Recently, the New Drug Application (NDA) for Indetek's first product, IDT-001 Gel, has been successfully accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This drug is indicated for the treatment of skin and soft tissue infections (SSTI) in patients ranging from infants to adults, including those with renal insufficiency and extensive infections.
IDT-001 Gel utilizes an innovative film-forming and sustained-release mechanism. After application, the drug forms a bioadhesive protective film on the skin surface, allowing the active ingredient to be continuously released at the infection site while maintaining an effective drug concentration. Compared to traditional ointment/cream formulations, the gel formulation provides longer drug retention time in the skin and more prolonged efficacy. The formed film barrier not only effectively isolates external irritants and pathogens, reducing the risk of infection, but also avoids adverse reactions such as contact dermatitis, rashes, and erythema that may be caused by traditional dressings, demonstrating good safety and tolerability. It is worth mentioning that IDT-001 Gel has a lightweight texture, is colorless and transparent, adheres strongly without being easily rubbed off by clothing, and facilitates daily activities, significantly improving patient compliance and quality of life, thereby better meeting real-world treatment needs.
Results from the Phase III confirmatory clinical study conducted in China showed that, with a reduced dosing frequency compared to the positive control drug, IDT-001 Gel not only successfully achieved the primary efficacy endpoint and all secondary efficacy endpoints during the cure examination period but also demonstrated excellent safety, tolerability, and good patient compliance.
The acceptance of the NDA for IDT-001 Gel marks Indetek's entry into a new stage. In the future, as the product is launched and marketed, the company will gradually establish an independent "blood-making" mechanism, providing sustainable financial support for the R&D investment of subsequent innovative pipelines.
