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

Phase II study of iza-bren (BL-B01D1) in combination with serplulimab in patients with small cell lung cancer (SCLC) (ELCC 2026) - P2 | "In stage II, treatment-naive pts were treated with iza-bren at 2.5 or 2.75 mg/kg D1D8 Q3W plus serplulimab or plus serplulimab and anlotinib. Legal entity responsible for the study Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. Funding Baili-Bio (Chengdu) Pharmaceutical Co., Ltd."

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

On 26 March 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Hetronifly. (European Medicines Agency) - "Hetronifly in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC). Hetronifly in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5."

CHMP • Esophageal Squamous Cell Carcinoma • Small Cell Lung Cancer

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

SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases (clinicaltrials.gov) - P2 | N=51 | Recruiting | Sponsor: First Affiliated Hospital of Zhejiang University | N=102 ➔ 51

Enrollment change • Mismatch repair • pMMR • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor • MLH1 • MSH2 • MSH6

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

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 | "The combination of fruquintinib and serplulimab showed promising anti-tumor activity with acceptable tolerability as first-line treatment for metastatic or unresectable nccRCC. This novel combination therapy has the potential to become a valuable therapeutic option for this challenging disease."

Clinical • Metastases • P2 data • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Solid Tumor • FH • TFE3

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

Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Sun Yat-sen University

IO biomarker • New P2 trial • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer. (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Checkpoint inhibition • Monotherapy • New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Focusing on broader clinical needs, clinical development and regulatory progress for serplulimab advance with full acceleration across China, the European Union, the United States, Japan, and other emerging markets. (The Manila Times) - "The corresponding marketing application has been accepted and granted priority review, with approval anticipated in the first half of 2026. In parallel, a New Drug Application (NDA) for limited-stage SCLC (LS-SCLC) is planned for submission in China in 2026. In the EU, additional indications-including squamous and non-squamous NSCLC and esophageal squamous cell carcinoma (ESCC)-are expected to receive approval in 2026. In the United States, the bridging study for first-line ES-SCLC has completed enrolment, with a Biologics License Application (BLA) submission planned for 2026."

China approval • China filing • EMA approval • FDA filing • Esophageal Squamous Cell Carcinoma • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Small Cell Lung Cancer

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

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=167 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=90 ➔ 167 | Trial completion date: Jul 2028 ➔ Jan 2029

Enrollment change • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Henlius Reports 2025 Results: Sustained Growth in Both Revenue and Profit, Advancing Innovation Validation and Global Operations (The Manila Times) - "The Company's flagship product, serplulimab (trade name: Hetronifly in Europe), continued to deliver global commercial momentum. During the reporting period, it recorded global sales revenue of RMB 1.4926 billion, representing a year-on-year increase of 13.7%...Its core product HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe) achieved global sales revenue of RMB 2.9645 billion, up 5.5% year-on-year...HANNAIJIA (neratinib) generated sales revenue of RMB 0.3012 billion, representing a year-on-year increase of 564.2%...HANBEITAI (bevacizumab) generated sales revenue of RMB 0.3564 billion, up 80.8%."

Sales • Colorectal Cancer • Gastric Cancer • HER2 Positive Breast Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Small Cell Lung Cancer

Serplulimab consolidation after concurrent hypofractionated chemoradiotherapy for limited-stage small cell lung cancer (ELCC 2026) - P2, P3 | "Here, we report updated outcomes from the ASTRUM-LC01 (NCT05443646) trial.Methods This multicenter, single-arm, phase II trial evaluates the efficacy and safety of serplulimab consolidation in response LS-SCLC patients following four cycles of carboplatin/cisplatin plus etoposide with concurrent hypofractionated radiotherapy (45Gy/3Gy/15F). Grade 3-4 radiation pneumonitis and esophagitis occurred in 7.3% (n=4) and 1.8% (n=1) of patients, respectively.Conclusions ASTRUM-LC01 trial demonstrated that serplulimab consolidation following Hypo-cCRT yields compelling survival benefits with a manageable safety. The significant OS improvement over control group support serplulimab after Hypo-cCRT as a potential therapeutic strategy, warranting validation in randomized controlled trials."

