复宏汉霖PD-L1 ADC HLX43后线晚期sqNSCLC国际多中心II/III期研究完成中国首例患者给药，全球开发加速推进

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¹。其中，非小细胞肺癌（NSCLC）是最常见的肺癌类型（约85%），可分为鳞状细胞癌（约30%）、肺腺癌（约50%）等，且鳞状NSCLC通常预后更差²。尽管以抗PD-1/L1单抗为代表的免疫检查点抑制剂联合化疗显著改善了晚期或转移性鳞状NSCLC患者的生存率。但在病情进展的2线或以上的后线人群治疗上，疗效优异的产品较少，主要依赖于多西他赛为基础的化疗方案，存在较大的未被满足的临床需求^3-4。近年来，抗体偶联药物（ADC）在肿瘤治疗中已展现出卓越的临床疗效，并在后线鳞状NSCLC的临床探索中显示了积极信号^5-6。同时，抗EGFR单抗联合化疗在鳞状NSCLC治疗中取得一定进展^7-9，但疗效多集中于EGFR高表达人群。抗EGFR单抗联合新型治疗方案在EGFR低表达患者中的疗效亟待进一步探索。

HLX43是一款潜在同类最优的广谱抗肿瘤PD-L1 ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。目前，HLX43在NSCLC等实体瘤中展现出“高效、低毒”的初步临床疗效。根据2026年美国临床肿瘤学会（ASCO）年会公布的HLX43单药治疗NSCLC研究的摘要， 在161名可评估疗效的患者中（各剂量组分别为1 mg/kg 2人、2 mg/kg 69人、2.5 mg/kg 64人、3 mg/kg21人、4 mg/kg 5人），研究者评估的客观缓解率（ORR）为31.1%。其中，在EGFR野生型非鳞状NSCLC患者中（n=19），HLX43已展现出初步的临床优势，ORR达47.4%。针对既往多西他赛失败的患者（n=15），ORR仍达到40.0%。生物标志物探索分析显示，疗效与PD-L1表达无明显相关，PD-L1阳性（n=83）和PD-L1阴性（n=78）患者的ORR分别为30.1%和32.1%。总体上，199名患者（97.1%）出现治疗相关不良事件（TRAEs），其中88名（42.9%）为≥3级。最常见的≥3级TRAEs（发生率≥10%）包括淋巴细胞计数降低（n=47，22.9%）、白细胞计数降低（n=27，13.2%）、贫血（n=25，12.2%）和中性粒细胞计数降低（n=23，11.2%）。因TRAEs导致停药的患者为17人（8.3%）。完整数据将于美国中部时间5月30日下午以快速口头报告的形式正式发布。值得注意的是，本次发布将首次披露亚组无进展生存期（PFS）数据，以进一步确证HLX43单药在后线难治性NSCLC治疗中的临床应用潜力与价值。

Pimurutamab是复宏汉霖自主研发的一款抗EGFR单克隆抗体，具备更低的免疫原性和更优的EGFR靶点亲和力。同时通过Fc端改造，显著延长其半衰期，3周的给药频率使其更适合与肿瘤免疫产品的临床联用。临床前研究表明，pimurutamab相较同类抗EGFR单抗具有更出色的生物活性，在不同肿瘤模型中均能显著抑制肿瘤细胞的生长。因此，HLX43有望协同抗EGFR单抗pimurutamab，发挥出较HLX43单药及抗EGFR单抗联合化疗更高的治疗潜力，进一步提升鳞状NSCLC等晚期实体瘤患者的治疗获益。

目前，复宏汉霖正全力推进HLX43的临床开发进程，在全球入组超过700例患者。其中NSCLC患者占比超过60%（400例），包括一项针对NSCLC的国际多中心II期临床研究（HLX43-NSCLC201）正在中、美、日、澳等地同步开展。此外，公司已累计开展十余项HLX43单药或联合其他产品的临床研究，广泛覆盖宫颈癌（CC）、食管鳞癌（ESCC）、头颈鳞癌（HNSCC）、鼻咽癌（NPC）、结直肠癌（mCRC）、胃癌/胃食管交界部（G/GEJ）癌、胰腺导管腺癌（PDAC）、乳腺癌（BC）等，持续探索和挖掘HLX43在实体瘤中的广谱治疗潜力，其在CC、ESCC、NPC、HNSCC等肿瘤中的概念验证（PoC）研究数据已在/将在ESMO Asia、ASCO GI、ASCO、ESMO等大会上陆续读出。单药之外，基于HLX43展现出的IO疗效，公司积极探索HLX43与其他多元分子如公司自研创新抗EGFR单抗pimurutamab、H药 汉斯状^®（斯鲁利单抗，抗PD-1单抗）的联合治疗潜力，不断挖掘和最大化该产品在临床中的应用价值。

Henlius Advances Global Development of PD-L1 ADC HLX43 as Phase 2/3 MRCT in Previously Treated Advanced sqNSCLC Completes First Patient Dosed in China

On May 27, 2026, Henlius (2696.HK) announced that the first patient has been dosed in China in the phase 2/3 international multicentre clinical trial (HLX43-NSCLC302) evaluating the company’s innovative PD-L1 ADC HLX43 for the treatment of patients with previously treated advanced/metastatic squamous non-small cell lung cancer (sqNSCLC), marking the official initiation of the study in the country. Recently, the study also received tacit approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). The trial will be conducted across multiple countries, including China, the United States, and Japan. The phase 3 stage is expected to serve as the first pivotal registration study for HLX43 and represents a significant milestone for HLX43 in the field of NSCLC, poised to offer a new therapeutic option for refractory sqNSCLC patients who have progressed on prior standard therapies.

