Cetuximab biobetter(Shanghai Henlius Biotech, Inc.)、Humanized anti-EGFR monoclonal antibody(Shanghai Henlius Biotech, Inc.)、Recombinant Anti-EGFR Humanised Monoclonal Antibody(Shanghai Henlius Biotech, Inc.)

+ [3]

靶点

EGFR

作用方式

拮抗剂

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)

治疗领域

肿瘤呼吸系统疾病消化系统疾病+ [3]

在研适应症

皮肤鳞状细胞癌鳞状非小细胞肺癌鼻咽癌+ [7]

非在研适应症

晚期肝细胞癌晚期鳞状非小细胞肺癌晚期肺非鳞状非小细胞癌+ [6]

原研机构

上海复宏汉霖生物技术股份有限公司

在研机构

上海复星医药产业发展有限公司上海复宏瑞霖生物技术有限公司上海复宏汉霖生物医药有限公司

+ [1]

非在研机构

Henlix, Inc.

权益机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评-

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结构/序列

Sequence Code 616724690H

来源: *****

Sequence Code 616724691L

来源: *****

关联

项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的临床试验

NCT06542588

/ Recruiting临床2期IIT

A Multicenter, Single-arm, Open-label Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07 and Serplulimab in the Treatment for RAS/BRAF Wild Type Locally Advanced Rectal Cancer

The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of patients with RAS/BRAF wild type locally advanced rectal cancer(LARC) treated with short-term radiotherapy, sequential HLX07, Serplulimab and CAPOX. A total of 29 patients were included in this study.

开始日期2024-07-19

申办/合作机构

华中科技大学同济医学院附属协和医院

NCT05360368

/ Unknown status临床1期

A Phase I Clinical Study To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors

This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.

开始日期2023-03-30

申办/合作机构

上海复宏汉霖生物技术股份有限公司

NCT05354700

/ Unknown status临床2期

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)

This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

开始日期2023-03-29

申办/合作机构

上海复宏汉霖生物技术股份有限公司

100 项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的临床结果

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100 项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的转化医学

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100 项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的专利（医药）

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项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的文献（医药）

2024-12-01·Cancer Communications

HLX07 alone or combined with serplulimab, cisplatin and 5‐fluorouracil for advanced esophageal squamous cell carcinoma: A phase 2 study

Article

作者: Hu, Xuhui ; Wang, Lin ; Zhuang, Wu ; Yang, Mudan ; Li, Ning ; Liu, Bo ; Liu, Yun ; Zhu, Jun ; Wang, Ying ; Zhu, Yanrong ; Huang, Jing ; Chen, Jiayan ; Wang, Qingyu ; Wang, Yanfeng ; Zhou, Jin ; Wu, Tao ; Liu, Zhenyang ; Yuan, Yuan ; Tan, Zhenbo ; Yu, Haoyu

Abstract:

Background:

The combination of anti‐PD‐1 antibody serplulimab and chemotherapy is considered standard first‐line therapy for advanced esophageal squamous cell carcinoma (ESCC), but few later‐line treatments are available. Here we evaluated the therapeutic efficacy of the recombinant, humanized anti‐EGFR antibody HLX07 when used alone or together with serplulimab and chemotherapy against advanced ESCC.

Methods:

This open‐label, non‐randomized, two‐cohort, phase 2 trial involved patients 18‐75 years old with histologically or cytologically confirmed locally advanced, unresectable, or metastatic ESCC, and an Eastern Cooperative Oncology Group performance status of 0‐1. Patients who had failed first‐line immuno‐chemotherapy or at least two lines of other systemic therapy received HLX07 monotherapy intravenously at a dose of 1,000 mg once every 2 weeks (Q2W). Patients with no prior systemic therapy received HLX07 (1,000 mg, day 1) and serplulimab (200 mg, day 1) intravenously Q2W for up to 2 years, concurrently with cisplatin (50 mg/m2, day 1) for up to 8 cycles and 5‐fluorouracil (1,200 mg/m2, days 1‐2) for up to 12 cycles intravenously Q2W. The primary endpoints were progression‐free survival (PFS) and objective response rate (ORR).

Results:

Overall, 50 patients were enrolled. In the HLX07 monotherapy group, ORR was 15.0% (3/20), and the median PFS was 1.5 months (95% confidence interval [CI], 1.3 to 3.7). The median duration of response was not reached, and the rate of patients showing an objective response lasting at least 6 months was 66.7% (95% CI, 5.4 to 94.5). Two (10.0%, 2/20) patients experienced grade 3‐4 treatment‐related adverse events (TRAEs), including hypomagnesemia, hypocalcemia, and fatigue. No patient experienced grade 5 TRAEs. In the HLX07 combination group, the ORR was 60.0% (18/30), and the median PFS was 7.8 months (95% CI, 3.3 to 9.1). Fourteen (46.7%, 14/30) patients experienced grade 3‐4 TRAEs, and one (3.3%, 1/30) patient died due to serplulimab‐related pneumonitis.

Conclusions:

HLX07 monotherapy and its combination with serplulimab and chemotherapy showed manageable toxicity and promising antitumor activity in patients with recurrent or metastatic ESCC. Randomized controlled trials are warranted to further establish the safety and efficacy of HLX07 against ESCC.

Trial registration:

This trial was registered at Clinicaltrials.gov (NCT05221658).

2021-11-02·Expert opinion on biological therapy3区 · 医学

Distinguishing features of a novel humanized anti-EGFR monoclonal antibody based on cetuximab with superior antitumor efficacy

3区 · 医学

Article

作者: Ho, Chieh-Hsin ; Jiang, Weidong ; Chen, Shih Chieh ; Liu, Eugene ; Cheng, Yun-Chih ; Issafras, Hassan ; Wang, Yanling ; Lin, Pei-Hua ; Tseng, Chi-Ling

BACKGROUND:

Cetuximab, the first approved EGFR targeting therapeutic antibody, is currently used to treat colorectal cancer and head and neck cancer. While effective, cetuximab is associated with a higher rate of skin rash, infusion reactions, and gastrointestinal toxicity, which was suggested to be linked to the presence of heterogeneous glycan contents on the Fab of the SP2/0-produced cetuximab.

OBJECTIVE AND METHODS:

To improve efficacy and minimize toxicity of EGFR inhibition treatment, we re-engineered cetuximab by humanizing its Fab regions and minimizing its glycan contents to generate HLX07.

RESULTS:

HLX07 binds to EGFR with similar affinity as cetuximab and shows better bioactivity compared to cetuximab in vitro. In vivo studies demonstrated that HLX07 significantly inhibited the growth of A431, FaDu, NCI-H292, and WiDr tumor cells and synergized them with chemotherapeutics and immune simulator agents such as anti-PD-1. In cynomolgus monkeys, 13-week repeat-dose GLP toxicokinetic studies showed minimal-to-mild toxicities in the dose range of up to 60 mg/kg/wk. In the preliminary phase 1 dose-escalation study, HLX07 had showed lower incidence of skin rashes with grade >2 severities.

CONCLUSION:

HLX07 is currently under phase 1/2 clinical development. We believe HLX07 would potentially be an alternative for patients who have been suffering from cetuximab-mediated toxicity.

2021-10-01·Investigational new drugs3区 · 医学

Phase I first-in-human study of HLX07, a novel and improved recombinant anti-EGFR humanized monoclonal antibody, in patients with advanced solid cancers

3区 · 医学

Article

作者: Zhu, Yunting ; Zhang, Xiaodi ; Hou, Ming-Mo ; Lin, Hsuan-Yu ; Ho, Ching-Liang

Summary:

Purpose This study aimed to evaluate the safety and pharmacokinetic (PK) profiles of HLX07, a novel, recombinant, humanized anti-epidermal growth factor receptor (EGFR) antibody, in patients with advanced solid cancers who had failed standard therapy or for whom no standard therapy was available. Methods In this prospective, open-label, Phase I dose escalation study, patients aged ≥18 years (≥20 years for patients in Taiwan) with histologically-confirmed metastatic or recurrent epithelial carcinoma that had no K-RAS or B-RAF mutations were enrolled in a ‘3 + 3’ escalation design. HLX07 was administered weekly by 2-h intravenous infusion at doses ranging from 50 to 800 mg. The primary endpoint was summary listing of participants reporting treatment-emergent adverse events (TEAEs). Secondary endpoints included PK analysis, serum anti-HLX07 antibody assessments and efficacy. Results In total, 19 patients were enrolled between 1 October 2016 and 16 July 2019 to receive HLX07 at doses of 50 (n = 3), 100 (n = 3), 200 (n = 3), 400 (n = 3), 600 (n = 3) and 800 (n = 4) mg per week. All patients experienced at least one TEAE, most commonly fatigue (68.4%), nausea (47.4%), paronychia (31.6%) and vomiting (31.6%). Serious TEAEs were reported in 11 patients but only one serious TEAE (dyspnea in 600 mg cohort) was regarded as possibly related to study treatment. No dose limiting toxicity (DLT) was reported. Systemic exposure to HLX07 increased proportionally with dose. Anti-HLX07 antibodies were not detected in any patients. Conclusion HLX07 was well tolerated (at dose levels up to 800 mg/week) and promising in patients with advanced solid cancers.Clinical Trial Registration: The study was registered at ClinicalTrials.gov: NCT02648490 (Jan 7, 2016).

