跳至主要内容

Medicilon helps Sungening Biological's first innovative drug SG1001 oral tablet obtain IND approval in China

Recently, Sungening Biological's (Sungening) first innovative drug SG1001 successfully obtained the implicit clinical trial approval from the National Medical Products Administration (Acceptance Number: CXHL2400203).  The approved indication is invasive fungal disease (IFD), and clinical trials are about to begin.  This milestone progress not only marks Sungening’s official entry into the ranks of clinical-stage innovative drug companies, but also promotes China’s drug innovation process in the field of antifungal infections.



Shanghai Medicilon Inc. (Medicilon), as a partner of Sungening Biological, relies on its technical strength and rich experience in the field of biopharmaceutical preclinical research and development to provide pharmacokinetics and GLP safety evaluation research services for the research and development of SG1001, and fully ensures its efficient and high-quality research and development.

The success of every R&D collaboration is the accumulation and improvement of Medicilon's professional knowledge and skills, and it also lays a solid foundation for Medicilon to provide more efficient services in the future.  Sungening's SG1001 has obtained clinical trial approval, which is undoubtedly another affirmation of the professional strength and excellent service of Medicilon's preclinical research service platform, and also adds another important success story to the platform.

Currently, Medicilon's preclinical research service platform has a laboratory of 29,000 square meters, has obtained the NMPA GLP laboratory certification qualification, and has established a research operation process and quality system that complies with international standards.  Medicilon complies with the GLP laboratory standards of the US FDA, Australian TGA, and EU EMA; the animal experimental facilities have passed the International Laboratory Animal Assessment and Accreditation (AAALAC) and the non-human primates, dogs, mice, rabbits, guinea pigs, mini pigs and other experimental animals can be raised at the same time.  Complete and professional facilities provide Medicilon with strong support for pharmacological efficacy, pharmacokinetic research and safety evaluation services, ensuring the accuracy and reliability of experimental results.

About Sungening Biological

Founded in 2021, Sungening Biological is an innovative drug company focusing on innovative antifungal infection drugs and oral cyclic peptides. Sungening Biological also has a complete independently developed drug pipeline and mature commercialization capabilities.  With the vision of "focusing on the research and development of new drugs to solve clinical needs and protecting human health", Sungening Biological strives to develop innovative drugs that can fulfill clinical needs.

标签：
地点: 美国

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