Medicilon Assists Zhigen Pharmaceutical's new antidepressant drug ZG-001 to get approval for clinical trials

Recently, the Class 1 innovative drug ZG-001 developed by Shanghai Zhigen Pharmaceutical Technology Co., Ltd. (Zhigen Pharmaceutical) has received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration (NMPA). ZG-001 is intended for the treatment of depressive disorders in adults, including major depressive disorder associated with suicidal ideation or behavior (MDSI) or treatment-resistant depression (TRD) or major depressive disorder (MDD).

Shanghai Medicilon Inc. (Medicilon), as a partner of Zhigen Pharmaceutical, provided ZG-001 with one-stop R&D services such as pharmaceutical research (including raw materials and preparations), preclinical research (including pharmacokinetics, safety evaluation), and IND filing application, which successfully obtained the clinical approval and accelerated the R&D process.

One-stop preclinical R&D service platform
Medicilon empowers new drug R&D to be faster and cheaper

For new drug research and development, speed and quality are key factors that determine success or failure, and they are also industry challenges that have attracted much attention. Medicilon's "One-stop biopharmaceutical preclinical R&D service platform" can shorten the R&D cycle and improve the quality of new drug R&D.

Having been deeply involved in the field of preclinical R&D for nearly 20 years, Medicilon continues to innovate R&D technology and expand upstream and downstream service areas of the industrial chain based on the needs of new drug R&D. Medicilon has successfully created a comprehensive and integrated pre-clinical CRO service model, which can not only seamlessly connect traditional R&D links in series, but also integrate into a parallel R&D model. Relying on the service advantages of rigorous planning, efficient collaboration, and orderly advancement, Medicilon can empower the R&D of new drugs faster, better, and more cost-effective.

Medicilon congratulates Zhigen Pharmaceutical on its clinical approval of ZG-001 and looks forward to ZG-001 achieving positive results in clinical trials and bringing about revolutionary changes in clinical drug selection for depression as soon as possible. Medicilon's one-stop biopharmaceutical R&D service platform will continue to innovate and iterate to improve and accelerate global drug R&D.

About Zhigen Pharmaceutical
Zhigen Pharmaceutical is a company mainly engaged in the research and development of new drugs, committed to the research and development of innovative small molecule drugs, focusing on unmet clinical needs in severe mental illness, autoimmune diseases, tumors and other fields, as well as develop First in Class or Best in Class chemical innovative drugs. Zhigen Pharmaceutical's main innovative drugs under development have obvious advantages in terms of efficacy, metabolism and safety.

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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