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

Custom Synthesis

Medicilon has synthesized over 10,000 individual compounds from gram to kilogram quantities, and many compounds are synthesized with more than ten synthetic steps. The overall synthesis success rate is over 95%. High quality products from mg to kg scale Reagents, intermediates, building blocks, and scaffolds Preparation of API or reference standards Development of synthetic routes for impurities and metabolites   On-site analytical support Product delivered with COA Medicilon offers integrated drug discovery services -- Chemistry, Biology & Preclinical Services
发表评论
阅读全文

In Vitro Enzyme Activity Assay

  Kinases play extensive and important roles in signal transduction and co-ordination of complex functions. Currently, about 300 kinase inhibitors have been approved for marketing, among which receptor tyrosine kinase (RTK) inhibitors are the main ones. Medicilon provides high-quality kinase profile screening and has one-stop kinase research services from assay development, high-throughput screening to selectivity analysis. In addition, Medicilon provides many other enzyme activity screens. Wide Variety Provides 200+  in vitro  enzymatic detection methods; 100+ kinases, including CTK, RTK, AGC, CMGC and other kinase families as well as important common mutations Project Flexibility Various types of plates for screening, such as 96 and 384; Multiple flexible kinase profiles, including TK kinase family, CDK kinase family, etc., to meet different customer customization needs. Various Methods Fluorescence detection; Chemiluminescence detection; Absorbance detection LanthaScr...
发表评论
阅读全文

Pharmacokinetics Services

Pharmacokinetics Services Our pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, ranging from small molecules to large molecules, such as protein and antibody. The animal species involved in our services are non-human primate, canine, mice, rat, rabbit and hamster. Meanwhile, non-human primate experimental platform and isotope platform for protein/antibody are certified by the Shanghai government. Preclinical Pharmacokinetics Method development and validation (GLP,Non-GLP) Bioanalysis Pharmacokinetics (Tumor bearing rodents, Bioavailability, Crossover studies, Cassette (N in 1) dosing and analysis, effects of gender on pharmacokinetics, BBB penetration ) Stability in vehicles and plasma Drug interaction studies In vitro metabolic stability CYP 450 inhibition Plasma protein binding studies Distribution studies Excretion studies Prediction an...
发表评论
阅读全文