Hanbeitai (bevacizumab biosimilar) / Fosun Pharma, Eurofarma - LARVOL DELTA

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

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

On the taxonomy of genus Simplicia Guene, with a new species from India (Lepidoptera: Erebidae: Herminiinae). (PubMed, Zootaxa) - "The study also presents a first ever global checklist of Simplicia comprising 70 species (including the newly described species) along with their synonyms and distributional records. Detailed description of new species, diagnoses of all the studied species with close congeners along with their habitus and genitalia images and the distributional notes are provided."

Journal

Hepatic Arterial Infusion Chemotherapy with Serplulimab and the Bevacizumab Biosimilar HLX04 for Advanced Hepatocellular Carcinoma: A Prospective, Observational Phase II Clinical Trial (Multidisciplinary Digital Publishing Institute) - "A total of 32 patients were enrolled. The best outcomes showed an ORR of 53.1%, including 17 partial responses (PR, 53.1%) and 12 stable diseases (SD, 37.5%), resulting in a DCR of 90.6%. Subgroup analysis showed a higher ORR in patients with a single lesion and those receiving ≥3 treatment cycles, with an ORR of 60.7% in the latter group."

P2 data • Hepatocellular 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

Henlius Bevacizumab Secures First Overseas Approval, Accelerating Henlius' Expansion into Latin American Market (Henlius Press Release) - "Recently, HANBEITAI (bevacizumab), independently developed and produced by Henlius, has been officially approved by Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) for marketing in Bolivia under the trade name LONGIVA....The approval is based on the exclusive commercial cooperation between Henlius and Eurofarma, a leading pharmaceutical company in Brazil and Latin America....The approval of HANBEITAI by AGEMED in Bolivia is mainly based on the review of a series of data. The application dossier is mainly based on the information submitted to China’s National Medical Products Administration (NMPA) in the New Drug Application (NDA). Henlius has conducted a set of head-to-head comparisons between HANBEITAI and the reference bevacizumab, including analytical similarity studies, non-clinical studies and clinical studies."

Approval • Breast Cancer • Cervical Cancer • Colorectal Cancer • Glioblastoma • Hepatocellular Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Renal Cell Carcinoma

Phase 2 Study Evaluates Serplulimab Plus HLX04 as First-Line Treatment for Advanced Hepatocellular Carcinoma (Pharmacy Times) - P2 | N=123 | NCT03973112 | Sponsor: Shanghai Henlius Biotech | "An open-label, multicenter phase 2 study (NCT03973112) conducted in China aimed to investigate the safety and initial effectiveness of serplulimab (Hansizhuang; Shanghai Henlius Biotech Inc) a new programmed death (PD)-1 inhibitor, when used alone or in combination with bevacizumab biosimilar HLX04 (Shanghai Henlius Biotech Inc) as a first-line treatment option for individuals with advanced hepatocellular carcinoma (HCC)....The results demonstrated that, of the 61 enrolled patients followed for a median of 25.5 months, 47.5% experienced grade 3 or higher treatment-emergent adverse events, including hypertension and proteinuria, with 1 treatment-related death. The objective response rate, as assessed by an independent radiological review committee, was 29.3%, with a median progression-free survival of 7.3 months and a median overall survival of 20.4 months, according to study authors."

P2 data • Hepatocellular Cancer

A Clinical Study to Compare the Efficacy, Safety and Immunogenicity of HLX04 and Bevacizumab Combined XELOX or mFOLFOX6 in the First-line Treatment of mCRC (clinicaltrials.gov) - P3 | N=677 | Completed | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Completed

Trial completion • Colorectal Cancer • Oncology • Solid Tumor • BRAF

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. (clinicaltrials.gov) - P2 | N=117 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=347; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; N=439 ➔ 347

Clinical • Enrollment change • Enrollment open • IO biomarker • Mismatch repair • Monotherapy • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=200; Recruiting; Sponsor: National Cancer Institute (NCI); N=347 ➔ 200

Clinical • Enrollment change • IO biomarker • Mismatch repair • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=231; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting

Clinical • Enrollment open • IO biomarker • Mismatch repair • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=200; Suspended; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Suspended

Clinical • IO biomarker • Mismatch repair • Trial suspension • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Henlius Maintains Patient-Centric Focus, Drives Sustainable Growth, and Accelerates Overseas Expansion in 2024 H1 (Henlius Press Release) - "HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB1.4743 billion, RMB677.8 million and RMB86.7 million, respectively. In addition, the company received sales revenues of RMB227.0 million and RMB13.6 million based on the collaboration with partners for HANLIKANG (rituximab)..."

Sales • Colorectal Cancer • Esophageal Cancer • Follicular Lymphoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer • Lung Non-Small Cell Squamous Cancer • Neuroendocrine Tumor • Small Cell Lung Cancer

The first patient was dosed in the Phase II clinical trial of HLX53 combined with H drug and Hanbetai as the first-line treatment for hepatocellular carcinoma in a dual immune combined anti-vascular targeted therapy [Google translation] (Sina Corp) - "On August 8, 2024...announced that the first patient was dosed in a Phase II clinical trial (NCT06349980) of the company's independently developed innovative anti-TIGIT Fc fusion protein HLX53 in combination with H-drugs HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) in patients with locally advanced or metastatic hepatocellular carcinoma."

Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

First-line serplulimab in metastatic colorectal cancer: Phase 2 results of a randomized, double-blind, phase 2/3 trial. (PubMed, Med) - P2/3 | "Serplulimab plus HLX04 and XELOX exhibits promising efficacy and is safe and tolerable in patients with treatment-naive mCRC."

Clinical • Journal • Metastases • P2/3 data • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov) - P2/3 | N=568 | Recruiting | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Recruiting | N=114 ➔ 568 | Trial completion date: Jun 2025 ➔ Dec 2026 | Trial primary completion date: Nov 2024 ➔ Sep 2025

Combination therapy • Enrollment change • Enrollment open • Metastases • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1

First-line serplulimab plus HLX04 and XELOX versus placebo plus bevacizumab and XELOX in metastatic colorectal cancer: A phase 2/3 study. (ASCO 2024) - P2/3 | "With an extended follow-up duration, improved survival benefits demonstrated with the addition of serplulimab were maintained in the first-line treatment of mCRC, alongside a manageable safety profile. These results support serplulimab plus HLX04 and XELOX as a promising first-line treatment option for mCRC that warrants further investigation."

Clinical • IO biomarker • Metastases • P2/3 data • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • KRAS • PD-L1

IND Application for the Clinical Trial of Novel Anti-TIGIT Fc Fusion Protein HLX53 in Combination with HANSIZHUANG Plus HANBEITAI for the First-Line Treatment of Locally Advanced or Metastatic Hepatocellular Carcinoma Patients Approved by NMPA (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the investigational new drug application (IND) for the clinical trial of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first line treatment of locally advanced or metastatic hepatocellular carcinoma, has been approved by the National Medical Products Administration (NMPA). A phase 2 clinical trial will be initiated to evaluate the safety, tolerance and efficacy of the multiple immunotherapy-based treatment combinations in patients with advanced or metastatic hepatocellular carcinoma."

New P2 trial • Hepatocellular Cancer

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 With or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. (clinicaltrials.gov) - P2 | N=117 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Metastases • New P2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Henlius Reported Financial Results for the First Three Quarters of 2023: Total Revenue Exceeded RMB3.9 billion, Profitability Further Improved (PRNewswire) - "HANQUYOU (trastuzumab), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB737.8 million, RMB309.1 million and RMB36.4 million, respectively. In addition, the company received a profit-sharing of RMB131.0 million and RMB11.3 million based on the collaboration with partners for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively....Henlius also plans to submit New Drug Application (NDA) for HANSIZHUANG in the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) in the fourth quarter of 2023."

Non-US regulatory • Sales • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-line serplulimab plus HLX04 and XELOX versus placebo plus bevacizumab and XELOX in metastatic colorectal cancer: A phase 2/3 study. (ASCO-GI 2024) - P2/3 | "Serplulimab plus HLX04 and XELOX prolonged PFS compared to placebo plus bevacizumab and XELOX. Improvements in other efficacy endpoints were also observed with a manageable safety profile in patients with mCRC. Serplulimab plus HLX04 and XELOX is a promising first-line treatment option for mCRC patients that warrants further investigation."

Clinical • IO biomarker • Metastases • P2/3 data • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI • PD-L1

A phase II study of serplulimab (a programmed death-1 inhibitor) with or without HLX04 (a bevacizumab biosimilar) for the treatment of advanced hepatocellular carcinoma (ESMO Asia 2023) - P2 | "As assessed by an independent radiological review committee (IRRC) per RECIST v1.1, the objective response rate was 4.8% (95% confidence interval [CI] 0.1–23.8) in group C and 27.9% (95% CI 17.1–40.8) in group D. IRRC-assessed median progression-free survival was 1.8 months (95% CI 1.4–2.8) and 7.3 months (95% CI 2.8–11.0) in group C and D, respectively. Median overall survival was 16.0 months (95% CI 3.6–not evaluable [NE]) in group C and 19.1 months (95% CI 14.3–NE) in group D. Conclusions In the first-line and subsequent-line settings, serplulimab plus HLX04 and serplulimab monotherapy, respectively, showed a manageable safety profile together with encouraging efficacy in patients with advanced HCC."

Metastases • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Atezolizumab in Combination With Bevacizumab in Patients With Unresectable HCC Previously Untreated with Systemic Therapy: Interim Analysis Results from Phase IIIb Italian Amethista Trial (AIOM 2023) - P3b | N=152 | AMETHISTA (NCT04487067) | Sponsor: Hoffmann-La Roche | "At a median follow up of 13.4 months, in a pt population with uHCC comparable to clinical practice, our interim analysis results were consistent with the known safety and efficacy profile of atezo plus bev."

P3 data

A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P3 | N=643 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2023 ➔ Oct 2023

Combination therapy • Enrollment closed • IO biomarker • Metastases • Trial primary completion date • Tumor mutational burden • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • MSI • PD-L1 • ROS1 • TMB