肺癌新突破！复宏汉霖ADC与IO管线3项口头报告及更多创新成果亮相2025WCLC

此次发表的具体信息如下：

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）。

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。

Henlius to Present Latest Results on ADC and IO Therapies in Lung Cancer at 2025 WCLC

2025 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:

HLX43 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. 

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.