Henlius

2026年(中国)世界小组赛程

Oct 19, 2026｜2026

ESMO 2026 Preview | Henlius’ Serplulimab U.S. Bridging Study Selected as Proffered Paper presentation, with Studies Exploring Efficacy and Quality of Life in Multiple Solid Tumors

On October 19, 2026, local time, the European Society for Medical Oncology (ESMO) Annual Congress website released the abstracts selected for presentation at this year’s meeting. Ten studies of Henlius’ innovative anti-PD-1 monoclonal antibody(mAb) serplulimab (trade name in Europe: Hetronifly^®), have been selected for ESMO 2026. The studies included the U.S. bridging trial HLX10-005-SCLC301E (ASTRIDE), quality-of-life (QoL) analyses in approved indications for lung cancer and esophageal squamous cell carcinoma (ESCC), and investigations across a broader range of solid tumors, including gastrointestinal cancers. They cover diverse clinical settings, from first-line and neoadjuvant treatment to consolidation therapy following chemoradiotherapy, further highlighting the potential of serplulimab across solid tumors.

Notably, the ASTRIDE study has been selected for an oral presentation, while a study exploring first-line treatment for extrapulmonary neuroendocrine carcinoma has been selected for a Rapid Oral presentation. Comparing serplulimab against the current U.S. standard of care for first-line extensive-stage small cell lung cancer (ES-SCLC), the ASTRIDE trial represents the largest U.S. enrollment to date among completed clinical trials for ES-SCLC. It provides further evidence for evaluating serplulimab in U.S. patients. The positive results presented at ESMO further corroborate the clinical benefits of serplulimab and support the applicability of the international multi-center Phase 3 ASTRUM-005 trial results to ES-SCLC patients in the U.S.

Serplulimab is the world’s first* anti-PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer (SCLC) and perioperative treatment of gastric cancer. It has been approved in more than 50 countries and regions, including China, the United Kingdom, the European Union, Singapore, India, Switzerland, and Peru, covering nearly half of the world’s population. It has also been included in reimbursement or public healthcare coverage systems in more than 10 countries, including the United Kingdom, Austria, Denmark, Germany, Ireland, Italy, Spain, and Sweden, demonstrating broad potential for global clinical use.

U.S. ASTRIDE Trial Selected for Proffered Paper Session, Reinforcing 1L LC Advantage

In lung cancer, serplulimab is the world’s first* anti-PD-1 mAb approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Its approved lung cancer indications now span three major settings: first-line treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and non-squamous non-small cell lung cancer (nsqNSCLC). Henlius is also advancing a global, multicenter Phase 3 trial evaluating serplulimab in combination with chemotherapy and concurrent radiotherapy as first-line treatment for limited-stage small cell lung cancer (LS-SCLC). In parallel, bridging studies of serplulimab in ES-SCLC are underway in both the United States and Japan, with enrollment completed in October 2025 in the U.S. study and in May 2026 with the Japan study.

At ESMO 2026, the U.S. bridging study ASTRIDE, led by Professor David R. Gandara of the UC Davis Comprehensive Cancer Center, will be presented for the first time in a Proffered Paper session on October 26, local time. ASTRIDE is a randomized, head-to-head bridging study evaluating the efficacy and safety of serplulimab versus atezolizumab, each in combination with carboplatin and etoposide, in U.S. patients with ES-SCLC. As a bridging study, the statistical design was descriptive. Based on the positive results of the global, multicenter Phase 3 ASTRUM-005 trial, serplulimab has been approved for first-line treatment of ES-SCLC in more than 50 countries and regions worldwide.

According to the abstract, as of February 18, 2026, the median follow-up was 14.1 months. Median overall survival (OS) was 12.4 months in the serplulimab group versus 10.2 months in the atezolizumab group while the 24-month OS rates were 32.2% and 17.6%, respectively. The overall safety profiles were comparable between the two groups. These findings support the clinical benefit of serplulimab and the applicability of the findings from ASTRUM-005 trial to the U.S. patient population.

