IND Application for HLX316 Approved in China
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Investigational New Drug (IND) application for HLX316, a potential first‑in‑class (FIC) B7‑H3–targeting sialidase fusion protein, has been approved by the National Medical Products Administration (NMPA) of China. The approval enables the initiation of first‑in‑human (FIH) clinical studies of HLX316 in patients with advanced or metastatic solid tumors, representing an important translational milestone in the development of glyco‑immune checkpoint–modulating therapies.
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