2025年9月6日至9日,国际肺癌研究学会(IASLC)2025年世界肺癌大会(World Conference on Lung Cancer, WCLC)将在西班牙巴塞罗那举行。此次大会上,复宏汉霖将就公司肺癌领域核心创新产品的10项中选研究进行报告,其中包括3项口头报告(oral),2项壁报导览(poster tour),涵盖PD-L1 ADC HLX43 I期临床研究的更新数据,H药 汉斯状®一线治疗晚期非鳞状非小细胞肺癌III期临床研究(首次发布),以及H药在肺癌治疗领域的广泛探索结果,成为此次入选口头报告数目最多的中国生物制药企业。此次发表的具体信息如下:PD-L1 ADC HLX43:广谱抗肿瘤 兼具IO疗效的潜在同类最优ADCHLX43是一款靶向程序性死亡-配体1(PD-L1)的新型ADC候选药物,由全人源IgG1抗PD-L1抗体与创新连接子-拓扑异构酶抑制剂荷载偶联而成,其药物抗体比(drug-to-antibody ratio, DAR)约为8。HLX43兼具毒素精准杀伤和肿瘤免疫治疗的复合功能,其毒素不仅能够通过靶点内吞进入肿瘤细胞后进行释放,并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。此外,HLX43的PD-L1靶向抗体可激活免疫调节机制,发挥协同抗肿瘤效应。在2025 美国临床肿瘤学会(ASCO)年会上,HLX43的I期临床数据首次发布,展现出令人鼓舞的初步疗效和安全性,对鳞状/非鳞状非小细胞肺癌(NSCLC),有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者都展现了优异的治疗潜力,且安全性良好。目前,HLX43已获得中国、美国、日本及澳大利亚药监机构的注册批准,开展一项针对晚期非小细胞肺癌(NSCLC)的国际多中心II期临床研究,并在中国境内完成首例受试者给药。此次WCLC大会上,HLX43自多款ADC分子中脱颖而出,其I期更新临床数据入选壁报导览环节(逾1500份壁报中,仅5%入选壁报导览)。HLX43-FIH101研究论文题目:抗PD-L1 ADC HLX43在晚期/转移性实体瘤中的安全性、耐受性和初步有效性:I期研究展示形式:壁报导览场次:PT2.10-Metastatic Non-small Cell Lung Cancer - Antibody-Drug Conjugate and Cytotoxic Therapy摘要编号:1459牵头主要研究者:王洁 中国医学科学院肿瘤医院展示时间:2025年9月8日下午2:31- 2:39(西班牙时间)H药 汉斯状®:全球首个获批治疗SCLC的抗PD-1单抗 肺癌一线治疗全覆盖H药 汉斯状®(通用名:斯鲁利单抗注射液)为全球首个获批用于一线治疗小细胞肺癌的抗PD-1单抗,已在中国、英国、德国、新加坡、印度等近40个国家和地区获批上市。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,获批用于治疗鳞状非小细胞肺癌(sqNSCLC)、广泛期小细胞肺癌(ES-SCLC)、非鳞状非小细胞肺癌(nsNSCLC)三项肺癌适应症,同时正在全球范围内积极推动一项H药联合化疗同步放疗一线治疗局限期小细胞肺癌(LS-SCLC)的国际多中心III期临床试验。此外,H药治疗SCLC也已获得美国FDA、欧盟委员会和瑞士Swissmedic授予的小细胞肺癌(SCLC)孤儿药资格,英国创新许可与准入通道合作组织授予的创新通行证资格认定,以及韩国MFDS授予的广泛期小细胞肺癌(ES-SCLC)孤儿药资格,并在美国积极推进一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验。同时,公司积极推进H药与公司其他产品的协同以及与创新疗法的联合,探索免疫联合疗法在肺癌围术期患者、脑转移患者等广泛人群中的治疗潜力。HLX10-002-NSCLC301研究论文题目:ASTRUM-002:斯鲁利单抗联合化疗(联合或不联合HLX04)用于晚期非鳞状非小细胞肺癌的一线治疗展示形式:口头报告场次:OA05-lmmunotherapy for Special Populations摘要编号:1454牵头主要研究者:石远凯 中国医学科学院肿瘤医院展示时间:2025年9月7日下午4:46-4:56(西班牙时间)滑动查看更多H药在肺癌领域的研究信息HLX07HLX10-sqNSCLC201研究论文题目:HLX07联合斯鲁利单抗(联合或不联合化疗)用于鳞状非小细胞肺癌的一线治疗:一项II期研究展示形式:壁报场次:P3.12-Metastatic Non-small Cell Lung Cancer - Targeted Therapy摘要编号:1467牵头主要研究者:吴一龙 广东省人民医院展示时间:2025年9月9日上午10:00-11:30(西班牙时间)论文题目:斯鲁利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期研究展示形式:简短口头报告场次:MA10-Longer Follow Up and New IO Combinations摘要编号:2266牵头主要研究者:陈丽昆 中山大学肿瘤防治中心展示时间:2025年9月9日下午1:02-1:07(西班牙时间)论文题目:MRD动态监测在斯鲁利单抗联合化疗一线治疗广泛期小细胞肺癌的观察性研究展示形式:简短口头报告场次:MA03 New Advances in circulating Biomarkers摘要编号:1217牵头主要研究者:马克威 吉林大学第一医院展示时间:2025年9月7日下午3:17-3:22(西班牙时间)论文题目:贝伐珠单抗联合斯鲁利单抗及化疗治疗EGFR-TKI耐药的非鳞状NSCLC患者II期研究展示形式:壁报场次:P1.11-Metastatic Non-small Cell Lung Cancer -lmmunotherapy摘要编号:2217牵头主要研究者:王启鸣 河南省肿瘤医院展示时间:2025年9月7日上午10:30-12:00(西班牙时间)论文题目:一项II 期SPUR研究:多周期低剂量放射治疗重塑免疫化疗在广泛期小细胞肺癌中的应用展示形式:壁报导览场次:PT2.13 - Small Cell Lung Cancer and Neuroendocrine Tumors摘要编号:2316牵头主要研究者:卢铀 四川大学华西医院展示时间:2025年9月8日 下午2:23-2:31(西班牙时间)论文题目:斯鲁利单抗新辅助治疗局晚期非小细胞肺癌的一项前瞻性单臂研究展示形式:壁报场次:P2.08 - Local-Regional Non-small Cell Lung Cancer摘要编号:1954牵头主要研究者:曾剑 浙江省肿瘤医院展示时间:2025年9月8日上午10:30-12:00(西班牙时间)论文题目:PS评分≥2的广泛期小细胞肺癌患者的一线免疫联合化疗结果:来自ASTRUM-005R的真实世界证据展示形式:壁报场次:P3.13-Small Cell Lung Cancer and Neuroendocrine Tumors摘要编号:1534牵头主要研究者:邬麟 湖南省肿瘤医院,胡成平 中南大学湘雅医院展示时间:2025年9月9日上午10:00-11:30(西班牙时间)论文题目:一线免疫化疗在广泛期小细胞肺癌中的荟萃分析:ECOG 体能状态评分≥2 是否影响生存结局?展示形式:电子壁报摘要编号:1885牵头主要研究者:余新民 浙江省肿瘤医院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,5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。