GRAND PHARMA(00512): The global innovative product TP-03 for the treatment of demodex blepharitis has been approved for market in China.

GRAND PHARMA (00512) announced that the group has obtained the drug registration certificate issued by the China National Medical Products Administration for the global innovative ophthalmic drug GPN01768 "TP-03 (loteprednol eye drops) 0.25%" used to treat demodex blepharitis. The drug was approved without the need for additional information during the drug evaluation process. In March 2024, the group entered into a strategic cooperation agreement with Tarsus Pharmaceuticals, Inc. (developer of TP-03) to obtain exclusive development, production, and commercialization rights in the Greater China region (Mainland China, Hong Kong, Macao, and Taiwan). The approval of this product for marketing is another important development for the group in the ophthalmology sector in the field of eye medicine. Demodex is the root cause of demodex blepharitis, and GPN01768 is a selective non-competitive antagonist of the -aminobutyric acid-gated chloride ion channel (GABA-Cl) within insects and arachnids. By selectively inhibiting the GABA-Cl within the demodex, GPN01768 paralyzes and kills the mites, thereby treating demodex blepharitis. Additionally, GPN01768 has high lipophilicity, which promotes its absorption in the sebaceous glands of the mites eyelash follicles. GPN01768 received FDA approval for marketing in the United States in July 2023, becoming the world's first and only product approved for the treatment of demodex blepharitis. According to Tarsus Pharmaceuticals' publicly disclosed financial performance, the product generated approximately 180 million US dollars in revenue in the US in 2024, and about 450 million US dollars in revenue in 2025. Previously, GPN01768 was approved for marketing in Macao in May 2025. The approval by the Chinese Medical Products Administration is a critical step for the product to achieve comprehensive commercialization in the Greater China region. The group will actively promote the registration application of this product in Hong Kong and Taiwan. Demodex blepharitis is a chronic inflammatory reactive disease caused by demodex invading the eyelid margins, accounting for more than two-thirds of all cases of blepharitis, mainly affecting the eyelid skin, eyelash follicles, glands, and eyelid glands. The Chinese Expert Consensus on Diagnosis and Treatment of Demodex Blepharitis in China (2018) issued by the Chinese Medical Association indicates that demodex blepharitis presents with typical clinical symptoms such as itching of the eyelids, foreign body sensation in the eyes, dry eyes, hyperemic eyelid margins, scales, and sleeve-like secretions at the base of the eyelashes, and can cause complications of conjunctiva and cornea in severe cases. There are currently more than 40 million demodex blepharitis patients in China, and there were no drugs approved for demodex blepharitis prior to this, making it in urgent need of a safe and effective treatment medication that can act quickly and directly on the cause. As the only product approved for marketing, GPN01768 is expected to fill this clinical gap in China. The group has always considered the ophthalmology sector as one of its important strategic development directions, focusing on ophthalmic drug innovation, adhering to a professional development path, continuously enhancing its industry status and market competitiveness. Currently, the group has established an innovative drug product system that is "specialized, full range, and multi-variety." Through a combination of cooperation in introduction and independent research and development strategies, the group has reserved a number of global innovative products for the treatment of "pole-eye syndrome," "demodex blepharitis," "postoperative anti-inflammatory and analgesic treatments for ophthalmology," "pinguecula," and "myopia," building a differentiated competitive advantage and achieving significant research and development progress. The steroid nanosuspension eye drops GPN00833 for anti-inflammatory and analgesic treatments completed Phase III clinical trials in China in November 2024 and successfully met its clinical endpoints; the innovative improved novel drug GPN00153 (CBT-001) for treating pinguecula completed a global multicenter Phase III clinical trial with all participants enrolled in June 2025; the global innovative ophthalmic drug GPN00884 for delaying the progression of childhood myopia had its first patient enrolled in a Phase IIa clinical trial in China in October 2025. The group adheres to a strategy of coordinated innovation and development in multiple business sectors such as ophthalmology, continuously advancing the development process of innovative products. In 2026, several major innovative products are expected to be marketed and commercialized successively, with multiple sectors working together and the product portfolio continuously improving, consolidating the group's global innovation layout. These include the globally innovative dry eye treatment product tartaric acid varenicline nasal spray, the compound nasal spray Lertalin for treating allergic rhinitis, the adrenaline nasal spray Uminsu for treating type I allergic reactions, and the approved loteprednol eye drops, among other innovative products. These products will further solidify the group's pipeline layout in key areas, addressing clinical gaps and unmet treatment needs, driving the group to open up new golden markets and seize broad blue ocean incremental markets, injecting strong and lasting core growth momentum into long-term high-quality development. In terms of research and development innovation and international layout, the group is expected to achieve several landmark milestones in 2026, continuously demonstrating its global innovative research and development capabilities and global clinical promotion strength. The core groundbreaking global innovative drug for sepsis, STC3141, has made remarkable progress in its research and development, successfully reaching the preset Phase II clinical study endpoints in China in 2025. It is currently actively engaged in optimizing clinical protocols with international authorities such as the FDA, advancing the preparatory work for a comprehensive international multicenter Phase III clinical trial, and is expected to provide a breakthrough treatment for approximately 50 million sepsis patients globally in the future. The radiolabeled isotopes drug TLX591-CDx developed by the group for prostate cancer diagnosis has submitted a New Drug Application (NDA) and is expected to be formally approved for marketing in 2026. In addition, the global innovative FAP-targeted radiolabeled drug GPN01530 developed independently by the group, designed for solid tumor diagnosis, is expected to conduct a comprehensive Phase I/II clinical study in the United States this year; the global innovative GPC-3-targeted liver cell carcinoma diagnosis product GPN02006 is expected to submit a clinical trial application (IND) to the FDA this year, with steady progress in global innovative research and development. With breakthrough frontier technologies, a global collaborative clinical system, and a rich pipeline of nuclear medicine innovation, the group's nuclear medicine sector has established a global leading research and development technological barrier and core competitive advantage, leading the innovative development wave in the field of nuclear medicine diagnosis and treatment, laying a solid foundation for the group's long-term development.