SCLC

Randomized trial of serplulimab or atezolizumab plus chemotherapy in USA patients with extensive-stage small cell lung cancer (ASTRIDE)

Study Design：

Patients (Pts) with histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) and ≤1 prior cycle of chemotherapy (chemo) for ESSCLC were randomized 1:1 to receive up to 4 cycles of serplulimab (serplu; 300 mg) or atezolizumab (atezo), each in combination with carboplatin and etoposide, followed by maintenance serplu or atezo, respectively. Allowing 1 prior cycle of chemotherapy (chemo) reflected real-world practice. Treatments were administered intravenously every 3 weeks. The primary endpoint was overall survival (OS). As a bridging study, the statistical design was descriptive only.

Results：

From July 2022 to October 2025, 201 USA pts were enrolled at 63 centers and randomized to the serplu (n=101) or atezo (n=100) group. As of February 18, 2026, median follow-up was 14.1 months (mo, 95% confidence interval [CI], 11.4–18.5). The proportion of pts with liver metastasis was higher in the serplu group (49.5% vs 40.0%). Other baseline characteristics were balanced. In the ITT, median OS was 12.4 mo with serplu and 10.2 mo with atezo; 24-mo OS rates were 32.2% and 17.6%, respectively. Detailed efficacy results are shown below. Outcomes also appeared more favorable with serplu in pts without prior 1-cycle chemo. The incidence and severity of adverse events were comparable between groups, with no new safety signals identified.

Conclusion：

Serplu plus chemo compared favorably with the comparator in this bridging trial, showing numerically longer OS and higher 24-mo OS rates vs atezo plus chemo in USA pts with ES-SCLC. These results support the benefit of serplu and the applicability of ASTRUM-005 findings to the USA population.

In addition, quality-of-life analyses from two pivotal Phase 3 trials evaluating serplulimab in lung cancer have been respectively selected for the Poster and ePoster session at ESMO 2026. The ASTRUM-002 study, led by Professor Yuankai Shi from Cancer Hospital, Chinese Academy of Medical Sciences, evaluated serplulimab as first-line treatment for nsqNSCLC. The ASTRUM-004 study, led by Professor Caicun Zhou from Shanghai East Hospital, evaluated serplulimab as first-line treatment for sqNSCLC. Based on the positive results of these two pivotal trials, serplulimab has been approved for first-line treatment of sqNSCLC and nsqNSCLC in China, the European Union, and other countries and regions.

The quality-of-life analysis from ASTRUM-002 showed that, compared with chemotherapy, serplulimab plus chemotherapy prolonged the median time to deterioration in global health status/quality of life among patients with advanced nsqNSCLC. The ASTRUM-004 quality-of-life analysis showed that serplulimab was associated with consistent improvement in coughing, dyspnea, hemoptysis, pain in arm or shoulder, pain in chest, and peripheral neuropathy, and reduced the risk of deterioration in dyspnea and hemoptysis. Together, these findings provide further patient-centered evidence supporting serplulimab plus chemotherapy as first-line treatment for nsqNSCLC and sqNSCLC, respectively.

SCLC

Health-related quality of life in the phase 3 trial ASTRUM-002 of serplulimab plus chemotherapy with or without HLX04 for nonsquamous non-small cell lung cancer

Study Design：

Eligible patients (pts) were randomised 1:1:1 to receive intravenous serplulimab plus HLX04 and chemo (pemetrexed and carboplatin, group A), serplulimab plus HLX04 placebo and chemo (group B), or double placebo and chemo (group C), once every 3 weeks. Quality of life (QoL) was assessed using the EORTC QLQ-C30, EORTC QLQ-LC13, and EQ-5D-5L questionnaires. Analyses included all pts randomised into the study. A constrained longitudinal analysis model compared least squares mean (LSM) score changes from baseline (BL) to end-of-treatment (EoT) and a stratified Cox proportional hazards model assessed between-group differences in time to deterioration (TTD) of global health status (GHS)/QoL, physical functioning (PF) and role functioning (RF).

