Medicilon Assists Huaota's CD73-targeting ADC approved for clinical use in US

Recently, Shanghai Huaota Biopharmaceutical Co., Ltd. (Huaota) received a notification from the US FDA, agreeing that the third-generation antibody drug conjugate (ADC) project HB0052 developed by the company targeting the CD73 antigen will enter clinical trials. This is the first antibody conjugate drug project approved by Huaota Biotech to enter clinical trials by the FDA.

As a partner of Huaota, Shanghai Medicilon Inc. (Medicilon) relied on its antibody drug conjugate R&D service platform and its professional technical capabilities and rich project experience to provide HB0052 with R&D of the drug metabolism and safety evaluation tests that complied with GLP standards to ensure high-quality and efficient advancement.

Medicilon Antibody Drug Conjugate R&D Service Platform

Pressing the "Accelerator Button" for ADC Drug Development

As one of the rare one-stop biopharmaceutical preclinical R&D service platforms in China, Medicilon has established an antibody drug conjugate (ADC) R&D service platform. Through continuous technological innovation, Medicilon could provide 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 its establishment, the Medicilon Antibody Drug Conjugate (ADC) R&D service platform has reached many years of continuous collaboration with a lot of clients such as Bio-Thera Solutions, DAC Biotech, and Xuanzhu Biopharmaceutical. As of May 2023, Medicilon has successfully helped 17 ADC drugs obtain clinical approval, and there are multiple ongoing ADC projects currently.

About Huaota

Huaota Biopharmaceutical is a new biological drug R&D enterprise focusing on independent development and focusing on the world. Focusing on the research and development of new biological drugs in the fields of tumors, autoimmune diseases, and fundus lesions, there are currently 11 projects in the clinical stage: including the first Chinese developed IL-36R monoclonal antibody for pustular psoriasis (rare disease) that is about to enter the critical phase II; the PD-L1/VEGF dual antibody has been in clinical phase II and has observed positive signals in endometrial cancer and renal cancer; and core projects such as the first CD73-ADC with dual killing effect targeting refractory tumors such as pancreatic cancer.

Huaota Biopharmaceutical is currently actively looking for domestic and foreign partners to jointly promote and develop, and looks forward to providing high-quality and high-level biopharmaceuticals to the global market to meet the needs of patients for biopharmaceuticals with high accessibility and affordability, and implement the vision of innovation to change the world!

About Medicilon

Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. By the end of June 2023, Medicilon has provided new drug R&D services to more than 2,000 clients around the world, and participated in the R&D of 385 new drug projects that have been approved for clinical trials. Medicilon is proud to contribute to human health in the globe.

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

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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

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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

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