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As a new class of therapeutic drugs, Live Biotherapeutic Products (LBPs) are significantly different from traditional small molecule drugs. LBPs contain live microorganisms, such as bacteria and yeast, which are used to prevent, treat or relieve disease symptoms. Its main mechanism of action is to regulate the composition and function of the human microbial community, so as to play a therapeutic effect. In the context of an aging global population and rising patient demand for personalized medicine, living biologics have become an emerging force in the global pharmaceutical industry with their outstanding safety and potential to treat complex diseases.

Different from traditional drugs, which only act on a single target or a few targets, living biological drugs regulate the physiological state of the human body as a whole by means of multi-target synergistic mechanism, or by regulating the composition and function of the human microbial community. This regulatory process involves multiple physiological systems and signaling pathways, allowing it to respond more comprehensively to complex diseases. In addition, traditional drugs are gradually excreted after metabolism in the body, while the microorganisms in living biological drugs can colonize specific parts of the human body for a long time and continue to play a role. These microorganisms can also dynamically adjust according to the physiological state and environmental changes of the human body, and better meet the treatment needs of individuals in different disease stages and life states.

Microorganisms in living biological drugs will produce various metabolites and signal molecules after colonization in human body, activate the physiological regulation mechanism of human body, and achieve endogenous physiological function regulation. This adjustment method is closer to the natural physiological process of the human body, and can bring more lasting and stable treatment effects. Moreover, living biological drugs are usually composed of natural microorganisms, compared with a large number of chemical synthetic components in traditional drugs, their metabolic processes and products in the human body are more easily accepted by the human body, effectively reducing the potential toxic risk caused by chemical accumulation or metabolism.

With the rapid development of artificial intelligence technology, AI is playing an increasingly important role in the field of living biological drug research and development. With the help of multi-omics big data such as genomics, transcriptomics, and proteomics, AI can mine new targets for living biological drugs related to diseases. Through machine learning algorithms, AI can conduct in-depth analysis of the biological characteristics and functional data of a large number of microbial strains, quickly screen out strains with specific therapeutic potential and excellent characteristics, and provide strong support for the development of new drugs for living biological drugs. In addition, based on the individual data of patients, including genetic information, microbial community data, clinical symptoms, etc., AI can establish a predictive model to predict the therapeutic effect of living biological drugs in different subtypes of patients, providing biomarker reference basis for clinical protocol enrollment, thereby improving the success rate of treatment.

Influenced by many factors such as technological progress, clinical demand, policy support and huge market potential, living biologic drugs have become the development trend of the global medical industry. Governments around the world have introduced relevant policies to support the development of the biopharmaceutical industry and regard it as an important area to promote economic growth and enhance national competitiveness. At present, the scale of the living biologic drug market continues to expand, and it is estimated that the global living biologic drug market will maintain a double-digit growth rate in the next decade. The influx of a large amount of capital and the active participation of enterprises have further promoted the rapid development of this industry.