ArticleTherapeutic innovation & regulatory science2026
Patent Analysis Perspectives on China's Orphan Drug R&D: Status and Technology Characteristics.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundRare diseases present urgent public health challenges requiring coordinated global efforts. This study analyzes China's orphan drug innovation landscape through patent applications (1995-2023) to identify R&D patterns and policy implications.
methodsWe analyzed 323 Patent Cooperation Treaty applications from Chinese entities using IPC classification and bipartite network modeling. Data from World Intellectual Property Organization were retrieved via PatSnap, with diseases mapped to China's Rare Disease Catalogues (207 conditions). Network metrics quantified disease-technology linkages.
resultsThree key findings emerged: (1) Patent filings surged 58.2% (188 patents) during 2018-2023, coinciding with China's regulatory reforms; (2) Innovation concentrated in oncology/neurology (34.3% patents cover 2 diseases), with 66.2% of catalogued diseases lacking patents; (3) Dominant technologies are small molecules and genetic therapies. Network analysis revealed an R&D ecosystem without a single dominant entity, alongside robust collaborative ties between Chinese and U.S. organizations.
conclusionsChina's orphan drug innovation is expanding rapidly but remains uneven, concentrated in specific diseases and technological platforms. Policy interventions are needed to address therapeutic neglect through tiered incentives, dedicated funding for neglected diseases, and global partnerships to accelerate equitable treatment access.
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