医学史上最为顽固的挑战之一。从古代中医对“积聚”“胁痛”的观察，到现代科学揭示其分子机制，再到精准治疗的逐步实现，这一场跨越千年的抗争，既是生命与疾病的角力，也是人类智慧与仁心的史诗。 2025年，注定是中国乃至全球肝癌防治进程中具有里程碑意义的一年。这一年，以ASCO GI、ESMO等国际盛会为窗口，多项突破性研究相继发布，其中不乏由中国学者引领的原创性成果。从早筛技术的迭代升级，到系统治疗的多线突破；从转化治疗的临床实践，到全程管理理念的深化落地，中国声音正日益成为推动肝癌诊疗变革的重要力量。为铭记这一非凡历程，系统梳理肝癌领域在2025年的关键进展与历史坐标，《肿瘤瞭望》联合《国际肝病》特别推出《肝癌编年史·公元2025纪事》春节特别栏目。以史为鉴，结绳记事，本栏目以“编年”为脉络，以“纪事”为笔法，力求全景式呈现2025年肝癌诊疗格局的深刻演变。这不仅是一次对过往的总结，更是一份面向未来的宣言。我们相信，每一份努力都值得被记录，每一次突破都将照亮更多生命的希望。周俭院士·卷首语又到岁末年初，回顾过去的2025年，是肝癌领域浓墨重彩的一年，中国肝癌领域的全体同仁，交出了一份亮眼的成绩单。从基础研究到转化应用，从早期筛查到晚期系统治疗，结出了累累硕果，尤其是中国学者主导的研究，正大步走向国际舞台，让世界看到了中国肝癌防治的实力。在前辈专家的指导下、在各级领导的关心下，中国肝癌同仁同仁紧跟国际前沿的步伐，在肝癌早筛、转化治疗、系统治疗这些关键领域，做出了有全球影响力的原创成果。这些“中国方案”不仅成为国内肝癌临床实践的重要选择，而且改写了国际肝癌防治体系的重要指南。在肝癌诊疗研究取得日新月异的突破性进展的同时，及时更新肝癌诊疗实践指南、提升规范化临床实践水平是我们的另一大重要任务。今年1月10日，国家卫健委《原发性肝癌诊疗指南（2026年版）》专家修订版正式发布。在指南编写专家委员会主任委员樊嘉院士的统筹领导下，作为执行主任委员，我很荣幸能和樊嘉院士、滕皋军院士、陈孝平院士、窦科峰院士、蔡秀军院士、郑树森院士、董家鸿院士、夏强院士等百余位跨学科专家一起参与这项国家工程，而这份指南的背后，更是凝聚着全国肝癌领域同仁的智慧和实践经验。各位同仁，2025年的这些成果，从来都不是某一个人、某一个团队的功劳，也不是孤立的闪光点，而是中国肝癌防治体系，从过去的“经验驱动”全面迈向“证据引领”的最好证明。每一份成绩，都不是天上掉下来的。它是无数个深夜的讨论、无数次失败后的坚持、是患者信任托付下的责任担当。这些成果，是我们献给广大肝癌患者的希望之光，更是继续走好肝癌防治高质量发展之路的坚实路标。旧岁已展千重锦，新年再进百尺竿。2025年的成绩已经成为过去，2026年的新征程已经开启。路还长，挑战仍在，但我相信，只要我们继续脚踏实地、守望相助，中国肝癌防治的未来，一定会更加光明。 2025年1月 ASCO GI LEAP-012研究一项国际多中心、Ⅲ期临床试验，旨在评估帕博利珠单抗联合仑伐替尼（“可乐”方案）及TACE的三联方案，在不可切除、非转移性HCC患者中的疗效与安全性。 “可乐”方案联合TACE延长不可切除、非转移性HCC患者PFS；全球人群PFS达14.6个月，中国亚组更是达到16.6个月。 CARES-005研究一项多中心、开放标签、随机对照、Ⅱ期研究，旨在探讨不可切除HCC患者接受TACE+阿帕替尼联合卡瑞利珠单抗（“双艾”方案）对比TACE治疗的疗效和安全性。 TACE+“双艾”方案组的PFS明显较TACE组更长（10.8个月 vs 3.2个月），降低疾病进展或死亡风险达66%，达到PFS的主要终点，ORR改善较TACE组更明显。 RACB研究一项前瞻性、单臂、多中心的Ⅱ期临床试验，旨在评估贝伐珠单抗联合阿替利珠单抗治疗在技术上或肿瘤学上不可切除的HCC患者中实现转化手术的效果。总体切除率为48%，对于初始不可切除的HCC患者，贝伐珠单抗联合阿替利珠单抗治疗后进行转化手术是可行的。 CheckMate 9DW研究一项多中心、随机、开放标签的Ⅲ期临床研究，旨在评估纳武利尤单抗联合伊匹木单抗（“O+Y”方案）对比研究者选择的仑伐替尼/索拉非尼单药在未接受过系统治疗的晚期HCC患者中的疗效和安全性。 “O+Y”方案在晚期HCC一线治疗中具有持久生存获益，OS超48个月，ORR达36%。 EMERALD-1研究更新基于“6-and-12评分”基线肿瘤负荷的最新探索性分析。度伐利尤单抗+贝伐珠单抗+TACE三联方案对比单纯TACE方案，在“6-and-12评分”的各个亚组中均观察到PFS、TTP以及ORR的改善。 ≤6、＞6且≤12组，和＞12组对比对照组的PFS分别为：19.4 vs. 11.1（HR=0.69），13.9 vs. 9.7（HR=0.85），11.1 vs. 4.8（HR=0.61）个月。 