Artificial Tears Only for 'Angugonjojeung'? ... Challenging the Global Market with New Anti-Inflammatory Drug

Hanall Biopharma, Phase 3 Clinical Trials in US and China
Yuyu Pharma Progressing Smoothly in Phase 2 in US
Global Market Expected to Reach $5.6 Billion by 2026

Stock photo of dry eye syndrome.

[Asia Economy Reporter Lee Gwanju] Domestic pharmaceutical companies have thrown down the gauntlet in developing new drugs for "dry eye syndrome," a representative eye disease with high prevalence that causes discomfort in daily life. While artificial tears currently occupy more than half of the dry eye treatment market, the development of more effective treatments capable of suppressing inflammation is expected to have strong global competitiveness.

According to the pharmaceutical industry on the 22nd, domestic companies such as HanAll Biopharma and Yuyu Pharma are currently dedicated to developing new drugs for dry eye syndrome. HL036 (active ingredient: tanfanercept), jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, is currently undergoing Phase 3 clinical trials in the United States and China. Unlike existing treatments that provide temporary symptom relief, HL036 treats inflammatory eye diseases by inhibiting tumor necrosis factor (TNF), a cytokine that causes inflammation in the eye. It is administered as eye drops twice daily for 8 weeks.

Hanall Biopharma.

After transferring development and commercialization rights in Greater China in 2017, the Phase 3 clinical trial in China is being led by Harbormyomed and aims to conclude early next year. In the United States, the second Phase 3 clinical trial (clinical name VELOS-3) is being conducted jointly with Daewoong Pharmaceutical. Key results are expected to be announced as early as this year. Lee Seonkyung, a researcher at IBK Investment & Securities, stated, “HL036 is considered a promising candidate with advantages in efficacy and safety compared to existing treatments. Especially since no new drugs approved in the U.S. have been introduced in the Chinese market, HL036 has a high potential to become the first new drug in China, which could lead to significant sales.”

The Phase 2 clinical trial of Yuyu Pharma’s dry eye treatment candidate “YP-P10” in the United States is also progressing smoothly. Yuyu Pharma received approval from the U.S. Food and Drug Administration (FDA) to proceed with Phase 2 trials in April this year and began dosing the first patient in July. The trial plans to enroll 240 dry eye patients across seven hospitals in the U.S. YP-P10 is a new drug utilizing synthetic peptides, and preclinical trials have confirmed its superior anti-inflammatory mechanism and excellent corneal epithelial cell healing effects compared to existing drugs.

Yuyu Pharmaceutical Jecheon Plant.

Additional studies on animal models showed that YP-P10 reduced various inflammatory mediators related to dry eye and improved corneal damage. The company explained that these results indicate YP-P10 has anti-inflammatory effects similar to corticosteroids in treating dry eye syndrome. A Yuyu Pharma representative said, “Our first global clinical project is progressing smoothly,” adding, “We aim to successfully complete the trials and provide more effective and diverse treatment options for dry eye patients.”

The prevalence of dry eye syndrome is estimated to vary widely from 5% to 50% of the population. However, only four treatments have been approved by the FDA to date, and about 50% of the treatment market is occupied by artificial tears, indicating a large demand for more effective therapies. The Korea Pharmaceutical and Bio-Pharma Manufacturers Association forecasts that the global dry eye syndrome market will reach $5.6 billion (approximately 7 trillion KRW) by 2026.

This content was produced with the assistance of AI translation services.