Results：

A total of 636 pts were randomised to groups A (n = 212), B (n = 214) and C (n = 210). Median follow-up duration was 47.0 months as of August 07, 2025. Completion rates exceeded 50% through cycle 9 with >95% compliance for all 3 groups. Longitudinal profiles of QLQ-C30 domains, QLQ-LC13 symptoms and EQ-5D-5L from BL up to EoT were similar between groups B and C. A more pronounced amelioration in PF, RF, QLQ-LC13“chest pain”and“pain in other parts”symptoms and EQ-5D-5L visual analogue scale were reported for pts in group B compared to group C. Median TTD was also longer in group B than C: not reached (NR) vs 28.1 months (HR 0.65, 95% CI 0.45-0.95; p = 0.026) for GHS/QoL. Longitudinal profiles and TTD were similar between groups A and B.

Conclusion：

QoL were maintained or improved with the addition of serplulimab to chemo. Adding HLX04 to serplulimab and chemo did not adversely affect QoL. Together with the efficacy and safety data, these findings support serplulimab and chemo as a first-line treatment option for nsq-NSCLC.

Health-related quality of life in the phase 3 trial ASTRUM-004 of first-line serplulimab plus chemotherapy for locally advanced or metastatic squamous non-small cell lung cancer

Study Design：

Eligible patients (pts) were randomized in a 2:1 ratio to receive serplulimab (4.5 mg/kg) or placebo for up to 2 years. All pts also received 4–6 cycles of nab-paclitaxel (100 mg/m2 ) plus carboplatin (area under curve 5 or 6). All study drugs were administered intravenously in 21-day cycles. QoL analysis was conducted in the intent-to-treat population, defined as all randomized pts. A mixed-effect model with repeated measures model was used to compare least squares mean (LSM) score changes from baseline (BL) in QLQ-LC13. A stratified Cox proportional hazards model was used to assess the between-group differences in time to deterioration (TTD), defined as time to first onset of a ≥10-point deterioration from BL confirmed by ≥10-point deterioration from BL at the next visit.

Results：

In total, 537 pts were randomized to the serplulimab (n = 358) and placebo groups (n = 179). The median follow-up duration was 31.1 months as of January 31, 2023. The completion rates were above 50% in both groups up to cycle 9, with compliance rates of 98.9%–100%. Serplulimab was associated with consistent improvement in coughing, dyspnea, hemoptysis, pain in arm or shoulder, pain in chest, and peripheral neuropathy, while the two groups showed similar longitudinal profiles in other symptoms. Significant improvements in hemoptysis, dysphagia, and dyspnea were observed in the serplulimab group. Moreover, the serplulimab group had significantly prolonged TTD for dyspnea (HR 0.51, 95% CI 0.36–0.72, p < 0.001) and hemoptysis (HR 0.37, 95% CI 0.15–0.96, p = 0.033).

Conclusion：

As first-line treatment in pts with sqNSCLC, serplulimab was associated with improvement in several symptoms, including coughing, pain in chest, hemoptysis, dysphagia, dyspnea, and a reduced risk of deterioration in dyspnea and hemoptysis.

Exploring New Frontiers in Immunotherapy Combinations Across Solid Tumors

In gastrointestinal cancers, serplulimab has been approved for first-line treatment of advanced esophageal squamous cell carcinoma (ESCC) and perioperative treatment of gastric cancer, making it the world’s first* anti-PD-1 mAb approved for a perioperative gastric cancer indication. Meanwhile, the global, multicenter Phase 3 ASTRUM-015 trial evaluating serplulimab in combination with bevacizumab and chemotherapy as first-line treatment for metastatic colorectal cancer (mCRC) has completed patient enrollment. The study has the potential to address an unmet clinical need for first-line immunotherapy in patients with microsatellite-stable (MSS) mCRC.

Several studies of serplulimab in gastrointestinal cancers have also been selected for presentation at ESMO 2026. In ESCC, a quality-of-life analysis from the Phase 3 ASTRUM-007 trial, led by Professor Jing Huang of the Cancer Hospital, Chinese Academy of Medical Sciences, showed comparable health-related quality of life between patients receiving serplulimab plus chemotherapy and those receiving chemotherapy. These findings provide further support for the use of serplulimab plus chemotherapy in the first-line treatment of PD-L1-positive ESCC.