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 2022.¹ Non-small cell lung cancer (NSCLC) is the predominant type of lung cancer (approximately 85%). By histology, NSCLC can be classified into squamous cell carcinoma (approximately 30%), adenocarcinoma (approximately 50%) and other subtypes, with a generally poorer prognosis for sqNSCLC.² While immune checkpoint inhibitors (ICIs) combined with chemotherapy have significantly improved survival in advanced/metastatic sqNSCLC, effective options remain limited for patients progressing after first-line therapy. The current second-line and later-line treatment landscape is dominated by docetaxel-based regimens, with few agents demonstrating superior efficacy, highlighting a substantial unmet medical need.^3-4 In recent years, antibody-drug conjugates (ADCs) have demonstrated favorable clinical efficacy in oncology, with promising activity observed in the later-line treatment of sqNSCLC.^5-6 Separately, anti-EGFR monoclonal antibodies combined with chemotherapy have achieved progress in sqNSCLC, albeit primarily in EGFR-high expressing populations.^7-9 The efficacy of novel therapeutic regimens incorporating anti-EGFR monoclonal antibodies in patients with low EGFR expression remains an area requiring further exploration.

HLX43 is a potentially best-in-class pan-tumour ADC candidate targeting PD-L1, which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. Currently, it has demonstrated a manageable safety profile and encouraging efficacy in various solid tumours, with notable anti-tumour activity observed in multiple NSCLC patient subgroups. According to the abstract of the HLX43 monotherapy study for NSCLC presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, among the 161 response‑evaluable patients (2, 69, 64, 21, and 5 in the 1, 2, 2.5, 3, and 4 mg/kg groups, respectively), the investigator‑assessed ORR was 31.1%. Among patients with EGFR wild-type non-squamous NSCLC (n=19), HLX43 has shown preliminary clinical advantages, with an ORR of 47.4%. For patients who had previously failed docetaxel (n=15), the ORR still reached 40.0%. Biomarker exploratory analyses showed that efficacy was not associated with PD‑L1 expression, with ORRs of 30.1% and 32.1% in patients with PD‑L1‑positive (n=83) and PD‑L1‑negative tumours (n=78), respectively. Overall, 199 (97.1%) patients experienced treatment-related adverse events (TRAEs), of whom 88 (42.9%) had grade ≥3 in severity. Most common Grade ≥3 TRAEs (incidence ≥10%) included lymphocyte count decreased (n=47, 22.9%), white blood cell count decreased (n=27, 13.2%), anaemia (n=25, 12.2%), and neutrophil count decreased (n=23, 11.2%). TRAEs led to treatment discontinuation in 17 (8.3%) patients. The full data will be formally released as a Rapid Oral Presentation on the afternoon of May 30 (CDT). Notably, the presentation will include the first disclosure of subgroup PFS data, further evaluating the clinical potential and therapeutic value of HLX43 in the treatment of relapsed/refractory NSCLC.

Pimurutamab is a humanized anti-EGFR mAb developed by Henlius, featuring reduced immunogenicity and enhanced binding affinity to the EGFR target. Through Fc engineering, pimurutamab demonstrates a significantly prolonged half-life, and the 3-week dosing frequency makes it more suitable for clinical use in combination with immunotherapies. Preclinical trials have shown that, compared with existing anti-EGFR mAbs, pimurutamab exhibits improved biological activity, significantly inhibiting tumour cell growth across multiple tumour models. HLX43 is thus expected to synergize with the anti-EGFR mAb pimurutamab. This combination has the potential for superior efficacy compared to HLX43 monotherapy or an anti-EGFR antibody combined with chemotherapy, thereby offering greater clinical benefit to patients with advanced solid tumours such as sqNSCLC.

The company is currently accelerating the clinical development of HLX43. To date, over 700 patients have been enrolled globally in HLX43 studies, including more than 400 patients with NSCLC (over 60%). Among them, a multi-regional phase 2 trial (HLX43-NSCLC201) is currently underway in China, the US, Australia, and Japan. Henlius has initiated over 10 clinical studies of HLX43, covering non-small cell lung cancer (NSCLC), cervical cancer (CC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), metastatic colorectal cancer (mCRC), gastric/gastroesophageal junction cancer (G/GEJ), pancreatic ductal adenocarcinoma (PDAC) and breast cancer (BC). Proof-of-concept (PoC) data in CC, ESCC, NPC, and HNSCC have been or will be presented at international conferences including ESMO Asia, ASCO GI, ASCO, and ESMO. Building on its intrinsic immuno-oncology (IO) activity, Henlius is exploring combination therapies, such as with the in-house anti-EGFR antibody pimurutamab and anti-PD-1 mAb serplulimab, to maximize HLX43's clinical value.

媒体：PR@Henlius.com

投资者：IR@Henlius.com