HLX37 / Fosun Pharma, Shanghai Henlius Biotech - LARVOL DELTA

Shanghai Henlius Biotech, Inc. announced that China’s National Medical Products Administration has approved the investigational new drug application for a phase 1 clinical trial of HLX37 in combination with chemotherapy or with HLX43 in patients with advanced or metastatic solid tumours. (TipRanks) - "The company plans to initiate these trials in the Chinese Mainland, expanding the clinical evaluation of its PD-L1/VEGF bispecific antibody and PD-L1-targeting ADC."

New P1 trial • Solid Tumor

A novel anti-PD-L1/VEGF bispecific antibody (HLX37) with immune checkpoint inhibition, anti-angiogenic, and antineoplastic activities (AACR 2025) - "HLX37 is an anti-PD-L1/VEGF bispecific antibody with immune checkpoint inhibitory, anti-angiogenic, and antineoplastic properties. It demonstrated strong preclinical efficacy and a favorable safety profile, with enhanced tumor enrichment. It holds promising potential for further application in various types of tumors."

Bispecific • Checkpoint inhibition • Breast Cancer • Colon Cancer • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma • KDR

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=254 | Recruiting | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Recruiting

Enrollment open • First-in-human • Hepatocellular Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • MET • NTRK • PD-L1

The First Patient has been Dosed in a Phase 1 Clinical Study of HLX37 (Recombinant Humanised Anti-PD-L1 and Anti-VEGF Bispecific Antibody) in Patients with Advanced/Metastatic Solid Tumours in Chinese Mainland (HKEXnews) - "This study is an open-label, first-in-human phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetic (PK) profiles, and preliminary efficacy of HLX37 in subjects with advanced/metastatic solid tumours."

Trial status • Solid Tumor

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=254 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

The Investigational New Drug application of HLX37 (recombinant humanised anti-PD-L1 and anti-VEGF bispecific antibody) for the treatment of patients with advanced/metastatic solid tumours approved by the National Medical Products Administration (NMPA) (HKEXnews)

New trial • Solid Tumor

Henlius to Present Three Preclinical Studies at AACR 2025 (Henlius Press Release) - "The American Association for Cancer Research 2025 Annual Meeting (AACR 2025) is set to take place from April 25 to April 30 in Chicago, the United States. Henlius will share three latest preclinical research results from its pipeline programs. The results to be presented include the novel anti-PD-L1/VEGF bispecific antibody HLX37, a novel KAT6A/B inhibitors with best-in-class potential, and a first-in-class ADC linker-payload featuring a highly differentiated killing mechanism."

Preclinical • Oncology