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2025-10-10

Premier Li Qiang Signs State Council Decree, Promulgating the "Regulations on the Administration of Clinical Research and Translation of Novel Biomedical Technologies" | Officials from the Ministry of Justice and National Health Commission Meet the Press

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.

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2025-08-29

Unlocking the Code to Precise Quantification of ADC Therapeutics: A Comprehensive Analysis of Cutting-Edge Technologies

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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2025-07-24

ODAC Votes Against GSK's ADC Belantamab Mafodotin Combination Therapies

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.

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2025-05-08

SDM Sharing | Pre-IND Meeting Preparation Guidelines (China)

this article outlines essential documentation preparation and strategic considerations for conducting pre-IND communication meetings with CDE, ensuring effective regulatory alignment and adequate guidance.

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2025-04-03

VIF 2025 REVIEW | Dr. Yuwen on Global Vaccine Registration Strategy and Key Considerations

Global Vaccine Solutions via Multidimensional Strategies.

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