ZHONGSHENGYAOYE has obtained the drug registration certificates for Cyclosporine Eye Drops (III) and Compound Tropicamide Eye Drops
I'm LongbridgeAI, I can summarize articles.ZHONGSHENGYAOYE recently obtained the drug registration certificates for Cyclosporine Eye Drops (III) and Compound Tropicamide Eye Drops approved by the National Medical Products Administration. Cyclosporine Eye Drops (III) are used for the treatment of severe spring allergic conjunctivitis in children and adolescents, demonstrating good efficacy and safety. Compound Tropicamide Eye Drops are used for fundus disease screening and myopia prevention, classified as Category B drugs under medical insurance, with clinical validation showing safety and effectiveness
According to the Zhitong Finance APP, ZHONGSHENGYAOYE (002317.SZ) announced that the company recently received the drug registration certificates for Cyclosporine Eye Drops (III) and Compound Tropicamide Eye Drops approved by the National Medical Products Administration.
It is reported that Cyclosporine Eye Drops (III) are clinically used for the treatment of severe spring allergic conjunctivitis in children and adolescents aged 4 and above. The indications approved globally for the same product include conjunctivitis and dry eye syndrome. This product is a cationic water-in-oil nanoemulsion, which, due to its cationic properties, can remain on the eye surface longer than non-cationic eye formulations. Foreign clinical research literature has reported that it shows good efficacy, tolerability, and safety in the treatment of conjunctivitis and dry eye syndrome. The company has developed the key pharmaceutical excipient Cetrimonium Bromide for this product to ensure the safety and quality of the product supply chain, and in accordance with the "Implementation Measures for the Early Resolution Mechanism of Drug Patent Disputes," has promoted the domestic first generic approval for Cyclosporine Eye Drops (III). At the same time, Cyclosporine Eye Drops (III) is the first generic eye nanoemulsion approved for marketing in China through clinical research exemption, and it is also the company's first complex eye formulation approved for marketing. In the future, the company will timely promote research on expanding the indications of the product to further broaden clinical medication scenarios.
Compound Tropicamide Eye Drops are clinically used for the purpose of diagnosis and treatment of mydriasis and accommodation paralysis. They are widely used in fundus disease screening, myopia screening, and the prevention and treatment of pseudomyopia in children and adolescents. They are recommended medications in the consensus of ciliary muscle paralysis optometry experts and the guidelines for the diagnosis and treatment of pseudomyopia, holding a high clinical status. Compound Tropicamide Eye Drops belong to Category B drugs under medical insurance, and their safety and efficacy have been widely validated in clinical practice