Several investigator-initiated trials (IITs) exploring serplulimab across different treatment settings for ESCC have also been selected for presentation at ESMO 2026. One Phase 2 study, led by Professor Yongling Ji of Zhejiang Cancer Hospital, evaluated serplulimab in combination with chemotherapy as consolidation therapy following concurrent chemoradiotherapy in patients with unresectable ESCC. Another Phase 2 study evaluated serplulimab in combination with an anti-angiogenic agent and chemotherapy in patients with ESCC receiving second-line or later treatment. Together, these studies expand the clinical evidence for serplulimab-based combination regimens across different treatment settings for ESCC.

In colorectal cancer, one study led by Professor Tao Zhang of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, investigated a neoadjuvant regimen for patients with RAS/BRAF wild-type locally advanced rectal cancer (LARC). The regimen combines short-course radiotherapy followed by the anti-EGFR mAb HLX07, serplulimab, and chemotherapy. This prospective translational study explores a neoadjuvant immunotherapy-based regimen incorporating radiotherapy and chemotherapy in patients with RAS/BRAF wild-type LARC. Another study, the SCAR trial, led by Professor Kefeng Ding of the Second Affiliated Hospital of Zhejiang University School of Medicine, investigated a novel neoadjuvant regimen for patients with locally advanced mid-to-low rectal cancer. The regimen combines serplulimab with targeted therapy and chemotherapy, with radiotherapy omitted from the treatment protocol. This study explores a radiotherapy-free, immunotherapy-based neoadjuvant strategy for locally advanced rectal cancer.

ESCC

Health-related quality of life in the phase 3 ASTRUM-007 study of serplulimab or placebo plus chemotherapy for PD-L1-positive esophageal squamous cell carcinoma

Study Design：

Eligible patients were randomised 2:1 to receive serplulimab (3 mg/kg) or placebo for up to 2 years. All patients also received cisplatin (50 mg/m2) for up to 8 cycles and 5-FU (2,400 mg/m2) for up to 12 cycles. All study drugs were administered intravenously every 2 weeks. HRQoL was assessed using the EORTC QLQ-C30, EORTC QLQ-OES18, and EQ-5D-5L questionnaires. The analysis population included all patients randomised into the study. A constrained longitudinal analysis model was used to compare least squares mean (LSM) score changes from baseline (BL) to Week 45 in the three questionnaires. A stratified Cox proportional hazards model was used to assess the between-group differences in time to deterioration (TTD) in global health status (GHS)/QoL, physical functioning (PF) and role functioning (RF)

Results：

Overall, 551 patients were randomised to the serplulimab (n = 368) and placebo (n = 183) groups. By-visit longitudinal changes in scores of QLQ-C30 global health status, functioning domains and symptom domains, most of the symptom subscales of QLQ-OES18, and EQ-5D-5L visual analogue scale from baseline to Week 45 were similar between the two groups. Median TTD was comparable between groups: not reached (NR) vs NR months for GHS/QoL (hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.61-1.28; p-value = 0.519), NR vs NR for PF (HR 0.93, 95% CI 0.63-1.36; p-value = 0.708), and NR vs NR for RF (HR 1.19, 95% CI 0.80-1.78; p-value = 0.393).

Conclusion：

HRQoL was not adversely impacted when serplulimab was added to chemotherapy. Together with the efficacy and safety data, these findings support this regimen as a first-line treatment option for PD-L1-positive ESCC.

S-1 plus serplulimab consolidation after concurrent chemoradiotherapy in unresectable locally advanced esophageal squamous cell carcinoma: a phase II trial

Study Design：

This was a prospective, single center, single arm phase II trial. Eligible patients were aged 18-75 years, had an ECOG performance status of 0–1, and had pathologically confirmed unresectable LA-ESCC staged as cT1-4bN1-3M0-1a. Patients received CCRT with radiotherapy 50.4 Gy in 28 fractions plus cisplatin and S-1, followed by consolidation with S-1 plus serplulimab 300 mg every 3 weeks for up to 12 months or until progression or unacceptable toxicity. The primary endpoint was the 1 year progression free survival (PFS) rate. Secondary endpoints included clinical complete response (cCR), overall survival (OS), and safety

