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Addressing Perioperative Treatment Needs in NSCLC and Exploring an Innovative Combination Regimen

According to GLOBOCAN, lung cancer is the most commonly diagnosed cancer and the leading cause of cancer-related death worldwide. In 2022, there were more than 2.48 million new lung cancer cases globally, accounting for 12.4% of all lung cancer new cases.¹ NSCLC is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases. For patients with early- and middle-stage NSCLC, surgery remains one of the primary treatment approaches. Despite the opportunity for curative resection, more than half of those with stage II–III NSCLC still face risks of local recurrence or distant metastasis after surgery.²

In recent years, ICIs and targeted therapies have significantly advanced the treatment strategies for NSCLC. Multiple phase 3 clinical studies have shown that neoadjuvant immunotherapy, with or without chemotherapy, can improve pathological response rates and prolong event-free survival and overall survival in patients with resectable stage II–III NSCLC.^3-5 These advances have established perioperative immunotherapy as a new standard of care for stage II–III NSCLC. 

Serplulimab (trade name: Hetronifly^® in Europe) is an anti-PD-1 monoclonal antibody (mAb) independently developed by Henlius. It has been approved in 50 markets worldwide and has established comprehensive coverage in lung cancer, including first-line treatment for key indications such as extensive-stage small cell lung cancer (ES-SCLC), squamous non-small cell lung cancer (sqNSCLC) and non-squamous non-small cell lung cancer (nsqNSCLC). Its international multi-center phase 3 clinical study as first-line treatment for limited-stage small cell lung cancer (LS-SCLC) has also completed global enrollment, laying a solid foundation for Henlius to continue exploring immunotherapy-based combination regimens in lung cancer.

Henlius has established a deep and comprehensive presence in the lung cancer therapeutic landscape, building a diversified product portfolio that spans multiple histological subtypes, treatment stages, and therapeutic mechanisms, including immunotherapy, targeted therapy, anti-angiogenic agents, and antibody–drug conjugates (ADCs). In addition to HLX43 and serplulimab, the company is continuing to advance lung cancer R&D around bevacizumab HLX04, anti-EGFR mAb pimurutamab, as well as early-stage innovative assets including HLX3901, a DLL3 x DLL3 x CD3 x CD28 tetraspecific T-cell engager for small cell lung cancer, and HLX48, a c-MET x EGFR bispecific ADC for NSCLC.

Looking ahead, Henlius will continue to deepen its innovation-driven strategy in lung cancer, leveraging a diversified portfolio and global clinical development capabilities to deliver more breakthrough therapies, generate greater clinical value, and create meaningful societal impact for 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. Preliminary clinical results of HLX43 were presented at the 2025 ASCO Annual Meeting, 2025 WCLC, and the 2026 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC. In addition, Henlius is actively exploring the therapeutic potential of HLX43 across multiple 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. Beyond 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.

About Serplulimab

Serplulimab is a recombinant humanized anti-PD-1 mAb injection (trade name: Hetronifly^® in Europe). It is the world’s first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer (SCLC) and for perioperative gastric cancer. Up to date, it has been approved in 50 countries and regions including China, the U.K., EU, Singapore, India, Switzerland, and Peru.

In March 2022, serplulimab was officially approved  in China and is currently indicated for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung cancer (nsqNSCLC), and gastric cancer (GC). With the approval of the gastric cancer indication, serplulimab has become the world’s first perioperative regimen for gastric cancer to replace adjuvant chemotherapy with immunotherapy monotherapy.

Henlius continues to advance an extensive global clinical programme for serplulimab, with more than 10 combination immunotherapy studies ongoing worldwide and over 5,700 patients enrolled, with over 30% of patients enrolled in two pivotal international studies being Caucasian, making it one of the anti-PD-1 mAbs with the most extensive international clinical data. Bridging studies for ES-SCLC are being conducted in the United States and Japan.

In colorectal cancer, ASTRUM-015, the global phase 3 study evaluating serplulimab in combination with bevacizumab and chemotherapy for first-line treatment of metastatic colorectal cancer (mCRC) has completed patient enrolment, while emerging data from its phase 2 stage further underscore serplulimab’s potential to expand its clinical value across high-burden gastrointestinal malignancies.

Three pivotal clinical studies of serplulimab have been published in leading journals including The Lancet, The Journal of the American Medical Association (JAMA), Nature Medicine, and the British Journal of Cancer. In addition, serplulimab has been included in several authoritative clinical guidelines, such as the CSCO Guidelines for SCLC, NSCLC, ESCC, GC, Clinical Application of Immune Checkpoint Inhibitors, and Chinese Guidelines for Radiotherapy in Esophageal Cancer, providing important references for oncology clinical practice. Internationally, serplulimab for the treatment of SCLC has been granted Orphan Drug Designations (ODDs) by regulatory authorities of multiples countries, including the U.S. FDA.