Malignant Ascites

Unmet Medical Need

Malignant ascites is a severe and debilitating complication of advanced malignancies, with incidence rates reaching 60%–80% in ovarian cancer, 20%–40% in gastric cancer, and approximately 20% in colorectal cancer. Despite its devastating impact on patient quality of life and survival, there are currently no globally approved, effective pharmacological treatments available for this condition.

Proven Safety and Preclinical Efficacy

To address this critical medical void, G&E Herbal Biotechnology is advancing the development of the SR-T100 injection. SR-T100 has demonstrated an exceptional safety profile through comprehensive pharmacokinetic studies, GLP-certified animal toxicology tests, and human clinical trials across various formulations (oral, topical, and injectable). In rigorous in vivo efficacy models—conducted in collaboration with the National Laboratory Animal Center—SR-T100 successfully inhibited tumor growth, significantly reduced ascitic fluid accumulation, and prolonged the overall survival of mice with ovarian and hepatocellular carcinoma-induced malignant ascites.

Clinical Development Status

The investigational new drug (IND) enabling studies, including comprehensive preclinical toxicology evaluations in rodent and canine models, have been successfully completed by certified GLP testing facilities. The regulatory data package has been submitted to Taiwan’s Center for Drug Evaluation (CDE) for pre-IND consultation. Subject to regulatory clearance, G&E anticipates initiating the Phase I human clinical trial for terminal cancer-induced malignant ascites in the second or third quarter of 2025. This milestone will not only extend the lifespan and improve the quality of life for patients but also mark a significant achievement for Taiwan's biopharmaceutical industry on the global stage.

Competitive Edge and Market Potential

Historically, global clinical trial registries indicate that only about 12 new drug candidates have attempted to target malignant ascites. However, these trials were largely discontinued or failed due to severe dose-limiting toxicities that exacerbated patient suffering. SR-T100 overcomes these historical bottlenecks with its highly favorable safety and efficacy profile. Upon successful clinical validation, the SR-T100 injection is poised to become the world’s first approved targeted therapy for malignant ascites, unlocking boundless potential in the international oncology market and offering renewed hope to cancer patients globally.