Huahai Pharmaceutical Subsidiaries Receive IND Approval for Anti-Tumor Drug HB0025 Injection

Huahai Pharmaceutical (600521.SH) announced that recently, its subsidiaries, Shanghai Huaota Biopharmaceutical Co., Ltd. ("Huaota") and Huabo Biopharm Co., Ltd. ("Huabo Biopharm"), received the "Drug Clinical Trial Approval Notice" for HB0025 injection issued by the National Medical Products Administration (NMPA).

It is reported that HB0025 (International Nonproprietary Name: Sotiburafusp alfa) is a bispecific fusion protein formed by connecting the second Ig-like domain of the extracellular region of VEGFR1 to the N-terminus of the heavy chain of an IgG1-type anti-PD-L1 monoclonal antibody via a flexible linker. It can simultaneously bind with high specificity and high affinity to two targets, PD-L1 and VEGF. Extensive research has shown that blocking the PD-1/PD-L1 signaling pathway can relieve the immunosuppressive effects mediated by this pathway and activate cytotoxic T lymphocytes, thereby inhibiting tumor growth. Blocking the VEGF/VEGFR signaling pathway can inhibit vascular endothelial cell proliferation and the formation of new blood vessels, achieving the goal of suppressing tumor growth. Additionally, blocking the VEGF/VEGFR signaling pathway can improve the tumor microenvironment and enhance the infiltration of cytotoxic T lymphocytes within the tumor microenvironment, which is beneficial for immunotherapy. Therefore, simultaneously blocking these two signaling pathways can exert synergistic antitumor effects. Both clinical and preclinical studies have demonstrated that HB0025 exhibits favorable efficacy and safety in various tumors, and ongoing clinical studies have also observed positive efficacy signals.