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.

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 toxicity of the compou

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

阅读全文

Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

阅读全文

Shanghai Medicilon Inc.

搜索此博客