ASCO GI 2026 | ORR高达61.5%，复宏汉霖广谱抗肿瘤PD-L1 ADC HLX43末线食管鳞癌II期数据首次发布

• HLX43食管鳞癌概念验证数据首发，为其广谱抗肿瘤价值再添有力新证

• 初步临床疗效优异且安全性良好，优势人群获益潜力显著，3mg/kg剂量组ORR和DCR分别达61.5%和100%，cORR达38.5%

• 潜在BIC的PD-L1 ADC，“高效低毒”构筑明确差异化优势

食管癌是全球范围内常见的恶性肿瘤，2022年全球新发食管癌约51.1万例，死亡约44.5万例^[1]。中国是该疾病最为高发的国家，根据2022年肿瘤登记数据，我国食管癌年发病22.4万例，死亡18.8万例，发病与死亡人数占全球近一半^[2]。其中食管鳞癌（ESCC）是主要的病理类型。尤其在中国等高发地区，ESCC占比高达90%以上^[3]。近年来，免疫联合化疗已成为中外权威指南推荐的标准一线方案，显著改善了患者生存。但对免疫化疗失败后的难治人群，多西他赛、伊立替康等二线化疗的客观缓解率（ORR）仅约7%，中位总生存期（mOS）仅为5-7个月^{[4, 5]}，疗效极为有限。对于二线治疗再次失败的患者，目前全球范围内尚无标准的三线治疗方案，可见ESCC的后线治疗仍存在巨大的未满足临床需求。

本次发布基于一项评估 HLX43 在复发/转移性食管鳞癌中有效性和安全性的多中心、随机的II 期临床研究。研究入组了经组织学或细胞学确诊的复发/转移性ESCC的患者，接受一线化免治疗后进展或不耐受，并按1:1:1的比例随机分组，接受每3周一次静脉注射2 mg/kg、2.5 mg/kg或3 mg/kg 的HLX43。主要终点为研究者根据RECIST v1.1评估的客观缓解率（ORR）和无进展生存期。次要终点包括其他有效性终点、安全性、药代动力学、免疫原性和生物标志物探索。

截至数据截止日期2025年11月25日，共有37名患者随机分组并接受HLX43治疗，剂量分别为2 mg/kg（n = 12）、2.5 mg/kg（n = 12）和3 mg/kg（n = 13）。大多数患者的ECOG PS评分为1（86.5%）。既往抗肿瘤治疗线数中位数为2（范围，1–4）。全部患者（100%）接受过化疗及免疫治疗，27.0%的患者接受过靶向治疗，CPS≥1患者占75.7%，中位随访时间为3.5个月。

33例疗效可评估的患者中，观测到了积极信号，ORR为30.3%，DCR为81.8%。尤为值得关注的是，在3 mg/kg剂量组的13例疗效可评估的患者中，8例患者达到了部分缓解，ORR为61.5%，DCR为100.0%，确认的ORR（cORR）为38.5%；3 mg/kg剂量下，CPS≥1的PD-L1阳性患者（n = 10）中，ORR为60.0%，DCR为100%；CPS＜1的PD-L1阴性患者（n=2）ORR为50%，DCR为100%，初步提示HLX43疗效不限患者PD-L1表达限制，但仍待后续更大样本量的随机对照研究进一步验证。

安全性方面，33例患者（89.2%）发生了治疗相关不良事件（TRAEs），其中11例患者（29.7%）报告了≥3级TRAEs，最常见的≥3级TRAEs（发病率≥5%）包括贫血（13.5%）、白细胞计数下降（13.5%）、淋巴细胞计数降低（8.1%）、中性粒细胞计数降低（8.1%）、肺炎（5.4%）等。TRAEs导致1例（2.7%）患者用药剂量减少，1例（2.7%）患者永久停药，1例患者死亡。其中，在疗效信号更为显著的3mg/kg剂量组中，HLX43安全性良好，5例患者（38.5%)报告了≥3级TRAEs，1例患者(7.7%) 因TRAEs导致用药剂量减少，无患者（0%）因TRAE导致永久停药或死亡。

