Gongwin-KY's Liver Cancer Therapy Published in International Journal; Phase III Clinical Trial Planned
MoneyDJ News 2026-08-06 10:08:25 Press release News Link
Gongwin-KY (6617) announced on August 6 that PTS100, a novel liver cancer drug developed by its subsidiary Gongwin Biopharm Taiwan, has achieved another important milestone. Following the completion of patient enrollment in its Phase II clinical trial in June this year, the results of a clinical case study evaluating PTS100 for the treatment of hepatocellular carcinoma have been published in the international Journal of Hepatocellular Carcinoma (JHC). Upon completion of data collection for the primary efficacy endpoint of PTS100 in the third quarter, the company plans to initiate preparations for a multinational, multicenter Phase III clinical trial in Taiwan, Japan, Thailand, and the United States, further advancing its global clinical development strategy.
PTS100 is the core product of Gongwin’s Intratumoral Drug Ablation (IDA) platform and is a novel tumor-ablation agent. PTS100 induces tumor cell apoptosis and inhibits the PI3K/Akt/mTOR signaling pathway, thereby suppressing tumor cell growth and survival. In combination with Gongwin’s Minimally Invasive Targeted Tumor Ablation (MITTA) technique, PTS100 is administered directly into the tumor under image guidance, enabling a higher local drug concentration while reducing systemic exposure and associated adverse effects.
Gongwin-KY stated that PTS100 has therapeutic potential across multiple cancer types, with potential applications in both human and veterinary medicine, and that liver cancer is the first indication under development. According to the World Health Organization (WHO), liver cancer is the second leading cause of cancer-related death worldwide, with approximately 90% of primary liver cancers classified as hepatocellular carcinoma (HCC).
The newly published paper from Gongwin Biopharm Taiwan reports the results of a clinical case study evaluating PTS100 for the treatment of HCC. The article was published in the Journal of Hepatocellular Carcinoma (JHC), published by Dove Medical Press. The journal focuses on advances in liver cancer clinical trials and translational research and is an important publication in the field of hepatocellular carcinoma research.
The article, entitled “Intratumoral Injection of Para-Toluenesulfonamide (PTS100) for Recurrent Hepatocellular Carcinoma Adjacent to the Heart: A Case Report,” evaluates the therapeutic outcome of PTS100 in a patient with an unresectable, medium-to-large HCC located in a high-risk anatomical region. The patient experienced recurrent HCC and had previously undergone six unsuccessful embolization procedures. Because the large tumor was located immediately adjacent to the heart, surgical resection and physical locoregional therapies were not feasible. Following three intratumoral injections of PTS100, complete tumor ablation was achieved. Liver cancer biomarkers and liver function remained within normal ranges. Treatment-related adverse events were mild and reversible, with no Grade 3 or higher adverse events or serious adverse events reported. These findings provide encouraging preliminary evidence of the efficacy, safety, and tolerability of PTS100 in the treatment of HCC.
Gongwin-KY noted that patient enrollment in the Phase II clinical trial of PTS100 for patients with primary liver cancer who are unsuitable for surgery or who have failed locoregional therapy was completed in June this year. Data collection for the primary efficacy endpoint is expected to be completed in the third quarter, after which the company plans to begin preparations for a multinational, multicenter Phase III clinical trial in Taiwan, Japan, Thailand, and the United States. The actual timeline will be adjusted and announced according to the progress of clinical development.
Mao-Yuan Lin, General Manager of Gongwin-KY, stated that the publication of the PTS100 treatment results in JHC is expected to attract significant attention from the international liver cancer medical community and support the development of the planned multinational, multicenter Phase III clinical trial, which is expected to be conducted concurrently in Taiwan, Japan, Thailand, and the United States. Beyond liver cancer, PTS100 also has the potential to expand into lung cancer and other solid tumor indications. Investigator-Initiated Trials (IITs) are currently underway in China to further evaluate the therapeutic potential of PTS100 in indications beyond liver cancer, with the goal of providing additional treatment options for patients with malignant tumors worldwide.