The Phase III clinical trial of GPN00833, a hormone nano-suspension eye drops developed by Yuanda Pharmaceuticals for anti-inflammatory and analgesic purposes, has successfully enrolled its first patient for treatment.

According to the news from the Zhongtong Finance APP, Yuanda Pharmaceutical (00512) announced that the Phase III clinical trial of GPN00833, a nano-suspension eye drop for anti-inflammatory and analgesic purposes, has recently completed the first patient dosing. This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III clinical trial, which plans to enroll 252 patients undergoing cataract surgery to evaluate the efficacy and safety of GPN00833 in treating inflammation and pain after cataract surgery in the Chinese population. This is another important research and development progress for the group in the field of ophthalmic disease treatment.

It is reported that GPN00833 is a nano-suspension eye drop of anti-inflammatory and analgesic hormones. Its main active ingredient, chlorobutanol propionate, is a potent glucocorticoid with highly effective local anti-inflammatory activity and strong capillary constriction. At the same time, its unique nano-formulation process effectively solves the low water solubility of hormone products, which leads to low bioavailability and safety risks. This product has successfully achieved clinical endpoints in overseas Phase II clinical trials and two Phase III clinical trials. According to clinical results, GPN00833 has shown significant effectiveness in treating postoperative inflammation and analgesia in ophthalmology, and it has good safety. Currently, the product has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of this year.

The announcement stated that as one of China's major comprehensive enterprises in ophthalmic drug research and development, production, and sales, the group has nearly 30 ophthalmic products on the market, mainly focusing on mainstream indications such as dry eye, retinal hemorrhage, glaucoma, cataract, anti-inflammatory, and myopia-related conditions. It covers chemical formulations, traditional Chinese medicine formulations, and eye health products, including prescription drugs, over-the-counter drugs, devices, and consumer goods, creating a "prevention + treatment + health care" integrated "public eye care ecosystem." In terms of innovative research and development, the group has reserved multiple globally innovative products for the treatment of "myopia," "dry eye," "pterygium," and "postoperative anti-inflammatory and analgesic" conditions. Among them, the innovative product CBT-001 for the treatment of pterygium was approved to conduct Phase III clinical trials in China in March this year, and the small molecule peptide drug GPN00136 (BRM421) for the treatment of dry eye was approved to conduct Phase II clinical trials in China in April this year. In the future, this sector will adhere to the development strategy of "being led by heavyweight innovative drugs and devices, based on the public eye care ecosystem products," continuously strengthen industry influence, and achieve new breakthroughs in business areas.

The group has always attached great importance to the research and development of innovative products and advanced technologies, with patient needs as the core and technological innovation as the driving force. In response to unmet clinical needs, it has increased investment in global innovative products and advanced technologies, enriched and improved product pipelines and industrial layouts, and adopted a strategy of "global operation layout and dual-cycle business development" to form a new pattern of domestic and international dual-cycle linkage development and mutual promotion. It fully leverages the group's industrial advantages and research and development capabilities, quickly brings technological innovation products to market, and provides more advanced and diverse treatment options for patients worldwide.