Zhitong Finance App News, Yuanda Pharmaceutical (00512) announced that the Group's partner in ophthalmology, Taixin Pharmaceutical Co., Ltd. announced that its new drug marketing application (NDA) for GPN00833 (APP13007), a hormone nano-suspension eye drop used for anti-inflammatory pain relief after ophthalmology surgery, was recently officially approved by the US Food and Drug Administration (FDA). The Group has exclusive rights to develop and commercialize this product in mainland China, Hong Kong, and Macau, China. Major overseas developments of this product will further support the registration process in China.

GPN00833 is an anti-inflammatory analgesic hormone nano-suspension eye drop. Its main active ingredient, clobetasol propionate, is a potent glucocorticoid with efficient local anti-inflammatory activity and strong capillary-constrictive effects. At the same time, its unique nano-formulation process effectively addresses the low bioavailability and safety risks caused by low water solubility of hormone products. The product's overseas phase II clinical studies and two phase III clinical studies have successfully reached clinical endpoints. According to clinical results, GPN00833 has remarkable efficacy in treating anti-inflammatory and analgesic pain after ophthalmology surgery, and is safe. Currently, the product was approved for phase III clinical research in China in April 2023, and the first patient was enrolled in the drug group.

As one of the major comprehensive ophthalmic drug R&D, production and sales enterprises in China, the Group sells nearly 30 products, mainly focusing on mainstream indications such as dry eye syndrome, fundus hemorrhage, glaucoma, cataracts, anti-inflammatory, myopia, etc., covering chemical preparations, traditional Chinese medicine preparations and eye health products, including prescription drugs, OTC, devices, consumer goods, etc., to create a “popular eye care ecosystem” integrating “prevention+treatment+health care”. In terms of innovative research and development, we have prepared a number of innovative global products to treat “myopia,” “dry eye,” “pterygium,” and “anti-inflammatory pain after ophthalmology.” Among them, CBT-001, an innovative product for treating pterygium, was approved to conduct phase III clinical research in China in March 2023, and GPN00136 (BRM421), a small molecule polypeptide drug to treat dry eye, was approved for phase II clinical research in China in April 2023. GPN00884, an innovative drug used to slow the progression of myopia in children, went to the China National Drug Administration in December 2023 Applications for clinical trials of new drugs are submitted and accepted. In the future, the sector will adhere to the development strategy of “led by major innovative pharmaceutical devices and based on popular eye care ecosystem products”, continuously 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, with patient needs as the core and scientific and technological innovation as the driving force, increasing investment in global innovative products and advanced technology in response to unmet clinical needs, enriching and improving the product pipeline and industrial layout, adopting the “global operation layout, dual cycle management development” strategy to form a new pattern of domestic and international dual cycle linked development and mutual promotion, giving full play to the Group's industrial advantages and R&D capabilities to quickly launch scientific and technological innovative products on the market to provide more advanced treatment plans for patients around the world.