Huaota Biopharma Announces Phase III Clinical Trial Initiation of HB0025, a Novel PD-L1/VEGF Bispecific Fusion Protein, for First-Line Treatment of NSCLC

On December 29, Huaota announced that it hadHB0025 Combined with Chemotherapy as First-Line Treatment for Squamous and Non-Squamous Non-Small Cell Lung CancerMeeting communication with CDE at the end of Phase II clinical trial / before the initiation of Phase III clinical trial will officially launch the Phase III clinical trial of HB0025 injection.

Source: Huaota Official WeChat

HB0025 is a product independently developed by Huaota.Innovative anti-PD-L1/VEGF bispecific fusion proteinTargeting both the tumor immune escape pathway PD-L1 and the tumor angiogenesis pathway VEGF simultaneously. The drug design achieves high-affinity binding to both targets, synergistically modulating the tumor immune microenvironment and angiogenesis, featuring a dual anti-tumor mechanism of "immune enhancement + anti-angiogenesis." Following communications with the CDE, Huaota will initiate two confirmatory Phase III clinical trials.

Currently, Akeso has developed Eftokimab.(PD-1/VEGF bispecific antibody)Approved for marketing in China, BMS's PM8002(PD-L1/VEGF bispecific antibody)Pfizer's SSGJ-707(PD-1/VEGF bispecific antibody), Sinocelltech'sSCTB14(PD-1/VEGF bispecific antibody)Has entered Phase III clinical trials.HB0025 progress is in the first tier globally.

Huaota Presented Phase II Clinical Data of HB0025 Combined with Chemotherapy as First-Line Treatment for Advanced Squamous Cell Carcinoma and Adenocarcinoma of the Lung at the 2025 ESMO Conference, Demonstrating a Favorable Objective Response Rate and Disease Control Rate, Particularly a High ORR in PD-L1 Negative Populations, with Grade 3 or Higher Immune-Related Adverse Events（irAEs）Low incidence.

The smooth progress of the Phase III study of HB0025 in combination with chemotherapy as a first-line treatment for advanced squamous cell carcinoma and adenocarcinoma of the lung is expected to become a PD-L1/VEGF bispecific antibody drug for treating squamous cell carcinoma and adenocarcinoma of the lung regardless of PD-L1 expression levels, offering a new first-line treatment option for patients with advanced non-small cell lung cancer. Meanwhile, multiple Phase II clinical trials of HB0025 are currently being evaluated, covering various solid tumors including endometrial cancer, colorectal cancer, and triple-negative breast cancer.

Cover source: ZCool HaiLo

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