Henlius

Sep 07, 2025｜2025

The Updated Clinical Results for PD-L1 ADC HLX43 at the 2025 WCLC, Demonstrate Outstanding Efficacy in NSCLC

Broad Therapeutic Effects: HLX43 exhibits outstanding efficacy in IO & chemo treated NSCLC. The ORR was 28.6% for ≥4L squamous NSCLC patients, 30.0% for those who previously received docetaxel; cORR was 46.7% for EGFR wild-type non-squamous NSCLC, and 60.0% for those receiving HLX43 at 2.5 mg/kg
Biomarker Independent: HLX43 demonstrates robust anti-tumor efficacy in various types of NSCLC (with or without EGFR mutation, with or without brain metastases, PD-L1 positive and negative). cORR was 36.4% and DCR was 100.0% for patients with brain metastasis
Favorable Safety Profile：Low hematological toxicity (Grade ≥3 TRAEs) was observed for HLX43, supporting its potential for expansion into first-line setting and combination regimens. The most common grade ≥3 TRAEs include anemia (19.6%), white blood cell count decreased (19.6%), and platelet count decreased (3.6%). Immune-related AE (irAE) was reported, indicating HLX43 is capable of eliciting immunotherapeutic effects

The 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC) was held from September 6-9 in Barcelona, Spain‌. Among the highlights is the updated results of the Phase 1 clinical trial of HLX43, Henlius’ PD-L1 ADC, which secured spots in both the oral presentation and poster tour session. During the Joint IASLC-CSCO-CAALC Session co-hosted by IASLC, the Chinese Society of Clinical Oncology (CSCO), and the China Lung Cancer Prevention and Treatment Alliance (CAALC), HLX43's updated phase 1 results were reported in the form of an oral presentation on September 6 (11:00 AM-11:06 AM). Professor Jie Wang from the Cancer Hospital of the Chinese Academy of Medical Sciences serves as the leading principal investigator(PI) of this study.

The updated data further validated HLX43‘s outstanding efficacy in advanced/ metastatic solid tumors such as non-small cell lung cancer (NSCLC). It is poised to offer a superior treatment option for heavily treated NSCLC patients who have failed standard therapies (including immunotherapy, chemotherapy, targeted therapy, etc.) . Furthermore, with its broad-spectrum anti-tumor profile, HLX43 may serve as a cornerstone therapeutic agent, expanding into front-line treatment and combination therapy regimens. The results from the phase 1 clinical trial of HLX43 has been first released at the 2025 ASCO Annual Meeting.

Sustained Efficacy in NSCLC, Highlights Potential for EGFR Wild-Type Later-Line Setting

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]. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer (approximately 85%). The majority of lung cancer patients are diagnosed at advanced stages with a poor five-year survival prognosis ^[2], highlighting a significant unmet clinical need. 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].

The updated data released at the 2025 WCLC was from the open-label, first-in-human phase 1 clinical trial evaluating the safety, pharmacokinetics, and preliminary efficacy of HLX43 (Anti-PD-L1 ADC) in patients with advanced/metastatic solid tumors (with updated NSCLC cohort data). This study includes two parts. Phase 1a and 1b were a dose escalation and dose expansion phase, respectively. In phase 1a, patients with histologically or cytologically confirmed advanced/metastatic malignant solid tumors that were refractory to or could not receive standard therapies received intravenous HLX43 at 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 2.5 mg/kg, 3 mg/kg, or 4 mg/kg, Q3W. In phase 1b, patients with advanced/metastatic non-small cell lung cancer (NSCLC) refractory to standard treatment received HLX43 at 2 mg/kg, 2.5 mg/kg, or 3 mg/kg, Q3W. The primary endpoints for phase 1b were the recommended phase 2 (RP2D) dose and objective response rate (ORR).

