According to the Zhitong Finance APP, Grandpharma (00512) recently announced that the group has completed Phase III clinical trials in China for the glucocorticoid nanosuspension eye drops GPN00833 used for post-operative ophthalmic anti-inflammatory and analgesic purposes, achieving the clinical endpoints successfully. This marks another significant milestone for the group in the otorhinolaryngology field and ophthalmic direction.

It is reported that GPN00833 is an anti-inflammatory and analgesic glucocorticoid nanosuspension eye drops, with its main active ingredient chlorobutanol acetate being a potent glucocorticoid with highly effective local anti-inflammatory activity and strong vasoconstrictor effects. Simultaneously, its unique nanosuspension process effectively addresses the low solubility of steroid products leading to low bioavailability and safety risks. This product was approved in April 2023 in China to conduct a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III clinical study, enrolling a total of 255 patients who underwent cataract surgery, assigned in a 2:1 ratio to the study drug group and placebo group, evaluating the effectiveness and safety of GPN00833 in treating postoperative inflammation and pain after cataract surgery in the Chinese population. The primary clinical endpoint of this study is the percentage of patients with zero anterior chamber cell count (no inflammation) between the 8th and 15th days after cataract surgery, with the secondary endpoint being the percentage of patients with zero eye pain grade between the 4th and 15th days after surgery.

The study results show that in terms of anti-inflammatory effects, the percentage of patients with zero anterior chamber cell count between the 8th and 15th days after surgery in the study drug group was significantly higher compared to the placebo group, at 31.8% and 20.0% respectively, demonstrating statistical significance and clinical relevance. For analgesic effects, the percentage of patients with zero eye pain grade between the 4th and 15th days after surgery was significantly higher in the study drug group compared to the placebo group, at 91.2% and 55.3% respectively, also showing statistical significance and clinical relevance. Additionally, the product demonstrated good safety, tolerability, and pharmacokinetic characteristics as expected. Overall analysis indicates that GPN00833 is significantly more effective than the placebo in treating postoperative inflammation and pain after cataract surgery, with good safety profile. In terms of international registrations, the product obtained approval from the United States Food and Drug Administration (FDA) in March 2024.

As one of the leading comprehensive enterprises in China's otolaryngology pharmaceutical research, production, and sales sector, the group ranks at the forefront in terms of the number of product pipelines. Their treatment areas cover ophthalmology, otolaryngology, dentistry, and other multi-departmental diseases, including chemical preparations, traditional Chinese medicine preparations, and health products encompassing prescription drugs, OTC, medical devices, consumer goods, and more. They have comprehensive channel coverage both inside and outside hospitals, creating an integrated 'large otorhinolaryngology ecosystem' that combines prevention, treatment, and healthcare. In terms of innovative research and development, they have reserved a range of globally innovative products for treating myopia, dry eye syndrome, pterygium, postoperative ophthalmic anti-inflammatory and analgesic solutions, demodex blepharitis, and meibomian gland dysfunction caused by demodex, among others. In the future, this sector will uphold a development strategy of integrating Chinese and Western medicine and integrating pharmaceuticals and medical devices, continuously strengthening industry influence and achieving new breakthroughs in business areas.

The group has always placed great importance on the research and development of innovative products and advanced technologies, focusing on patient needs and using technological innovation as a driver. They increase investment in global innovative products and advanced technologies to address unmet clinical needs, enrich and improve product pipelines and industrial layouts, adopt a 'globalized operational layout, dual-cycle business development' strategy, form a new pattern of domestic and international dual-cycle interconnection and mutual promotion, fully leverage the group's industrial advantages and R&D capabilities, rapidly bring technological innovation products to market, and provide more advanced and diverse treatment options for global patients.