DUBHE-H-106研究该项Ⅰb/Ⅱ期研究旨在初步评估两种一线方案治疗不可切除HCC的安全性与疗效：其一是新型抗PD-1/CTLA-4双特异性抗体艾帕洛利托沃瑞利单抗（QL1706）联合贝伐珠单抗；其二是抗PD-1单抗艾帕洛利单抗（QL1604）联合贝伐珠单抗。 QL1706或QL1604分别联合贝伐珠单抗在不可切除HCC中具有潜力的抗肿瘤活性。QL1706（7.5 mg/kg）联合贝伐珠单抗（15 mg/kg，每3周给药）的组合可能具备更优的疗效信号。 2025年2月 JOH EASL指南更新在过去十年中，欧洲肝脏研究学会（EASL）已发布多部HCC诊疗相关指导文件，最新一版发布于2018 年。自2018年版指南发布以来，相关领域研究取得了重大突破，从个体化筛查、诊断技术优化，到不同肿瘤分期的微创手术、免疫系统性治疗，HCC诊疗的各个环节均实现了革新。因此，亟需更新EASL HCC临床实践指南。此次指南更新内容之一为：在严格评估基础上可对部分多发病灶患者实施根治性切除。 2025年3月 NMPA 基于CheckMate-9DW研究的阳性结果，NMPA正式批准了纳武利尤单抗联合伊匹木单抗（“O+Y”方案）用于不可切除或晚期HCC成人患者的一线治疗。这也是目前我国首个且唯一获批用于肝癌一线治疗的双免疫联合疗法，标志着我国肝癌免疫治疗进入新的发展阶段。 2025年4月 The Innovation 一项单臂Ⅱ期研究，评估HAIC联合靶向药安罗替尼及PD‑L1抑制剂TQB2450（贝莫苏拜单抗）用于具有高复发风险因素的HCC患者术后辅助治疗。 1年与2年DFS率分别为84.4%与65.8%，1年与2年OS率分别为96.1%与89.8%，且4周期与8周期组的DFS与OS无显著差异，为HAIC在术后辅助治疗领域提供了新的临床证据与可行路径。 2025年6月 NMPA 基于LEAP-012研究中中国亚组取得的突破性成果，帕博利珠单抗成功获批HCC一线治疗适应症。帕博利珠单抗联合仑伐替尼和TACE的治疗方案不仅为我国不可切除HCC的临床治疗提供了全新的选择，更为局部治疗联合系统治疗提供了可借鉴的成功模式。 2025年7月 ESMO GI TALENTACE研究一项前瞻性、开放标签、随机、多中心的Ⅲ期临床试验，评估了阿替利珠单抗+贝伐珠单抗联合按需TACE在未接受过全身系统治疗的不可切除HCC患者中的疗效和安全性。主要终点TACE-PFS取得了统计学和临床意义上的显著改善（HR=0.71，95%CI，0.55-0.92；P=0.009）。由RECIST v1.1标准评估的PFS也观察到了有临床意义的改善，联合治疗组的mPFS为10.32个月，而单独TACE组为6.37个月。 2025年10月 ESMO CS1003-305研究一项全球多中心Ⅲ期临床研究，该研究报道了人重组IGg4抗PD-1单克隆抗体Nofazinlimab联合仑伐替尼对比安慰剂联合仑伐替尼一线治疗不可切除或转移性HCC的结果。 Nofazinlimab联合仑伐替尼组在研究终点mOS上显示出了优势，ORR（33.1% vs. 18.8%；P=0.0006）和PFS（9.2 vs. 6.9个月；HR=0.72，95%CI：0.58-0.88；P=0.0017）显示出了统计学差异且安全性可控。 CARES-009研究一项随机、开放标签Ⅲ期临床试验，首次证实对于可切除且伴中高危复发风险的HCC患者，采用卡瑞利珠单抗联合阿帕替尼进行新辅助治疗，术后再予以辅助治疗的“三明治”围术期治疗模式，相较于单纯手术治疗，可显著延长患者的中位无事件生存期（EFS：42.1个月 vs 19.4个月）。该研究也是全球首个在HCC围手术期治疗取得阳性结果的Ⅲ期研究，为降低术后复发风险确立了新的标准治疗方案。 TALENTOP研究一项多中心、开放标签、随机Ⅲ期临床研究，创新性地聚焦于“经系统治疗后获得疾病控制的局部晚期HCC患者”这一特殊群体，比较了经阿替利珠单抗+贝伐珠单抗初步治疗后获得PR或SD的晚期HCC患者接受肝切除术+维持治疗的有效性和安全性。手术治疗组的TTF达20.4个月，显著优于持续药物治疗组的11.8个月。回望2025，肝癌诊疗的每一步突破，都凝聚着医者的智慧与患者的信任。从“经验驱动”迈向“证据引领”，中国方案正照亮全球肝癌防治之路。站在新起点，我们继续以科学为灯、以仁心为舵，为更多生命赢得希望，因为每一份坚持，终将化作春日里的新生。（来源：《肿瘤瞭望》编辑部）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。

