HLX26 / Fosun Pharma - LARVOL DELTA

HLX26HLX10-NSCLC201: A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients (clinicaltrials.gov) - P2 | N=132 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Trial primary completion date: Jul 2025 ➔ Feb 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • LAG3 • PD-L1 • ROS1

Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients with MCRC (clinicaltrials.gov) - P2 | N=2 | Terminated | Sponsor: Shanghai Henlius Biotech | N=49 ➔ 2 | Trial completion date: Apr 2026 ➔ Dec 2023 | Suspended ➔ Terminated | Trial primary completion date: Aug 2024 ➔ Dec 2023; Due to poor clinical trial accrual, the study was terminated.

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection in Patients With Solid Tumor or Lymphoma (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Completed | N=11 ➔ 18

Enrollment change • Metastases • Trial completion • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Lymphoma • Oncology • Solid Tumor

A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients (clinicaltrials.gov) - P2 | N=132 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=60 ➔ 132

Enrollment change • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • LAG3 • PD-L1 • ROS1

Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Completed

Trial completion • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Safety, preliminary efficacy, and pharmacokinetics of HLX26 plus serplulimab in advanced solid tumours: An open-label, dose-escalation phase I study (ESMO Asia 2023) - P1 | "Conclusions No new safety signals were observed for the different doses of HLX26 in combination with serplulimab. HLX26 plus serplulimab was safe and well tolerated in patients with advanced solid tumours who had failed or could not receive standard therapies."

Clinical • Metastases • P1 data • PK/PD data • Cervical Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Results from Four Phase 1/2 Clinical Trials of Henlius’ Innovative Products Released at 2023 ESMO Asia (Henlius Press Release) - "Recently, results from four phase 1/2 clinical trials conducted in patients with advanced solid tumours of Henlius' self-developed novel products...were released as poster presentations at...ESMO Asia Congress 2023....HLX26-002:...As of 19 July 2023, 9 patients with primary stage IV non-small cell lung cancer (n=4, 44.4%), small cell lung cancer (n=2, 22.2%), gastric cancer (n=1, 11.1%), cervical cancer (n=1, 11.1%), or endometrial cancer (n=1, 11.1%) were enrolled and received HLX26 at 500 mg (n=3), 800 mg (n=3), or 1600 mg (n=3), in combination with 300 mg serplulimab....No DLT was reported and the MTD was not determined yet. Among the 8 efficacy evaluable patients, none had achieved complete or partial response; 3 (37.5%) patients (one in each group) had a best overall response of stable disease."

P1 data • Cervical Cancer • Endometrial Cancer • Gastric Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Henlius Announces Upcoming Mini Oral Presentation and Five Posters at the ESMO Asia 2023 (Henlius Press Release) - "From 1 to 3 December 2023, the European Society for Medical Oncology Asia (ESMO Asia) Congress will be held in Singapore. At this congress, Henlius will share the latest results of clinical trials of several products, including anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), HLX208 (BRAFV600E small molecule inhibitor), HLX07 (anti-EGFR mAb), and HLX26 (anti-LAG-3 mAb). Notable among them is the updated analysis of HLX208-LCH/ECD201 study, the phase 2 study of HLX208 in adult patients with Langerhans cell histiocytosis and/or Erdheim-Chester disease harbouring BRAFV600E mutation...and the results from this updated analysis were selected for a mini oral presentation. Moreover, results from the Asian subgroup of the pivotal phase 3 study (ASTRUM-004) of serplulimab in treating squamous non-small cell lung cancer (sqNSCLC)...will be presented in the form of a poster presentation....The company will also present data from four other clinical studies in poster..."

Clinical data • Non Small Cell Lung Cancer

Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2023 ➔ Aug 2023

Combination therapy • Enrollment closed • Metastases • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection in Patients With Solid Tumor or Lymphoma (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Lymphoma • Oncology • Solid Tumor

A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • LAG3 • PD-L1 • ROS1

Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients With mCRC (clinicaltrials.gov) - P2 | N=49 | Suspended | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Suspended

Combination therapy • Trial suspension • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS

Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients With mCRC (clinicaltrials.gov) - P2 | N=49 | Recruiting | Sponsor: Shanghai Henlius Biotech | Trial completion date: Nov 2023 ➔ Apr 2026 | Trial primary completion date: Aug 2023 ➔ Aug 2024

