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GK01 is a preclinical-stage live biotherapeutic product (LBP) being developed by Zhiyi Pharmaceutics (Guangzhou Zhiyi Biological Technology). It is classified as a Class 1 biological product in China, a category reserved for innovative biologics that have not been previously marketed. The drug is currently part of a co-development program, although the specific development partner and the primary therapeutic indication have not been publicly disclosed. As an LBP, GK01 likely utilizes a specific microbial strain or consortium designed to exert therapeutic effects by modulating the host's microbiome or immune system.
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