The only one in the world! GRAND PHARMA (00512) has obtained domestic approval for a groundbreaking innovative eye medicine, benefiting millions of patients, and the volume of nuclear medicine will accelerate again by 2025.

In recent days, GRAND PHARMA (00512) has successively announced two major news. The company's global innovative ophthalmic drug GPN01768 [TP-03, Lotilanadrops 0.25%] for the treatment of demodex blepharitis has officially obtained the drug registration certificate issued by the National Medical Products Administration, and no supplementary information notice was received during the drug review process, achieving "zero supplementary information" approval for listing. GPN01768 is the first drug approved by the FDA in the United States, the first in the world, and currently the only drug specifically used for the treatment of demodex blepharitis globally. Its entry into the domestic market this time fills the treatment gap for demodex blepharitis in China and will bring a new treatment option for over 50 million patients in China. It is worth noting that since its launch in the United States in 2023, the sales revenue of this product has achieved explosive growth. In 2024, it achieved sales of approximately 180 million US dollars in the United States, and in 2025, it achieved sales of approximately 450 million US dollars, representing a significant year-on-year increase of over 150%. It is expected that the peak sales value of this product will exceed 2 billion US dollars, and the product is expected to become another best-selling blockbuster for GRAND PHARMA. In addition, the company has also released its 2025 annual performance forecast. The company's full-year revenue is expected to be between approximately 12 billion Hong Kong dollars to 12.5 billion Hong Kong dollars, representing a year-on-year growth of approximately 3% to 7%. The proportion of revenue from innovative barrier products has achieved a historic breakthrough, rising to approximately 50% for the first time; among them, the core products in the nuclear medicine anti-tumor diagnosis and treatment sector continue to increase sales volume, maintaining rapid revenue growth year on year. After excluding the impact of the fair value changes of Telix investments on the company's profits, the adjusted operating net profit attributable to shareholders of the company for 2025 is expected to be between approximately 1.4 billion Hong Kong dollars to 1.45 billion Hong Kong dollars, and the phased impact of centralized procurement on GRAND PHARMA has been fully cleared. Overseas markets validate clinical value, annual sales in the US reach 4.5 billion, with over 150% growth, aiming for a peak of 20 billion US dollars It is reported that GPN01768 was approved by the FDA for listing in the United States in July 2023, becoming the world's first and only drug approved to treat demodex blepharitis, which not only increased people's awareness of demodex blepharitis but also promoted doctors to conduct more comprehensive screenings. The product has gained continuous recognition among doctors and patients in the United States since its launch in July 2023, achieving explosive sales growth. It achieved sales of approximately 180 million US dollars in the US in 2024 and approximately 450 million US dollars in 2025, representing a year-on-year increase of over 150%, making it one of the fastest-growing products in the prescription eyedrop market. The management of the product developer Tarsus has recently raised the estimated peak sales of the product from over 1 billion US dollars to over 2 billion US dollars in the next few years, hoping to become another best-selling blockbuster. Analysts point out that based on this expectation, the company's earnings per share (EPS) are expected to increase to nearly $20, corresponding to a stock price of over $300, indicating a huge potential increase of nearly 350% from its current price of around $67 per share. With the approval of this product in the domestic market, it is expected to replicate the growth trajectory in the US market and become another strong engine driving revenue growth for GRAND PHARMA, providing a new treatment option for demodex blepharitis patients in China. Global first-in-class targeted drug for demodex blepharitis, filling the domestic treatment gap covering over 50 million domestic patients Demodex blepharitis is a chronic inflammatory disease caused by demodex mite infection of the eyelid margins, accounting for more than two-thirds of all cases of blepharitis, characterized by itching of the eyelids, sensation of foreign body in the eye, dry eye, redness of the eyelids, scales, and sleeve-like secretions at the base of the eyelashes, which can lead to complications of conjunctivitis and keratitis in severe cases. It is reported that demodex mite infection is very common and highly contagious, and the incidence rate increases with age. Research data shows that the global prevalence of demodex mite infection is approximately 60%, reaching 100% in the population aged 70 and above. Specifically, in the United States, about 25 million patients are deeply troubled by demodex blepharitis, and the global number of demodex blepharitis patients has exceeded 400 million, projected to exceed 500 million patients by 2029. The scale of patients in China has been steadily over 50 million, with a pressing clinical need and a vast market size. For a long time, the treatment options for demodex blepharitis in China have been very limited. Due to the lack of specific drugs, doctors often use physical cleaning, topical anti-inflammatory drugs, or artificial tears for symptomatic treatment, which not only cannot completely eliminate the mites but also have issues such as slow onset, easy recurrence, and eye surface irritation. The introduction