项与匹姆瑞妥单抗(上海复宏汉霖生物) 相关的新闻（医药）

2025-08-16

·汇聚南药

谁来填上PD-1挖下的“大坑”？

Keytruda（K药）为代表的PD-1药物，改写了癌症治疗格局，开创了免疫治疗（IO）的黄金时代。可PD-1药物辉煌背后，却因应答率和耐药性问题而充满遗憾。PD-1药物400亿美元的规模之下，谁能填补PD-1挖下的坑，谁就有望成为IO疗法2.0时代的答案，这亦是全球各大药企争夺的焦点。如何全面填补PD-1留下的空白呢？行业之中并未达成共识。有的企业布局药物联用，有的企业重注PD-1双抗。对于这个问题，拥有PD-1药物的复宏汉霖，自2022年5月就开始尝试解题，并最终在今年ASCO上给出了一个出人意料的答案——HLX43（PDL-1 ADC）。 8月14日，世界肺癌大会（WCLC）更新了最新（摘要）数据，显示出该分子在晚期实体瘤、特别是多数接受过检查点抑制剂治疗并失败的后线耐药NSCLC患者中的高效低毒潜力，尤其在EGFR野生型非鳞状NSCLC等亚组中展现了更瞩目的疗效，客观缓解率（ORR）达到47.4%，且安全性良好。当然，HLX43距离最终成药还有一定的距离，尚存不确定因素。但现有的数据已经足以说明PD-1药物留下的坑是可以完美填上的，矗立于潮头的复宏汉霖HLX43无疑是最有希望的玩家。 01 横空出世的“补全计划” 肺癌是全球发病率和死亡率最高的癌症，大部分肺癌患者确诊时已处于疾病晚期阶段，如肺癌Ⅳ期五年生存率就小于5%。据GLOBOCAN最新数据显示，2022年全球约有超过248万新发肺癌病例，占癌症新发病例的12.4%，这其中约85%的肺癌类型为非小细胞肺癌（NSCLC）。进一步划分，NSCLC又可分为鳞状细胞癌（约30%）、肺腺癌（约50%）以及其他癌种。图：NSCLC分类一览现阶段，表皮生长因子受体（EGFR）是公认的肺癌第一大驱动基因，围绕这一靶点已经诞生了三代EGFR-TKI，整体治疗方案已经趋向于成熟。可即使如此，依然没有彻底改变肺癌预后较差的局面，原因在于“野生型”的患者才是大多数。所谓“野生型”，其实是一个相对概念。肺癌细胞中常存在驱动肿瘤生长的基因突变，如EGFR、ALK、ROS1等，这些含有基因突变的肺癌即被称为“突变型”。通过基因检测，若未发现某基因突变，即为相应基因的“野生型”。在全部NSCLC患者中，EGFR野生型的占比高达70%-85%，涵盖几乎所有的鳞状细胞癌和大部分的肺腺癌患者。由于缺乏驱动基因，无法使用针对性的靶向药物，因此“野生型”肺癌十分难治，好在PD-1单抗的出现，解决了“野生型”肺癌难以对症下药的难题。然而，PD-1药物虽好，但却并不是万能的。即使在PD-L1高表达的NSCLC癌患者中，单药有效率也不足40%，多数初始响应的患者最终会在12-18个月内重新出现疾病进展。而一旦PD-1药物耐药后，化疗则成为唯一治疗手段，无进展生存期（PFS）仅有2-3个月，有效率仅有10%左右。 HLX43是一款靶向程序性死亡-配体1（PD-L1）的新型ADC候选药物，由公司自研的全人源IgG1抗PD-L1抗体，与宜联引进的创新连接子-拓扑异构酶抑制剂荷载偶联而成，药物抗体比（drug-to-antibody ratio, DAR）约为8。它巧妙兼顾了PD-1的肿瘤免疫作用和ADC毒素的精准杀伤，其毒素不仅能够基于靶点内吞进入肿瘤细胞后释放，还可以在肿瘤微环境中释放后借助旁观者效应进入肿瘤细胞，阻断DNA复制，从而导致肿瘤细胞凋亡。 HLX43的I期临床研究结果首次在2025 ASCO上公布，WCLC将更新更大样本量数据：提示HLX43良好的耐受性，不同剂量下均未产生新的安全信号，对标准疗法治疗失败的晚期实体瘤患者、尤其NSCLC、TSCC患者显示出令人鼓舞的初步疗效。具体而言，HLX43的I期临床研究主要分为两大部分：Ia（剂量递增阶段）及Ib期（剂量扩增阶段）患者的既往中位治疗线数分别为2和3。其中，Ib期患者之前均接受过铂类药物治疗。也就是说，HLX43入组的患者，尤其是Ib期的NSCLC患者，基本都是经过IO以及其他方案治疗后的末线耐药人群，能在这样的基线患者中取得38.1%（2mg，21例）和33.3%（2.5mg，21例）的ORR是非常不易的。更为惊喜的是，几近终末期的脑转移NSCLC患者的疾病控制率（DCR）达到100%。对于几乎100% EGFR野生型的肺鳞癌患者，亚组ORR为40%，数据可以说相当亮眼。此外，在EGFR野生型的非鳞状NSCLC患者中，HLX43展现了更为优异的疗效，客观缓解率（ORR）达47.4%。同时，HLX43在PD-L1阳性/阴性/未知患者人群中皆显示良好的疗效，在PD-L1阳性NSCLC患者（n=50）ORR为32.0%（16/50），而PD-L1阴性/未知的患者（n=19）ORR为31.6%（6/19），无明显差异，提示不依赖肿瘤标志物筛选。以最终的结果看，无论肺癌分型，PD-L1表达水平，亦或是否发生脑转移和肝转移，HLX43均展现出良好的疗效，有望完美填补PD-1单抗耐药后所留下的临床空白。疗效出众的同时，HLX43还展现出极好的安全性，尽管所有患者均报告有治疗期间出现的不良事件（TEAEs），但大多为较轻的1-2级。发生3级及以上TRAE的患者为5例（23.8%），均来自3 mg/kg和4 mg/kg组，最常见的为中性粒细胞计数降低（19%）、白细胞计数降低（19%）和贫血（14.3%）。值得关注的是，本研究中报告了免疫相关不良事件（irAE），提示HLX43可通过免疫激活机制强化抗肿瘤疗效；而报告irAE患者人群ORR得到提升。一直以来，ADC药物都极容易出现毒性副作用，而血小板是否减少就是关键性指标。在2.0 mg/kg剂量下HLX43血液学毒性较低，且没有出现血小板下降和中性粒细胞下降，展现出良好的安全性，这才是ADC药物能否站上一线的前提。综合来看，低毒、广谱、疗效好，是对于HLX43 I期临床数据的高度概括，而这正是一款大药所需要的特质。 02 一次全方面超越纵观PD-L1 ADC赛道，目前入局的玩家并不多，公开可查的信息仅有3款靶向PD-L1的ADC产品（含双抗ADC）进入临床，而HLX43是唯一进展至国际多中心Ⅱ期临床的。在HLX43公布临床数据之前，辉瑞收购Sengen所得的PF-08046054为这个赛道的领头羊，目前正处于临床I期，并计划在下半年开启Ⅲ期临床，而HLX43的横空出世无疑让业界开始重新审视这一赛道的竞争格局。所有ADC产品都拥有三大核心要素：抗体、连接子、毒素。复宏汉霖的HLX43几乎在这三方面全部进行了差异化创新设计，相较之下曾经的“领头羊”辉瑞PF-08046054的设计已经略显陈旧。图：HLX43结构图抗体在ADC药物中，充当着“司机”的作用，它负责将细胞毒性有效载荷定向输送到肿瘤部位，经内吞后在细胞内释放毒素，所以抗体的亲和力与内吞效率对于ADC药物而言至关重要。 HLX43的抗体骨架采用复宏汉霖自主研发的HLX20，具有抗原的高结合能力及肿瘤细胞的内吞效率，同时HLX20是Fc端静默的抗体，无ADCC效应。