Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced encouraging results from two Phase III clinical studies for its innovative drug candidate, albenatide (CJC-1134-PC). This Category 1 drug is a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), modified with Drug Affinity Complex (DAC) technology based on exenatide.
CSCJC DM301 Study: Efficacy and Safety in Metformin-Treated Patients
The multi-center, randomized, double-blind, placebo-controlled CSCJC DM301 study evaluated the weekly administration of albenatide in type 2 diabetes patients with inadequate blood sugar control after metformin or metformin combined with insulin secretagogues. After 24 weeks, the experimental group showed superior HbA1c reduction compared to the placebo group, establishing the efficacy of CJC-1134-PC injection in improving and maintaining target HbA1c levels with a good safety profile.
CSCJC DM302 Study: Efficacy and Safety in Previously Untreated Patients
The CSCJC DM302 study, another multi-center, randomized, double-blind, placebo-controlled Phase III trial, assessed the weekly administration of albenatide in previously untreated type 2 diabetes patients with poor blood sugar control. The 24-week trial demonstrated a significant decrease in HbA1c levels for the experimental group compared to the placebo, indicating the drug’s superiority. Albenatide also increased fasting insulin levels, improved HbA1c target rates, and maintained these levels with a good safety and tolerability profile, consistent with other GLP-1 receptor agonists.-Fineline Info & Tech
