GRAND PHARMA (00512) is the only company in the world that has been granted approval for the treatment of Demodex blepharitis. Global sales are rapidly increasing, with peak sales potentially exceeding 2 billion US dollars!

On March 22, Grand Pharma (00512), a Hong Kong-listed technology innovative international pharmaceutical company, received good news. The company's innovative eye medicine product pipeline has added a heavyweight product - GPN01768, a global innovative ophthalmic drug for treating Demodex blepharitis [TP-03, (Loteplalan Eye Drops) 0.25%], has officially been approved for listing in China, and no supplementary information notifications were received during the drug review process, achieving approval without additional data requests. It is expected that the peak sales of this product will exceed USD 2 billion, and this product is expected to become another popular single-product for Grand Pharma. GPN01768 is the first drug approved by U.S. FDA for treating Demodex blepharitis, the only drug in the world specifically for treating this condition. Its landing in the domestic market fills the treatment gap for Demodex blepharitis in China, bringing a new treatment option for over 50 million patients in China. Notably, since its launch in the U.S. in 2023, the product's sales revenue has shown explosive growth. It achieved approximately USD 180 million in revenue in 2024 and around USD 450 million in revenue in 2025, a significant year-on-year increase of over 150%. The validation of clinical value in overseas markets, annual sales exceeding USD 4.5 billion in the U.S., with a growth rate of over 150%, and a peak value aimed at USD 20 billion. According to reports, GPN01768 was approved for listing in the U.S. in July 2023, becoming the first and only drug approved for the treatment of Demodex blepharitis. It has not only raised awareness of Demodex blepharitis but also encouraged doctors to conduct broader screenings. It has gained continuous recognition among doctors in the U.S., and the product has tremendous growth potential in the future. The commercial performance of this product in overseas markets directly confirms its clinical value and growth potential. Since its launch in the U.S. in July 2023, the product rapidly gained recognition from doctors and patients, achieving explosive growth in sales revenue. It generated approximately USD 180 million in revenue in the U.S. in 2024 and about USD 450 million in 2025, a year-on-year increase of over 150%, making it one of the fastest-growing prescription eye drops in the market. The management of the product development company Tarsus recently raised the expected sales peak of the product from over USD 1 billion to over USD 2 billion. It is expected to become another popular single-product. Analysts point out that based on these expectations, Tarsus's earnings per share (EPS) could increase to nearly USD 20, with the corresponding stock price exceeding USD 300, representing a huge increase of nearly 350% from its current price of approximately USD 67. After this product receives approval for listing in China, it is expected to replicate the growth trend in the eye care market in the U.S., becoming another strong engine driving the revenue growth of Grand Pharma and bringing a new treatment option for Demodex blepharitis patients in China. Global first-in-class targeted drug for Demodex blepharitis, filling the treatment gap in China, covering over 50 million Chinese patients. Demodex blepharitis is a chronic inflammatory disease caused by Demodex mite infection of the eyelid margin, accounting for more than two-thirds of all cases of blepharitis, mainly manifested as eyelid itching, foreign body sensation in the eyes, dry eyes, reddened eyelids, scales, and sleeve-like secretions at the base of the eyelashes, with severe cases leading to complications of the conjunctiva and cornea. It is reported that Demodex infection is very common and highly contagious, with the incidence rate increasing with age. Research data shows that the global infection rate of Demodex is around 60%, reaching 100% in the population aged 70 and above. In terms of patient size, in the U.S., approximately 25 million patients are affected by Demodex blepharitis. Globally, there are over 400 million patients with Demodex blepharitis, projected to exceed 500 million by 2029, with the patient scale in China consistently exceeding 50 million, with a pressing clinical need and a large market size. For a long time, the clinical treatment options for Demodex blepharitis in China have been extremely limited. Due to the lack of specific drugs, doctors often resort to symptomatic treatments such as physical cleansing, local anti-inflammatory drugs, or artificial tears, which not only fail to completely eradicate the mites but also have issues with slow onset, frequent relapses, and eye surface irritation. The introduction of GPN01768 changes the lack of effective treatment for Demodex blepharitis. According to the announcement, GPN01768 is a selective non-competitive antagonist targeting -aminobutyric acid-gated chloride ion channels (GABA-Cl) inside insects and arachnids, which selectively inhibits GABA-Cl inside Demodex mites, causing paralysis and death of the mites, thereby treating Demodex blepharitis. In addition, GPN01768 has high lipophilicity, promoting absorption in the oil secretions of the Demodex mites' eyelash follicles. Clinical data shows that TP-03 has a statistically significant mite eradication rate in patients with Demodex blepharitis (p<0.001), with high safety and good tolerance, significant clinical efficacy, and considerable future market potential. Innovative iterations in the ophthalmology pipeline, forward-looking layout solidifying the leading position in ophthalmology. In recent years, with the increasing awareness of public health, eye health has received more attention, driving a broad development space for the ophthalmic drug market. Data shows that the global ophthalmic drug market is expected to reach around USD 70.3 billion by 2033, with the Chinese ophthalmic drug market expected to exceed USD 10 billion by 2032 and reach USD 11.9 billion by 2033, presenting a huge market space. For the ophthalmic drug market, Grand Pharma has made forward-looking layouts. The company focuses on ophthalmic drug innovation, adheres to a professional development path, and continuously enhances industry status and market competitiveness. Currently, Grand Pharma has established an innovative pharmaceutical product system that is "professional, full range, and multi-variety," through a combination of cooperative introductions and independent research and development strategies, reserving treatments for "dry eye syndrome," "Demodex blepharitis," "postoperative anti-inflammatory analgesics for ophthalmic surgery," "pinguecula," and "myopia," among other global innovative products, establishing differentiation in competitive advantages and achieving significant research and development progress. Among them, GPN00833, a nanosuspension eye drops for anti-inflammatory analgesia, completed Phase III clinical trials domestically and reached clinical endpoints in November 2024; the innovative improved drug GPN00153 (CBT-001) for pinguecula treatment completed Phase III multicenter international clinical trials with all patients enrolled in June 2025; and the global innovative ophthalmic drug GPN00884 for delaying childhood myopia progression completed its first patient enrolled in a Phase IIa clinical trial conducted in China in October 2025. In recent years, Grand Pharma has achieved significant innovations in research and development, entering a period of innovation harvest. In 2026, several major innovative products from Grand Pharma are expected to be launched and commercially expanded, consolidating the company's global innovation layout. Among them, innovative ophthalmic drugs such as the innovative dry eye treatment product tartaric acid Vanniculan nasal spray and the approved Loteplalan eye drops are expected to be successively released, helping the company open up new gold tracks, capture vast blue ocean incremental markets, and inject strong and lasting core growth momentum for its long-term high-quality development. The approval of GPN01768 in China with no additional information requests will help Grand Pharma directly enter a blank market with over 50 million patients and replicate the high-speed growth trajectory overseas. From sales in the U.S. exceeding USD 450 million after two years of listing, with over 150% growth, to the peak sales expected to be raised to USD 20 billion, GPN01768 has already demonstrated its commercial value as a major eye care product. Analysts point out that with the successive release of this product and other global innovative eye medications to address dry eye syndrome, myopia prevention, and control, Grand Pharma is accelerating its entry into an innovation harvest period, with the ophthalmology segment likely to become one of the company's most explosive growth poles in the next few years, becoming another strong engine for the "Go Global" strategic development.