Gelonghui, March 27 | Yuanda Pharmaceutical (00512.HK) announced that the Group reached a strategic cooperation agreement with Liantuo Biotechnology Co., Ltd. and Tarsus Pharmaceuticals, Inc. (“Tarsus”). After the relevant conditions are met, the Group will obtain exclusive rights for the development, production and commercialization of TP-03, a globally innovative ophthalmic formulation for the treatment of demodex blepharitis and meibomian gland dysfunction caused by demodex mite in Greater China at the cost of a down payment of US$15 million and a certain registration milestone fee. This strategic cooperation will deepen the Group's product layout in the field of ophthalmology.
TP-03 is a selective non-competitive antagonist for gamma-aminobutyric acid-gated chloride channels (“GABA-Cl”). It selectively inhibits GABA-Cl in demodex, causing paralysis and death, thereby completely curing demodex blepharitis. Furthermore, TP-03 is highly lipophilic and can promote its absorption in lash hair follicle oils where mites live. TP-03 has completed two key clinical studies in the US, involving more than 800 patients with demodex blepharitis. According to clinical results, both studies reached the primary end point and all secondary endpoints, which are statistically significant, and there were no serious treatment-related adverse events. This product was approved for marketing by the US Food and Drug Administration (“FDA”) in July 2023. It is currently the first and only drug approved by the FDA against demodex blepharitis. Additionally, a phase II clinical study of TP-03 in the US to treat meibomian gland dysfunction caused by demodex mites also showed positive top-line results.