Here we present results in the NSCLC patients (from the phase 1a + phase 1b 2.0 and 2.5 mg/kg cohorts). Median follow-up duration was 9.0 months.
As of the data cut-off date Jun 28, 2025, a total of 56 (29 [51.8%] had squamous type and 27 [48.2%] had non-squamous) NSCLC patients were enrolled in phase 1a and phase 1b 2.0 and 2.5 mg/kg cohorts. In squamous population, 10 (34.5%) failed docetaxel treatment while in non-squamous NSCLC, 15 (51.8%) had a EGFR wild-type status and 12 (48.2%) had EGFR mutations.
Among them, patients with non-squamous NSCLC were in the third-line or later setting (median prior lines of therapy: 2), while patients with squamous NSCLC were in the fourth-line or later setting (median prior lines of therapy: 3). Of all the patients, 54 (96.4%) had received platinum-based chemotherapy, 50 (89.3%) had received immunotherapy, 26 (46.4%) had received targeted therapy, and 14 (25.0%) had been treated with docetaxel.

Investigator-assessed ORR in the 54 response-evaluable patients was 37.0%, with a disease control rate (DCR) of 87.0%.

Subgroup analysis showed that in heavily pre-treated patients with squamous NSCLC (fourth-line or later, n=28), HLX43 conferred an ORR of 28.6% and a DCR of 82.1%, representing a significant clinical benefit compared to standard therapy docetaxel (ORR=12.8%). Notably, in patients who had received prior docetaxel treatment (n=10), the ORR reached 30.0% with a DCR of 80.0%. Furthermore, among these patients who receive HLX43 at the 2 mg/kg dose (n=15), ORR was 40.0% with a DCR of 73.3%, underscoring its potent therapeutic potential in heavily treated squamous NSCLC.
ORR was 46.2%, with a DCR of 96.2% in the third-line or later non-squamous NSCLC population (n=26). Notably, confirmed ORR (cORR) was 46.7% for patients with an EGFR wild-type non-squamous NSCLC (n=15). Among these patients, cORR was 60.0% for those receiving HLX43 at 2.5 mg/kg (n=5)，highlighting superior efficacy of HLX43 in the non-squamous NSCLC subgroup.
In advanced NSCLC patients with brain metastasis (n=11), HLX43 still delivered significant clinical benefits, with a cORR of 36.4% and DCR of 100.0%.
Moreover, HLX43 exhibits rubust efficacy in PD-L1 negative (TPS <1%, n=21) patients, with a ORR of 38.1% and DCR of 85.7%, indicating its differented therapeutic potential to cover a broader patient population regardless of PD-L1 expression.

In terms of safety and tolerability, the most common grade ≥3 TRAEs were anemia (19.6%), white blood cell count decreased (19.6%), neutrophil count decreased (16.1%), and lymphocyte count decreased (12.5%). Platelet count decreased was reported in 3.6% of all treated patients. Building onto the favorable safety profile previously disclosed at the 2025 ASCO annual meeting, HLX43 continued to demonstrate low hematological toxicity, supporting its potential for expansion into first-line setting and combination therapies.
Immune-related AE was reported in 12 (21.4%) patients. Immune-mediated lung disease was reported in 8 (14.3%) patients, most of which were grade 1-3.
In these patients with immune-mediated lung disease, the cORR was 50.0% and 100% tumor shrinkage was observed, highlighting the immunotherapeutic effects of HLX43 in addition to its payload-mediated cytotoxic tumor cell killing.

Potential Best-in-class PD-L1 ADC, Advances Global Development in China, the U.S., Japan, and Australia etc. Key Markets

HLX43 is a broad-spectrum 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 good anti-tumor effects and a favorable tolerability profile in non-small cell lung cancer (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 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.

Currently, Henlius is advancing the clinical development of HLX43 at full speed, with over 300 patients enrolled globally and patient recruitment progressing smoothly in multiple countries including China, the U.S., and Japan. For NSCLC, HLX43 has already been approved to conduct phase 2 MRCT in China, the U.S., Japan and Australia, with first patients successfully dosed in both China and the U.S. Simultaneously, as the world's first PD-L1 ADC indicated for thymic carcinoma (TC), HLX43 has received clinical trial approvals for the indication in the U.S. and other regions. A MRCT is planned to be initiated, aiming to fill the therapeutic gap in ADC treatment for this aggressive cancer type.