Results：

A total of 31 patients were enrolled; 11 remain on treatment and have not yet reached the efficacy evaluation timepoint. Among the 20 efficacy-evaluable patients, 14 patients (70.0%) achieved cCR. Of these, 4 patients (20.0%) achieved CR during CCRT, while 10 patients (50.0%) converted to CR during S-1 plus serplulimab consolidation after CCRT; 6 patients (30.0%) never achieved CR. With a median follow-up of 17.3 months, the overall 1-year PFS and OS rates were 73.7% (95% CI, 56.2–96.6) and 94.4% (95% CI, 84.4–100), respectively. No PFS events occurred within 12 months among patients achieving CR either during CCRT or during consolidation, compared with a 1-year PFS rate of 16.7% (95% CI, 2.8–99.7) in patients who never achieved CR. Grade ≥3

adverse events included esophageal pain (55.0%), neutropenia (50.0%), dysphagia (25.0%), leukopenia (15.0%), and gastric hemorrhage (5.0%), radiation pneumonitis(5.0%) and radiation dermatitis (5.0%).

Conclusion：

S-1 plus serplulimab consolidation after CCRT showed encouraging early disease control in unresectable LA-ESCC, with 50.0% of patients converting to CR during consolidation. These exploratory findings support further evaluation of post-CCRT chemoimmunotherapy consolidation as a response-deepening strategy.

Serplulimab Plus Anlotinib and S-1 in Second-Line or Later-Line Advanced Esophageal Squamous Cell Carcinoma (ESCC): A Phase II Study

Study Design：

This prospective single-arm phase II study enrolled patients with pathologically confirmed ESCC who had disease progression (PD) following PD-1 inhibitor therapy excluding serplulimab. Patients received serplulimab (4.5 mg/kg) plus anlotinib (10 mg, QD, D1–14) and S-1 (75 mg/m²/d, BID, D1–14) in 3-week cycles until PD or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.

Results：

Thirty-seven patients (median age: 63; range: 46–75) were enrolled, with 43.2% (16/37) presenting distant metastases. Most patients (28/37, 75.7%) received the regimen in the second-line setting, whereas 24.3% (9/37) were treated in the third-line or beyond. At analysis cutoff, patients received a median of 6 cycles (range: 2–26), and 2 had not yet undergone assessment. In the efficacy-evaluable cohort, the ORR was 22.9% (8/35, 95% CI 10.4%–40.1%), consisting entirely of partial responses, and the DCR reached 82.9% (29/35, 95% CI 66.4%–93.4%). With a median follow-up of 13.17 months in the overall cohort, the median PFS was 6.77 months (95% CI 5.8–17.1). While the median OS was not reached, the estimated 12-month OS rate was 74.98%. Treatment-emergent adverse events occurred in 70.3% of patients, with grade 3–4 events in 10.8%. The most common grade 3–4 adverse event was fistula (8.11%), which was clinically manageable. No new safety signals were observed

Conclusion：

Serplulimab plus anlotinib and S-1 showed promising efficacy and manageable safety in PD-1-inhibitor pretreated ESCC, with a particularly encouraging 12-month OS rate. This synergistic regimen offers a potential novel option for immune-resistant ESCC

Rectal Cancer

Neoadjuvant short-course radiotherapy followed by HLX07, serplulimab, and CAPOX in RAS/BRAF wild-type locally advanced rectal cancer (LARC): A multicenter, single-arm, phase II trial

Study Design：

Eligible patients(pts) with RAS/BRAF wild-type LARC received SCRT (25 Gy/5 fractions) followed by six 3-week cycles of HLX07 (at the RP2D), serplulimab (300 mg iv on D1), and CAPOX (oxaliplatin 130 mg/m² iv on D1 and capecitabine 1000 mg/m² bid on D1–14). Surgery was performed one week after neoadjuvant therapy. The primary endpoint was complete response (CR), defined as the composite of pathological complete response (pCR) and clinical complete response (cCR).

Results：

Among the 24 included pts, circumferential resection margin (CRM) was involved in 10 (41.7%) and extramural venous invasion (EMVI) was present in 14 (58.3%). With a median follow-up of 12(7-16) months,12 pts (50.0%, 12/24) achieved CR. Seventeen pts underwent surgery, with 9 (52.9%, 9/17) achieving TRG0 (pCR) and 2 (11.8%, 2/17) achieving TRG1. Seven pts did not undergo surgery, with 3 (42.9%, 3/7) achieving cCR. Adverse events were generally manageable, with hematologic toxicity being the most common.

