GI Innovation's next-generation immuno-oncology drug candidate GI-102 has been designated as a 'rare drug in development stage.'
The company noted on the 16th that the Ministry of Food and Drug Safety designated GI-102 as a rare drug in development stage for treating patients with inoperable or metastatic melanoma the previous day.
Drugs designated as rare in the development stage are applicable to diseases with a prevalence of fewer than 20,000 people in the country, where no suitable treatment methods or medications exist, or when a drug under development significantly improves safety or efficacy compared to existing alternatives.
Upon designation, corporations can receive several benefits for the drug, including an extension of the item license validity period, exemption from certain safety and efficacy documentation during the license application, relaxed data requirements for manufacturing and quality control standards, and exemption from some preliminary review fees.
According to the company, GI-102 has demonstrated a disease control rate of 83% in metastatic melanoma patients who failed immuno-oncology therapy as a monotherapy. In a similar patient population, the FDA-approved standard treatment, Opdualag from the U.S. pharmaceutical company Bristol-Myers Squibb (BMS), had a disease control rate of 40%, indicating that GI-102 showed stronger anti-cancer activity.
The company recently started clinical trials for the subcutaneous injection formulation of GI-102.
Jang Myung-ho, Chief Strategy Officer (CSO), emphasized that "GI-102 garnered significant attention from global pharmaceutical companies during the JP Morgan Conference held in San Francisco from the 13th to the 16th" and noted, "Along with the development of the subcutaneous injection formulation, we gained additional growth momentum through global technology transfer and commercialization."