"Accelerating development of subcutaneous injection formulations for inoperable or metastatic melanoma"
[by Ji, Yong Jun] GI Innovation announced on January 16 that its next-generation immunotherapy candidate, 사설 바카라102, has been designated as an orphan drug during its development stage.
This orphan 사설 바카라 designation applies to the treatment of unresectable or metastatic melanoma, granted by the Ministry of Food and 사설 바카라 Safety on January 15. The official announcement will be made on the official website and other platforms.
If recognized as an orphan 사설 바카라, the benefits include: an extension of the product approval timeline, the option to replace exploratory clinical trial data with therapeutic confirmatory clinical trial data under certain conditions, partial exemptions from safety and efficacy data requirements when applying the approval, relaxed standards for manufacturing and quality control evaluations, and partial exemption from pre-review fees.
Orphan 사설 바카라s in the development stage can be designated for diseases with fewer than 20,000 patients in Korea, where no suitable treatment exists, or when a 사설 바카라 under development demonstrates significantly improved safety or efficacy compared to existing alternatives.
사설 바카라102 has shown a disease control rate of 83% in metastatic melanoma patients who previously failed immunotherapy with monotherapy. In a similar patient group, it has demonstrated significantly stronger anticancer activity than the 40% disease control rate of BMS' 'Opdualag', which is used as the standard treatment by the U.S. Food and Drug Administration (FDA).
In particular, with the recent start of clinical trials for the subcutaneous injection (SC) formulation of 사설 바카라102, there is growing potential for developing it as a safer, more effective, and more convenient immunotherapy.
“사설 바카라102 attracted considerable attention from global pharmaceutical companies at this year’s JP Morgan Healthcare Conference. We announced the news of 사설 바카라102's orphan drug designation in the development stage ahead of this year's technology transfer,” said Jang Myoung-ho, CSO of GI Innovation. “Along with the development of the SC formulation, we have gained further momentum for global technology transfer and commercialization.”