综上所述，HLX43 在复发/转移性食管鳞癌（ESCC）的后线治疗中展现出可控的安全性和令人鼓舞的初步疗效，尤其在3.0 mg/kg 剂量下疗效更为显著，值得进一步研究。

HLX43是一款潜在同类最优及疾病领域最优的广谱抗肿瘤ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。临床前研究显示，HLX43在PD-1/PD-L1单抗耐药的非小细胞肺癌、宫颈癌、食管鳞癌等多个瘤种中展现出治疗潜力，且耐受性良好。其I期临床数据于2025美国临床肿瘤学会（ASCO）年会及2025 世界肺癌大会（WCLC）上先后发布，在NSCLC等实体瘤中展现出“高效、低毒”的显著疗效，尤其在NSCLC的治疗上，HLX43展现了全人群覆盖的潜力。

目前，复宏汉霖已累计开展约10项HLX43治疗多项实体瘤中的临床研究，在全球入组超过500例患者，广泛覆盖肺癌、宫颈癌等晚期妇科肿瘤、食管鳞癌、头颈鳞癌、鼻咽癌、结直肠癌、胃癌/胃食管交界部癌、胰腺导管腺癌、肝细胞癌等，其中NSCLC患者超过300例。后续，HLX43在鼻咽癌、头颈鳞癌等实体瘤中的概念验证数据也将在2026 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HLX07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。

未来，复宏汉霖将持续聚焦患者未满足的临床需求，立足于HLX43等核心创新管线，不断放大产品的差异化治疗潜力，加速推动更大临床价值的释放，为全球患者带来更具突破疗效的治疗方案。

Henlius Debuts Phase 2 Results for Its Broad Anti-tumor PD-L1 ADC HLX43 in Second-Line or Subsequent Treatment of Esophageal Squamous Cell Carcinoma at ASCO GI 2026

• The company first unveiled HLX43's proof-of-concept data in esophageal squamous cell carcinoma, providing compelling new evidence for its broad anti-tumor potential.

• It has demonstrated encouraging preliminary efficacy and a favorable safety profile, with significant potential benefit in target populations. In the 3 mg/kg cohort, the ORR and DCR reached 61.5% and 100%, respectively, with a cORR of 38.5%.

• As a potential best-in-class PD-L1 ADC, its “high efficacy and low toxicity” profile establishes a clear differentiated advantage.

Shanghai, China, January 9, 2026—Shanghai Henlius Biotech, Inc. (2696.HK) today announced the first presentation of Phase II proof-of-concept (POC) data for its PD-L1 antibody-drug conjugate (ADC), HLX43, in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO GI). The study was led by Professor Jinming Yu from Shandong Cancer Hospital. The data suggest that HLX43 holds therapeutic potential in pretreated advanced ESCC, demonstrating encouraging efficacy with a manageable safety profile. Consistent clinical activity has been observed across multiple solid tumors—including non-small cell lung cancer(NSCLC), cervical cancer(CC), ESCC, and thymic carcinoma (TC)—supporting its broad anti-tumor profile and underpinning further indication expansion.

Esophageal cancer is a prevalent malignancy worldwide, with approximately 511,000 new cases and 445,000 deaths globally in 2022 ^[1]. China bears the highest disease burden, reporting 224,000 new cases and 188,000 deaths in 2022, accounting for nearly half of the global incidence and mortality ^[2]. Esophageal squamous cell carcinoma (ESCC) is the predominant histologic subtype, representing over 90% of cases in high-incidence regions including China ^[3]. While immunotherapy combined with chemotherapy significantly improving patient survival and has become the recommended first-line standard, therapeutic options are limited for those who progressed. Second-line chemotherapies such as docetaxel or irinotecan achieve an objective response rate (ORR) of only about 7%, with a median overall survival (mOS) of 5–7 months ^[4,5]. For patients who further progressed beyond second-line therapy, there is currently no established standard regimen globally, highlighting a substantial unmet medical need in the later-line treatment of ESCC.