of GPN01768 has changed the situation where there were no drugs available for demodex blepharitis. According to the announcement, GPN01768 is a selective non-competitive antagonist of the -aminobutyric acid-gated chloride ion channel (GABA-Cl) in insects and arachnids, which can selectively inhibit the GABA-Cl in demodex mites, causing paralysis and death of the mites, thus treating demodex blepharitis. In addition, GPN01768 has high lipophilicity, promoting its absorption in the sebaceous glands of eyelashes where mites reside. Clinical data shows that TP-03's eradication rate of demodex mites in patients with demodex blepharitis has statistical significance (p <0.001), with high safety and good tolerability, significant clinical efficacy, and very promising market potential in the future. Deepening technological innovation to solidify competitiveness, maintaining high-quality development with strong resilience In the blue ocean market of eye drugs, GRAND PHARMA has made forward-looking layouts. The company focuses on innovation in ophthalmic drugs, adheres to a path of specialized development, continuously enhances its industry position and market competitiveness. Currently, GRAND PHARMA has established an innovative product system with "specialized, full range, and multi-variety" of drugs, through a combination of cooperation and independent research and development strategies, has reserved a range of global innovative products for the treatment of "dry eye syndrome," "demodex blepharitis," "postoperative ocular anti-inflammatory analgesia," "pinguecula," and "myopia," building a differentiated competitive advantage and achieving significant research and development progress. It is worth mentioning that, including innovative eye drugs, GRAND PHARMA has been practicing the development strategy of synergistic innovation in multiple core business sectors of the company, continuously enriching the pipeline of innovative products, and advancing the product development process. In 2025, the proportion of revenue from innovative barrier products has achieved a historic breakthrough, rising to approximately 50%, marking a milestone achievement in the transformation and upgrading of the product structure. Thanks to the company's deep cultivation of technological innovation, GRAND PHARMA has rapidly absorbed the impact of centralized procurement during the year, demonstrating strong resilience in core business quality, continuous increase in sales volume of core products in the nuclear medicine anti-tumor diagnosis and treatment sector, and maintaining rapid revenue growth year on year, fully affirming the forward-looking strategic layout of GRAND PHARMA and building a solid core support and strong momentum for long-term high-quality development. In 2026, GRAND PHARMA's various business sectors may "blossom in many places," with multiple blockbuster innovative products expected to be successively launched and commercially expanded, continuously consolidating the company's global innovative layout. Among them, the global first-in-class innovative product for dry eye syndrome treatment tartaric acid vanillin nasal spray, the compound nasal spray Lertling for allergic rhinitis treatment, the adrenaline nasal spray Optimspeed for type I allergic reactions, as well as the approved Lotilanadrops eyedrops, and other innovative products are expected to increase in sales volume, helping the company open up a new golden track and seize a vast blue ocean market to inject strong and lasting core growth momentum for its long-term high-quality development. In terms of research and development innovation and internationalization layout, GRAND PHARMA is expected to achieve multiple significant milestones in 2026, continuously reflecting its global innovative research and development capabilities and global clinical advancement strength. The company's blockbuster global innovative drug for sepsis, STC3141, is currently actively communicating with international authoritative regulatory agencies such as the FDA to optimize clinical programs and fully promote the pre-preparatory work for international multicenter Phase III clinical trials, with possible breakthrough treatment options for nearly 50 million sepsis patients worldwide in the future; the radiolabeled drug TLX591-CDx for prostate cancer diagnosis is expected to be officially approved for listing in 2026; the US Phase I/II clinical study of the company's independently developed global innovative FAP target radiolabeled drug GPN01530 for solid tumor diagnosis is expected to start comprehensively during the year; and the global innovative GPC-3 target hepatocellular carcinoma diagnostic product GPN02006 is expected to submit a clinical trial application (IND) to the FDA within the year. The global innovation research and development layout is steadily landing. The approval of GPN01768 in the domestic market with "zero supplementary information" is expected to help GRAND PHARMA directly enter the underserved market of over 50 million patients, replicating the high-speed growth trajectory overseas. From sales breaking 4.5 billion US dollars in the US within two years of launch, with over 150% growth, to the peak sales value expected to be raised to 20 billion US dollars, GPN01768 has validated its commercial value as a blockbuster eye care product through actual performance. Analysts point out that with the successive increase in sales of this product and other global innovative eye drugs for dry eye syndrome, myopia prevention, etc., GRAND PHARMA is accelerating its entry into the period of innovation harvest, and its ophthalmology sector is expected to become one of the most explosive growth poles for the company in the next few years, becoming another strong engine for the development of the "Go Global" strategy.