Henlius to Present Latest Results on ADC and IO Therapies in Lung Cancer at 2025 WCLC2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer(IASLC) will be held from September 6-9 in Barcelona, Spain. At the conference, Henlius will showcase 10 latest results from its innovative products on lung cancer, which includes 3 oral presentations and 2 poster tours, covering updated phase 1 clinical data for PD-L1 ADC HLX43, the results(first release) from ASTRUM-002, a phase 3 clinical trial of serplulimab (anti-PD-1 monoclonal antibody) in the first line treatment of advanced non-squamous non small cell lung cancer (NSCLC) as oral presentation, along with further research findings on serplulimab in lung cancer, making it the Chinese biopharmaceautical with most oral presentations.Details of the release are as follows:PD-L1 ADC HLX43HLX43 is a novel PD-L1-targeting ADC, composed of a fully humanized anti-PD-L1 IgG1 antibody, a novel tripeptide linker and topoisomerase inhibitor payload. The drug to antibody ratio (DAR) is around 8. Its mechanisms of action integrates targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1 blockade. Upon binding to PD-L1-expressing tumor cells, HLX43's cytotoxic payload can be delivered into tumor cells via dual mechanisms—First, the ADC undergoes receptor-mediated endocytosis, releasing the cytotoxic payload intracellularly via linker cleavage, and the payload further diffuses into neighboring tumor cells via bystander effect, thereby blocking DNA replication and triggering tumor cell apoptosis. Meanwhile, the anti-PD-L1 antibody of HLX43 activates immune modulation and blocks immune checkpoints, driving synergistic antitumor efficacy. At WCLC 2025, HLX43 stands out among multiple ADC molecules, with its updated phase 1 clinical data selected for poster tour session.(only 5% were chosen for this session from over 1500 posters)The results from the phase 1 clinical trial of HLX43 has been first released at the 2025 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC, including squamous and non-squamous NSCLC patients (sqNSCLC and nsqNSCLC), patients with or without EGFR mutation, patients with or without brain/liver metastasis, and PD-L1 positive or negative patients. To date, HLX43 has been approved by the China NMPA, the U.S. FDA, Australia TGA and Japan's PMDA to initiate phase 2 multi-regional clinical trial in patients with advanced non-small cell lung cancer (NSCLC). Additionally, the first patient dosing has been completed in China. HLX43-FIH101Title: Safety, Tolerability and Preliminary Efficacy of Anti-PD-L1 ADC HLX43 in Advanced/Metastatic Solid Tumors: A Phase I studyForm: Poster TourSession: PT2.10-Metastatic Non-small Cell Lung Cancer - Antibody-Drug Conjugate and Cytotoxic TherapyAbstract Number: 1459Leading PI: Jie Wang, Cancer Hospital Chinese Academyof Medical SciencesTime: Sep 8, 2025 2:31 PM-2:39 PM (CEST)HANSIZHUANG(serplulimab, anti-PD-1 mAb)HANSIZHUANG is the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer. It has been approved in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India. Henlius continues to expand the layout of HANSIZHUANG in the field of lung cancer. Up to date, it has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). 