May 06, 2026｜2026
Henlius' HLX43 (anti-PD-L1 ADC) Receives PMDA’s Acknowledge to Initiate Global Phase 2/3 Trial in sqNSCLC
Shanghai, China – May 4, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that its innovative anti-PD-L1 antibody–drug conjugate (ADC), HLX43, has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to conduct the HLX43-NSCLC302 study — an international, multicenter phase 2/3 clinical trial in patients with advanced squamous non-small cell lung cancer (sqNSCLC). 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-tumor 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 tumors, with notable anti-tumor activity observed in multiple NSCLC patient subgroups. According to updated data presented at the 2025 WCLC, in the later-line treatment of sqNSCLC, HLX43 has demonstrated preliminary encouraging efficacy. Among patients receiving HLX43 at 2.0 mg/kg , the objective response rate (ORR) reached 40.0%, with a disease control rate (DCR) of 73.3%. Notably, in patients who had received prior docetaxel treatment, the ORR reached 30.0% with a DCR of 80.0%. HLX07 is an innovative anti-EGFR mAb developed by Henlius. Compared with cetuximab, HLX07 demonstrates lower immunogenicity and higher target affinity. According to updated results from the 2025 WCLC, the combination of HLX07 with serplulimab and chemotherapy demonstrated remarkable antitumor activity and durable efficacy in patients with EGFR-overexpressing sqNSCLC. At a median follow-up of 18.6 months, both dose groups achieved an objective response rate (ORR) of approximately 70% and a disease control rate (DCR) of over 90%. The median progression-free survival (PFS) reached 17.4 months in the high-dose group. HLX43 is expected to synergize with the anti-EGFR monoclonal antibody HLX07. 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 tumors 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 HLX07 and anti-PD-1 mAb serplulimab, 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.
About HLX43-NSCLC302
This study is a randomized, open‑label, multi-center, global phase 2/3 clinical study designed to evaluate the efficacy and safety of HLX43 (anti-PD‑L1 ADC) as monotherapy or in combination with HLX07 (a recombinant anti‑EGFR humanized monoclonal antibody injection) compared with docetaxel in patients with advanced or metastatic squamous non‑small cell lung cancer (NSCLC) who have failed prior therapy.
The study consists of two stages. Stage 1 is an open-label, randomized, multi-center phase 2 study, eligible subjects will be randomized in a 1:1:1 ratio to one of the following treatment arms: Group A (HLX43 monotherapy), Group B (HLX43 in combination with HLX07) or Group C (Docetaxel). Stage 2 is an open‑label, randomized, multi-center phase 3 study. Based on the results from Stage 1, either HLX43 monotherapy or HLX43 in combination with HLX07 will be selected as the investigational group. Approximately 566 subjects will be randomized in a 1:1 ratio to Investigational group (HLX43 monotherapy or HLX43 + HLX07) or Control group (Docetaxel).
The primary objective of this study is to evaluate the clinical efficacy of HLX43 monotherapy or HLX43 combined with HLX07 in the treatment of advanced squamous NSCLC after failure of first-line treatment, and the study adopts overall survival (OS) and progression‑free survival (PFS) as dual primary endpoints. Secondary objectives of this study include evaluation of safety of HLX43 monotherapy or HLX43 in combination with HLX07 vs. docetaxel, pharmacokinetic (PK) characteristics and immunogenicity of HLX43 and HLX07, and exploration of potential predictive or resistance biomarkers.
References
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.Wang, Y., et al. Immunotherapy for advanced-stage squamous cell lung cancer: the state of the art and outstanding questions. Nat Rev Clin Oncol 22, 200–214 (2025).
3.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
4.NCCN Guidelines Version 3. 2025, Non-Small Cell Lung Cancer.
5.Ahn MJ, et al. TROPION-Lung01 Trial Investigators. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. 2025 Jan 20;43(3):260-272.
6.Paz-Ares LG, et al. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872.
7.Pirker R, et al. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 2012 Jan;13(1):33-42.8.
8.Thatcher N, et al. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74.
9.Becotatug (JMT101, Beco) combined with docetaxel (albumin-bound, HB1801) for the treatment of patients (pts) with locally advanced squamous cell non-small cell lung cancer (sqNSCLC): A randomized control phase II study (BATTLE study). ESMO Asia 2025|2025-12-05.
