Celltrion (068270.KS) Chairman Suh Jung-jin disclosed that the company is currently developing a fourth-generation obesity treatment and plans to enter Phase 1 clinical trials next year.
After completing key agenda votes at Celltrion's 35th annual general meeting held at Songdo Convensia on the day, Suh told shareholders during a Q&A session, "What I'm interested in right now is obesity treatment, and the obesity drug we are developing is a fourth-generation product." He added, "We will begin regulatory animal studies in May, and results will come out within the year."
"If the animal study results are positive, we will begin Phase 1 clinical trials next year," Suh said. "In fact, we don't have just one obesity drug candidate — we have three fourth-generation products. This will be the first attempt with the first of those three compounds." He particularly noted, "The most important thing in obesity treatment is efficacy — the key point is how uniformly the weight comes off." Suh continued, "The fourth-generation obesity drug we are developing shows minimal muscle loss while delivering consistent efficacy. I believe we are ahead among fourth-generation contenders." He added, "The advantage of obesity treatments is that it's easy to recruit patients. Clinical trials will proceed at speed."
Suh also introduced Celltrion's major pipeline. The company is pursuing a two-track approach of novel drugs and biosimilar development. It has 23 novel drug candidates, including nine antibody-drug conjugates (ADCs), five multispecific antibodies, one fusion protein, one peptide, and three microbiome-based therapies.
"For novel drugs, four are already in Phase 1 clinical trials," Suh said. "Data from these will start coming out from the first quarter of next year." For biosimilars, 11 products are currently commercialized, and a liquid formulation of the cancer treatment Herzuma will be launched next year. "Two more biosimilar products will be launched in 2028, and the number will grow to 18 by 2030 and 41 by 2038," Suh explained.
He also addressed factory expansions for in-house production and the contract development and manufacturing organization (CDMO) business.
Celltrion announced on the day production facility expansions for stable manufacturing and supply of next-generation biosimilars and novel drugs under development, as well as for expanding its global contract manufacturing organization (CMO) business. The company will invest 1.2265 trillion won ($905 million) to simultaneously build Plants 4 and 5 with a combined capacity of 180,000 liters at its Songdo campus in Incheon, and has decided to expand its Branchburg, New Jersey production facility from the originally planned 66,000 liters to 75,000 liters.
Once domestic and overseas expansions are completed, Celltrion's drug substance (DS) production capacity will expand significantly from the current 316,000 liters to 571,000 liters.
"As disclosed today, we have already placed the design order for breaking ground on the Songdo Plants 4 and 5," Suh stressed. "Of the expanded 571,000 liters, approximately 80% will be used for our own products and 20% for CDMO." He added, "This will make us third in the world in terms of facilities, after Samsung Biologics and Lonza."