Conclusion：

This biomarker-driven innovative TNT regimen has broken the efficacy ceiling in RAS/BRAF wild-type LARC. Through the mechanistic synergy of SCRT, dual targeted-immune blockade, and chemotherapy, this approach achieved an exceptional 50.0% CR rate with manageable safety in patients with unfavorable baseline characteristics, representing a promising strategy to maximize tumor downstaging and promote organ preservation.

Serplulimab Combined with CAPOX and Celecoxib as Neoadjuvant Therapy for Proficient Mismatch Repair Locally Advanced Mid-to-Low Rectal Cancer (SCAR)

Study Design：

SCAR is a single-arm, phase II trial (NCT05731726). Eligible patients were aged 18–75 years, ECOG 0–1, with pathologically confirmed mid-to-low rectal adenocarcinoma (≤10 cm from anal verge), pMMR status, and clinical stage cT2-4N0-2M0 (except cT2N0M0). Patients received 4–8 cycles of Serplulimab (300 mg, IV, q3w) plus CAPOX (oxaliplatin 130 mg/m², IV, d1, q3w;capecitabine 1000 mg/m², PO, BID, d1–14, q3w) and Celecoxib (200 mg, PO, BID,d1–21). Primary endpoint was pCR(ypT0N0). Secondary endpoints included R0 resection rate, ORR, DFS, and safety. Immune correlates were explored by single-cell RNA sequencing (scRNA-seq).

Results：

As of March 2026, 50 patients were enrolled (median age 60 years; 84.8% male). 43 patients had finished the neoadjuvant treatment. 38 patients achieved PR or CR (ORR 88.4%). 40 patients underwent radical surgery; R0 resection rate was 100%. pCR was achieved in 11/40 resected patients (27.5%). By tumor regression grade (TRG) evaluation, TRG0 (11), TRG1 (4), TRG2 (20), TRG3 (5). Grade ≥3 treatment-related adverse events occurred in 10/50 patients (20%). No unexpected perioperative safety signals were observed. ScRNA-seq analysis revealed increased CD8+ T-cell abundance with enhanced activation/cytotoxicity signatures in post-treatment samples, alongside increased antigen presentation–related signaling between CD8+ T cells and myeloid cells in responders (PR/CR).

Conclusion：

The combination of serplulimab, CAPOX, and celecoxib as neoadjuvant therapy for pMMR mid to-low LARC demonstrated primary efficacy and safety. Immune profiling suggests treatment associated CD8+ T-cell activation in responders.

Several IITs of serplulimab in extrapulmonary neuroendocrine carcinoma and non-clear cell renal cell carcinoma have also been selected for presentation at ESMO 2026, further expanding its clinical investigation across a broader range of solid tumors. One study initiated by Professor Tao Zhang of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, evaluated serplulimab in combination with targeted therapy and chemotherapy as first-line treatment for extrapulmonary neuroendocrine carcinoma. The findings will be presented in a Rapid Oral Presentation session on October 23, local time. Another Phase 2 study, led by Professor Wei Xue of Renji Hospital, Shanghai Jiao Tong University School of Medicine, investigated serplulimab in combination with an anti-angiogenic agent as first-line treatment for metastatic non-clear cell renal cell carcinoma. The study aims to generate further clinical evidence in this rare and heterogeneous disease setting, where treatment options remain limited.

NEC

Latest efficacy and safety analysis of surufatinib combined with EP regimen and serplulimab as first-line treatment for extrapulmonary neuroendocrine carcinoma

Study Design：

This phase Ib/II study enrolled systemic treatment-naïve patients with advanced/metastatic extrapulmonary NEC. Patients received SUR (250 mg, QD, PO, Q3W) plus EP regimen (etoposide 100 mg/m², cisplatin 25mg/m², both d1-3 IV, Q3W) and SER (300mg, d1, IV, Q3W) for up to 6 cycles, followed by SUR + SER maintenance. Primary endpoint was PFS, with secondary endpoints of ORR, DCR, OS and safety.