相关研究显示，HLX20在靶点亲和力、肿瘤抑制功能、内吞能力等方面皆与阿替利珠单抗类似。辉瑞PF-08046054的PD-L1抗体同样消除了ADCC效应，亲和力与内容效率较为相似。不过，HLX43在NHP Tox试验中表现出脱靶毒性较低的高稳定性，因此支持三周一次的给药间隔，而PF-08046054的给药频率则为三周两次。患者依从性方面，HLX43有着明显的比较优势。连接子方面，HLX43采用的是可裂解的三肽连接子，引进自具有技术优势的宜联TMALIN®平台，不仅通过内吞途径胞内释放毒素，还能够在肿瘤微环境中激活释放毒素，实现毒素于“胞内”和“胞外”的双重释放。而辉瑞PF-08046054采用的则是传统VC-MMAE连接子，血液中稳定性较差，容易引发毒副作用。毒素方面，HLX43更是优势明显。HLX43采用的是新型强效载荷毒素C24，DAR为8。辉瑞PF-08046054采用的则是二代ADC常用的 MMAE（vedotin）有效载荷，DAR为4，毒性不及C24而且半衰期更短，这成为其较为明显的技术短板。今年的ASCO大会上，首次披露人体临床数据的HLX43即显示出超强竞争力，在PD-L1低表达的患者仍然显示出40%的ORR，且临床进度也几乎追上PF-08046054，展现出成为Best in class（BIC）和First in class（FIC）的双重潜力。图：两款PD-L1 ADC药物Ⅰ期临床结果对比辉瑞其实也看到了PF-08046054身上的不足，因此它已经悄然布局新一代药物PF-08046037，属于PD-L1 ISAC药物（抗体免疫刺激偶联物），采用甘露糖苷酶可切割的马来酰亚胺丙酰甘露糖接头，与基于咪唑喹啉的 TLR7 激动剂相连。不过这款药物目前仅处于临床前阶段，想要商业化仍有很长的路要走。综合来看，HLX43在设计理念上全方面领先于PF-08046054，虽然二者临床进度相近，但HLX43却更像是下一代的迭代产品。 03 下一代“药王” 从现有临床数据看，PD-L1 ADC已然具备填补PD-1单抗身后空白的潜力，由于其靶点为PD-L1，具备抗癌广谱性，进而有望成为一款真正的“药王”级产品。如果PD-L1 ADC产品后续发展顺利，那么它很可能复制第三代EGFR-TKI奥希替尼的成长逻辑。在奥希替尼之前，EGFR曾出现过两代产品，分别是吉非替尼为代表的第一代EGFR-TKI，阿法替尼为代表的第二代EGFR-TKI。之所以存在代际之分，其核心诱因正是患者不断出现的耐药性。第一代EGFR-TKI其实已经十分优秀，它成功的将患者的平均存活周期由18个月提升至28.7个月，但最终还是败给了耐药性问题。真正让患者生存周期显著拉长的，正是神奇的奥希替尼，它攻克了T790M耐药性突变的问题，如今已经成为一款年销售额突破65亿美元的大药，这已经是吉非替尼销售峰值的10倍（吉非替尼销售峰值为6.47亿美元）。与EGFR-TKI类似，目前PD-1单抗最核心的问题其实也是耐药性和应答不足，而ADC机制的加入有望攻克这个难题。当PD-L1 ADC疗效得到验证，它完全有希望像奥希替尼一样从后线提升至一线，甚至成为接替PD-1单抗的IO疗法主流（或与PD-1单抗联用）。一语以弊之，PD-L1 ADC最大的特点正是有能力填补PD-1单抗留下的空白，但其核心价值却并不仅限于此，它是完全有潜力成为一线主流疗法的。如今，HLX43展现出的BIC和FIC双重潜力，极有可能助推其成为“药王”级别的大药。令人更为惊喜的是，复宏汉霖的进击之路远不止于此，最新出炉的WCLC摘要中，复宏汉霖公布了HLX07联合斯鲁利单抗和化疗一线治疗晚期sqNSCLC 的ORR可达70%左右，获益显著。尤为有趣的是，此次亮相的II期临床的入排标准是EGFR表达H-score≥150，意味着精准针对EGFR中高表达人群。上帝关上一扇门，必将打开一扇窗。EGFR野生型肺癌固然凶猛，但野生型≠无特征。另一组数据悄然揭示了新的突破口—肺癌患者中高达62%的患者却是EGFR高表达，鳞状NSCLC患者EGFR高表达率更是占到了总体的89%。这意味着，大量“野生型”患者其实具备潜在生物标志物，只是这个特征从未真正转化为循证治疗路径。当前，PD-1抑制剂已成为晚期sqNSCLC一线治疗的主轴，但对于EGFR高表达亚群，并无专门设计的免疫联合策略。临床上的空白，让这一亚群长期处于“被平均”状态，是盲点，也是机会，这是一条看似冷门、实则潜藏巨大人群基数的精准赛道。复宏汉霖正试图打破这一现状，结合既往研究，开展了HLX07（EGFR单抗）联用斯鲁利单抗（PD-1单抗）和化疗的多种联合方案，一线治疗晚期鳞状非小细胞肺癌（sqNSCLC）患者，直指晚期sqNSCLC患者一线治疗的空白。根据此次更新数据的摘要，HLX07联合斯鲁利单抗及化疗在EGFR高表达sqNSCLC患者中在两个剂量组中都展现出显著的抗肿瘤活性和持久疗效。中位随访18.6个月时，两个剂量组均实现了约七成的ORR；高剂量组DCR高达100%，PFS达到17.4个月，低剂量组的中位PFS在随访时尚未达到，两组的中位OS和持续缓解时间（DOR）均未达到，显示出疗效持久且有进一步改善的潜力。多数治疗期间不良事件（TEAEs）如皮疹、血小板减少等均在可控范围内，安全性良好。如果这一路径在之后更大规模临床试验中被验证，不仅将填补临床盲区，也意味着行业有机会在标准分型之外，基于表达水平主动划定一个全新亚型——是一种“临床意义上的再分型”，路径精准，实则潜藏巨大人群基数。如果成功，这不仅是一个新方案的建立，更可能是肺癌免疫治疗分型逻辑的一次局部改写。此外，“后IO时代”用药荒并非肺癌的特例，其他很多癌症也出现类似问题，如预后较差的胸腺癌就亟待安全且有效的新型治疗方案。由于胸腺癌普遍存在驱动基因缺乏、耐药机制复杂、不良反应严重等治疗局限，因此治疗手段严重受限。一线治疗主要为联合化疗方案，虽然K药已经获批二线疗法，却仍留下了巨大的需求空白。结合HLX43的I期临床数据，晚期实体瘤患者整体ORR为36.8%，其中胸腺鳞状细胞癌（TSCC）疗效尤为值得关注，患者ORR达到75%（3/4），尽管患者基数过少，但从复宏汉霖近期的动作来看，计划在美国等地同步开展HLX43治疗胸腺癌中的国际多中心研究，足见还是非常看好产品在胸腺癌中的潜力。胸腺癌之外，公司也在更广谱的实体瘤中进行POC试验，目前已累计启动7项针对非小细胞肺癌、结直肠癌、宫颈癌、肝细胞癌、食管鳞癌、头颈鳞癌、鼻咽癌等实体瘤的II期临床，探索联用自有的PD-1单抗的治疗方案，种种趋势显示其或将对标DS-8201 的开发路径，通过普适性验证，快速覆盖广泛瘤种，加速奔向下一款肿瘤治疗领域的重磅药物。喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~ 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：医曜往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