In addition, the company is also accelerating the phase 2 clinical development of HLX43 in various solid tumors, including cervical cancer (CC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), colorectal cancer (CRC) and gastric/gastroesophageal junction cancer (GC/GEJC). Both monotherapy and combination therapies of HLX43 with other products are ongoing simultaneously to further exploit the synergistic effects of ADC-mediated cytotoxicity and immunotherapy-induced immune activation. HLX43 may benefit more patients with advanced or metastatic solid tumors by providing a novel treatment option for those who are unresponsive or have developed resistance to PD-1/PD-L1-targeted therapies, as well as the patients who have failed prior chemotherapy or TKI therapies.

Reference

[1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263.

[2] Robinson CG, et al. Postoperative Radiotherapy for Pathologic N2 Non–Small-Cell Lung Cancer Treated with Adjuvant Chemotherapy: A Review of the National Cancer Data Base. Journal of Clinical Oncology 2015, 33(8): 870-876.

[3] Stanzione, B.; et al. Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor (EGFR) Common Mutations: New Strategies. Cancers 2025, 17, 1515.

[4]中国临床肿瘤学会中国临床肿瘤学会(CSCO).(2024)非小细胞肺癌诊疗指南

[5] NCCN Guidelines Version 3. 2025, Non-Small Cell Lung Cancer.

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Introduction

Shanghai Henlius Biotech, Inc., and, where applicable, its affiliates and subsidiaries (collectively, “we” , “us” or “our”) attach great importance to the protection of your privacy and personal information. This Privacy Notice (this “Policy”) is formulated in accordance with applicable PRC laws and regulations governing the protection of personal information in the People’s Republic of China (“PRC”).

This Policy applies when: (1) you browse or use our website and other online resources (such as our WeChat official accounts); (2) subscribe to our news or announcements; or (3) contact us through the contact details or other interactive features made available on our website, or otherwise interact with us through our website.. The purpose of this Policy is to explain how and why we process your personal information, the types of personal information involved, applicable retention periods, your rights, and the measures we take to protect personal information. Please read this Policy carefully to ensure that you fully understand its content.

In certain business scenarios, we may provide additional explanations regarding the processing of your personal information through separate agreements, privacy statements, or personal information notices. In the event of any inconsistency, such documents shall prevail. For example, where a recruitment function is provided through a third-party platform or service, the relevant third party privacy policy or notice may also apply.

For the purposes of this Policy, “personal information” refers to all kinds of information related to identified or identifiable natural persons, excluding anonymized information.

We collect, use, store, transfer and otherwise process personal information in strict compliance with applicable PRC laws and regulations of the People’s Republic of China.

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If you have any questions or concerns regarding this Policy or our processing of personal information, please contact us using the details provided below.

This Policy will help you understand:

I. How we collect your personal information

II. How we use your personal information

III. How we entrust, share, transfer and publicly disclose your personal information

IV. Cross border transfer of personal information

V. How we store your personal information

VI. Security measures

VII. Your rights

VIII. Personal information of minors

IX. Updates to this Policy

X. How to contact us

I. How do we collect your personal information?

In addition to our employees, we may process personal information of the following persons:

• Visitors and users of our website;

• Healthcare Professionals;

• Investigators of clinical trial institutions and personnel of contract research organizations in clinical trials;

• Subjects of clinical trials and their relatives;

• Consumers/patients and their relatives using our products or services;

• Staff of business partners (including vendors, distributors, partners, etc.); and

• Our applicants.

We may process personal information of website visitors and individuals who contact or interact with us through our website or other online resources. Depending on the relevant page, function, or interaction, separate privacy notices, consents, platform privacy policies, contracts, or other notices may apply.

Based on the context in which you interact with us, we may collect personal information by the following means and on the legal bases permitted by applicable PRC laws and regulations, including your consent, the necessity for entering into or performing a contract, compliance with legal obligations, protection of life, health or property, public health needs, or other circumstances permitted by law:

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In the course of our daily business operations, we may collect personal information from our vendors or business partners. We require our vendors and business partners to comply with the requirements of the personal information protection laws and regulations of the PRC and to lawfully provide us with personal information. If you are an employee or representative of one of our vendors or business partners, we may collect personal information such as your name and contact details for the purpose of establishing business contacts and cooperations.

