Announcement • Apr 21

Sihuan Pharmaceutical Holdings Group Ltd. Announces Preliminary Results of Ng-350A Phase 1B Fortress Clinical Study

Sihuan Pharmaceutical Holdings Group Ltd. announced that preliminary results from the Phase 1b FORTRESS study of NG-350A were presented at the 2026 Annual Meeting of the American Association for Cancer Research on 20 April 2026. NG-350A, an oncolytic immunotherapy being developed for the treatment of mismatch repair-proficient locally advanced rectal cancer, was in-licensed by Xuanzhu Biopharmaceutical Co. Ltd., a non wholly-owned subsidiary of the Group, from Akamis Bio Inc., a clinical-stage oncology company working to advance the standard of care in colorectal cancer. The Phase 1b FORTRESS study (NCT06459869) is an open-label, single-arm, and multicenter trial of NG-350A in combination with chemoradiotherapy in adult patients with mismatch repair-proficient locally advanced rectal cancer and at least one risk factor for local or distant recurrence or with oligometastatic disease. The ongoing study is assessing the anti-tumor effects of NG-350A combined with chemoradiotherapy following a 12-week active treatment period to establish whether NG-350A can improve composite response rates-defined as the proportion of patients achieving a clinical complete response or a near clinical complete response in mismatch repair-proficient locally advanced rectal cancer patients relative to expected outcomes from chemoradiotherapy alone. The benchmark composite response rate (clinical complete response + near clinical complete response) with chemoradiotherapy alone at 12 weeks is approximately 25%. The study results demonstrate a 50% composite response rate in the first 10 patients who completed the 12-week active treatment period, with no serious adverse events or new safety signals identified related to NG-350A. NG-350A is a clinical-stage, intravenously delivered Tumor-Specific Immuno-Gene (T-SIGn®) therapeutic designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells resident in solid tumors and their draining lymph nodes. Once activated, antigen-presenting cells recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. Akamis has evaluated NG-350A’s safety, tolerability, and preliminary efficacy as a monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in patients with metastatic or advanced epithelial tumors. Across these studies, NG-350A has demonstrated a consistent safety and tolerability profile, as well as strong evidence of tumor-selective delivery, replication and transgene expression. Xuanzhu Biopharm holds exclusive rights to the development, manufacturing and commercialization of NG-350A in Greater China. Xuanzhu Biopharm is actively advancing the application for clinical trials of NG-350A in the People’s Republic of China.

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