Xuanzhu Biopharmaceutical Co., Ltd. (2575), a subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., announced that NG-350A—licensed from clinical-stage oncology company Akamis Bio Ltd.—has been granted Fast Track designation by the U.S. Food and Drug Administration. This designation focuses on treating mismatch repair-proficient locally advanced rectal cancer and is designed to facilitate expedited development and regulatory review of therapies addressing serious conditions with unmet medical needs.

NG-350A is an intravenously delivered oncolytic viral vector in the T-SIGn® platform that expresses a CD40 agonist monoclonal antibody directly inside tumors, leading to the activation of antigen-presenting cells. This process aims to trigger a robust anti-tumor immune response by drawing T cells into the tumor microenvironment. Xuanzhu Biopharmaceutical holds exclusive rights to develop, produce, and commercialize NG-350A in Greater China.

Xuanzhu Biopharmaceutical focuses on major disease areas including oncology, digestive diseases, and non-alcoholic steatohepatitis. Backed by a research and development team with extensive experience, the company operates both small molecule and large molecule biologics R&D systems, driving innovation in its domestic pipeline of proprietary novel drugs and biologics. The announcement was made on October 28, 2025, to inform the market of this latest development in the Group’s product portfolio.