Results：

As of 29 Apr 2026, 43 enrolled patients were efficacy-evaluable post-baseline. Median age was 59 years (range32–77), 65.1% were male, 65.1% had liver metastases. Median Ki‑67 index was 70% (range 30–90%), 79.1% hadki‑67 ≥55%. Median PFS was 9.4 months (95% CI 6.5–13.9). Notably, 1 patient achieved significant tumorresponse after 3.6 months of combination therapy, enabling successful R0 resection. ORR was 69.8%, DCR95.3%. Patients achieving CR/PR had significantly longer PFS than non-responders (11.5 vs 6.6 months,p=0.0041). Commonest treatment-emergent adverse events (TEAEs) were anemia (62.8%), hypertriglyceridemia(32.6%), nausea (32.6%) and neutropenia (30.2%).

Conclusion：

Surufatinib plus serplulimab and EP regimen demonstrates encouraging efficacy and manageable safety as first-line therapy for extrapulmonary NEC, delivering a high response rate, meaningful PFS benefit and curativeR0 conversion in one patient with initially unresectable disease.

RCC

First-Line Fruquintinib Plus Serplulimab for Metastatic Non-Clear Cell Renal Cell Carcinoma: Updated Results from the Phase II FRONTIER Study

Study Design：

Treatment-naive patients aged 18-80 years with metastatic or unresectable nccRCC and ECOG PS 0-1 received fruquintinib 5 mg orally once daily (2 weeks on/1 week off) plus serplulimab 4.5 mg/kg IV every 3 weeks. Primary endpoint was investigator-assessed progression-free survival (PFS) per RECIST v1.1. Secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety.

Results：

Thirty-nine patients were enrolled. Median age was 54 years (range 19-78); 43.6% had ECOG PS 1. Histologies included papillary (51.3%), unclassified (17.9%), and other subtypes; 5 patients had sarcomatoid features. Common metastatic sites were lymph nodes (53.8%), lung (33.3%), peritoneum (33.3%), and bone (30.8%). At a median follow-up of 16.0 months (95% CI 15.2-21.8), median PFS was 19.0 months (95% CI 13.9-NR), with a 12-month PFS rate of 81.3%. Among 39 evaluable patients, 3 achieved complete response, 20 partial response, and 15 stable disease, yielding an ORR of 59.0% (95% CI 43.5-74.4) and DCR of 97.4% (95% CI 86.5-99.9). Clinical activity was observed across histologic subtypes, with highest activity in FH-deficient RCC (ORR 80.0%, 4/5). Grade >=3 treatment-related adverse events occurred in 4 patients. No treatment-related adverse events led to permanent discontinuation or death.

Conclusion：

Fruquintinib plus serplulimab demonstrated durable disease control, clinically meaningful PFS, and manageable toxicity in a heterogeneous nccRCC population. Translational biomarker analyses are ongoing to identify predictors of benefit.

* In June 2026, serplulimab received NMPA approval as the world's first anti-PD-1 mAb for perioperative gastric cancer treatment. As of October 2026, it remains the only one. In January 2023, serplulimab received NMPA approval as the world's first anti-PD-1 mAb for the first line treatment of ES-SCLC.

**As of October 2026

Reference

1. Issafras H, et al. Structural basis of HLX10 PD-1 receptor recognition, a promising anti-PD-1 antibody clinical candidate for cancer immunotherapy. PLoS One. 2021;16(12):e0257972.

2. Shan Y, Zhang Y, Wei R, et al. Insights into the mechanisms of serplulimab: a distinctive anti-PD-1 monoclonal antibody, in combination with a TIGIT or LAG3 inhibitor in preclinical tumor immunotherapy studies. mAbs. 2024;16(1):2419838.

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• 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@cnhorse.net

Cookies Policy

When you visit our website, we may place small data files known as “cookies” on your device. Cookies enable our website to recognize your browser and help us understand how visitors use the site.