ASCO会议抗体药物偶联物免疫疗法临床结果临床研究

2025-08-14

·复星医药

WCLC抢先看！肺癌全覆盖，复星医药子公司复宏汉霖创新产品10项研究入选，4项口头报告即将亮相

太平洋时间2025年8月13日，2025年世界肺癌大会（World Conference on Lung Cancer, WCLC）官网公布了本届大会入选研究摘要的详细信息，复星医药子公司复宏汉霖三款肺癌领域核心创新型产品PD-L1 ADC HLX43、抗EGFR单抗HLX07和抗PD-1单抗H药汉斯状®的10项肺癌领域研究入选大会口头报告、壁报导览、壁报展示等多个专场，其中包括4项口头报告，2项壁报导览，覆盖非鳞状/鳞状非小细胞肺癌（nsNSCLC/sqNSCLC）及广泛期小细胞肺癌（ES-SCLC）的一线治疗，同时，也探索了免疫联合疗法在脑转移患者、肺癌围术期患者等广泛人群中的治疗潜力。据GLOBOCAN最新数据显示，肺癌是全球发病率和死亡率最高的癌症，2022年全球约有超过248万新发肺癌病例，占癌症新发病例的12.4%[1]。肺癌分为小细胞肺癌（SCLC）和非小细胞肺癌（NSCLC），其中约85%的肺癌类型为NSCLC。进一步划分，NSCLC又可为鳞状细胞癌（约30%）、肺腺癌（约50%）以及其他癌种。复宏汉霖在肺癌治疗领域持续深耕，从H药引领小细胞肺癌免疫治疗，到HLX43、HLX07等多元管线覆盖非小细胞肺癌多个分子特征，公司已逐步构建差异化、全人群覆盖的产品矩阵。 HLX43是全球首个进入临床II期阶段的PD-L1的广谱抗肿瘤ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。HLX43在晚期实体瘤、尤其是绝大多数接受过检查点抑制剂（CPI）治疗并失败的后线耐药NSCLC患者中，持续表现出高应答率，在特定亚组如EGFR野生型nsNSCLC人群中展现了更为优异的疗效，ORR达47.4%，同时延续了良好的安全性。HLX07是公司自主开发的改良型靶向EGFR的人源化单抗，其联合斯鲁利单抗及化疗在EGFR高表达sqNSCLC患者中展现出显著的抗肿瘤活性和持久疗效。在中位随访18.6个月时，高剂量组疾病控制率（DCR）高达100%，中位无进展生存期（PFS）达到17.4个月。H药为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗，迄今已在近40个国家和地区获批上市，覆盖全球近半数人口。在肺癌领域，H药已获批联合化疗用于一线治疗驱动基因阴性的鳞状非小细胞肺癌（sqNSCLC）、非鳞状非小细胞肺癌（nsNSCLC）以及广泛期小细胞肺癌（ES-SCLC）。重磅口头报告，印证NSCLC疗效本次大会上，由中国医学科学院肿瘤医院石远凯教授担任牵头主要研究者的H药联合化疗一线治疗晚期非鳞状非小细胞肺癌的III期临床（ASTRUM-002）研究，将以口头汇报的形式首次发布，mPFS显著延长5.4个月，脑转移人群获益明确。同时，多项探索H药免疫联合疗法的IIT研究结果也入选大会简短口头报告（Mini Oral）、壁报导览和壁报展示环节，印证了H药在nsNSCLC脑转移患者、EGFR-TKI耐药和非小肺癌围术期患者中的疗效与安全性，展现在更广泛人群中的治疗潜力。 ASTRUM-002研究是一项三臂、随机、双盲、多中心III期研究，患有局部进展期或转移性非鳞状非小细胞肺癌、不携带EGFR致敏突变和ALK/ROS重排、且无系统性治疗史的患者，按1:1:1比例随机分配接受斯鲁利单抗联合HLX04（贝伐珠单抗）及化疗（卡铂-培美曲塞）、斯鲁利单抗联合化疗或化疗。研究结果表明，斯鲁利单抗联合化疗对比化疗一线治疗晚期非鳞状非小细胞肺癌（NSCLC），中位无进展生存期（mPFS）显著延长（11.0个月 vs. 5.6个月；分层HR=0.55，95%置信区间[CI]：0.43-0.69，P < 0.0001），达到预设的优效标准，且具有良好的安全性，未观察到新的安全性信号。在脑转移患者亚组中，斯鲁利单抗联合化疗组的中位PFS达8.1个月，较对照组延长4.0个月，降低疾病进展或死亡风险49%（HR=0.51, 95%CI：0.30-0.87，P=0.0115）。一项斯鲁利单抗联合贝伐珠单抗和化疗治疗初治非鳞状非小细胞肺癌伴脑转移的II期研究。研究共纳入40例未经治疗的伴有脑转移的非鳞状非小细胞肺癌患者，接受斯鲁利单抗联合贝伐珠单抗以及化疗（培美曲塞和卡铂）的一线治疗。中位随访13.3个月，中位颅内无进展生存期（iPFS）为13.1个月，颅内肿瘤客观缓解率（ORR）为84.6%，颅外ORR为64.1%，显示出强大的抗肿瘤活性。研究结果显示，斯鲁利单抗联合贝伐珠单抗和化疗一线治疗伴有脑转移的非鳞状非小细胞肺癌患者表现出有前景的颅内抗肿瘤有效性和可控的安全性。 EGFR高表达肺癌，潜力优势治疗选择在全球非小细胞肺癌（NSCLC）患者中，EGFR高表达的比例约为40%–89%（取决于病理分型、种族等因素），意味着每年有数百万新发患者属于这一人群[2-4]。尤其是在sqNSCLC患者中，高达89%表现为EGFR高表达[2-3]。复宏汉霖亦积极推进一项创新型抗EGFR单抗HLX07联合斯鲁利单抗的创新疗法用于一线治疗EGFR高表达的sqNSCLC的临床II期研究，以满足该领域的临床未尽之需。这项研究的最新临床数据结果入选本次WCLC大会的壁报展示环节。 HLX10HLX07-sqNSCLC-201研究是一项随机、多中心的二期研究，包括4个部分，评估了HLX07（不同剂量）、斯鲁利单抗和化疗的多种组合。第3部分评估了三药组合的初步有效性，EGFR高表达（H评分≥150）且无既往系统治疗的患者被随机分为1:1两组，接受静脉注射HLX07 800 mg或1000 mg，联合斯鲁利单抗和化疗。在中位随访18.6个月时，两个剂量组均实现了约七成的客观缓解率（ORR），且中位总生存期（mOS）和持续缓解时间（mDOR）均未达到显示出疗效持久且有进一步改善的潜力，且安全性良好。尤其值得注意的是，高剂量组疾病控制率（DCR）高达100%，中位无进展生存期（PFS）达到17.4个月。研究结果显示，HLX07联合斯鲁利单抗和化疗一线治疗晚期sqNSCLC患者显示出令人鼓舞的初步疗效，且安全性可控，支持对该治疗方案的进一步评估。肺癌一线全覆盖，ES-SCLC广获益复宏汉霖持续深化该产品在肺癌治疗领域的多元布局，目前已全面覆盖肺癌一线治疗。在小细胞肺癌领域，基于国际多中心III期临床ASTRUM-005研究，H药已于中国、英国、德国、新加坡、印度等全球近40个国家和地区获批用于一线治疗广泛期小细胞肺癌（ES-SCLC），该研究结束分析结果已于2025年美国临床肿瘤学会（ASCO）大会上发布，4年OS率达到21.9%。针对ES-SCLC，H药于全国范围内开展的中国ES-SCLC领域样本量最大的真实世界研究（ASTRUM-005R）最新结果已于2025年欧洲肺癌大会（ELCC）上发布，研究结果显示，中位rwPFS为8.2个月，中位OS达到17.2个月，为斯鲁利单抗联合化疗一线治疗ES-SCLC补充了有力证据。在本届WCLC大会上，该研究中针对PS评分≥2的ES-SCLC患者亚组研究分析数据，以及一项评估在ECOG PS≥2 的ES-SCLC患者人群中的荟萃分析等研究结果将进行发布，展现了免疫联合疗法对于ES-SCLC患者人群的广泛获益。目前，复宏汉霖正在加速推进H药治疗ES-SCLC的全球开发进程，其中日本的桥接临床试验已完成首例患者入组。同时，公司正在开展一项国际多中心III期临床试验，评估H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的疗效，进一步拓展其在SCLC治疗领域的全球布局。更多研究完整数据与亮点，敬请关注 WCLC 2025！参考文献 [1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. [2] Prabhakar CN. Epidermal growth factor receptor in non-small cell lung cancer. Transl Lung Cancer Res. 2015;4(2):110-118. doi:10.3978/j.issn.2218-6751.2015.01.01 [3] Karlsen E-A, Kahler S, Tefay J, Joseph SR, Simpson F. Epidermal Growth Factor Receptor Expression and Resistance Patterns to Targeted Therapy in Non-Small Cell Lung Cancer: A Review. Cells. 2021; 10(5):1206. https://doi.org/10.3390/cells10051206 [4] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. 关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，6个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Ten studies on Henlius' innovative products to be showcased at WCLC 2025, Including Three Oral Presentations On August 13, 2025 (Pacific Time), the World Conference on Lung Cancer (WCLC) 2025 has officially unveiled the list of accepted abstracts. Ten studies on Henlius' innovative PD-L1 ADC HLX43, anti-EGFR mAb HLX07 and anti–PD-1 monoclonal antibody(mAb)HANSIZHUANG(serplulimab) have been selected for multiple sessions, including oral presentations, poster tours, and poster presentations. Among these, 4 will be featured as oral presentations and 2 as poster tours. The selected studies span first-line treatment for non-squamous non–small cell lung cancer (nsNSCLC), squamous non–small cell lung cancer (sqNSCLC), and extensive-stage small cell lung cancer (ES-SCLC). In addition, innovative therapies are being actively promoted to explore the therapeutic potential of immunotherapy in a wide range of populations, including the perioperative setting for patients with NSCLC and patients with brain metastases. Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases [1]. Lung cancer is classified into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC making up approximately 85% of all cases. NSCLC can be further divided into sqNSCLC(about 30%), nsNSCLC(about 50%), and other subtypes. HLX43, a broad-spectrum anti-tumor PD-L1 ADC, is the first PD-L1 ADC progressed to phase 2 clinical trial development globally, exhibiting dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. HLX43 continues to demonstrate a high response rate in patients with advanced solid tumors, particularly in pretreated NSCLC patients who failed checkpoint inhibitor therapy. HLX43 exhibits superior efficacy in specific subgroups, with an objective response rate (ORR) of 47.4% in EGFR wild-type non-squamous NSCLC, while maintaining a favorable safety profile. HLX07 is a novel anti-EGFR mAb developed by Henlius, which demonstrated significant anti-tumor activity and durable efficacy when combined with serplulimab and chemotherapy in patients with EGFR high-expression sqNSCLC. At a median follow-up of 18.6 months, the high dose group reached a disease control rate (DCR) of 100% and a median progression-free survival (PFS) of 17.4 months. HANSIZHUANG is the world’s first anti–PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for marketing in nearly 40 countries and regions, covering almost half of the global population. HANSIZHUANG has been approved in combination with chemotherapy as a first-line treatment for sqNSCLC, nsNSCLC and ES-SCLC. Spotlight Oral Presentation: Demonstrating Efficacy in NSCLC In NSCLC, At this year’s WCLC, the Phase III ASTRUM-002 study, led by Professor Yuankai Shi of the Cancer Hospital, Chinese Academy of Medical Sciences, will debut its results in an oral presentation. The study evaluates serplulimab plus chemotherapy as a first-line treatment for advanced nsNSCLC, showing a median