HB0025 Achieves Key Milestone: PD-L1/VEGF Bispecific Fusion Protein Combined with Standard of Care for Advanced or Recurrent Endometrial Cancer Submits EOP2 and Advances Toward Phase III Clinical Trial

Abstract

Recently,Zhejiang Huahai Pharmaceutical Co., Ltd. Subsidiary, Shanghai Huaota Biopharmaceutical Co., Ltd.(Huaota) announced: Its self-developed PD-L1/VEGF bispecific fusion protein HB0025, in combination with standard of care (SOC) for advanced or recurrent endometrial cancer, has officially submitted a pre-Phase III confirmatory clinical trial initiation meeting application to the CDE. This marks that the project is about to enter the critical stage of Phase III clinical development and is also an important turning point in its global development pathway.

As one of the earliest companies in China to develop a PD-L1/VEGF dual-target fusion protein, Huaota has been committed to addressing the treatment challenges posed by the coexistence of immunosuppression and abnormal vasculature in various solid tumors through a "dual-antibody integration" strategy since the project's inception.

About HB0025

HB0025 is an innovative bispecific fusion protein targeting PD-L1 and VEGF independently developed by Huaota. It has the ability to simultaneously target the tumor immune escape pathway PD-L1 and the tumor angiogenesis pathway VEGF. The drug achieves high-affinity binding to both targets through structural design, synergistically modulating the tumor immune microenvironment and angiogenesis, with potential "Immune Enhancement + Anti-angiogenesis"Dual Antitumor Mechanism. Relevant research findings were published in the international journal 'Frontiers in Immunology' in 2021."（DOI: 10.3389/fimmu.2021.778978）, demonstrating its significant advantages in mechanism validation and early efficacy.

In clinical research, HB0025 combined with paclitaxel and carboplatin has shown positive efficacy for first-line treatment of locally advanced, recurrent, or metastatic endometrial cancer. The latest data was presented at the American Society of Clinical Oncology Annual Meeting (ASCO 2025) in June 2025.（Abstract #5602, NCT06758557）：In the pMMR population, the objective response rate (ORR) reached as high as 85.4%, demonstrating favorable universal efficacy and population coverage capability.。

Currently, HB0025 is being evaluated in multiple Phase I/II clinical trials, covering various solid tumors such as non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer. It is also planned to expand to indications like colorectal cancer and ovarian cancer in the future. Meanwhile, several Phase III registrational clinical studies are proceeding in an orderly manner. As research continues to advance, HB0025 is expected to provide patients with various types of tumors a treatment option featuring a more synergistic mechanism, becoming a significant breakthrough in the "immunotherapy plus angiogenesis" dual-target antibody therapeutic strategy.

About Huaota

Huaota Bio is a biopharmaceutical company focused on independent research and development with a global perspective. The company specializes in the R&D of novel biologics for cancer and autoimmune diseases. Currently, it has 11 projects in clinical stages: including an IL-36R monoclonal antibody, the first self-developed treatment in China for generalized pustular psoriasis, which has completed pivotal clinical trials with all endpoints achieved; a PD-L1/VEGF bispecific antibody currently in Phase II clinical trials showing promising signals in multiple cancers such as endometrial cancer and non-small cell lung cancer; a CD73-ADC with dual cytotoxic effects targeting refractory tumors; a TSLP/IL-11 bispecific antibody independently developed for severe asthma treatment, the first of its kind globally; and a groundbreaking bispecific antibody targeting both IL-17A and IL-36R, which aims to overcome the limitations of existing single-target therapies.

Huaota is currently actively seeking domestic and international partners to jointly advance and co-develop, aiming to provide high-quality, cutting-edge biopharmaceuticals to the global market. These efforts are designed to meet the needs of a broad patient base for innovative biologics that are safe, effective, accessible, and affordable, with a commitment to changing the world through innovation!