Hetronifly (serplulimab) / Fosun Pharma, PT Kalbe Farma, Intas, Lotus Pharmaceutical - LARVOL DELTA

Final analysis of first-line serplulimab plus chemotherapy with or without HLX04 in advanced nonsquamous non-small cell lung cancer: The ASTRUM-002 phase III study (ESMO 2025) - P3 | "The addition of HLX04 to serplulimab and chemo did not lead to a further improvement. Both investigated treatment regimens had manageable safety profiles."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • ALK • EGFR • ROS1

First-line serplulimab plus chemotherapy with or without HLX04 versus chemotherapy in locally advanced or metastatic non-squamous non-small-cell lung cancer (ASTRUM-002): a randomised, double-blind, multicentre phase 3 trial. (PubMed, Lancet Respir Med) - P3 | "The addition of serplulimab to chemotherapy led to significantly longer progression-free survival in patients with locally advanced or metastatic non-squamous NSCLC compared with chemotherapy alone and represents an alternative first-line treatment option for this patient population. HLX04 plus serplulimab and chemotherapy did not confer further statistical benefit compared with serplulimab plus chemotherapy."

IO biomarker • Journal • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

Phase II Trial of Serplulimab Plus Bevacizumab and Chemotherapy for Treatment-Naïve Non-Squamous NSCLC with Brain Metastases (SUPER BRAIN) (IASLC-WCLC 2025) - P2/3 | "Patients received serplulimab combined with bevacizumab, pemetrexed, and carboplatin for four to six cycles, followed by maintenance therapy with serplulimab plus bevacizumab and pemetrexed until disease progression, unacceptable toxicity, or death, for up to two years. No treatment-related deaths were reported. Conclusions : Serplulimab plus bevacizumab and chemotherapy demonstrated promising intracerebral antitumor efficacy and a manageable safety profile for patients with non-squamous NSCLC with BMs in the first-line setting."

P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor

ECTOP-1036: Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC (clinicaltrials.gov) - P2 | N=116 | Recruiting | Sponsor: Fudan University

New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ASTRUM-002: First-Line Serplulimab Plus Chemotherapy With or Without HLX04 in Advanced Nonsquamous Non-Small Cell Lung Cancer (IASLC-WCLC 2025) - "Introduction : IMpower130 study demonstrated efficacy of atezolizumab plus chemotherapy (chemo) over chemo alone...This study, for the first time, evaluated serplulimab (anti-PD-1 antibody) plus HLX04 (bevacizumab biosimilar) and chemo (pemetrexed plus carboplatin) versus serplulimab plus chemo in nsNSCLC...Conclusions : The addition of serplulimab to chemo provided significantly longer PFS compared to chemo alone in patients with locally advanced or metastatic nsNSCLC, while the combination of serpluliamb, bevacizumab and chemo provided numerical improvements in PFS when compared to serplulimab and chemo. Both treatment regimens had manageable safety profiles."

Clinical • IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Phase II Study of iza-bren (BL-B01D1) in Combination with Serplulimab in Patients with Small Cell Lung Cancer (SCLC) (ELCC 2026) - No abstract available

Clinical • Combination therapy • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Serplulimab Consolidation after Concurrent Hypofractionated Chemoradiotherapy for Limited-stage Small-cell Lung Cancer (ELCC 2026) - No abstract available

Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Single-arm, Multi-center, Open-label Phase II Study to Investigate the Efficacy and Safety of Serplulimab in Combination with Chemotherapy in First-line Treatment of Pulmonary Neuroendocrine Carcinoma (ChiCTR) - P2 | N=162 | Recruiting | Sponsor: PLA General Hospital; PLA General Hospital

New P2 trial • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor • ALK • EGFR • ROS1

First-line Serplulimab for Advanced Squamous Non-small Cell Lung Cancer: Updated Survival of the ASTRUM-004R Trial (ELCC 2026) - No abstract available

Clinical • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A clinical study of carboplatin/albumin paclitaxel combined with PD-L1 inhibitor as neoadjuvant therapy for resectable Cervical Esophageal Squamous Cell Carcinoma (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

A Single-Arm, Single-Center, Prospective Clinical Trial of Regorafenib Combined with Serplulimab and Stereotactic Radiotherapy as Third-Line Treatment for Metastatic Colorectal Cancer (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Sichuan Cancer Hospital; Sichuan Cancer Hospita

New P2 trial • Colon Cancer • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2026 ➔ Aug 2027 | Trial primary completion date: Feb 2026 ➔ Dec 2026

Enrollment open • IO biomarker • Trial completion date • Trial primary completion date • Tumor mutational burden • Colorectal Cancer • Lung Cancer • Oncology • Solid Tumor • BRAF • MSI

Phase I/II clinical study of SYS6043 combined with PD-1/PD-L1 inhibitor ± chemotherapy in the treatment of advanced solid tumor participants (ChiCTR) - P1/2 | N=622 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study) (clinicaltrials.gov) - P2 | N=128 | Not yet recruiting | Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

New P2 trial • pMMR • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor • MLH1 • MSH2 • MSH6

Fruquintinib plus serplulimab as first-line therapy in metastatic or unresectable non-clear cell renal cell carcinoma (nccRCC): Updated efficacy and safety data from a multicenter, single-arm, phase II trial. (ASCO-GU 2026) - P2 | "Clinical Trial Registry Number: NCT05831891. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Metastases • P2 data • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Solid Tumor

Eisai Co., Ltd…and Shanghai Henlius Biotech, Inc…announced today the conclusion of an exclusive commercialization and co-exclusive development and manufacturing license agreement for the anti-PD-1 antibody serplulimab (generic name, marketed as HANSIZHUANG in China and Hetronifly in the EU) in Japan. (Eisai Press Release) - "In Japan, Henlius is currently conducting a Phase II bridging clinical trial for ES-SCLC, and plans to submit an application for fiscal year 2026 based on the results of this trial as well as the Phase III clinical trial data that supported approvals for this indication in China and Europe. Furthermore, a Phase III multi-national clinical trial for non-high-frequency microsatellite instability (non-MSI-High) metastatic colorectal cancer is underway, with development for new indications also planned."