progression-free survival (mPFS) of 11.0 months, an improvement of 5.4 months compared to chemotherapy alone, as well as clear benefit in patients with brain metastases. Additionally, multiple investigator-initiated trials (IITs) exploring serplulimab in combination immunotherapy have been selected for Mini Oral presentations, poster tours, and poster presentations. These studies further validate the efficacy and safety of serplulimab in nsNSCLC patients with brain metastases, in EGFR-TKI–resistant cases, and in the perioperative setting for non-small cell lung cancer, underscoring its potential in broader patient populations. The ASTRUM-002 study is a randomized, double-blind, multicentre phase 3 clinical study. Patients with locally advanced or metastatic nsNSCLC without EGFR sensitizing mutations or ALK/ROS rearrangements and no prior systemic therapy were randomized 1:1:1 to receive serplulimab + HLX04 + chemo, serplulimab +chemo, or chemo. The results indicated that serplulimab + chemo versus chemo as first-line treatment of advanced nsNSCLC significantly prolonged mPFS(11.0 months vs. 5.6 months; stratified HR= 0.55, 95% CI: 0.43-0.69, P < 0.0001), meeting the prespecified superiority criteria, with good safety profile and no new safety signals were observed. In the subgroup of patients with brain metastases, the median PFS in the serplulimab + chemo group reached 8.1 months, an extension of 4.0 months compared with the chemo group, reducing the risk of disease progression or death by 49% (HR = 0.51, 95% CI: 0.30-0.87, P = 0.0115). Title: ASTRUM-002: First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung Cancer Form: Oral Session: OA05-lmmunotherapy for Special Populations Abstract Number: 1454 Leading PI: Yuankai Shi, Cancer Hospital Chinese Academy of Medical Sciences Time: Sunday Sep 7, 2025 4:47 PM-4:57 PM (CEST) A Phase 2 trial evaluated serplulimab plus bevacizumab and chemotherapy in treatment-naïve non-squamous NSCLC with brain metastases. The study enrolled 40 nsNSCLC patients with untreated brain metastases to receive first line treatment of serplulimab combined with bevacizumab, pemetrexed, and carboplatin. The median sPFS was 13.3 months. The intracranial ORR was 84.6%, with a 64.1% extracranial ORR, demonstrating potent antitumor activity. Serplulimab plus bevacizumab and chemotherapy demonstrated promising intracerebral antitumor efficacy and a manageable safety profile for patients with non-squamous NSCLC with BMs in the first-line setting. Title: Phase II Trial of Serplulimab Plus Bevacizumab and Chemotherapy for Treatment-Naive Non-Squamous NSCLC with Brain Metastases(SUPER BRAIN) Form: Mini Oral Session: MA10-Longer Follow Up and New IO Combinations Abstract Number: 2266 Leading PI: Likun Chen, Sun Yat-Sen University Cancer Center Time: Sep 9,2025 1:02 PM-1:07 PM (CEST) Potential Advantageous Therapy Option for EGFR High-Expression Lung Cancer In patients with NSCLC worldwide, the prevalence of EGFR overexpression is estimated at approximately 40%–89% (depending on histological subtype, ethnicity, and other factors), representing millions of newly diagnosed patients each year [2–4]. Notably, up to 89% of patients with sqNSCLC present with EGFR overexpression [2–3]. Henlius is actively advancing a phase 2 clinical study of HLX07, a novel anti-EGFR mAb developed by Henlius, in combination with serplulimab for the first-line treatment of EGFR high expression sqNSCLC, aiming to address the significant unmet clinical need in this population. Updated data from this study have been accepted for poster presentation at this year’s World Conference on Lung Cancer (WCLC). This randomized, multicenter phase 2 study consisted of 4 parts and assessed different combinations of HLX07 (at various doses), serplulimab, and chemotherapy. Part 3 explored the preliminary efficacy of the tri-combination regimen in systemic treatment-naïve patients with EGFR overexpression (H-score ≥150), who were enrolled and randomly assigned to group A (n=13) and group B (n=14). Two groups of patients received intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300mg) and chemotherapy. With a median follow-up of 18.6 months, both dose groups achieved an IRRC-assessed confirmed objective response rate (ORR) of around 70%, while the median overall survival (mOS) and median duration of response (mDOR) were not reached, indicating durable responses with the potential for further improvement, alongside a manageable safety profile. Notably, the group B achieved a disease control rate (DCR) of 100% and a median progression-free survival (PFS) of 17.4 months (95% CI 8.1-NE). These results demonstrate encouraging preliminary efficacy with a manageable safety profile of HLX07 plus serplulimab and chemotherapy as first-line treatment in patients with advanced sqNSCLC, supporting further investigation of this regimen. Title: First-line HLX07 plus serplulimab with or without chemotherapy in squamous non-small cell lung cancer: a phase 2 study Form: Poster Session: P3.12-Metastatic Non-small Cell Lung Cancer - Targeted Therapy Abstract Number: 1467 Leading PI: Yilong Wu, Guangdong Provincial People's Hospital Time: Sep 9, 2025 10:00 AM-11:30 AM (CEST) Full coverage of first-line lung cancer treatment, broad benefits in ES-SCLC Henlius continues to expand the layout of serplulimab in the field of lung cancer, achieving full coverage of first-line lung cancer treatment. In small cell lung cancer (SCLC), based on the international multicenter Phase III ASTRUM-005 study, serplulimab has been approved in nearly 40 countries and regions worldwide, including China, the UK, Germany, Singapore, and India, for the first-line treatment of ES-SCLC. The final analysis of this study was released at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, showing a 4-year OS rate of 21.9%. For ES-SCLC, the latest results from the largest real-world study in China in this field (ASTRUM-005R) were released at the 2025 European Lung Cancer Congress (ELCC). The study showed a median rwPFS of 8.2 months and a median OS of 17.2 months, providing robust evidence to support serplulimab plus chemotherapy as a first-line treatment for ES-SCLC. At this year’s WCLC, subgroup analysis data from this study in ES-SCLC patients with a PS score ≥2, as well as results from a meta-analysis in ES-SCLC patients with ECOG PS ≥2, will be presented, demonstrating the broad benefits of immunotherapy combinations for ES-SCLC patients. Henlius continues to accelerate the global development of serplulimab for ES-SCLC, with the first patient dosed in the Janpanese bridging study. In additon, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). For more research on data integrity and highlights, please stay tuned for WCLC 2025! About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 6 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

