中欧美日澳开发再提速，复宏汉霖PD-L1 ADC HLX43 全球II期临床完成欧盟首例患者给药

• 全球开发提速：HLX43针对NSCLC的国际多中心II期临床在中欧美日澳等地启动，加速产品全球开发进程

• NSCLC全人群覆盖：HLX43在鳞状/非鳞状、有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者中都展现疗效，且安全性良好

• “高效低毒”持续验证：HLX43针对NSCLC更新数据即将以口头报告形式亮相2026 ASCO，持续验证“高效低毒”特质，提示其多线治疗潜力

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，占所有癌症新发病例的12.4%¹。大部分肺癌患者确诊时已处于疾病晚期阶段²，存在巨大的尚未满足的临床需求。非小细胞肺癌（NSCLC）是最常见的肺癌类型（约85%），主要包括鳞状细胞癌（约30%）和肺腺癌（约50%）等。在全部NSCLC患者中，EGFR野生型占比高达70%-85%，涵盖几乎所有的鳞癌患者和半数以上的肺腺癌患者（50-55%）³。当前疗效优异的产品仍较少，特别在接受过标准治疗的后线人群治疗上，现行临床实践仍高度依赖以多西他赛为基础的化疗方案，且临床获益有限^4,5。

HLX43是一款靶向程序性死亡-配体1（PD-L1）的广谱抗肿瘤ADC，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，药物抗体比（drug-to-antibody ratio, DAR）约为8。HLX43兼具毒素精准杀伤（ADC）和肿瘤免疫治疗（IO）的复合功能：其毒素不仅能够藉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。2025年11月，HLX43肺癌领域的关键数据更新发布，并整合了HLX43-NSCLC201临床研究的初步结果。此次分析明确了2.0 mg/kg 或 2.5 mg/kg 作为HLX43用于治疗NSCLC的II/III期推荐剂量（RP2/3D），并持续印证了HLX43在对应剂量下的疗效和安全性。

复宏汉霖正全力推进HLX43临床开发进程，其用于晚期鳞状非小细胞肺癌的II/III期国际多中心临床研究（HLX43-NSCLC302）将于中国、美国、日本等多国开展，其III期研究阶段有望成为HLX43首个、同时也是其在非小细胞肺癌领域的关键注册临床研究，为既往标准治疗失败后的sqNSCLC患者这一难治群体带来新的治疗选择。除NSCLC外，公司积极探索其在多种实体瘤中的治疗潜力，包括食管鳞癌、宫颈癌、乳腺癌、胃癌/胃食管交界部（G/GEJ）癌 、头颈鳞癌等。单药之外，HLX43联用其他产品的临床试验也正在进行中，进一步探索ADC与其他疗法的协同抗肿瘤疗效。HLX43不仅展现出克服PD-1/L1免疫疗法不响应或耐药问题的临床潜力，并对化疗、TKI治疗失败的患者都具有潜在疗效，有望为更多晚期/转移性实体瘤患者带来新的治疗选择。

Global Development Accelerates Further: Henlius’ PD-L1 ADC HLX43 Completes First Patient Dosing in EU for Phase 2 MRCT

• Global Development Accelerated:  Phase 2 MRCT for HLX43 in NSCLC fully initiated across      China, the U.S., Australia and Japan

• Broad Efficacy in NSCLC: HLX43      demonstrates broad efficacy in NSCLC patients, regardless of histology      (squamous or non-squamous), EGFR mutation status, presence of brain/liver      metastases, or PD-L1 expression, with a favorable safety profile

• Continued Validation of High Efficacy and Low Toxicity: Updated clinical data for HLX43 in NSCLC will be featured in an      upcoming oral presentation at the 2026 ASCO Annual Meeting, further      validating its exceptional efficacy, favorable tolerability, and immense      potential across multiple lines of therapy.

Shanghai, China, May 21, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient in the European Union (EU) has been successfully dosed in Spain in the international multi-center Phase 2 clinical trial (HLX43-NSCLC201) evaluating HLX43, an innovative programmed death-ligand 1 (PD-L1) targeting antibody-drug conjugate (ADC), for the treatment of advanced non-small cell lung cancer (NSCLC). The HLX43-NSCLC201 study has now been fully initiated across China, the EU, the United States, Japan, and Australia, marking comprehensive coverage of major global markets for the clinical development of this first-in-class PD-L1 ADC. Building on its broad efficacy and favorable safety profile across diverse patient populations, the latest research results of HLX43 in NSCLC are also scheduled for a highly anticipated oral presentation at the 2026 ASCO Annual Meeting.

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 The majority of lung cancer patients are diagnosed at advanced stages,² indicating a significant unmet clinical need. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer (approximately 85%). By histology, NSCLC can be classified into squamous cell carcinoma (approximately 30%), adenocarcinoma (approximately 50%) and other subtypes including large cell carcinoma. EGFR wild-type cases account for 70%-85% of all NSCLC patients, including nearly all squamous cell carcinoma cases and 50-55% of adenocarcinoma cases.³ Currently, the treatment landscape of EGFR wild-type NSCLC remains limited by a scarcity of highly effective options, particularly in second-line and later (2L+) therapy, where docetaxel-based chemotherapy continues to serve as the standard of care despite its suboptimal efficacy.^4,5

HLX43 is a broad-spectrum anti-tumor ADC candidate targeting PD-L1, 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 integrate targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1 blockade. Upon bonding to tumor cells with PD-L1 expression, the cytotoxic payload of HLX43 will be delivered into tumor cells via dual mechanisms. HLX43 will undergo 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 anti-tumor efficacy. 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. In November 2025, updated data in lung cancer—integrating preliminary results from the HLX43-NSCLC201 study—were released. This analysis established 2.0 mg/kg or 2.5 mg/kg as the recommended Phase 2/3 dose (RP2/3D) for HLX43 in NSCLC, consistently validating the drug's efficacy and safety at these dose levels.

Henlius is vigorously advancing the clinical development of HLX43. An international multi-center Phase 2/3 study (HLX43-NSCLC302) for advanced squamous NSCLC (sqNSCLC) is slated to launch across multiple countries, including China, the US, and Japan. The Phase 3 portion of this study is poised to become the first pivotal registrational trial for HLX43 in NSCLC, potentially offering a novel therapeutic option for the hard-to-treat population of sqNSCLC patients who have failed prior standard therapies. Beyond NSCLC, the company is actively exploring the potential of HLX43 across various solid tumors, including esophageal squamous cell carcinoma (ESCC), cervical cancer, breast cancer, gastric/gastroesophageal junction (G/GEJ) cancer, and head and neck squamous cell carcinoma (HNSCC). In addition to monotherapy, clinical trials investigating HLX43 in combination with other agents are ongoing to further explore the synergistic anti-tumor efficacy of ADCs with complementary therapies. HLX43 demonstrates the clinical potential to overcome primary or acquired resistance to PD-1/L1 immunotherapies and offers potential efficacy for patients who have failed chemotherapy or TKI treatments, bringing hope for a new generation of treatments to patients with advanced or metastatic solid tumors.

媒体：PR@Henlius.com

投资者：IR@Henlius.com