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AbstractOsteoarthritis (OA), a highly prevalent degenerative joint disease, is characterized by chronic pain and loss of mobility, which significantly affects the quality of life of middle-aged and elderly people. Current treatments methods mainly focus on symptom relief, and there is a lack of innovative drugs that can delay disease progression. To address these unmet clinical needs, the Center for Drug Evaluation of the National Medical Products Administration issued the “Guidance for Clinical Research and Development of New Drugs for Osteoarthritis” on August 14, 2025. The guidance aims to standardize clinical study design, optimize the efficacy evaluation system, and promote exploration of targeted therapy and precision medicine. This article systematically interprets the core content of this guidance, with a focus on key issues in exploratory and confirmatory clinical studies, and also discusses challenges in drug development for osteoarthritis and future directions for clinical research, aiming to provide a scientific reference for new drug development in this field.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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