Shanghai, China, January 27, 2026—Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for a clinical trial of HLX43, the innovative programmed death-ligand 1 (PD-L1) targeting antibody-drug conjugate (ADC), in combination with the company's anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) and independently developed innovative anti-EGFR mAb HLX07 has been approved by the China National Medical Products Administration (NMPA), for the treatment of advanced solid tumors.
Immune checkpoint inhibitors represented by anti-PD-1/PD-L1 monoclonal antibodies have become a cornerstone of cancer treatment. However, there are still many patients who do not respond to or derive limited benefit from monotherapy1, which has fueled the development of combination strategies. Among these, immunochemotherapy has become a first-line standard of care for multiple tumor types. As novel therapies expand the combination immunotherapy landscape, antibody-drug conjugates (ADCs) have emerged as a highly effective option. Their combination with immunotherapy (IO) may create synergy for more potent and durable responses while overcoming resistance, thereby addressing critical unmet clinical needs2. A major breakthrough has been the approval of an IO-ADC combination as first-line treatment for advanced urothelial cancer3. This success has accelerated exploration in other solid tumors like gastric cancer (GC), non-small cell lung cancer (NSCLC), breast cancer (BC), and head and neck squamous cell carcinoma (HNSCC), positioning it as a key next-generation approach4-5.
EGFR (Epidermal Growth Factor Receptor) overexpression is considered a crucial driving mechanism in the development of various malignant tumors, including lung cancer, colorectal cancer (CRC), and HNSCC, establishing it as one of the validated key targets in solid tumor treatment6. Although EGFR-targeted therapies, such as cetuximab, have significantly altered the treatment landscape for many cancers, abnormal EGFR activation can lead to immune evasion and create an immunosuppressive microenvironment, resulting in limited efficacy for single agent targeted therapy. Previous studies have shown that combination of cetuximab and irinotecan (a topoisomerase inhibitor) demonstrates potent efficacy in metastatic colorectal cancer, and is now approved for both first-line and later-line treatment of the disease7-8. Furthermore, strategies of "anti-PD-1/L1 mAb plus anti-EGFR mAb" and "anti-PD-1/L1 mAb plus anti-EGFR mAb plus chemotherapy" are widely explored in the later-line, adjuvant, and neoadjuvant settings for various solid tumors, including HNSCC, cutaneous squamous cell carcinoma (CSCC) and CRC9-12.
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. Preliminary clinical data has indicated a manageable safety profile and encouraging efficacy in various solid tumors, with notable anti-tumor activity observed in various NSCLC patient subgroups. Serplulimab (HANSIZHUANG) is the world’s first and only anti-PD-1 mAb to have succeeded in a phase 3 registration study for perioperative gastric cancer, and the first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC). It has shown unique advantages in various solid tumors via its differentiated mechanism. HLX07 is an innovative anti-EGFR mAb developed by Henlius. Compared with cetuximab, HLX07 demonstrates lower immunogenicity and higher target affinity. The company has initiated clinical trials of HLX43 in combination with serplulimab, as well as HLX43 combined with HLX07, for the treatment of advanced solid tumors. Leveraging the broad therapeutic potential of serplulimab and the PD-L1 ADC HLX43, along with encouraging clinical data for the anti-EGFR mAb HLX07 plus serplulimab with or without chemotherapy, the company plans to expand from two ongoing dual combination therapies—HLX43 plus serplulimab and HLX43 plus HLX07—into a triple-combination regimen. This strategy aims to maximize the clinical value of its core innovative products by harnessing the synergistic effects of dual immune checkpoint blockade and precision targeting.
By strategically prioritizing solid tumor domain as a core therapeutic area, Henlius continues to uphold its patient-centric mission, accelerating differentiated innovation to address unmet medical needs and delivering high-quality, affordable therapies to tumor patients worldwide.
About HLX43
HLX43 is a potential best-in-class pan-tumor ADC candidate targeting PD-L1, which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. Preclinical data has shown that, HLX43 has promising anti-tumor activity 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. In addition, phase 2 proof of concept (POC) data of HLX43 in CC and ESCC continue to emerge, providing compelling new evidence for its pan-tumor therapeutic potential.
