Grand Pharmaceutical Group Limited (Grand Pharma) announced that the National Medical Products Administration (NMPA) has granted a Drug Registration Certificate for GPN01768 [TP-03, lotilaner ophthalmic solution 0.25 %], the first product approved in China for the treatment of Demodex blepharitis. The application was cleared with a “zero supplementation request,” indicating no additional data were required during review.
In March 2024 Grand Pharma secured the exclusive development, manufacturing and commercialization rights for TP-03 in Mainland China, Hong Kong, Macao and Taiwan through a strategic cooperation agreement with the drug’s developer, Tarsus Pharmaceuticals. The product was first approved by the U.S. Food and Drug Administration in July 2023 and generated USD180.00 million and USD450.00 million in U.S. sales in 2024 and 2025, respectively. Macao authorities authorized the therapy in May 2025.
Demodex blepharitis accounts for more than two-thirds of all blepharitis cases in China, affecting over 40 million patients, yet no approved pharmacological treatment was previously available. TP-03 selectively inhibits gamma-aminobutyric-acid-gated chloride channels in Demodex mites, leading to paralysis and death of the parasite, and its lipophilic profile facilitates penetration into eyelash follicles.
The NMPA approval reinforces Grand Pharma’s ophthalmology strategy, which combines in-house R&D with product licensing. The pipeline includes: • GPN00833, a hormone nanosuspension eye drop that met its Phase III primary endpoint in November 2024; • GPN00153 (CBT-001) for pterygium, which completed global Phase III enrollment in June 2025; • GPN00884, a pediatric myopia therapy now in Phase IIa in China.
Beyond ophthalmology, 2026 milestones are expected for several late-stage assets, including the sepsis candidate STC3141, radionuclide-drug conjugate TLX591-CDx for prostate-cancer diagnosis, and multiple radiopharmaceutical programs targeting solid tumors and hepatocellular carcinoma.
Management cautioned that production, sales and profit contributions from TP-03 and other pipeline assets remain subject to market dynamics and other uncertainties, and advised shareholders and prospective investors to exercise caution when dealing in the company’s securities.