Yongtai Pharma (00512) receives domestic approval for the world's only Demodex blepharitis eye drop, global sales surge dramatically, peak value may exceed $2 billion!

iFintech News APP has learned that on March 22, Hong Kong-listed innovative international pharmaceutical company Yuanda Pharmaceuticals (00512) announced positive news. The company’s innovative eye drug pipeline has added a heavyweight product—GPN01768, a globally innovative ophthalmic medication for treating Demodex blepharitis.

[TP-03, (Lotte拉纳滴眼液) 0.25%] has officially been approved for listing in China. During the drug review process, no supplementary information was requested, achieving “zero additional submission” approval. The peak sales are expected to exceed $2 billion, and this product is poised to become another blockbuster for Yuanda Pharmaceuticals.

GPN01768 is the first FDA-approved, globally novel, and currently the only drug specifically for treating Demodex blepharitis. Its entry into the Chinese market fills a treatment gap domestically and will bring a new treatment option to over 50 million patients in China. Notably, since its US launch in 2023, sales revenue has exploded, reaching approximately $180 million in 2024 and approximately $450 million in 2025, representing a year-over-year growth of over 150%.

Validated clinical value overseas, US annual sales of $450 million with over 150% growth, peak aiming for $2 billion

It is reported that GPN01768 received FDA approval in July 2023, becoming the first and only approved drug for Demodex blepharitis worldwide. This not only raised awareness of the disease but also encouraged broader screening by physicians, gaining ongoing recognition among US doctors. The product has significant growth potential.

Commercial performance overseas confirms its clinical value and growth prospects. Since its US launch in July 2023, the product has rapidly gained recognition from doctors and patients, with sales soaring. In 2024, US revenue reached about $180 million, and in 2025, about $450 million, a substantial increase of over 150% year-over-year. It is one of the fastest-growing prescription eye drops in the market. Recently, Tarsus, the developer of the product, has raised its future peak sales forecast from over $1 billion to over $2 billion, potentially becoming another blockbuster. Analysts suggest that based on this outlook, Tarsus’s EPS could rise to nearly $20, with a corresponding stock price exceeding $300, representing nearly 350% upside from its current approximately $67. The approval of this product in China is expected to replicate the US growth trend in the domestic ophthalmology market, becoming another strong driver of Yuanda Pharmaceuticals’ revenue growth and providing a new treatment option for Demodex blepharitis patients in China.

Global first targeted Demodex blepharitis drug, filling domestic treatment gap with over 50 million patients covered

Demodex blepharitis is a chronic inflammatory disease caused by Demodex mite infestation of the eyelid margin, accounting for over two-thirds of all blepharitis cases. Symptoms include eyelid itching, foreign body sensation, dryness, conjunctival hyperemia, scales, and sleeve-like secretions at the eyelash roots. Severe cases can lead to conjunctival and corneal complications.

Demodex infestation is widespread and highly contagious, with incidence increasing with age. Studies show a global infestation rate of about 60%, reaching 100% in those over 70. In the US, approximately 25 million patients suffer from Demodex blepharitis. Globally, over 400 million people are affected, expected to exceed 500 million by 2029. China’s patient population has long been over 50 million, with urgent clinical needs and a huge market.

For a long time, domestic treatments for Demodex blepharitis have been very limited. Due to the lack of specific drugs, doctors mainly use physical cleaning, topical anti-inflammatory drugs, or artificial tears, which cannot completely eliminate mites and often have slow effects, high recurrence, and eye irritation. The emergence of GPN01768 changes the situation of no available drugs for Demodex blepharitis.

According to the announcement, GPN01768 is a non-competitive antagonist that selectively targets GABA-Cl channels in insects and arachnids, inhibiting Demodex mites by blocking their GABA-Cl channels, causing paralysis and death, thus treating Demodex blepharitis. The drug is highly lipophilic, promoting absorption into the sebaceous glands of eyelash follicles where mites reside. Clinical data show that TP-03 achieves statistically significant mite eradication rates (p<0.001), with high safety and tolerability, and excellent clinical efficacy. Its market potential is very promising.

Innovative ophthalmic pipeline iteration, forward-looking layout consolidates ophthalmology leadership

In recent years, with increasing health awareness, eye health has gained more attention, driving the ophthalmic drug market toward broad development. Data indicates that the global ophthalmic drug market is expected to reach about $70.3 billion by 2033, with China’s market expected to surpass $10 billion by 2032 and reach $11.9 billion by 2033, offering vast market space.

In this blue ocean market, Yuanda Pharmaceuticals has made strategic forward-looking arrangements. The company focuses on ophthalmic drug innovation, adhering to a specialized development path to enhance industry standing and market competitiveness. Currently, Yuanda has built an “expertise, full-range, multi-product” innovative drug portfolio. Through a combination of partnerships and independent R&D, it has a pipeline including treatments for dry eye, Demodex blepharitis, post-ocular surgery anti-inflammatory and pain relief, pterygium, and myopia, creating differentiated competitive advantages with significant R&D progress.

Among these, the anti-inflammatory and analgesic steroid nano suspension eye drop GPN00833 completed Phase III clinical trials in China in November 2024; the innovative modified drug GPN00153 (CBT-001) for pterygium completed international multicenter Phase III trials with all centers recruiting by June 2025; and the global innovative drug GPN00884 for delaying myopia progression in children completed its first patient enrollment in China’s Phase IIa trial in October 2025.

In recent years, Yuanda’s innovation and R&D achievements have been abundant. The company is entering a period of harvest from its innovation pipeline. By 2026, several key innovative products are expected to be launched and commercialized, continuously strengthening its global innovation layout. These include first-in-class treatments for dry eye such as the travoprost nasal spray Varniclan and the recently approved Lotte拉纳 eye drops, which are expected to ramp up sales, opening new high-growth tracks and capturing broad blue ocean markets, injecting long-term, high-quality growth momentum.

The domestic approval of GPN01768, achieving “zero additional submission,” helps Yuanda directly penetrate a market of over 50 million patients, potentially replicating the rapid overseas growth trajectory. From US sales exceeding $450 million in two years and over 150% growth, to the peak sales forecast raised to $2 billion, GPN01768 has demonstrated its commercial value as a major ophthalmic blockbuster. Analysts believe that as this product and other global innovative eye drugs for dry eye and myopia control are launched, Yuanda’s ophthalmology segment is expected to become one of the most explosive growth engines in the coming years, supporting its “Go Global” strategic development.