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).The product was granted orphan drug designations from the FDA, the EC and Swissmedic for the treatment of SCLC, as well as from the Korean Ministry of Food and Drug Safety (MFDS) for the treatment of ES-SCLC. Its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way. Focusing on lung cancer, the synergy of HANSIZHUANG with in-house products of the company and 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.HLX10-002-NSCLC301Title: ASTRUM-002: First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-small Cell Lung CancerForm: OralSession: OA05-lmmunotherapy for Special PopulationsAbstract Number: 1454Leading PI: Yuankai Shi, Cancer Hospital Chinese Academy of Medical SciencesTime: Sunday Sep 7, 2025 4:46 PM-4:56 PM (CEST)click to view more research information about serplulimabHLX07HLX10-sqNSCLC201Title: First-line HLX07 plus serplulimab with or without chemotherapy in squamous non-small cell lung cancer: a phase 2 studyForm: PosterSession: P3.12-Metastatic Non-small Cell Lung Cancer - Targeted TherapyAbstract Number: 1467Leading PI: Yilong Wu, Guangdong Provincial People's HospitalTime: Sep 9, 2025 10:00 AM-11:30 AM (CEST)Title: Phase II Trial of Serplulimab Plus Bevacizumab and Chemotherapy for Treatment-Naive Non-Squamous NSCLC with Brain Metastases(SUPER BRAIN)Form: Mini OralSession: MA10-Longer Follow Up and New IO CombinationsAbstract Number: 2266Leading PI: Likun Chen, Sun Yat-Sen University Cancer CenterTime: Sep 9,2025 1:02 PM-1:07 PM (CEST)Title: Minimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive-Stage Small Cell Lung CancerForm: Mini OralSession: MA03 New Advances in circulating BiomarkersAbstract Number: 1217Leading PI: Kewei Ma, Jilin University the First HospitalTime: Sep 7,2025 3:17 PM - 3:22 PM (CEST)Title: Bevacizumab Plus Serplulimab and Chemotherapy for EGFR-TKI-Resistant Non-squamous Non-small-cell Lung Cancer: A Phase 2 StudyForm: PosterSession: P1.11-Metastatic Non-small Cell Lung Cancer -lmmunotherapyAbstract Number: 2217Leading PI: Qiming Wang, Henan Cancer HospitalTime: Sep 7,2025 10:30 AM-12:00 AM (CEST)Title: Multi-Cycle Low-Dose Radiotherapy Reshapes lmmunochemotherapy forES-SCLC: The SPUR Phase II TrialForm: Poster TourSession: PT2.13 - Small Cell Lung Cancer and Neuroendocrine TumorsAbstract Number: 2316Leading PI: You Lu, West China School of Medicine/West China Hospital of Sichuan UniversityTime: Sep 8, 2025 2:23 PM-2:31 PM (CEST)Title: Serplulimab in Neoadjuvant Therapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Single-Arm StudyForm: PosterSession: P2.08 - Local-Regional Non-small Cell Lung CancerAbstract Number: 1954Leading PI: Jian Zeng, Zhejiang Cancer HospitalTime: Sep 8, 2025 10:30 AM-12:00 AM (CEST)Title: First-Line Immunochemotherapy in ES-SCLC Patients with ECOG PS ≥2: Real-World Evidence from the ASTRUM-005R TrialForm: PosterSession: P3.13-Small Cell Lung Cancer and Neuroendocrine TumorsAbstract Number: 1534Leading PI: Lin Wu, Hunan Cancer Hospital | Chengping Hu, Xiangya Hospital of Central South UniversityTime: Sep 9,2025 10:00 AM-11:30 AM (CEST)Title: Meta-Analysis of First-Line Immunochemotherapy in ES-SCLC: Does ECOG PS ≥2 Affect Survival Outcomes?Form: E-PosterAbstract Number: 1885Leading PI: Xinmin Yu, Zhejiang Cancer HospitalAbout HenliusHenlius (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 5 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