About Serplulimab
Serplulimab is the world’s first and only anti-PD-1 mAb to have succeeded in a phase 3 registration study for perioperative gastric cancer, to receive Breakthrough Therapy Designation from the CDE as well as being granted Priority Review for the treatment of this indication. Meanwhile, it is the first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC). Up to date, serplulimab has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsqNSCLC). It has been approved in over 40 countries and regions including China, the U.K., Germany, Singapore, and India, covering nearly half of the global population and accelerating global accessibility. Serplulimab demonstrates unique advantages in various solid tumors via its differentiated mechanism, especially achieving groundbreaking progress in both lung and gastric cancers. The results of 4 pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA), Nature Medicine, Cancer Cell and British Journal of Cancer, respectively. It has also received orphan drug designations granted by the US FDA, the European Commission, Swissmedic, Korea MFDS and Mexico COFEPRIS.
About HLX07
HLX07 is an innovative anti-EGFR mAb developed by Henlius. Compared with cetuximab, HLX07 demonstrates lower immunogenicity and higher target affinity. Henlius is conducting phase 2 clinical trials to explore HLX07 as monotherapy or in combination with serplulimab for the treatment of solid tumors including sqNSCLC, CSCC, nasopharyngeal carcinoma (NPC) and ESCC. According to the updated results in 2025 WCLC, the combination of HLX07 with serplulimab and chemotherapy demonstrated remarkable antitumor activity and durable efficacy as first-line treatment for patients with EGFR overexpression sqNSCLC. At a median follow-up of 18.6 months, both dose groups achieved an objective response rate (ORR) of around 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. This indicates that the combination of HLX07 and serplulimab blocks EGFR signaling while activating immune responses, supporting strong therapeutic synergy.
References
1. Attili I, et al. Strategies to overcome resistance to immune checkpoint blockade in lung cancer[J]. Lung cancer: Journal of the International Association for the Study of Lung Cancer, 2021(154-):154.
2. Eleonora. Nicolò, et al. "Combining antibody-drug conjugates with immunotherapy in solid tumors: current landscape and future perspectives." Cancer treatment reviews 106(2022):102395.
3. Maguire WF, Lee D, et al. FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2024 May 15;30(10):2011-2016.
4. Martin Reck, Jyoti D. Patel, et al. First-Line Sacituzumab Govitecan Plus Pembrolizumab in Metastatic NSCLC: PD-L1 TPS Less Than 50% and More Than or Equal to 50% Cohorts of the EVOKE-02 Study, Journal of Thoracic Oncology, 2025.
5. Tolaney S M , Azambuja E D , et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study.[J].Journal of Clinical Oncology, 2025, 43(17_suppl):LBA109-LBA109.
6. Mitsudomi T, Yatabe Y. Epidermal growth factor receptor in relation to tumor development: EGFR gene and cancer[J]. Febs Journal, 2010, 277(2):301-308
7. E Van Cutsem, CH Köhne, E Hitre et al. Cetuximab and chemotherapy as initial treatment formetastatic colorectal cancer. N Engl J Med. 2009, 360: 1408-1417.
8. I LLC. Cetuximab FDA label. 2021.09.24.
9. AG Sacco, R Chen, FP Worden et al. Pembrolizumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label, multi-arm, non-randomised, multicentre, phase 2 trial. Lancet Oncol. 2021, 22: 883-892.
10. JI D, SANG Y, et al. A phase Ⅱ clinical trial of camrelizumab combined with cetuximab and chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)［J］. Ann Oncol, 2024, 35: S626.
11. YAO Z W, WANG J S, et al. Pembrolizumab plus cetuximab with neoadjuvant chemotherapy for head and neck squamous cell carcinoma［J］. Head Neck, 2025, 47(1): 289-299.
12. Yi-Long Lung Cancer Wu et al. A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced squamous non-small cell lung cancer. J Clin Oncol 43, 8561-8561(2025).