Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced that the National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for its innovative drug GPN01768 (TP-03, lotilaner ophthalmic solution, 0.25%). The Chinese company is seeking approval for the drug to treat Demodex blepharitis, a condition caused by Demodex mites.
GPN01768’s Mechanism of Action
GPN01768 is designed to eradicate Demodex mites, the root cause of Demodex blepharitis, by selectively inhibiting the mite’s GABA-Cl channels. The drug’s highly lipophilic molecule may also promote its uptake in the oily sebum of the eye lash follicles, where the mites reside, enhancing its effectiveness.
Development and Licensing Background
GPN01768 was developed by US firm Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) and is the first and only FDA-approved drug for Demodex blepharitis. In March of this year, Grand Pharma inked a licensing agreement with Tarsus to exclusively develop, manufacture, and commercialize the drug in Greater China. This licensing agreement follows a previous deal granted to Shanghai-based LianBio in March 2021, which allowed for the manufacturing rights to be retained by Tarsus.-Fineline Info & Tech