ASCO会议

2026-02-09

·lanovamedicines.com

LaNova Medicines Announces Completion of Subject Enrollment in Phase III Clinical Trial of LM-302

LaNova Medicines Ltd. announced that tecotabart vedotin (research and development code: LM-302) "CLDN18.2 ADC", a national Category 1 innovative drug, has successfully completed patient enrollment in its Phase III registrational clinical trial (LM302-03-101) for the treatment of third-line and later CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. Notably, LM-302 is the world's first CLDN18.2 ADC to complete enrollment in a registrational Phase III clinical trial. LM-302 is an antibody-drug conjugate (ADC) targeting CLDN18.2. By specifically binding to CLDN18.2-positive tumor cells, LM-302 is internalized via endocytosis and subsequently releases a small molecule cytotoxic payload, thereby enabling precise and targeted tumor cell killing. As a potential first-in-class (FIC) therapy, LM-302 has demonstrated promising clinical development potential across various gastrointestinal tumors, including gastric cancer, pancreatic cancer and biliary tract cancer, and is expected to provide new treatment options for patients with low CLDN 18.2 expression and low PD-L1 expression. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, LaNova Medicines presented the latest results from a study evaluating LM-302 in combination with toripalimab for the treatment of gastric cancer [1]: among 41 efficacy-evaluable patients, the overall response rate (ORR) was 65.9% and the disease control rate (DCR) was 85.4%; among 32 patients with CLDN18.2 expression ≥25%, the ORR reached 71.9% and the DCR reached 96.9%. In the stratified analysis conducted based on PD-L1 expression, the ORR in patients with PD-L1 CPS <1 was 63.3% and the ORR in patients with CPS ≥1 was 77.8%. This results indicate that the LM-302 combination regimen demonstrated significant anti-tumor activity with a manageable safety profile in CLDN18.2-positive patients. In addition to the ongoing Phase III registrational study in the third-line and later setting, LM-302 is planning to initiate another Phase III registrational clinical trial in China, in combination with a PD-1 monoclonal antibody, for the first-line treatment of CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, further expanding its therapeutic potential in the field of gastric cancer. Moreover, multiple indications of LM-302 have been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, and LM-302 has also received the Orphan Drug Designation (ODD) from the United States Food and Drug Administration (FDA). Leveraging Sino Biopharm Group's robust resource support and industrial capabilities, LaNova Medicines is accelerating the clinical translation and commercialization of innovative therapies, with a continued commitment to delivering high-quality and accessible treatment options to cancer patients worldwide. Source: [1] Haiping Jiang et al. Efficacy and safety of LM-302 (anti-claudin 18.2 ADC) in combination with anti-PD-1 therapy for advanced gastric, gastroesophageal junction cancer and esophageal adenocarcinoma: Early-phase study results.. J Clin Oncol 43, 4039-4039(2025).

ASCO会议临床结果抗体药物偶联物

2026-01-23

·有驾

2026十大创新药巨头：谁将率先撞线？

2026年刚开年，创新药交易就像打了鸡血：管线授权、合作研发、跨境License-in轮番上演，动辄十几亿美元的“大单”屡见不鲜。历史经验显示，只要产品顺利推进到关键注册节点，相关药企股价常迎来3–5个涨停。谁手握“王炸”管线，谁就有机会在下一轮竞赛中率先撞线？下文把“在研管线最多”的十家本土药企一次说透。综合《2025中国药品研发综合实力排行榜TOP100》《2025中国生物药研发实力排行榜TOP50》等权威榜单，在研管线数量TOP10的企业名单如下——它们几乎包揽了国内所有“重磅”赛道。 2.1 ◆ 恒瑞医药——“老大哥”再升级连续8年稳坐国内创新药研发头把交椅，全球研发管线规模仅次于辉瑞。 163项自研管线覆盖肿瘤、代谢、心血管、免疫等全线病种，HER2 ADC、GLP-1受体激动剂等已逼近上市。与默沙东、GSK等跨国巨头达成超140亿美元海外授权，部分产品已进入欧美市场。 2.2 ◆ 百济神州——“免疫天团”加速跑国内生物药龙头，2025年首次跻身全球研发TOP25。 77项在研管线押注肿瘤免疫，泽布替尼（BTK抑制剂）全球销售额破26亿美元，是首个在欧美获批的国产抗癌药。 ADC、双抗齐发，EGFR/MET三抗BG-T187、4-1BB/GPC3双抗BGB-2033已步入临床。 2.3 ◆ 正大天晴——“AI+肝药”转型样板老牌肝病、肿瘤企业，2025年全球研发排名升至第15位。 125项在研管线中104项为自研，安罗替尼在肺癌III期击败国际“药王”K药，创中国方案新纪录。通过“AI+生物医药”把研发周期缩短60%，2024年研发投入占收入19%，创新收入占比从11%飙升至42%。 2.4 ◆ 石药集团——“老牌劲旅”出海记转型典范，2025年全球研发排名再进第19位。 102项在研管线覆盖肿瘤、感染、心血管，SYS6010为进展最快的EGFR ADC之一，具备“best in class”潜力。与阿斯利康、百济神州等达成超50亿美元海外授权，ROR1 ADC SYS6005潜在总交易额12.4亿美元。 2.5 ◆ 复星医药——“多元巨头”的CAR-T首张牌照国内多元化创新药龙头，管线同时覆盖化学药、生物药、中药。阿基仑赛注射液获批复发/难治大B细胞淋巴瘤，拿下国内首个CAR-T“通行证”。与BioNTech合作开发的mRNA新冠疫苗已进入全球多中心临床。 2.6 ◆ 齐鲁制药——“化学+生物”双轮驱动 80项以上在研管线，覆盖肿瘤、心血管、代谢。 QL1604 PD-1、QLS31901 ADC等已进入III期，部分产品剑指“同类最佳”。 2.7 ◆ 科伦药业——ADC赛道“收割机” 通过子公司科伦博泰布局生物药，70项以上在研管线。 TROP2 ADC SKB264授权默沙东，交易额创纪录14亿美元；OptiDC™平台让科伦在全球ADC竞赛中抢得先手。 2.8 ◆ 翰森制药——中枢神经与肿瘤“双引擎” 60项以上在研管线，GLP-1/GIP双激动剂HS-20094用于肥胖症已进入III期。 2024年HS-10535出海超20亿美元，证明其创新能力获国际“盖章”。 2.9 ◆ 信达生物——“PD-1王者”再出鞘拥有15款商业化产品，信迪利单抗拿下FDA快速通道资格。 50项以上在研管线覆盖肿瘤、代谢、心血管，PD-1/LAG-3双抗IBI318、GLP-1/GCGR双激动剂IBI362已进III期。与礼来、罗氏等跨国巨头合作不断，信迪利单抗授权礼来总金额超10亿美元。 2.10 ◆ 上海医药——流通+工业“双轮车”上的研发突围者 40项以上在研管线，ADC SPH2690、双抗 SPH4336等已进入临床阶段，有望填补国内空白。以“快消”思维做药品分销，反向把市场洞察注入研发端，形成独特优势。纵观十强，三条主线愈发清晰：头部垄断：恒瑞、百济、正大天晴等以百亿级管线规模筑起护城河；前沿技术领跑：ADC、双抗/多抗、细胞基因治疗（CGT）成为兵家必争之地；国际化提速：恒瑞、百济、石药等产品已在美国、欧洲落地，本土企业正从“跟跑”迈向“并跑”“领跑”。当研发强度普遍突破15%， “全球新”药物诞生的概率正在指数级上升；谁能率先把在研管线变成上市产品，谁就能拿下下一座“金山”。