2025-08-14

·复宏汉霖

WCLC抢先看！肺癌全覆盖，复宏汉霖创新产品10项研究入选，4项口头报告即将亮相

太平洋时间2025年8月13日，2025年世界肺癌大会（World Conference on Lung Cancer, WCLC）官网公布了本届大会入选研究摘要的详细信息，复宏汉霖三款肺癌领域核心创新型产品PD-L1 ADC HLX43、抗EGFR单抗HLX07和抗PD-1单抗H药汉斯状®的10项肺癌领域研究入选大会口头报告、壁报导览、壁报展示等多个专场，其中包括4项口头报告，2项壁报导览，覆盖非鳞状/鳞状非小细胞肺癌（nsNSCLC/sqNSCLC）及广泛期小细胞肺癌（ES-SCLC）的一线治疗，同时，也探索了免疫联合疗法在脑转移患者、肺癌围术期患者等广泛人群中的治疗潜力。据GLOBOCAN最新数据显示，肺癌是全球发病率和死亡率最高的癌症，2022年全球约有超过248万新发肺癌病例，占癌症新发病例的12.4%[1]。肺癌分为小细胞肺癌（SCLC）和非小细胞肺癌（NSCLC），其中约85%的肺癌类型为NSCLC。进一步划分，NSCLC又可为鳞状细胞癌（约30%）、肺腺癌（约50%）以及其他癌种。复宏汉霖在肺癌治疗领域持续深耕，从H药引领小细胞肺癌免疫治疗，到HLX43、HLX07等多元管线覆盖非小细胞肺癌多个分子特征，公司已逐步构建差异化、全人群覆盖的产品矩阵。 HLX43是全球首个进入临床II期阶段的PD-L1的广谱抗肿瘤ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。HLX43在晚期实体瘤、尤其是绝大多数接受过检查点抑制剂（CPI）治疗并失败的后线耐药NSCLC患者中，持续表现出高应答率，在特定亚组如EGFR野生型nsNSCLC人群中展现了更为优异的疗效，ORR达47.4%，同时延续了良好的安全性。HLX07是公司自主开发的改良型靶向EGFR的人源化单抗，其联合斯鲁利单抗及化疗在EGFR高表达sqNSCLC患者中展现出显著的抗肿瘤活性和持久疗效。在中位随访18.6个月时，高剂量组疾病控制率（DCR）高达100%，中位无进展生存期（PFS）达到17.4个月。H药为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗，迄今已在近40个国家和地区获批上市，覆盖全球近半数人口。在肺癌领域，H药已获批联合化疗用于一线治疗驱动基因阴性的鳞状非小细胞肺癌（sqNSCLC）、非鳞状非小细胞肺癌（nsNSCLC）以及广泛期小细胞肺癌（ES-SCLC）。重磅口头报告，印证NSCLC疗效本次大会上，由中国医学科学院肿瘤医院石远凯教授担任牵头主要研究者的H药联合化疗一线治疗晚期非鳞状非小细胞肺癌的III期临床（ASTRUM-002）研究，将以口头汇报的形式首次发布，mPFS显著延长5.4个月，脑转移人群获益明确。同时，多项探索H药免疫联合疗法的IIT研究结果也入选大会简短口头报告（Mini Oral）、壁报导览和壁报展示环节，印证了H药在nsNSCLC脑转移患者、EGFR-TKI耐药和非小肺癌围术期患者中的疗效与安全性，展现在更广泛人群中的治疗潜力。 ASTRUM-002研究是一项三臂、随机、双盲、多中心III期研究，患有局部进展期或转移性非鳞状非小细胞肺癌、不携带EGFR致敏突变和ALK/ROS重排、且无系统性治疗史的患者，按1:1:1比例随机分配接受斯鲁利单抗联合HLX04（贝伐珠单抗）及化疗（卡铂-培美曲塞）、斯鲁利单抗联合化疗或化疗。研究结果表明，斯鲁利单抗联合化疗对比化疗一线治疗晚期非鳞状非小细胞肺癌（NSCLC），中位无进展生存期（mPFS）显著延长（11.0个月 vs. 5.6个月；分层HR=0.55，95%置信区间[CI]：0.43-0.69，P < 0.0001），达到预设的优效标准，且具有良好的安全性，未观察到新的安全性信号。在脑转移患者亚组中，斯鲁利单抗联合化疗组的中位PFS达8.1个月，较对照组延长4.0个月，降低疾病进展或死亡风险49%（HR=0.51, 95%CI：0.30-0.87，P=0.0115）。一项斯鲁利单抗联合贝伐珠单抗和化疗治疗初治非鳞状非小细胞肺癌伴脑转移的II期研究。研究共纳入40例未经治疗的伴有脑转移的非鳞状非小细胞肺癌患者，接受斯鲁利单抗联合贝伐珠单抗以及化疗（培美曲塞和卡铂）的一线治疗。中位随访13.3个月，中位颅内无进展生存期（iPFS）为13.1个月，颅内肿瘤客观缓解率（ORR）为84.6%，颅外ORR为64.1%，显示出强大的抗肿瘤活性。研究结果显示，斯鲁利单抗联合贝伐珠单抗和化疗一线治疗伴有脑转移的非鳞状非小细胞肺癌患者表现出有前景的颅内抗肿瘤有效性和可控的安全性。 EGFR高表达肺癌，潜力优势治疗选择在全球非小细胞肺癌（NSCLC）患者中，EGFR高表达的比例约为40%–89%（取决于病理分型、种族等因素），意味着每年有数百万新发患者属于这一人群[2-4]。尤其是在sqNSCLC患者中，高达89%表现为EGFR高表达[2-3]。复宏汉霖亦积极推进一项创新型抗EGFR单抗HLX07联合斯鲁利单抗的创新疗法用于一线治疗EGFR高表达的sqNSCLC的临床II期研究，以满足该领域的临床未尽之需。这项研究的最新临床数据结果入选本次WCLC大会的壁报展示环节。 HLX10HLX07-sqNSCLC-201研究是一项随机、多中心的二期研究，包括4个部分，评估了HLX07（不同剂量）、斯鲁利单抗和化疗的多种组合。第3部分评估了三药组合的初步有效性，EGFR高表达（H评分≥150）且无既往系统治疗的患者被随机分为1:1两组，接受静脉注射HLX07 800 mg或1000 mg，联合斯鲁利单抗和化疗。在中位随访18.6个月时，两个剂量组均实现了约七成的客观缓解率（ORR），且中位总生存期（mOS）和持续缓解时间（mDOR）均未达到显示出疗效持久且有进一步改善的潜力，且安全性良好。尤其值得注意的是，高剂量组疾病控制率（DCR）高达100%，中位无进展生存期（PFS）达到17.4个月。研究结果显示，HLX07联合斯鲁利单抗和化疗一线治疗晚期sqNSCLC患者显示出令人鼓舞的初步疗效，且安全性可控，支持对该治疗方案的进一步评估。肺癌一线全覆盖，ES-SCLC广获益复宏汉霖持续深化该产品在肺癌治疗领域的多元布局，目前已全面覆盖肺癌一线治疗。在小细胞肺癌领域，基于国际多中心III期临床ASTRUM-005研究，H药已于中国、英国、德国、新加坡、印度等全球近40个国家和地区获批用于一线治疗广泛期小细胞肺癌（ES-SCLC），该研究结束分析结果已于2025年美国临床肿瘤学会（ASCO）大会上发布，4年OS率达到21.9%。针对ES-SCLC，H药于全国范围内开展的中国ES-SCLC领域样本量最大的真实世界研究（ASTRUM-005R）最新结果已于2025年欧洲肺癌大会（ELCC）上发布，研究结果显示，中位rwPFS为8.2个月，中位OS达到17.2个月，为斯鲁利单抗联合化疗一线治疗ES-SCLC补充了有力证据。在本届WCLC大会上，该研究中针对PS评分≥2的ES-SCLC患者亚组研究分析数据，以及一项评估在ECOG PS≥2 的ES-SCLC患者人群中的荟萃分析等研究结果将进行发布，展现了免疫联合疗法对于ES-SCLC患者人群的广泛获益。目前，复宏汉霖正在加速推进H药治疗ES-SCLC的全球开发进程，其中日本的桥接临床试验已完成首例患者入组。同时，公司正在开展一项国际多中心III期临床试验，评估H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的疗效，进一步拓展其在SCLC治疗领域的全球布局。更多研究完整数据与亮点，敬请关注 WCLC 2025！参考文献 [1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. [2] Prabhakar CN. Epidermal growth factor receptor in non-small cell lung cancer. Transl Lung Cancer Res. 2015;4(2):110-118. doi:10.3978/j.issn.2218-6751.2015.01.01 [3] Karlsen E-A, Kahler S, Tefay J, Joseph SR, Simpson F. Epidermal Growth Factor Receptor Expression and Resistance Patterns to Targeted Therapy in Non-Small Cell Lung Cancer: A Review. Cells. 2021; 10(5):1206. https://doi.org/10.3390/cells10051206 [4] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. 关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，6个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Ten studies on Henlius' innovative products to be showcased at WCLC 2025, Including Three Oral Presentations On August 13, 2025 (Pacific Time), the World Conference on Lung Cancer (WCLC) 2025 has officially unveiled the list of accepted abstracts. Ten studies on Henlius' innovative PD-L1 ADC HLX43, anti-EGFR mAb HLX07 and anti–PD-1 monoclonal antibody(mAb)HANSIZHUANG(serplulimab) have been selected for multiple sessions, including oral presentations, poster tours, and poster presentations. Among these, 4 will be featured as oral presentations and 2 as poster tours. The selected studies span first-line treatment for non-squamous non–small cell lung cancer (nsNSCLC), squamous non–small cell lung cancer (sqNSCLC), and extensive-stage small cell lung cancer (ES-SCLC). In addition, innovative therapies are being actively promoted to explore the therapeutic potential of immunotherapy in a wide range of populations, including the perioperative setting for patients with NSCLC and patients with brain metastases. Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases [1]. Lung cancer is classified into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), with NSCLC making up approximately 85% of all cases. NSCLC can be further divided into sqNSCLC(about 30%), nsNSCLC(about 50%), and other subtypes. HLX43, a broad-spectrum anti-tumor PD-L1 ADC, is the first PD-L1 ADC progressed to phase 2 clinical trial development globally, exhibiting dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. HLX43 continues to demonstrate a high response rate in patients with advanced solid tumors, particularly in pretreated NSCLC patients who failed checkpoint inhibitor therapy. HLX43 exhibits superior efficacy in specific subgroups, with an objective response rate (ORR) of 47.4% in EGFR wild-type non-squamous NSCLC, while maintaining a favorable safety profile. HLX07 is a novel anti-EGFR mAb developed by Henlius, which demonstrated significant anti-tumor activity and durable efficacy when combined with serplulimab and chemotherapy in patients with EGFR high-expression sqNSCLC. At a median follow-up of 18.6 months, the high dose group reached a disease control rate (DCR) of 100% and a median progression-free survival (PFS) of 17.4 months. HANSIZHUANG is the world’s first anti–PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for marketing in nearly 40 countries and regions, covering almost half of the global population. HANSIZHUANG has been approved in combination with chemotherapy as a first-line treatment for sqNSCLC, nsNSCLC and ES-SCLC. Spotlight Oral Presentation: Demonstrating Efficacy in NSCLC In NSCLC, At this year’s WCLC, the Phase III ASTRUM-002 study, led by Professor Yuankai Shi of the Cancer Hospital, Chinese Academy of Medical Sciences, will debut its results in an oral presentation. The study evaluates serplulimab plus chemotherapy as a first-line treatment for advanced nsNSCLC, showing a median progression-free