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We may collect personal information of medical and healthcare professionals from such publicy available sources, such as the official websites of medical institutions and the official websites of competent government departments, and process such information within a reasonable scope and for lawful purposes. For example, for the purpose of lawful academic or professional interaction with healthcare professionals, we may collect the name, gender, employer, position, practitioner registration information, academic title, degree, educational background, specialty expertise, and profile information, where such information has been lawfully made public.

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• Providing subscription services for our news, announcements, or investor-related updates;

• Managing and maintaining our relationship and communications with business contacts who reach us through our website;

• Recruiting and human resource management;

• Internal compliance management，audit，record-keeping; and

• Complying with applicable PRC laws and regulations, for example, monitoring and reporting adverse events for purposes of performing drug quality management responsibilities, providing medical information and dealing with product complaints, etc..

We will process personal information only to the extent necessary for the relevant purpose. Where required by applicable law, we will obtain your consent or separate consent before processing your personal information or sensitive personal information. Where a third-party platform or service is used in connection with a particular function, the relevant third party may process your personal information in accordance with its own privacy policy and applicable law.

III. How do we entrust, share, transfer and publicly disclose your personal information?

1. Entrustment

We may entrust our business partners with the processing of your personal information for the purpose(s) described in this Policy. We will enter into appropriate confidentiality, data processing and security agreements with such entrusted parties and require them to process personal information in accordance with our instructions , this Policy and applicable PRC laws and regulations.

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If you submit your information through or in connection with a third-party platform or service referred to on our website, the relevant third party may independently process your personal information in accordance with its own privacy policy and applicable law.

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IV.How do we provide your personal information across borders?

In principle, personal information that we collect and generate in the course of our operations within the territory of the PRC will be stored within the PRC. In certain circumstances, it may be necessary for us to provide your personal information to recipients outside the PRC in connection with our business operations, website functions, or communications, where permitted by applicable PRC laws and regulations. As required by applicable laws and regulations regarding the protection of personal information, we will provide you with the required notice and obtain your separate consent before providing your personal information across any border, unless otherwise permitted by law. We will use lawful cross-border transfer mechanisms to transfer your personal information oversea and will take necessary measures to ensure that the oversea recipients provide a level of protection required by applicable PRC laws and regulations.

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We will retain your personal information for the minimum period necessary to achieve the purposes described in this Policy ,unless a longer retention period is required or permitted by applicable PRC laws and regulations. Upon expiration of the applicable retention period, we will promptly delete or anonymize your personal information in accordance with applicable PRC laws and regulations. Our criteria for determining the period for which personal information shall be retained include:

• Applicable laws, regulations and other relevant requirements;

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VI. What security measures do we take to protect your personal information?

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• To correct or supplement your personal information;

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• To change the scope of your consent or revoke your consent , where processing is based on your consent.

If you wish to exercise your rights with respect to personal information, you may contact us through the contact information listed in this Policy and we will respond to any request in accordance with applicable relevant laws and regulations. When you exercise the above rights, we may verify your identity to safeguard the security of your personal information. Subject to applicable PRC laws and regulations, there may be circumstances where we are unable to respond to all or part of your request.

VIII. How do we process the personal information of minors?

For the purposes of this Policy and in accordance with applicable PRC laws and regulations, our products, websites and services are not targeted at minors under the age of 14. Minors under the age of 14 should not provide personal information to us without the consent of a parent or legal guardian.

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IX. Updates of the Policy

We may revise our Privacy Policy from time to time. We will post the updated version on our website and update the “Last Updated” date above or below this Policy.

Last updated: March 30, 2026.

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If you have any questions, comments or suggestions concerning this Policy, or any questions or concerns about our processing of your personal information, you may contact us in the following ways:

Address: 11/F, B8 Building, No.188 Yizhou Rd, Xuhui District, Shanghai

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Shanghai Henlius Biotech, Inc. (“Henlius”) is committed to improving the accessibility and user friendliness of its website for all visitors.

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Last updated: March 30, 2026

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