Cookies and similar technologies used on this website may collect online identifiers, device information, browser information, IP address, and information about how you interact with the website. In certain circumstances, such information may constitute personal information or may be associated with you under applicable PRC laws and regulations. Information collected through cookies is used for purposes such as ensuring website operation, maintaining security, analyzing traffic and performance, remembering user preferences, and improving website content and user experience.

You may choose to accept or decline cookies by adjusting your browser settings or through any cookie banner or preference center made available on our website, if applicable. Please note that disabling cookies may affect the functionality of certain parts of the website.

For more information about how we process personal information, please refer to our Privacy Notice.

Some cookies may be provided by third parties. Where third-party cookies or similar technologies are used, such third parties may process the relevant information in accordance with their own privacy policies and applicable PRC laws and regulations.

Accessibility

Shanghai Henlius Biotech, Inc. (“Henlius”) is committed to improving the accessibility and user friendliness of its website for all visitors.

We strive to ensure that the content on our website can be accessed and used by individuals with diverse needs, including those who rely on assistive technologies. As our website continues to evolve, we recognize that accessibility is an ongoing effort, and we are continuously working to improve usability and accessibility across our digital platforms.

If you experience difficulty accessing any part of our website, or have suggestions on how we can enhance accessibility, we welcome your feedback. To help us respond effectively, please include the specific webpage address (URL) and a brief description of the issue encountered.

Email: PR@cnhorse.net

(Please include “Website Accessibility” in the subject line)

Henlius will make reasonable efforts to review accessibility-related feedback and improve the overall online experience for all users. While we strive to improve accessibility, we do not guarantee that every page or feature will be fully accessible to every user in all circumstances.

This website (http://www.cnhorse.net/) is developed and operated by Shanghai Henlius Biotech, Inc. (“Henlius”). Please read these Terms of Use carefully before accessing or using this website. By accessing, browsing or using this website, you acknowledge that you have read, understood and agreed to be bound by these Terms of Use and applicable PRC laws and regulations.

Henlius reserves the right to modify or update these Terms of Use at any time. Any updated version will be posted on this website with a revised “Last Updated” date. Please review them periodically for updates.

Prohibited Conduct:

You shall not infringe the lawful rights and interests of Henlius or any third party, nor interfere with or attempt to interfere with the normal operation, security, or integrity of this website by any means. Without limitation, you shall not use this website for any unlawful purpose, attempt unauthorized access to any part of the website or related systems, introduce malicious code, scrape or extract website content through automated means, or otherwise interfere with the website’s operation or security features.

All content on this website, including but not limited to text, data, logos, graphics, audio, video and other materials, is owned by Henlius or its respective rights holders, unless otherwise stated. Such content is protected by applicable Chinese and international copyright laws. This website and its content may be accessed and used only for lawful, personal, and non-commercial purposes. Without prior written consent, no entity or individual may copy, reproduce, republish, upload, post, transmit, distribute, modify, create derivative works from, mirror, or otherwise use such content for commercial or public purposes.

Disclaimers

To the fullest extent permitted by applicable PRC laws and regulations, Henlius makes no warranties or representations, express or implied, regarding the content of this website, including but not limited to accuracy, completeness, timeliness or suitability for any particular purpose. Henlius does not undertake any obligation to update the content of this website , except as otherwise required by applicable PRC laws and regulations.

You use this website and any information obtained from it at your own risk. To the fullest extent permitted by applicable PRC laws and regulations, Henlius shall not be liable for any loss or damage arising from the use or inability to use this website, including but not limited to system failures, computer viruses or data loss.

Medical Information

Nothing on this website constitutes medical advice, diagnosisor treatment recommendations. Medical decisions should always be made in consultation with qualified healthcare professionals. Any product-related or disease-related information provided on this website is provided for general informational purposes only and should not be construed as medical advice, diagnosis, or treatment recommendations; any product information is subject to the approved prescribing information and applicable local laws and regulations.

Third Party Websites

This website may contain links to third party websites for convenience. Henlius is not responsible for the content, availability, privacy practices, terms or use of such third-party websites. Access to third party websites is at your own risk.

Privacy

Henlius respects your privacy. Please refer to our Privacy Notice for details.

Governing Law

These Terms of Use shall be governed by the laws of the People’s Republic of China.

Last updated: March 30, 2026