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Medicilon assists Shanghai Institute of Biological Products' innovative ADC drug obtain clinical approval

On February 19, SIBP-A17, the second class I innovative antibody drug conjugate (ADC) independently developed by China National Pharmaceutical Group's Shanghai Institute of Biological Products, received a clinical trial approval notice from the National Medical Products Administration (NMPA).  The SIBP-A17 is intended for clinical trials in patients with advanced malignant solid tumors. Shanghai Medicilon Inc. (Medicilon), as a partner of Shanghai Institute of Biological Products, provides preclinical research services such as pharmacokinetics and safety evaluation for the research and development of SIBP-A17.  This is another successful case of Medicilon helping the rapid implementation of research and development results in the ADC field. Medicilon Antibody Drug Conjugate R&D Service Platform One-Stop Service Promotes Efficient Drug Research and Development Honest innovation drives the Shanghai Institute of Biological Products to continuously upgrade its products, and al...

Medicilon Assists Xuanzhu Biopharmaceutical's KM501, a First Double-antibody ADC Drug that Completely Knocks Out Fucose, has been Approved for Clinical Trials

  Recently, Xuanzhu Biopharmaceutical (Xuanzhu) and its wholly-owned subsidiary Beijing Xuanzhu Bio, obtained clinical trial approval for the double-antibody ADC drug KM501 (No.: 2023LP00278).  This product is suitable for the treatment of advanced/metastatic solid tumors with positive/expression, amplification or mutation of HER2, including related advanced tumors with low expression of HER2.  The drug is the world's first double-antibody ADC drug that completely knocks out fucose, and is expected to become the "Best in Class" drug. Shanghai Medicilon Inc. (Medicilon), as a partner of Xuanzhu, provided KM501 with GLP-compliant preclinical research services based on the Medicilon Antibody Development Service Platform, including pharmacokinetic studies and  safety evaluation . This has won time for Xuanzhu to advance the KM501 into clinical research as fast as possible. Medicilon Antibody Drug Conjugate (ADC) R&D Service Platform The whole process facilitates the ...

ADCs – From Lab to Clinical Development

  Table of Contents Mechanism of Action of ADCs ADC Pharmacodynamic Evaluation ADC Pharmacokinetics Evaluation ADC Toxicokinetics and Safety evaluation Antibody-drug conjugates (ADCs)  are a family of targeted therapeutic agents for the treatment of cancer. Compared to traditional small-molecule approaches, ADCs offer enhanced targeting of cancer cells along with reduced toxic side effects, making them an attractive prospect for the field of oncology.  An antibody-drug conjugate (ADC) is typically composed of a monoclonal antibody (mAbs) covalently attached to a cytotoxic drug via a chemical linker. As all these components affect the ADC performance in equal measure, their optimisation is essential for the development of successful conjugates. Download the brochure:  Medicilon’s one-stop ADC R&D services platform It has taken a while for this field to take off, but to date, over 100 ADCs are under clinical development. Since December 2021, after several decades o...