By Fineline Cube 
Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) announced that its New Drug Application (NDA) for GPN01768 (TP-03, lotilaner ophthalmic solution, 0.25%) has been approved by the drug regulatory agency in Macau, China. This approval allows the drug to be marketed for the treatment of demodectic blepharitis in the region.
Drug Mechanism and Indication
GPN01768 is designed to treat demodectic blepharitis, a condition caused by demodex infection and characterized by inflammation, redness, and eye irritation of the eyelid margin. The active ingredient, lotilaner, is an antiparasitic agent that targets the eradication of Demodex by selectively inhibiting the γ-aminobutyric acid gated chloride channel (GABA Cl).
Development and Licensing
Developed by US firm Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), GPN01768 is the first and only FDA-approved drug for Demodex blepharitis. Grand Pharma entered into a licensing agreement with Tarsus in March 2024, securing exclusive rights to develop, manufacture, and commercialize the drug in Greater China. This followed an earlier licensing deal between Tarsus and Shanghai-based LianBio in March 2021, which granted LianBio rights to the drug in Greater China, excluding manufacturing.-Fineline Info & Tech