Grand Pharmaceutical's First-in-Class Demodex Blepharitis Treatment GPN01768 (TP-03) Receives NMPA Approval with 'Zero Deficiency' in China

Recently, Grand Pharmaceutical’s globally innovative ophthalmic drug GPN01768 [TP-03, (lotilaner ophthalmic solution) 0.25%], indicated for the treatment of Demodex blepharitis, has been officially approved for marketing in China. Notably, no requests for additional information were issued during the regulatory review process, achieving approval with “zero deficiencies.”

Demodex infestation is highly prevalent and contagious, with incidence rates increasing with age. Research data indicate that the global prevalence of Demodex infestation is approximately 60%, reaching 100% among individuals aged 70 and older. In terms of patient population, around 25 million people in the United States suffer from Demodex blepharitis, while the global number of patients exceeds 400 million. This figure is projected to surpass 500 million by 2029. China consistently maintains a patient population of over 50 million, reflecting urgent clinical needs and a substantial market size.

For a long time, clinical treatment options for Demodex blepharitis in China have been extremely limited. Due to the lack of specific therapeutic agents, physicians have largely relied on symptomatic management strategies such as physical lid hygiene, topical anti-inflammatory drugs, or artificial tears. These approaches not only fail to completely eradicate the mites but are also associated with slow onset of action, high recurrence rates, and ocular surface irritation.

It is reported that GPN01768 received approval from the U.S. FDA for market launch in July 2023. Notably, since its commercialization in the United States in 2023, the product has experienced explosive growth in sales revenue, generating approximately $180 million in the U.S. in 2024 and further surging to around $450 million in 2025, representing a year-over-year increase of more than 150%.