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

A prospective study of neoadjuvant serplulimab plus chemotherapy for stage II-IIIB non-small cell lung cancer (NSCLC) (ELCC 2026) - "Grade 3-4 AEs occurred in 23.2% of patients (n=19), with 2.4% (n=2) reporting grade 3-4 immune-related AEs. Four patients (4.9%) reported grade 3-4 surgery-related complications.Conclusions Neoadjuvant serplulimab plus chemotherapy yielded substantial pathologic responses with a manageable safety in stage II-IIIB locally advanced NSCLC."

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

First-line serplulimab for advanced squamous non-small cell lung cancer: Updated survival of the ASTRUM-004R trial (ELCC 2026) - "The median PFS benefit was comparable between patients receiving nab-paclitaxel and those receiving paclitaxel (17.5 vs. 15.2 months, P = 0.677), suggesting no significant difference in efficacy between the two groups. The incidence of any grade adverse events (AEs) was 36.4%, with grade ≥3 immune-related AEs reported in 6.8% of patients.Conclusions The updated results confirm that first-line serplulimab plus platinum-based therapy provides a significant survival benefit with a manageable safety profile in sqNSCLC, consistent with findings from the ASTRUM-004 trial. The long-term survival benefit requires further validation with additional follow-up."

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

First-Line Serplulimab versus Other Anti-PD-1/PD-L1 Antibodies Plus Chemotherapy for Esophageal Squamous Cell Carcinoma: A Systematic Review with Benefit-Risk Assessment via Matching-Adjusted Indirect Comparison. (PubMed, Biologics) - "The pooled adjusted OS HR was 0.98 (95% CI, 0.87-1.11), with numerically favorable OS versus nivolumab (HR, 0.76; 95% CI 0.47-1.24) and comparable OS versus pembrolizumab (HR, 0.93; 95% CI, 0.71-1.22) and camrelizumab (HR, 0.93; 95% CI, 0.70-1.24). The pooled adjusted PFS HR was 0.91 (95% CI, 0.81-1.02), significantly favoring serplulimab over nivolumab (HR, 0.56; 95% CI, 0.33-0.96), with favorable trends versus pembrolizumab (HR, 0.83; 95% CI, 0.63-1.10) and sugemalimab (HR, 0.86; 95% CI, 0.63-1.16)...This indirect comparison provides comparative benefit-risk evidence to inform first‑line treatment selection for locally advanced or metastatic ESCC. Serplulimab plus chemotherapy demonstrated a clinically meaningful PFS benefit, comparable OS after matching, and a manageable safety profile consistent with the PD-1/PD-L1 inhibitor class."

Benefit-risk assessment • Journal • Review • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Serplulimab Combined with Bevacizumab and Chemotherapy as First-Line Treatment for Recurrent or Metastatic Cervical Cancer (ASTRUM-CC01): A Phase II Trial (SGO 2026) - No abstract available

Clinical • Metastases • P2 data • Cervical 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

Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=84 | Not yet recruiting | Sponsor: Xijing Hospital

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L1 • PGR

Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC (clinicaltrials.gov) - P2 | N=46 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

PRAC adopted an extension of indication for HETRONIFLY in combination with carboplatin and pemetrexed for first-line treatment of adults with locally advanced or metastatic non-squamous NSCLC without EGFR or ALK mutations, based on interim Phase III HLX10-002-NSCLC301 results. SmPC sections 4.1, 4.8, 5.1 and 5.2 and the Package Leaflet were updated accordingly. RMP version 1.1 was submitted. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 9 – 12 Mar 2026: [AI generated summary]

PRAC • Lung Cancer • Non Small Cell Lung Cancer • Oncology

FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer (clinicaltrials.gov) - P4 | N=42 | Not yet recruiting | Sponsor: Ye Xu

New P4 trial • pMMR • Tumor mutational burden • Colorectal Cancer • Oncology • Solid Tumor • MSI

Neoadjuvant immunochemotherapy plus thymalfasin in locally advanced gastric cancer: a prospective clinical trial. (PubMed, BMC Med) - P2 | "Neoadjuvant serplulimab, SOX, and thymalfasin produced encouraging pathological response, substantial nodal clearance, and an acceptable safety profile in stage III G/EGJ adenocarcinoma. Peripheral immune and transcriptomic profiling are consistent with a hypothesis in which thymalfasin may help preserve and coordinate systemic antitumor immunity without excessive toxicity. These findings warrant further larger randomized trials."

IO biomarker • Journal • Gastric Cancer • Oncology • Solid Tumor • CD69 • CD8

NAPTSOX24: Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Zekuan Xu | Trial primary completion date: May 2025 ➔ Jan 2026

Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2