100 项与艾帕洛利单抗相关的药物交易

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研发状态

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
肿瘤	申请上市	中国	齐鲁制药有限公司	2023-09-17
子宫颈转移癌	临床3期	中国	齐鲁制药有限公司	2020-09-23
进展期胃腺癌	临床3期	中国	齐鲁制药有限公司	2020-07-01
肝细胞癌	临床3期	中国	齐鲁制药有限公司	2020-05-27
头颈部鳞状细胞癌	临床2期	中国	齐鲁制药有限公司	2025-05-25
晚期肝细胞癌	临床2期	中国	齐鲁制药有限公司	2022-01-04
肝癌	临床2期	中国	齐鲁制药有限公司	2022-01-04
宫颈鳞状细胞癌	临床2期	中国	齐鲁制药有限公司	2020-09-14
晚期癌症	临床2期	中国	齐鲁制药有限公司	2020-07-08
MSI-H 癌症	临床2期	中国	齐鲁制药有限公司	2020-07-08

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临床结果

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


DUBHE-L-201 (Pubmed \| J Hematol Oncol) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	31	Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (cohort 5)	鏇鏇鏇構襯淵選壓夢積(鑰範糧鏇獵蓋醖衊憲鑰) = 鬱醖窪蓋憲憲蓋窪壓鏇醖夢膚構繭遞繭鹽鑰鹹 (糧顧獵簾鏇鏇選製夢獵, 12.81 ~ NR) 更多	积极	2025-07-26
				Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (21L858R mutation + cohort 5)	鏇鏇鏇構襯淵選壓夢積(鑰範糧鏇獵蓋醖衊憲鑰) = 醖鑰壓糧願願夢鏇積願醖夢膚構繭遞繭鹽鑰鹹 (糧顧獵簾鏇鏇選製夢獵 ) 更多
NCT05603039 (DUBHE-H-106, ASCO_GI2025) 人工标引	临床1/2期	不可切除的肝细胞癌一线	116	QL1706QL1706 5 mg/kg + BEV 15 mg/kg Q3W	網網襯繭憲顧範蓋壓製(構願構糧觸鏇選醖範淵) = 鏇膚繭壓獵製膚壓齋築衊壓範襯鑰鹽壓鬱廠夢 (製鬱壓廠構廠窪齋構醖, 25–54) 更多	积极	2025-01-23
				QL1604 200 mgQL1604 200 mg + BEV (safe dose) Q3W	網網襯繭憲顧範蓋壓製(構願構糧觸鏇選醖範淵) = 鏇艱簾窪構網艱積夢夢衊壓範襯鑰鹽壓鬱廠夢 (製鬱壓廠構廠窪齋構醖, 9–44) 更多
NCT04326829 (NCT04326829, Pubmed \| J Hematol Oncol)	临床2期	MSI-H 实体瘤 PD-1	120	Iparomlimab 200 mg	觸廠餘製遞獵選簾鹹艱(獵遞願膚網鹹膚憲選遞) = 繭獵膚鹽顧網膚鑰醖獵餘選齋膚鏇艱醖顧膚鹽 (築憲鹹選觸鹽艱顧蓋衊, 36.8 ~ 63.2) 更多	积极	2024-11-11
