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Progress and challenges in clinical research of new drugs for osteoarthritis
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Ri-ge-leng SE, Jie ZHANG, Yuan-hong LI, Tian ZHAO, Jian HOU, Qiu-mei DENG, Xing AI*
Chinese Journal of New Drugs | 2026, 35(19) : 2067 - 2071
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Chinese Journal of New Drugs | 2026, 35(19): 2067-2071
Progress and challenges in clinical research of new drugs for osteoarthritis
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Ri-ge-leng SE, Jie ZHANG, Yuan-hong LI, Tian ZHAO, Jian HOU, Qiu-mei DENG, Xing AI*
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2026-10-15 doi: 10.20251/j.cnki.1003-3734.2026.19.007
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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.

osteoarthritis  /  new drug research and development  /  clinical trial design  /  efficacy evaluation  /  safety monitoring
色日格楞, 张杰, 李远红, 赵田, 侯健, 邓秋梅, 艾星. 骨关节炎新药临床研究进展与挑战. 中国新药杂志, 2026 , 35 (19) : 2067 -2071 . DOI: 10.20251/j.cnki.1003-3734.2026.19.007
Ri-ge-leng SE, Jie ZHANG, Yuan-hong LI, Tian ZHAO, Jian HOU, Qiu-mei DENG, Xing AI. Progress and challenges in clinical research of new drugs for osteoarthritis[J]. Chinese Journal of New Drugs, 2026 , 35 (19) : 2067 -2071 . DOI: 10.20251/j.cnki.1003-3734.2026.19.007
Year 2026 volume 35 Issue 19
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doi: 10.20251/j.cnki.1003-3734.2026.19.007
  • Receive Date:2026-03-06
  • Online Date:2026-10-29
  • Published:2026-10-15
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  • Received:2026-03-06
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
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表12种不同金属材料的力学参数
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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