Zhitong Financial APP News, Broad Pharmaceutical (00512) announced that the III phase clinical trial of GPN00833, the group's anti-inflammatory and analgesic hormone nano-suspension eye drops, has recently completed the first patient to be administered. This is a multicenter, randomized, double-blind, placebo-controlled, parallel-grouped phase III clinical study of 252 patients undergoing cataract surgery to evaluate the efficacy and safety of GPN00833 in the treatment of inflammation and pain after cataract surgery in Chinese population. It is another important research and development progress of the group in the field of ophthalmic disease treatment.

It is reported that GPN00833 is an anti-inflammatory and analgesic hormone nano-suspension eye drops, and its main active ingredient clobetasol propionate is a powerful glucocorticoid with high local anti-inflammatory activity and strong capillary contraction. At the same time, its unique nano-gel process effectively solves the risk of low bioavailability and safety caused by low water solubility of hormone products. The overseas phase II clinical studies and two phase III clinical studies have successfully reached the clinical end point. according to the clinical results GPN00833 has significant effectiveness and good safety in the treatment of anti-inflammation and analgesia after ophthalmic surgery. At present, the product has submitted a marketing license application (NDA) to the US Food and Drug Administration (Food and Drug Administration,FDA) in the first half of this year.

As one of the main ophthalmic drug R & D, production and sales enterprises in China, the group sells nearly 30 ophthalmic products, mainly focusing on mainstream indications such as xerophthalmia, fundus hemorrhage, glaucoma, cataract, anti-inflammation and myopia, covering chemical preparations, traditional Chinese medicine preparations and eye health products, the announcement said. Including prescription drugs, OTC, equipment, consumer goods and other categories to create a "public eye protection ecosystem" that integrates "prevention, treatment and health care". In terms of innovative research and development, a number of global innovative products for the treatment of "myopia", "dry eye", "pterygium" and "anti-inflammation and analgesia after ophthalmic surgery" have been stocked. CBT-001, an innovative product for pterygium, was approved to conduct phase III clinical research in China in March this year, and GPN00136 (BRM421), a small molecular peptide drug for xerophthalmia, was approved to conduct phase II clinical research in China in April this year. In the future, this sector will adhere to the development strategy of "leading by blockbuster innovative pharmaceutical equipment and based on Volkswagen eye protection biosphere products", constantly strengthen the influence of the industry and achieve new breakthroughs in the business field.

The group has always attached great importance to the research and development of innovative products and advanced technologies, taking patients' needs as the core, scientific and technological innovation as the driving force, and aiming at the unmet clinical needs, increasing investment in global innovative products and advanced technologies, enriching and improving product pipelines and industrial layout, and adopting the strategy of "global operation layout, dual-cycle operation and development", forming a new pattern of domestic and international double-cycle development and mutual promotion. Give full play to the group's industrial advantages and R & D strength, quickly put scientific and technological innovation products on the market, and provide more advanced and diverse treatment plans for patients around the world.