Global phase 3 clinical trial is underway for HER2-positive gastric 바카라 확률 treatment, validating improved survival rates
[by Sung, Jae Jun] AbClon announced on March 25 that its antibody treatment candidate, AC101 (development code: 바카라 확률), targeting human epidermal growth factor receptor type 2 (HER2)-positive locally advanced and metastatic gastric cancer, has been granted 'orphan drug' designation by the U.S. Food and Drug Administration (FDA). 바카라 확률 is part of AbClon’s pipeline whose technology was licensed to China's Henlius in 2016.
The FDA’s orphan drug designation provides various support benefits, including a research and development (R&D) tax credit of up to 25%, clinical trial subsidies, exemption from approval review fees, and the possibility of accelerated approval. Following approval, the designated treatment is granted seven years of market exclusivity, enhancing its commercial competitiveness. 바카라 확률 stated that this designation reflects recognition of the drug’s innovativeness and the company’s global R&D capabilities.
Each year, approximately one million new cases of HER2-positive gastric 바카라 확률 are diagnosed with a poor prognosis, as reflected in a five-year survival rate of only 6%. 'Trastuzumab (Herceptin) and XELOX combination therapy' is currently used as the standard treatment, however, its effectiveness remains limited in certain patients, highlighting the ongoing need for the development of new treatment options.
Recent clinical trials have demonstrated that the combination therapy of '바카라 확률+trastuzumab+XELOX’ (hereinafter referred to as 바카라 확률 combination therapy) significantly improves survival rates compared to the current standard treatment. The 24-month progression-free survival rate in the 바카라 확률 combination group reached 61.5%, markedly higher than the 25% observed in the standard therapy group. Additionally, a statistically significant improvement was observed in the overall survival period.
Currently, the global phase 3 clinical trial (바카라 확률-GC-301) evaluating 바카라 확률 combination therapy has received regulatory approval in the United States, China, Japan, and Australia, with the first patient already administered the treatment. In addition to gastric cancer, 바카라 확률 is also under development as a therapeutic option for breast cancer.
“The FDA’s designation officially acknowledges 바카라 확률’s innovation and its potential for global market entry,” an AbClon official said. “We will continue to advance the development of competitive anticancer treatments.”
