跳至主要内容

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 preclinical development of ADC drugs

As a one-stop pharmaceutical preclinical R&D service platform CRO, Medicilon has continuously iterated new drug R&D technologies for 19 years.  In the field of ADC drug research and development, Medicilon provides clients with one-stop preclinical research services such as ADC Payloads synthesis, ADC drug conjugation, ADC pharmacodynamics evaluation, ADC pharmacokinetics evaluation and ADC safety evaluation.

Since the establishment of Medicilon Antibody Drug Conjugate (ADC) R&D Service Platform, Medicilon has accumulated many well-known world wide pharmaceutical companies and scientific research institutions, successfully assisted in the clinical approval of ADC projects of innovative pharmaceutical companies such as Bio-Thera and DAC Biotech, and won the continuous trust and praise of clients and long-term collaboration.  Medicilon successfully assisted Xuanzhu’s KM501 in clinical approval, which provided valuable experience for the Medicilon Antibody Drug Conjugate (ADC) R&D Service Platform to assist in the preclinical research and development of more new generation ADC drugs.

Medicilon congratulates Xuanzhu’s KM501 on the clinical approval, and looks forward to the smooth clinical progress of the drug, providing a competitive new choice for patients with solid tumors.  The era of new drugs is moving forward.  Medicilon's latest technology platform will continue to help global clients develop new drugs through high-tech, high-efficiency, high-quality, and cost-effective R&D services.

标签：

评论

发表评论

此博客中的热门博文

What is preclinical testing?

In the process of  preclinical testing  of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a  preclinical research  phase followed, before which, as described above, the potential tox...
发表评论
阅读全文

Inventory of the three major in vitro pharmacokinetic research methods

  The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d...
发表评论
阅读全文

Enzyme Activity Assay Service

  Enzymatic assay Lance Assay Alphascreen Assay Z’-LYTE Assay Adapta Assay Kinase-Glo Assay ADP-Glo Assay Ligand Binding Assay ELISA Assay HTRF Assay Enzyme activity assays  are laboratory methods for measuring enzymatic activity. They are vital for the study of enzyme kinetics and enzyme inhibition. Enzyme units : Amounts of enzymes can either be expressed as molar amounts, as with any other chemical, or measured in terms of activity, in enzyme units. Medicilon provides various  enzyme activity assays  for  kinases , phosphatases, proteinases, deacetylase, peptidase, esterase, and other enzymes. Our line of well-characterized immunoassays and biochemical kits ensures accurate and reproducible results. Enzyme is a  large category of bio-molecules  that catalyze various biological processes including metabolic processes, cellular signaling and regulation, cell division and apoptosis. Enzymatic reactions convert substrate molecules into chemically modifi...
发表评论
阅读全文