GL PharmTech (Co-CEOs Yong-il Kim and Sung-pil Jin) announced on November 17 that it has submitted a marketing application for its new dry eye treatment Recoflavone, co-developed with Aju Pharm. The submission is being managed through its subsidiary GL Pharma, which completed pre-submission consultations with the MFDS in July this year.

According to the company, the filing showcases the formulation capabilities behind a newly developed Korean drug and serves as a strong example of inter-company R&D collaboration. With the MFDS moving toward a more expert-driven and predictable review system, GL PharmTech expects the evaluation to be completed within the standard 295-day timeline, enabling quicker market entry.

Recoflavone was originally in-licensed from Dong-A ST in November 2017. Since then, GL PharmTech has carried out formulation-enhancement research to improve intraocular absorption and, together with Aju Pharm, completed Phase 2 and 3 clinical trials. The Phase 3 study, concluded in April, demonstrated statistically significant superiority over placebo.

The company expects approval as early as the second half of 2026, followed by commercialization in 2027. The dry eye market in South Korea is estimated at approximately $342 million. Recoflavone—initially developed as a gastritis treatment—exhibits strong anti-inflammatory and mucin-secretion activity, and has minimal sensory side effects such as foreign-body sensation or bitterness. GL PharmTech believes these advantages may differentiate the product from existing therapies and expand long-term treatment options.

The company is also in final negotiations with a major Korean pharmaceutical firm for South Korean marketing rights and anticipates concluding the agreement soon. It projects achieving roughly a 10% market share within several years of launch. Overseas, discussions with global pharmaceutical companies are underway for export and technology collaboration across Asia, Europe, and the Americas. The global dry eye market is valued at around $4.44 billion and continues to grow due to rising screen exposure and environmental factors.

A company representative stated, “We will do our utmost to ensure Recoflavone’s successful global launch and to establish GL PharmTech as an internationally recognized pharmaceutical company.”