Recently, the important partner of Shanghai Medicilon (hereinafter referred to as “Medicine”) developed the treatment of type 2 diabetes by Cgenetech.The drug Shengtagliptin phosphate tablets has been formally approved by the National Center for Drug Evaluation, exempted from Phase II clinical trials and directly entered Phase III trials.
Shengtagliptin Phosphate Tablets is a new type of DPP-4 inhibitor with high activity and safety. It was successfully shortlisted in the national “Twelfth Five-Year Plan” and “Thirteenth Five-Year Plan” major in 2012 and 2018. Special project for new drug creation. The data from the large-scale clinical phase I trial completed this year show that: Compared with the positive control drug sitagliptin, Shengshitaike’s Shengtagliptin phosphate has a promising curative effect in type 2 diabetes and is safe and reliable.
Medicilon has provided great support for the preclinical to clinical studies of Shengtagliptin Phosphate Tablets. In order to successfully carry out the pharmacokinetics, safety evaluation and phase I clinical bioanalysis of Shengtagliptin Phosphate Tablets, the colleagues of Medicilon overcame difficulties, worked continuously, and actively took effective measures to solve the problems encountered in each stage. All kinds of difficult problems have contributed to the high-quality and efficient completion of the project and ensured the timely submission of clinical phase I study data.
Medicilon has rich experience in drug safety evaluation, pre-clinical and clinical bioanalysis services, and has established a drug safety evaluation system that meets the GLP standards of regulatory agencies such as CFDA, FDA and OECD, which can provide domestic and foreign customers with rapid, With high-quality drug preclinical safety evaluation services and high-quality bioanalytical data that comply with GLP/GCP/GCLP normative requirements, Medicilon helps customers shorten test cycles and reduce new drug research and development costs through cost control and efficient services. Since 2015, the company has participated in the completion of more than 60 new drug and generic drug projects that have been approved by China’s CFDA/NMPA, US FDA, and Australian TGA to enter Phase I clinical trials.
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Email: marketing@medicilon.com
Our Preclinical Pharmacokinetics Department has a number of professionals with rich theoretical knowledge and experimental experience for experiment design, experiment implementation, bioanalysis and data analysis. Our Pharmacokinetics Lab has passed the GLP certification by NMPA. Following the guiding principles of ICH, NMPA and FDA. The lab offers in vivo and in vitro pharmacokinetic tests according to the needs of our clients and provide them with complete sets of pharmacokinetic evaluation and optimization services. Our acclaimed quality data collection and efficient experiment can meet our clients’ needs from early drug discovery to new drug filing.
Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.
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