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瞄准百亿干眼症药物市场 ST未名创新药III期临床试验将全面启动
Core Viewpoint - The domestic first eye drop formulation containing recombinant human nerve growth factor, SMR001, is advancing towards market launch, with recent approval for its Phase III clinical trial aimed at treating moderate to severe dry eye disease [1][2]. Group 1: Product Development - ST Unimed's subsidiary, Shandong Yandu Biotechnology Co., has developed SMR001 eye drops, which are the first in China to use recombinant human nerve growth factor as an active ingredient [1][2]. - The product aims to repair damaged corneal nerves and promote epithelial regeneration, potentially offering a new treatment option for moderate to severe dry eye disease [1][2]. Group 2: Market Potential - The prevalence of dry eye disease globally ranges from 5% to 50%, with China reporting a rate of approximately 21% to 30%, indicating a significant public health issue [1]. - The incidence of dry eye among the 18-35 age group in China has reached 63%, a 400% increase over the past decade, driving growth in the pharmaceutical market [2]. - The Chinese ophthalmic drug market is projected to reach 44 billion yuan by 2025 and 108.4 billion yuan by 2030, with the dry eye drug segment expected to grow to 4.79 billion yuan in 2024, reflecting a compound annual growth rate of 16.17% from 2020 to 2024 [2]. Group 3: Clinical Trial Progress - SMR001 eye drops received a clinical trial notification on May 25, 2020, completed Phase I trials by February 26, 2022, and has shown effectiveness in treating moderate to severe dry eye disease in Phase II trials [3]. - The recent approval for the Phase III clinical trial marks a significant step in validating the efficacy and safety of SMR001 for patients with moderate to severe dry eye disease [3].