According to the Zhitong Finance APP, GRANDPHARMA (00512) announced that its globally innovative ophthalmic drug GPN01768 (TP-03, Loteprednol Etabonate Eye Drops, 0.25%) for the treatment of Demodex blepharitis has recently been approved for marketing by the Macao Special Administrative Region Government's Drug Regulatory Authority (Macao Drug Regulatory Authority). This marks another significant advancement for the group in the field of innovative ophthalmic treatments. The approval from the Macao Drug Regulatory Authority lays the foundation for future approvals in the Guangdong-Hong Kong-Macao Greater Bay Area and is expected to further facilitate its implementation in mainland China.
Demodex mites are the underlying cause of Demodex blepharitis. GPN01768 is a selective non-competitive antagonist of the γ-aminobutyric acid-gated chloride channel (GABA-Cl) in insects and arachnids, which paralyzes and kills the mites by selectively inhibiting GABA-Cl within the mites, thereby treating Demodex blepharitis. Additionally, GPN01768 has high lipophilicity, which promotes its absorption in the lipid of the eyelash follicle where the mites reside. GPN01768 was developed by Tarsus Pharmaceuticals Inc. (Tarsus) and is the first and only product approved by the U.S. Food and Drug Administration (FDA) for the treatment of Demodex blepharitis. GPN01768 generated approximately USD 180 million in revenue in the U.S. in 2024, with about 163,000 bottles sold; in the first quarter of 2025, it achieved approximately USD 78.3 million in revenue, an 18% increase compared to the fourth quarter of 2024. In March 2024, the group reached a strategic cooperation agreement with Tarsus for product introduction, obtaining exclusive development, production, and commercialization rights for the ophthalmic formulation GPN01768 for the treatment of Demodex blepharitis and meibomian gland dysfunction caused by Demodex in the Greater China region (mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, Taiwan). Previously, GPN01768 submitted a new drug application to the National Medical Products Administration of the People's Republic of China in December 2024 and received acceptance.
Blepharitis is a common ophthalmic disease. Demodex blepharitis is a chronic inflammatory reactive disease caused by Demodex infection of the eyelid margins, accounting for more than two-thirds of all blepharitis cases, primarily affecting the skin of the eyelid margins, eyelash follicles, glands, and meibomian glands, with typical clinical manifestations including itching of the eyelids, foreign body sensation in the eyes, dryness, congestion of the eyelid margins, scales, and sleeve-like secretions at the base of the eyelashes. In severe cases, it can lead to complications of the conjunctiva and cornea. Currently, there are over 40 million patients with Demodex blepharitis in China, and no drugs targeting Demodex blepharitis have been marketed, creating an urgent clinical need for a fast-acting and safe effective treatment drug that directly addresses the cause, which GPN01768 is expected to fill.
Moreover, Demodex mites are also one of the risk factors for meibomian gland dysfunction. Patients with meibomian gland dysfunction caused by Demodex often experience inflammation of the eyelid margins and blurred vision, which may lead to meibomian gland blockage and/or reduced secretion of meibomian lipids. If not treated promptly, it may result in permanent changes to the tear film and progressive loss of gland function
According to statistics, there are currently over 70 million patients with meibomian gland dysfunction in China. The Phase II clinical study of GPN01768 in the United States for the treatment of meibomian gland dysfunction caused by Demodex mites has also shown positive topline results.
The group has always regarded the ophthalmology field as one of its important strategic development directions, continuously focusing on innovation in ophthalmic drugs, adhering to a specialized development path, and constantly enhancing its industry position and market competitiveness. Currently, the group has established an innovative drug product system that is &#34;specialized, full-range, and multi-variety,&#34; and has reserved multiple globally innovative products for the treatment of &#34;myopia,&#34; &#34;dry eye,&#34; &#34;pterygium,&#34; &#34;post-operative anti-inflammatory analgesia,&#34; &#34;Demodex blepharitis,&#34; and &#34;meibomian gland dysfunction caused by Demodex mites,&#34; achieving significant progress in research and development, with multiple innovative products expected to be approved for market launch in the next three years.
Among them, the tartrate formulation of varenicline nasal spray (OC-01) for the treatment of dry eye is currently the world's first and only preservative-free, multi-dose, sterile packaging nasal spray approved for the treatment of mild, moderate, and severe dry eye. This product was approved for market launch in the United States in October 2021 and received approval from the drug regulatory authority for market launch in November 2024. It has already been sold in the Guangdong-Hong Kong-Macao Greater Bay Area and will soon be launched in mainland China; the hormone nano-suspension eye drops GPN00833 for anti-inflammatory analgesia will complete domestic Phase III clinical research and reach clinical endpoints in November 2024; the innovative modified new drug GPN00153 (CBT-001) for the treatment of pterygium will complete the first patient enrollment and administration in China's Phase III clinical research in March 2024, with all patient enrollment and administration expected to be completed by June this year; the globally innovative ophthalmic drug GPN00884 for delaying the progression of myopia in children will complete the first patient enrollment and administration in China's Phase I clinical research in June 2024. In the future, the group will accelerate the comprehensive and differentiated layout of its R&amp;D pipeline, continuously enriching the reserve of innovative products in the ophthalmic subdivision. In addition, the group has attracted and cultivated a group of professionals with both clinical and marketing experience in the ophthalmology field, establishing a customer-centered, academically-led specialized marketing team, and has formed long-term stable cooperation with large pharmaceutical distribution companies and chain pharmacies, creating a nationwide marketing network. With the continuous approval of innovative ophthalmic products, the group will fully leverage its core advantages in this field, continue to delve into the forefront of ophthalmic innovation tracks, further strengthen the specialized promotion and brand building of core products, and provide new momentum for the group's sustained healthy development.
The group has always placed great importance on the R&amp;D of innovative products and advanced technologies, focusing on patient needs, driven by technological innovation, increasing investment in global innovative products and advanced technologies to address unmet clinical needs, enriching and improving its product pipeline and industrial layout, adopting a strategy of &#34;global operational layout and dual circulation business development,&#34; forming a new pattern of domestic and international dual circulation development that promotes and interacts with each other, fully leveraging the group's industrial advantages and R&amp;D strength, and rapidly bringing technological innovation products to market to provide more advanced and diverse treatment options for patients worldwide

00512

GRANDPHARMA announced that its global innovative ophthalmic drug GPN01768 (TP-03, Loteprednol Etabonate Eye Drops, 0.25%) has been approved for marketing by the Macao SAR Health Bureau. This development lays the foundation for future promotion in the Guangdong-Hong Kong-Macao Greater Bay Area and is expected to facilitate its listing in mainland China. GPN01768 is the first product approved by the FDA for the treatment of Demodex blepharitis, with significant revenue expected in the United States in 2024 and the first quarter of 2025

Grandpharma's globally innovative treatment for Demodex blepharitis has been approved for market launch by the Macao SAR Health Bureau