Medicilon Supports Strategic Partner CGeneTech in Achieving Approval for Next-Generation DPP-4 Inhibitor

CGeneTech Biopharmaceutical Technology (Suzhou) Co., Ltd. (“CGeneTech”) recently marked a significant milestone with the approval of its innovative Class 1 drug, saxagliptin phosphate tablets, for marketing in China.

As a strategic partner, Medicilon provided comprehensive preclinical research services that complied with GLP standards, encompassing pharmacodynamics, pharmacokinetics, safety evaluations, and biomarker bioanalysis in Phase I clinical trials. Medicilon’s reliable research system—demonstrating high consistency between preclinical and clinical data—ensured a seamless path to regulatory approval for saxagliptin phosphate.

Saxagliptin Phosphate: A Best-in-Class, High-Selectivity DPP-4 Inhibitor

Developed by CGeneTech, saxagliptin phosphate is a cutting-edge DPP-4 inhibitor designed to improve glycemic control in adults with type 2 diabetes. As part of China’s 12th and 13th Five-Year Major New Drug Creation Programs, this drug secured a regulatory breakthrough by being exempted from Phase II clinical trials. That decision followed exceptional results from head-to-head Phase I trials, which showed superior efficacy compared to leading market competitors.

Phase III clinical trials, led by Professor Ji Linong, further confirmed saxagliptin phosphate’s outstanding performance. Both as monotherapy and in combination with metformin, it significantly lowered blood glucose levels, especially in patients with higher baseline glucose readings. Its strong safety profile was also validated, with adverse events in high-dose groups comparable to those of placebo—thus addressing key safety concerns associated with existing treatments.

This approval underscores CGeneTech’s leadership in diabetes drug innovation and highlights Medicilon’s pivotal role in accelerating the development of groundbreaking therapies.

Medicilon: Advancing Endocrine and Metabolic Research

Medicilon draws on extensive expertise in metabolic disease research, providing advanced animal models for conditions such as obesity, diabetes, hyperuricemia, fatty liver, NASH, and liver fibrosis. These robust models are critical to drug development, offering essential insights into disease mechanisms and therapeutic outcomes.

In addition, Medicilon offers a full spectrum of services for GLP-1 therapies, from discovery research to safety evaluations. By April 2024, Medicilon had successfully supported eight GLP-1 drug projects in achieving clinical trial approvals.

Medicilon congratulates CGeneTech on this breakthrough in diabetes treatment and looks forward to further innovative therapies that benefit global health. Upholding its “Innovation-Driven, Quality First” philosophy, Medicilon will continue to expand its research capabilities and platforms, providing high-quality, efficient preclinical R&D services to the global pharmaceutical community.

About CGeneTech

CGeneTech Biopharmaceutical Technology (Suzhou) Co., Ltd., established in 2010 in Suzhou Industrial Park, is a commercial-stage biotech company specializing in the development and commercialization of innovative small-molecule drugs. With decades of global experience covering the entire drug lifecycle, CGeneTech focuses on high-quality, differentiated products in areas such as diabetes, oncology, and autoimmune diseases. Its integrated drug development platform and diversified pipeline underscore the company’s commitment to delivering impactful therapies.

About Medicilon

Founded in 2004, Medicilon (Stock Code: 688202.SH) provides comprehensive preclinical drug research services for pharmaceutical companies and institutions worldwide. With more than 2,000 clients and 490 IND-approved drugs, Medicilon accelerates drug development through efficient project management and innovative solutions.