This randomized, multi-center phase 2 study evaluated the efficacy and safety of HLX43 in previously treated recurrent/metastatic ESCC. Patients with histologically or cytologically confirmed recurrent/metastatic ESCC who progressed on or are intolerant to first-line chemoimmunotherapy were enrolled and randomized 1:1:1 to receive intravenous HLX43 at 2 mg/kg, 2.5 mg/kg, or 3 mg/kg once every 3 weeks. The primary endpoints were investigator-assessed objective response rate (ORR) and progression-free survival per RECIST v1.1. Secondary endpoints included other efficacy endpoints, safety, pharmacokinetics, immunogenicity, and biomarker explorations.

As of data cutoff date Nov 25, 2025, 37 patients were randomized to and received HLX43 at 2 mg/kg (n = 12), 2.5 mg/kg (n = 12) and 3 mg/kg (n = 13) groups. Most enrolled patients had an Eastern Cooperative Oncology Group performance status score of 1 (86.5%). Patients received a median line of prior anti-tumor therapy of 2 (range, 1–4). All (100%) patients received chemotherapy and immunotherapy, 27.0% received targeted therapy, 75.7% had a PD-L1 combined positive score ≥ 1, and the median follow-up time was 3.5 months.

Among all of the 33 response-evaluable patients, promising efficacy results were observed，with an ORR of 30.3% and a DCR of 81.8%. Notably, in the 3 mg/kg group(n=13), the ORR was 61.5%( 8 partial response) and DCR was 100.0%, with a confirmed ORR (cORR) of 38.5%.In this dose group，patients with a PD-L1 CPS ≥ 1 (n=10) had an ORR of 60.0% and a DCR of 100%, compared with an ORR of 50.0% and a DCR of 100% in those with a CPS < 1 (n=2). HLX43 conferred promising efficacy regardless of PD-L1 expression. Large-scale randomized studies are required for definitive conclusion.

In terms of safety, treatment-related adverse events (TRAEs) were reported in 33 patients (89.2%,grade ≥3, 29.7%). Most common grade ≥3 TRAEs (≥5% in incidence) included anemia (13.5%), white blood cell count decreased (13.5%), lymphocyte count decreased(8.1%)，Neutrophil count decreased(8.1%) and Pneumonia(5.4%).  TRAEs led to a dose reduction in 1 patient (2.7%), treatment discontinuation in 1 patient (2.7%), and death in 1 patient（2.7%）. In the 3 mg/kg dose group, where more pronounced efficacy signals were observed, the treatment demonstrated a favorable safety profile.Grade ≥3 TRAEs were reported in 5 patients (38.5%). One patient (7.7%) required a dose reduction due to TRAEs, and no patient discontinued treatment or died due to TRAEs.

In conclusion, HLX43 conferred promising efficacy, particularly at 3 mg/kg dose, along with a manageable safety profile in patients with previously treated recurrent/metastatic ESCC. Further investigation is warranted.

HLX43 is a potential best-in-class broad anti-tumor ADC candidate targeting PD-L1, which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. Preclinical data have shown that HLX43 has potent anti-tumor effects and a favorable tolerability profile in NSCLC, cervical cancer (CC), esophageal squamous cell carcinoma (ESCC), and other tumor types that were PD-1/L1 mAb-resistant. The results from the phase 1 clinical trial of HLX43 were released at the 2025 ASCO Annual Meeting and 2025 WCLC, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC.

To date, Henlius has initiated about 10 clinical studies of HLX43, covering lung cancer, CC, ESCC, head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), colorectal cancer, gastric/gastroesophageal junction cancer (G/GEJ), pancreatic ductal adenocarcinoma (PDAC), and hepatocellular carcinoma (HCC), with over 500 patients enrolled globally, including more than 300 patients with NSCLC. Proof-of-concept (PoC) results in NPC and HNSCC are also expected to be released on the upcoming international academic conferences including the 2026 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 HLX07, to maximize HLX43's clinical value.

Guided by its commitment to address unmet medical needs, Henlius will continue to advance its core pipeline including HLX43 to deepen the differentiated therapeutic potential of our products, accelerate the delivery of greater clinical value, and ultimately deliver more breakthrough treatment options to patients worldwide.

媒体：PR@Henlius.com

投资者：IR@Henlius.com