By Fineline Cube 
Indetek Laboratory announced that the National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for its first product, IDT‑001 Gel. The gel is indicated for the treatment of Skin and Soft Tissue Infections (SSTIs) in patients aged one year and older, including infants, adults, those with renal impairment, and large‑area infections.
Key Highlights
- Regulatory Milestone – First NDA acceptance by the NMPA for an Indetek product.
- Broad Indication – Covers SSTIs from infants (≥1 yr) through adults, including renal‑impaired patients.
- Innovative Delivery – Film‑forming, sustained‑release mechanism that creates a bio‑adhesive protective layer on the skin.
- Clinical Advantage – Provides longer drug retention and a more sustained therapeutic effect versus conventional ointments or creams.
About IDT‑001 Gel
- Mechanism of Action – Formed film releases active ingredient continuously at the infection site, maintaining effective concentrations.
- Formulation Technology – Combines high‑viscosity polymer matrix with rapid‑adhesion properties, ensuring a stable barrier against microbial ingress.
- Safety Profile – Pre‑clinical data show minimal systemic absorption and negligible local irritation.
Implications for Healthcare
- Improved Patient Compliance – Once‑daily application with sustained release reduces dosing frequency.
- Expanded Therapeutic Reach – Effective in renal‑impaired patients where conventional antibiotics may pose dosing challenges.
- Market Position – Positions Indetek as a first‑mover in the Chinese SSTI market with a differentiated product platform.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech