Celltrion (068270.KS) has begun primate toxicity testing of its next-generation obesity drug candidate, accelerating preparations to enter global clinical trials. The strategy is to expand its new drug portfolio into areas such as obesity treatments and antibody-drug conjugates (ADCs), moving beyond a business structure centered on biosimilars to strengthen mid- to long-term growth drivers.
Celltrion announced on the 29th that it has started primate toxicity testing of its obesity drug candidate "CT-G32." The company is conducting final-stage preclinical development with the goal of submitting an Investigational New Drug (IND) application in the first half of next year. The test will evaluate safety, toxicity profile, pharmacokinetics (PK), and pharmacodynamics (PD) characteristics in 252 rats and 48 monkeys. It is a critical step to confirm appropriate dosage and safety before entering clinical trials.
CT-G32 is an obesity treatment that simultaneously acts on four targets, including glucagon-like peptide-1 (GLP-1). Celltrion is developing the candidate as a "first-in-class" new drug. The goal is to enhance weight loss effects while addressing limitations of existing GLP-1-based treatments, such as variability in weight loss across patients, muscle loss, and treatment adherence issues. In a separate preclinical trial conducted earlier, the candidate demonstrated superior weight loss effects at the same dose compared with a comparator drug currently in development, along with the potential to preserve lean mass including muscle.
Celltrion plans to develop CT-G32 not merely as a weight loss treatment but as a metabolic disease platform drug that regulates fat, muscle, and energy metabolism. The company is also reviewing plans to expand its indications beyond obesity to include diabetes and metabolic dysfunction-associated steatohepatitis (MASH). To this end, Celltrion has established a joint development framework with Japan's SCOHIA PHARMA, with Celltrion taking the lead on preclinical, clinical, and global commercialization activities.
The company is also developing an oral obesity treatment in parallel. Celltrion plans to develop a multi-action-based oral treatment alongside the quadruple-action injectable to secure a product lineup covering each treatment stage. The oral candidate is undergoing research to improve stability and bioavailability, with the goal of submitting an IND in the second half of 2028.
"CT-G32 is being developed as a next-generation new drug that complements the limitations of existing GLP-1-based treatments and covers metabolic diseases beyond obesity," a Celltrion official said. "Based on the global development and production capabilities secured through our biosimilar business, we will continue to expand our new drug pipeline in areas such as obesity and ADCs."
