The company, which built its name replicating blockbuster biologics, is now betting that the antibody expertise and global clinical, manufacturing and regulatory muscle honed over years of biosimilar work can accelerate its push into higher-value original drugs.
First in line is CT-G32, a quadruple-action obesity candidate that Celltrion is advancing as a potential first-in-class therapy.
The drugmaker is running GLP toxicology tests in 252 rats and 48 monkeys to nail down safe dosing, with results due at an academic conference in November and an Investigational New Drug application slated for February 2027.
Should approval proceed smoothly, the first patients would be dosed in the second quarter of next year. Earlier preclinical work showed CT-G32 outperformed a rival triple-target agonist on weight loss while sparing lean muscle mass, the company said.
Celltrion is simultaneously advancing four ADC and multi-antibody candidates that have entered patient dosing, two of which will wrap up their Phase 1 part-one studies this year, with topline readouts to follow through the first half of 2027.
Two of the programs, CT-P70 and CT-P71, have already secured U.S. Food and Drug Administration fast-track status, targeting hard-to-treat cancers from non-small-cell lung to breast and prostate.
The company is developing about 25 novel candidates in all and expects its roster of clinical-stage programs to more than triple from this year's levels by 2028, funneling the steady cash thrown off by its biosimilar franchise into research.
"The unveiling of preclinical data for our next-generation obesity treatment late this year, followed by key clinical results for our cancer ADC candidates in the first half of next year, will mark a pivotal turning point where the market can gauge our drug-development capabilities and pipeline potential," said a Celltrion spokesperson.
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