Siludi Pharmaceutical Co., Ltd. (01244): The 3D189 global critical phase III REGAL trial reached the pre-set number of events

Zhitongcaijing · 4d ago

According to Zhitong Finance App, Siludi Pharmaceutical Co., Ltd. (01244) announced the latest important progress of the 3D189 (Galinpepimut-S, GPS) cooperation project with SELLAS Life Sciences Group, Inc. (SELLAS). 3D189 is the company's second nearly commercialized product. It is an ongoing treatment for acute myeloid leukemia (AML). If approved, it will become the world's first WT1 tumor vaccine. The company obtained exclusive development and commercialization rights for 3D189 in Greater China in 2020. As of October 28, 2026, the critical phase III REGAL trial to evaluate GPS for AML patients had reached the expected 80 cases (number of deaths), triggering the final analysis of the study.

The REGAL trial is an event-driven overall survival study. Following the 80th incident, SELLAS will lock down the database, uncover research data, and carry out statistical analysis of key endpoint data. After the analysis is completed, SELLAS will announce the preliminary top-line results for the main endpoints of the test this quarter based on the statistical analysis plan (SAP) pre-formulated for the test.