survival (mPFS) of 11.0 months, an improvement of 5.4 months compared to chemotherapy alone, as well as clear benefit in patients with brain metastases. Additionally, multiple investigator-initiated trials (IITs) exploring serplulimab in combination immunotherapy have been selected for Mini Oral presentations, poster tours, and poster presentations. These studies further validate the efficacy and safety of serplulimab in nsNSCLC patients with brain metastases, in EGFR-TKI–resistant cases, and in the perioperative setting for non-small cell lung cancer, underscoring its potential in broader patient populations. The ASTRUM-002 study is a randomized, double-blind, multicentre phase 3 clinical study. Patients with locally advanced or metastatic nsNSCLC without EGFR sensitizing mutations or ALK/ROS rearrangements and no prior systemic therapy were randomized 1:1:1 to receive serplulimab + HLX04 + chemo, serplulimab +chemo, or chemo. The results indicated that serplulimab + chemo versus chemo as first-line treatment of advanced nsNSCLC significantly prolonged mPFS(11.0 months vs. 5.6 months; stratified HR= 0.55, 95% CI: 0.43-0.69, P < 0.0001), meeting the prespecified superiority criteria, with good safety profile and no new safety signals were observed. In the subgroup of patients with brain metastases, the median PFS in the serplulimab + chemo group reached 8.1 months, an extension of 4.0 months compared with the chemo group, reducing the risk of disease progression or death by 49% (HR = 0.51, 95% CI: 0.30-0.87, P = 0.0115). Title: ASTRUM-002: First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung Cancer Form: Oral Session: OA05-lmmunotherapy for Special Populations Abstract Number: 1454 Leading PI: Yuankai Shi, Cancer Hospital Chinese Academy of Medical Sciences Time: Sunday Sep 7, 2025 4:47 PM-4:57 PM (CEST) A Phase 2 trial evaluated serplulimab plus bevacizumab and chemotherapy in treatment-naïve non-squamous NSCLC with brain metastases. The study enrolled 40 nsNSCLC patients with untreated brain metastases to receive first line treatment of serplulimab combined with bevacizumab, pemetrexed, and carboplatin. The median sPFS was 13.3 months. The intracranial ORR was 84.6%, with a 64.1% extracranial ORR, demonstrating potent antitumor activity. Serplulimab plus bevacizumab and chemotherapy demonstrated promising intracerebral antitumor efficacy and a manageable safety profile for patients with non-squamous NSCLC with BMs in the first-line setting. Title: Phase II Trial of Serplulimab Plus Bevacizumab and Chemotherapy for Treatment-Naive Non-Squamous NSCLC with Brain Metastases(SUPER BRAIN) Form: Mini Oral Session: MA10-Longer Follow Up and New IO Combinations Abstract Number: 2266 Leading PI: Likun Chen, Sun Yat-Sen University Cancer Center Time: Sep 9,2025 1:02 PM-1:07 PM (CEST) Potential Advantageous Therapy Option for EGFR High-Expression Lung Cancer In patients with NSCLC worldwide, the prevalence of EGFR overexpression is estimated at approximately 40%–89% (depending on histological subtype, ethnicity, and other factors), representing millions of newly diagnosed patients each year [2–4]. Notably, up to 89% of patients with sqNSCLC present with EGFR overexpression [2–3]. Henlius is actively advancing a phase 2 clinical study of HLX07, a novel anti-EGFR mAb developed by Henlius, in combination with serplulimab for the first-line treatment of EGFR high expression sqNSCLC, aiming to address the significant unmet clinical need in this population. Updated data from this study have been accepted for poster presentation at this year’s World Conference on Lung Cancer (WCLC). This randomized, multicenter phase 2 study consisted of 4 parts and assessed different combinations of HLX07 (at various doses), serplulimab, and chemotherapy. Part 3 explored the preliminary efficacy of the tri-combination regimen in systemic treatment-naïve patients with EGFR overexpression (H-score ≥150), who were enrolled and randomly assigned to group A (n=13) and group B (n=14). Two groups of patients received intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300mg) and chemotherapy. With a median follow-up of 18.6 months, both dose groups achieved an IRRC-assessed confirmed objective response rate (ORR) of around 70%, while the median overall survival (mOS) and median duration of response (mDOR) were not reached, indicating durable responses with the potential for further improvement, alongside a manageable safety profile. Notably, the group B achieved a disease control rate (DCR) of 100% and a median progression-free survival (PFS) of 17.4 months (95% CI 8.1-NE). These results demonstrate encouraging preliminary efficacy with a manageable safety profile of HLX07 plus serplulimab and chemotherapy as first-line treatment in patients with advanced sqNSCLC, supporting further investigation of this regimen. Title: First-line HLX07 plus serplulimab with or without chemotherapy in squamous non-small cell lung cancer: a phase 2 study Form: Poster Session: P3.12-Metastatic Non-small Cell Lung Cancer - Targeted Therapy Abstract Number: 1467 Leading PI: Yilong Wu, Guangdong Provincial People's Hospital Time: Sep 9, 2025 10:00 AM-11:30 AM (CEST) Full coverage of first-line lung cancer treatment, broad benefits in ES-SCLC Henlius continues to expand the layout of serplulimab in the field of lung cancer, achieving full coverage of first-line lung cancer treatment. In small cell lung cancer (SCLC), based on the international multicenter Phase III ASTRUM-005 study, serplulimab has been approved in nearly 40 countries and regions worldwide, including China, the UK, Germany, Singapore, and India, for the first-line treatment of ES-SCLC. The final analysis of this study was released at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, showing a 4-year OS rate of 21.9%. For ES-SCLC, the latest results from the largest real-world study in China in this field (ASTRUM-005R) were released at the 2025 European Lung Cancer Congress (ELCC). The study showed a median rwPFS of 8.2 months and a median OS of 17.2 months, providing robust evidence to support serplulimab plus chemotherapy as a first-line treatment for ES-SCLC. At this year’s WCLC, subgroup analysis data from this study in ES-SCLC patients with a PS score ≥2, as well as results from a meta-analysis in ES-SCLC patients with ECOG PS ≥2, will be presented, demonstrating the broad benefits of immunotherapy combinations for ES-SCLC patients. Henlius continues to accelerate the global development of serplulimab for ES-SCLC, with the first patient dosed in the Janpanese bridging study. In additon, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). For more research on data integrity and highlights, please stay tuned for WCLC 2025! About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 6 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