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Privacy Policy
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.
Our website may contain links to third party websites for your convenience. We do not control, and are not responsible for, the privacy practices of such third parties. We encourage you to review their privacy policies before using those websites.
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:
• Your personal information provided to us voluntarily
When you subscribe to our news or announcements, contact us through the contact details or other interactive features made available on our website, a third-party platform or service linked or referred to on our website, or otherwise communicate with us in relation to our website, we may collect the personal information that you voluntarily provide, such as your name, contact details, organization, and the content of your inquiry or request, depending on the relevant page or function.
• Personal information collected by us independently through our website and other online channels
When you visit our website, most of our services do not require any registration, and you can visit our website without telling us who you are. However, some pages or functions may require you to provide certain personal information. If you choose not provide such information as we request, you may not be able to access certain content or functions or we may not be able to respond to your inquiry, request or subscription. Please refer to the relevant page or notice for further details about the categories of personal information collected in a specific scenario.
• Personal information we collect from vendors or business partners
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.
• Personal information we collect from publicly available sources
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.
Our website may include links, contact details, QR codes, or references to third-party platforms or services. Where you choose to interact with us through such third-party platforms or services, the relevant third party may also process your personal information in accordance with its own privacy policy and applicable law, and we encourage you to review such policy before submitting your information.
II. How do we use your personal information?
We may use your personal information for the following purposes:
• Operating, maintaining and improving our website and other online resource;
• Researching, developing, providing and continuously improving our products and services;
• Conducting and managing daily business;
• Academic interaction with healthcare professionals;
• Responding to your inquiries, requests, or communications sent through our website or the contact details made available on our website;
• 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.
2. Sharing and public disclosure
For the purpose(s) described in this Policy, we will share or publicly disclose your personal information only where permitted by applicable PRC laws and regulations and, where required, after obtaining your consent or separate consent. Such circumstances may include:
• Sharing your personal information among our affiliates and subsidiaries where necessary for legitimate business, management, compliance, or operational purposes;
• Sharing your personal information with vendors or business partners (such as conference service providers, travel service providers, data service providers, banking or insurance institutions, other professional service organizations, to the extent necessary for the relevant purpose); and
• Disclosing your personal information to the extent that it is permitted or required by applicable PRC laws and regulations or for the purpose of assisting with investigations by judicial, regulatory or law enforcement authorities.
• other circumstances permitted by applicable PRC laws and regulations.
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.
3. Transfer
We will not transfer your personal information to any other company, entity or individual unless otherwise permitted by applicable law and, where required, after obtaining your consent. Further, in the event of a merger, acquisition, insolvency, reorganization, division, dissolution, bankruptcy, or similar transaction, we will require the new processor of your personal information to continue to be bound by this Policy or we will require the new processor to obtain your consent again.
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.
You may obtain more information about cross-border transfers of personal information and oversea recipients through the contact methods referred to in this Policy.
V. How do we store your personal information?
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;
• The period of time needed for us to provide services, maintain business relations or interact with you; and
• The period of time needed for us to perform relevant agreements or fulfil the purposes described in this Policy.
VI. What security measures do we take to protect your personal information?
In accordance with applicable PRC laws, regulations, and the requirements of relevant national standards, we take reasonable and appropriate security and precautionary measures to protect the personal information we process against unauthorized access, public disclosure, use, modification, destruction or loss of data. However, you are also responsible for taking appropriate measures to protect the security of the devices, systems, and networks you use when accessing our website or communicating with us.
VII. Your rights
In accordance with the requirements of the applicable PRC laws and regulations, you may have the following rights in respect of your personal information:
• To know about and make decisions regarding the processing of your personal information;
• To access or copy your personal information;
• To correct or supplement your personal information;
• To delete your personal information;
• To request for explanation of rules regarding processing of personal information; and
• 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.
If a minor's personal information is collected with the consent of a parent or legal guardian, we will process the information only when permitted by law, with the express consent of the parent or legal guardian, or necessary for the protection of the minor. If we discover that we have collected personal information without obtaining verifiable prior consent of a parent or legal guardian, we will seek to delete the data as soon as possible.
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.
X. How to contact us?
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
Tel.: 021- 33395800
Postal Code: 200233
Email: PR@txzcvip.com
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Last updated: March 30, 2026
