Sihuan Pharmaceutical Holdings Group Ltd. (Stock Code: 0460) announced that NG‑350A, developed by its non wholly-owned subsidiary Xuanzhu Biopharmaceutical Co., Ltd. (Xuanzhu Biopharm) under a license from Akamis Bio Ltd., has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of mismatch repair-proficient locally advanced rectal cancer. According to the announcement, Xuanzhu Biopharm holds exclusive rights to develop, produce, and commercialize this candidate in Greater China.

NG‑350A is a clinical-stage T‑SIGn® therapeutic designed to drive intratumoral expression of a CD40 agonist monoclonal antibody. The resulting activation of antigen-presenting cells is intended to recruit T cells and elicit a potent anti-tumor immune response. The product has been evaluated in previous clinical studies both as a monotherapy and in combination with pembrolizumab, demonstrating safety, tolerability, and evidence of tumor-selective delivery and replication. NG‑350A is currently in a Phase Ib study in combination with chemoradiotherapy for patients with locally advanced rectal cancer and certain risk factors for recurrence.

Xuanzhu Biopharm focuses on major diseases such as oncology, gastrointestinal disorders, and non-alcoholic steatohepatitis, with a pipeline that includes small molecule drugs, biopharmaceuticals, and antibody-drug conjugates. Sihuan Pharmaceutical, founded in 2001 and listed on the Main Board of The Stock Exchange of Hong Kong Limited in 2010, is an international medical aesthetic and pharmaceutical company emphasizing innovation. The announcement highlights Sihuan Pharmaceutical’s strong research and development capabilities, diverse product pipeline, and comprehensive production and sales systems.