数智化驱动下辽宁生物医药政策与产业发展研究OA

Objective To evaluate the alignment between policies and industrial development in Liaoning Province over recent years,and to provide a quantitative reference for optimizing regional industrial policies.Methods Policy documents issued by five departments in Liaoning province—the Medical Products Administration,Health Commission,People's Government,Department of Industry and Information Technology,and Department of Science and Technology from January 2021 to April 2025 were collected.After preprocessing,policy topics were extracted using an improved Latent Dirichlet Allocation(LDA)model based on Term Frequency-Inverse Document Frequency(TF-IDF).The number of latent topics was determined using perplexity,consistency curve,and the results of pyLDAvis visualization.Topic evolution over time was analyzed through topic heat trends.Meanwhile,multi-source data from Yaozh.com,the National Medical Products Administration(NMPA),and other sources were used to examine the current state of Liaoning's biomedical industry across five dimensions:industrial clustering,product portfolio,knowledge output,technology validation,and capital investment.Results Four policy topics were identified:″ Microbiology and Biomedical Regulation″(Topic 1,55.21%),″ Traditional Chinese Medicine(TCM)Inheritance and Services″(Topic 2,18.60%),″ Digital and Intelligent Driven″(Topic 3,16.88%),and ″Drug Approval and Industrial Synergy″(Topic 4,9.31%).Topic 1 accounted for nearly 100%of policy focus in 2021,then gradually declined thereafter,and tended towards normalized development.Topic 2 exhibited intermittent attention characteristics.Topics 3 and 4 showed significantly increased attention from 2023.Regarding industrial development,three key characteristics emerged:insufficient market vitality(newly registered enterprises decreased from 162 in 2021 to 24 in 2024,with a survival rate of 93.98%),product structure imbalance(new drug output accounted for only 4.24%of the national total,and medical device registrations accounted for only 0.73%of the national total),and weak innovation momentum(decrease rate of patent count was 56.16%,innovative drug registrations accounted for 1.06%of the national total,and investment and financing accounted for 0.03%of the national total).Conclusion Liaoning's biomedical policies have formed four main topics centered on regulatory compliance,TCM inheritance,digital and intelligent transformation,and approval-coordinated synergy,following a progressive evolution path of ″safety-system-technology″.Structural mismatches exist between policies and industrial development,including insufficient linkage between accelerated approval and industrialization,failure of digitalization to effectively generate original technologies,lagging TCM standardization,and uneven regional and capital allocation.Recommendations include strengthening integrated support for approval and industry,enhancing technology transfer efficiency through digitalization,advancing TCM standardization and innovation transformation,and optimizing regional coordination and capital allocation mechanisms to promote the transition from a ″regulation-heavy″ to an ″innovation-driven″ industry.