Combination therapy • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS

Fosun International : First Patient Dosed of Phase 2 Clinical Trial of Serplulimab in Combination with Innovative Anti-LAG-3 mAb for the Treatment of Metastatic Colorectal Cancer Patients (Market Screener) - "Shanghai Henlius Biotech, Inc...announced that the first patient has been dosed in a phase 2 clinical trial (NCT05584137) of HANSIZHUANG (serplulimab injection), an innovative anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with HLX26, an innovative anti-LAG-3 mAb for the treatment of metastatic colorectal cancer (mCRC) patients who have received third-line treatment in Chinese mainland."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Safety, tolerability, and pharmacokinetics of HLX26 (an anti-LAG3 antibody) in patients with advanced or metastatic solid tumors or lymphomas. (ASCO 2023) - P1 | "In summary, no new safety signals were observed from 60 mg to 800 mg of HLX26. HLX26 was safe and well tolerated in patients with advanced or metastatic solid tumors. Clinical trial information: NCT05078593."

Clinical • IO biomarker • Metastases • PK/PD data • Dyslipidemia • Hematological Malignancies • Hypertriglyceridemia • Lymphoma • Metabolic Disorders • Oncology • Solid Tumor

Evaluate the Efficacy, Safety and Tolerability of HLX26 and HLX10 in Patients With Metastatic Colorectal Carcinoma That Have Received 3 Prior Lines of Therapy (clinicaltrials.gov) - P2 | N=49 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2022 ➔ May 2023

Enrollment open • Trial initiation date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS

Subsidiary of Fosun Pharma (600196.SH) Approves Clinical Trial Protocol for Treatment of Advanced Non-Small Cell Lung Cancer [Google translation] (Zhitong Finance) - "Zhitong Finance APP news, Fosun Pharma...issued an announcement that Shanghai Henlius Bio-Pharmaceutical Co., Ltd., the company's holding subsidiary, recently received approval from the State Drug Administration ('NMPA') for approval of HLX26 (i.e. recombinant anti-LAG-3 humanized monoclonal antibody injection) combined with Hansizhuang^® (i.e. serplulimab injection) and chemotherapy for the first-line treatment of advanced non-small cell lung cancer (NSCLC) (referred to as 'the treatment plan') ) to conduct clinical trials....In addition, Shanghai Henlius Biotechnology Co., Ltd. and/or its holding subsidiaries intend to carry out the phase II clinical trial of this treatment plan in China (excluding Hong Kong, Macao and Taiwan regions of China, the same below) when conditions are met."

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

A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal Antibody Injection) and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Metastases • New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • LAG3 • PD-L1 • ROS1

Method validation of a bridging immunoassay in combination with acid-dissociation and bead treatment for detection of anti-drug antibody. (PubMed, Heliyon) - "Moreover, no false-positive results were observed in the presence of 5% hemolyzed serum samples and 150 mg/dL of triglyceride in the serum samples, no hook effect was observed, and the stability performed normally under room temperature for 24 h, 2-8 °C for 7 d, and six freeze/thaw cycles. In summary, this ADA assay is feasible and could be used for evaluating the immunogenicity of HLX26 in clinical trials."

Combination therapy • Journal • LAG3

Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Evaluate the Efficacy, Safety and Tolerability of HLX26 and HLX10 in Patients With Metastatic Colorectal Carcinoma That Have Received 3 Prior Lines of Therapy (clinicaltrials.gov) - P2 | N=49 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Combination therapy • New P2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS

A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection in Patients With Solid Tumor or Lymphoma (clinicaltrials.gov) - P1 | N=11 | Recruiting | Sponsor: Shanghai Henlius Biotech | Trial completion date: May 2024 ➔ Aug 2023 | Trial primary completion date: May 2022 ➔ Aug 2023

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Lymphoma • Oncology • Solid Tumor

Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech | Trial completion date: Jan 2023 ➔ Dec 2023 | Trial primary completion date: Jan 2023 ➔ Dec 2023

Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 in Combination With HLX10 in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov) - P1 | N=9 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Combination therapy • New P1 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Oncology • Solid Tumor • ROS1

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection in Patients With Advanced/Metastatic Solid Tumor or Lymphoma (clinicaltrials.gov) - P1; N=11; Recruiting; Sponsor: Shanghai Henlius Biotech

Clinical • New P1 trial • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Lymphoma • Oncology • Solid Tumor