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sdm Insights
Authored by the SDM Bioanalysis Team, this article delves into the principles, delivery systems and advantages of mRNA technology, provides a comprehensive overview of its applications and clinical breakthroughs in three major fields—infectious disease prevention, cancer therapy and protein replacement therapy—and elaborates on the key bioanalytical methodologies.
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Premier Li Qiang has signed a State Council decree, promulgating the "Regulations on the Administration of Clinical Research and Translation of Novel Biomedical Technologies." This important regulation was adopted at the State Council executive meeting on September 12, 2025, and will take effect on May 1, 2026. This establishes a comprehensive legal framework for China's oversight of novel biomedical technologies throughout the entire chain from research to application.
SDM Bioservices has successfully established a hybrid immuno-capture LC-MS/MS platform for the simultaneous quantification of ADC total antibody, conjugated antibody, conjugated drug, and free small-molecule payload. This approach significantly reduces reliance on specific antibody reagents, enables rapid method development and validation, and supports high-throughput sample analysis—thereby accelerating project timelines and advancing drug development efforts.
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July 23, 2025 GSK disclosed that the FDA has postponed PDUFA date of the Blenrep® (belantamab mafodotin) combination therapy BLA. The agency established a new action date of October 23, 2025 for completion of BLA review.
this article outlines essential documentation preparation and strategic considerations for conducting pre-IND communication meetings with CDE, ensuring effective regulatory alignment and adequate guidance.
