According to the Zhitong Finance App, Huahai Pharmaceutical (600521.SH) issued an announcement. Recently, the company's subsidiary Shanghai Huaotai Biopharmaceutical Co., Ltd. (hereinafter referred to as “Huaotai”) and Huabo Biomedical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Huabo Biology”) received the “Drug Clinical Trial Approval Notice” for the HB0025 injection approved and issued by the China Drug Administration (hereinafter referred to as “China Drug Administration”).

According to reports, HB0025 (international generic drug name: Sotiburafusp alfa) is a bispecific fusion protein formed by connecting the second Ig-like structure domain outside the VEGFR1 membrane to the N-end of the IgG1 anti-PD-L1 monoclonal antibody heavy chain through a flexible connector. It can simultaneously bind to the two targets of PD-L1 and VEGF with high specificity and affinity. Numerous studies have shown that blocking the PD-1/PD-L1 signaling pathway can cancel the immunosuppressive effect mediated by this signaling 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 to achieve the goal of inhibiting tumor growth. Furthermore, blocking the VEGF/VEGFR signaling pathway can also improve the tumor microenvironment, increase the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, and facilitate immunotherapy. Therefore, blocking these two signaling pathways simultaneously can exert a synergistic antitumor effect. Both clinical and preclinical studies have shown that HB0025 has good efficacy and safety in a variety of tumors, and ongoing clinical studies have also observed positive efficacy signals.