Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Clinical Trials in Solid Tumors

Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its pipeline drug candidate ZG005. The approvals will pave the way for trials to evaluate the efficacy and safety of ZG005 in two distinct combinations: one with ZGGS18 for advanced solid tumors, and another with bevacizumab for advanced hepatocellular carcinoma.

ZG005 is an innovative anti PD-1/TIGIT bispecific antibody (BsAb) injection that is specifically targeted for the treatment of solid tumors. As a novel therapeutic, no similar product has been approved globally to date. Phase I/II clinical data have demonstrated that ZG005, when used as a monotherapy, shows promising tolerability, safety, and anti-tumor efficacy across various types of advanced solid tumors.

ZGGS18, another bispecific antibody in Zelgen’s portfolio, targets vascular endothelial growth factor (VEGF) and transforming growth factor-beta (TGF-β). This dual-targeting approach is designed to create a synergistic effect, inhibiting tumor growth, reducing metastasis, and improving the tumor microenvironment. Phase I/II clinical data have indicated that ZGGS18 has a favorable tolerability and safety profile, along with positive trends in anti-tumor efficacy.- Flcube.com

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