兴齐眼药低浓度阿托品滴眼液获批新规格

Core Viewpoint - The announcement highlights the approval of a new low-concentration atropine eye drop by the National Medical Products Administration, which is expected to uniquely position the company in the market for myopia treatment in children aged 6-12 [1] Group 1: Product Approval - The company received approval for supplementary applications of atropine sulfate eye drops in two new concentrations: 0.02% and 0.04% [1] - The approval numbers are H20258301 and H20258302, with a validity period until March 2029 [1] Group 2: Market Position - This product is the first of its kind in China aimed at delaying the progression of myopia in children with a spherical equivalent of -1.00D to -4.00D [1] - Phase III clinical trials demonstrated that both concentrations significantly delayed myopia progression compared to a placebo, with good safety profiles [1] - Currently, there are no competing products with the same concentrations available in the domestic or international markets, indicating a potential monopoly in this niche [1]