Japan filing • Licensing / partnership • MSI-H • Trial status • Colorectal Cancer • Microsatellite Instability • Small Cell Lung Cancer

A Prospective Study of Neoadjuvant Serplulimab Plus Chemotherapy for Stage II-IIIB Non-Small Cell Lung Cancer (NSCLC) (ELCC 2026) - No abstract available

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Surgery versus radiotherapy after induction therapy with serplulimab combined with chemotherapy for unresectable stage IIIB-IIIC non-small cell lung cancer: A randomized controlled, open-label, phase II trial (ESMO 2025) - P2 | "Background Chemoradiation followed by durvalumab is recommended for unresectable stage III non-small cell lung cancer (NSCLC) based on the PACIFIC trial. SAE and grade 3-5 treatment-related adverse event rates in induction therapy phase were 12.0% and 58.0%, respectively. Conclusions Induction chemoimmunotherapy showed good efficacy and safety in unresectable stage IIIB-IIIC NSCLC, and surgery brought longer EFS than radiotherapy."

Clinical • P2 data • Surgery • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Neoadjuvant immunotherapy with or without chemotherapy and minimally invasive esophagectomy in elderly patients for locally advanced esophageal squamous cell carcinoma: A prospective, single-arm, multicenter phase II clinical study (ChiCTR) - P2 | N=62 | Recruiting | Sponsor: Shanghai Geriatric Medical Center; Shanghai Geriatric Medical Center

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1

Long-term survival in extensive-stage small cell lung cancer: a case report on the integration of interventional bronchoscopy and systemic immunotherapy. (PubMed, Front Oncol) - "The patient initially responded to platinum-etoposide chemotherapy but experienced treatment interruption during the COVID-19 pandemic, followed by recurrent malignant airway obstruction and respiratory failure...Subsequently, chemotherapy combined with the programmed cell death protein-1 (PD-1) inhibitor serplulimab was initiated, followed by maintenance immunotherapy...At five years after initial diagnosis, the patient remains alive with stable disease and without severe treatment-related adverse events. This case highlights the potential role of integrating bronchoscopic local interventions with systemic chemotherapy and immunotherapy to enable durable disease control and long-term survival in selected patients with ES-SCLC complicated by central airway obstruction."

Journal • Infectious Disease • Lung Cancer • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • IL6

Panel Discussion: Re-inventing the wheel in Lung Cancer with Serplulimab (I-OSICON 2026) - No abstract available

Lung Cancer • Oncology • Solid Tumor

Neoadjuvant serplulimab and SOX chemotherapy for locally advanced gastric cancer: pathological responses and systemic immune signatures from a phase II trial. (PubMed, Front Immunol) - P3 | "The identification of non-invasive, blood-based immune biomarkers may help guide future patient selection and therapeutic optimization. The ongoing phase III trial (NCT04139135) will validate the efficacy of this perioperative immunochemotherapy strategy in LAGC."

IO biomarker • Journal • P2 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CD4 • CD8 • IL1B • TNFA

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. (ASCO 2025) - P2 | "Patients with stage IIIB/IIIC or IV sqNSCLC that was not amenable to surgery or radiation therapy and high tumor expression of epidermal growth factor receptor (H score≥150) and no prior systemic therapy were randomized 1:1 to receive intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300 mg) and chemotherapy (carboplatin and nab-paclitaxel), once every three weeks. First-line HLX07 plus serplulimab and chemotherapy showed encouraging preliminary efficacy with a manageable safety profile in patients with advanced sqNSCLC which warrants further investigation."

Clinical • IO biomarker • Metastases • P2 data • Alopecia • Anemia • Endocrine Disorders • Immunology • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Circulating tumor DNA refines consolidation immunotherapy for limited-stage small cell lung cancer patients. (PubMed, Signal Transduct Target Ther) - "For 44 patients receiving consolidation ICI with serplulimab, an investigational PD-1 inhibitor, ctDNA dynamics during consolidation ICI were also assessed at multiple time points...Furthermore, maintaining ctDNA negativity during consolidation ICI was associated with favorable outcomes. These data provide valuable insights into the individualized management of LS-SCLC in the era of immunotherapy."

Biomarker • Circulating tumor DNA • IO biomarker • Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Neoadjuvant chemotherapy and serplulimab in MSS/pMMR locally advanced rectal cancer (FIRM): a phase II trial (Henlius Press Release) - "Among 30 enrolled patients, 28 completed ≥4 cycles of nICT and were included in PPS. 2 discontinued due to adverse events. The pCR was achieved in 42.9% (12/28) of pts, and MPR in 67.9% (19/28). For high LARC (>10 cm from anal verge, ineligible for nCRT), the pCR and MPR rates were 71.4% and 85.7%."

Clinical data • pMMR • Rectal Cancer