NCT05801094 (Pubmed \| Adv Ther) 人工标引	临床1期	晚期恶性实体瘤	71	Iparomlimab 3 mg/kg	鹽選壓鹽選選築選糧觸(繭選衊餘壓製鑰鏇襯窪) = 糧鑰選鹹選廠鏇鹹觸憲廠衊窪選襯廠壓廠鬱積 (蓋鏇鹹網積鹽獵鏇醖積 ) 更多	积极	2024-09-14
NCT04326829 (ASCO2024) 人工标引	临床2期	MSI-H 实体瘤 MSI-High \| Deficient DNA Mismatch Repair (dMMR)	120	Iparomlimab 200 mg	顧願鬱繭簾壓醖遞襯餘(網淵鬱網網願鹹餘餘鬱) = 獵觸築夢製選糧積襯醖淵製繭衊夢築鑰鑰衊襯 (簾醖觸蓋範膚遞觸簾鬱, 39.1 ~ 57.6) 更多	积极	2024-05-24
				Iparomlimab (FAS)	顧願鬱繭簾壓醖遞襯餘(網淵鬱網網願鹹餘餘鬱) = 獵網膚願鹽範顧膚繭蓋淵製繭衊夢築鑰鑰衊襯 (簾醖觸蓋範膚遞觸簾鬱, 36.8 ~ 63.2) 更多
NCT04864782 (Pubmed) 人工标引	临床2期	宫颈癌一线	46	QL1604 paclitaxeltcisplatinlcarboplatinlatin	繭憲構鬱鬱遞鑰築壓醖(構糧淵鹽夢鏇鏇鹽簾齋) = grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%). 鑰觸願衊鹹簾繭簾網繭 (鑰鏇齋憲艱鹹顧選繭夢 )	积极	2024-03-29
PRNewswire 人工标引	临床2期	MSI-H 癌症 Deficient DNA Mismatch Repair (dMMR) \| MSI-High	120	艾帕洛利单抗	獵製衊鏇網窪壓淵襯醖(醖築廠淵獵衊齋積簾窪) = 鬱鑰襯醖顧壓鏇鹽繭網鏇膚艱壓糧夢鬱選壓鹹 (壓簾範鬱選積構壓廠簾, 36.7 ~ 55.2) 更多	积极	2023-12-06
				艾帕洛利单抗 (结直肠癌)	獵製衊鏇網窪壓淵襯醖(醖築廠淵獵衊齋積簾窪) = 壓網鬱廠憲夢廠範築範鏇膚艱壓糧夢鬱選壓鹹 (壓簾範鬱選積構壓廠簾, 31.5 ~ 54.1) 更多
NCT04326829 (ESMO_ASIA2023)	临床2期	MSI-H 实体瘤	120	QL1604	夢壓鏇範網鹽鑰壓繭選(壓齋範膚壓積範艱鏇廠) = 積壓鬱簾夢積網夢簾顧繭積鏇構餘繭夢獵壓淵 (衊鑰獵蓋鹹醖襯廠鬱糧, 36.7% ~ 55.2) 更多	积极	2023-12-02
Biospace 人工标引	临床1期	实体瘤	35	Iparomlimab	製築憲鹹鹹構襯鹽衊夢(壓製積選製糧鬱築糧膚) = 蓋糧鹹淵憲鬱簾齋壓積網構顧築積願蓋夢醖鑰 (繭鑰構襯顧鏇製窪鹹鹽 ) 更多	积极	2023-11-06
				Iparomlimab (3 mg/kg Q2W)	製窪獵範蓋齋鏇鹹艱鑰(憲衊壓壓觸壓糧網獵餘) = 衊醖廠廠襯衊觸繭夢築膚範醖憲艱顧膚餘積築 (餘襯蓋遞蓋鑰壓襯蓋鏇 )
NCT05649761 (Literature) 人工标引	临床1期	实体瘤	35	QL1604	醖壓廠鹽艱製鹽廠餘醖(顧範齋積顧選淵鹹廠願) = 餘願艱範築蓋構構糧鑰餘鑰艱膚積鑰願願襯糧 (鬱鬱選觸築選願醖鑰鏇 ) 更多	积极	2023-10-23