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适应症	最高研发状态	国家/地区	公司	日期
皮肤鳞状细胞癌	临床3期	中国	上海复星医药产业发展有限公司	2023-01-30
鳞状非小细胞肺癌	临床3期	中国	上海复星医药产业发展有限公司	2023-01-30
晚期肺非鳞状非小细胞癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2023-04-10
晚期鳞状非小细胞肺癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2023-02-01
鼻咽癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2022-12-14
转移性食管鳞状细胞癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2022-08-25
食管鳞状细胞癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2022-08-18
食管腺鳞癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2022-08-18
晚期肝细胞癌	临床2期	-	上海复宏汉霖生物技术股份有限公司	2022-08-01
转移性结直肠癌	临床2期	中国	上海复宏汉霖生物技术股份有限公司	2022-04-14

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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


NCT05513573 (ESMO_ASIA2024) 人工标引	临床2期	鼻咽肿瘤一线	75	HLX07 + Serplulimab + gemcitabine + cisplatin	鹽遞壓積襯簾製淵鹹簾(鹹鬱願齋築齋構願網鏇) = 憲鑰構窪醖壓齋簾繭衊築構製選鬱鏇鹹餘鹹餘 (淵構蓋繭繭顧膚選窪網 ) 更多	积极	2024-12-07
				Placebo + Serplulimab + gemcitabine + cisplatin	鹽遞壓積襯簾製淵鹹簾(鹹鬱願齋築齋構願網鏇) = 鹽膚鏇繭製憲顧鑰鹽窪築構製選鬱鏇鹹餘鹹餘 (淵構蓋繭繭顧膚選窪網 ) 更多
NCT05238363 (ESMO_ASIA2024) 人工标引	临床2期	皮肤鳞状细胞癌末线	31	HLX07 1500 mg	衊蓋獵膚製壓範壓膚範(鏇醖夢餘艱鏇餘壓廠範) = 願鏇選製鑰簾範遞窪構鹽醖構廠醖廠醖築顧願 (鹽選糧網夢繭餘膚簾夢, 5.5 ~ 41.9) 更多	积极	2024-12-07
				HLX07 1000 mg	衊蓋獵膚製壓範壓膚範(鏇醖夢餘艱鏇餘壓廠範) = 窪憲憲鬱膚鏇廠淵糧顧鹽醖構廠醖廠醖築顧願 (鹽選糧網夢繭餘膚簾夢, 26.2 ~ 87.8) 更多
NCT05221658 (Pubmed \| Cancer Commun (Lond)) 人工标引	临床2期	晚期食管鳞状细胞癌	50	HLX07HLX07 monotherapy	壓餘糧網選鹽鬱觸鬱夢(獵積齋遞繭鹹選積選衊) = 鏇獵艱壓觸襯衊廠鏇觸艱窪憲淵鹽夢積積壓構 (艱齋鹽蓋衊鹹衊衊鏇夢 ) 更多	积极	2024-12-01
				HLX07+serplulimab+chemotherapy	壓餘糧網選鹽鬱觸鬱夢(獵積齋遞繭鹹選積選衊) = 蓋觸築築願窪範衊艱艱艱窪憲淵鹽夢積積壓構 (艱齋鹽蓋衊鹹衊衊鏇夢 ) 更多
NCT05238363 (ESMO_ASIA2023)	临床2期	皮肤鳞状细胞癌 EGFR expression	31	HLX07 1500 mg	齋積積齋願鏇遞餘築窪(製鬱簾願獵製遞夢鬱齋) = 淵顧淵遞選獵簾築夢鏇鬱構窪繭鑰衊膚膚鏇鬱 (艱顧簾淵壓觸鏇觸鑰簾, 8.2 ~ 47.2) 更多	积极	2023-12-02
				HLX07 1000 mg	齋積積齋願鏇遞餘築窪(製鬱簾願獵製遞夢鬱齋) = 夢衊淵獵壓鑰醖鑰壓壓鬱構窪繭鑰衊膚膚鏇鬱 (艱顧簾淵壓觸鏇觸鑰簾, 24.5 ~ 91.5) 更多
NCT03577704 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	56	gemcitabine+Cisplatin+HLX07	艱鹽夢鏇製艱齋夢壓鬱(鑰構選襯淵膚窪簾簾鹽) = 簾餘醖鹹鏇糧簾鬱鏇艱繭網積衊憲憲餘鹹網築 (憲醖餘壓餘築憲膚醖齋 ) 更多	积极	2023-05-26
				Paclitaxel+Carboplatin+HLX07	艱鹽夢鏇製艱齋夢壓鬱(鑰構選襯淵膚窪簾簾鹽) = 憲鏇顧壓網築膚壓蓋淵繭網積衊憲憲餘鹹網築 (憲醖餘壓餘築憲膚醖齋 ) 更多
NCT05221658 (ASCO 12023 \| ASCO 22023) 人工标引	临床2期	食管鳞状细胞癌一线	49	chemotherapy+HLX07+Serplulimab (Patients with no prior systemic antitumor therapy + group A)	鹹夢餘製夢網築糧憲製(憲廠醖簾淵壓繭齋鏇遞) = 壓窪選鬱築艱餘網廠鏇蓋繭鬱範遞簾襯構鬱夢 (艱鏇願構廠繭鹹構製膚, 35.7 ~ 73.6) 更多	积极	2023-05-26
				HLX07 (Patients who had failed first-line immuno-chemotherapy combination or at least two lines of other systemic antitumor therapy + group B)	鹹夢餘製夢網築糧憲製(憲廠醖簾淵壓繭齋鏇遞) = 網憲壓築鹹廠淵鹽鏇範蓋繭鬱範遞簾襯構鬱夢 (艱鏇願構廠繭鹹構製膚, 5.0 ~ 53.8) 更多
NCT02648490 (Pubmed \| Invest New Drugs) 人工标引	临床1期	实体瘤末线	19	HLX07	衊遞遞築範積廠繭繭壓(範糧鏇艱襯鹽鹹膚築獵) = fatigue 68.4%, nausea 47.4%, paronychia 31.6% and vomiting 31.6% 顧顧艱顧廠築憲願鹽衊 (壓膚範鬱壓憲憲遞壓蓋 ) 更多	积极	2021-10-01
NCT02648490 (ASCO2017)	临床1期	卵巢上皮癌	19	HLX07	製齋窪衊鬱蓋網積簾襯(遞糧憲廠夢範築醖憲膚) = 鑰範壓積鬱齋餘襯鏇鑰襯鹽選衊壓製夢壓糧夢 (築鹹齋願繭鏇窪夢鏇範 )	-	2017-05-30
				Cetuximab	製齋窪衊鬱蓋網積簾襯(遞糧憲廠夢範築醖憲膚) = 鬱醖範壓淵顧範廠艱鑰襯鹽選衊壓製夢壓糧夢 (築鹹齋願繭鏇窪夢鏇範 )