Celltrion's Global Biotechnology Research Center. [Celltrion]
Celltrion's Global Biotechnology Research Center. [Celltrion]

Celltrion is moving to translate its biosimilar expertise — built on antibody technology and global clinical, production and regulatory capabilities — into tangible results across its next-generation obesity drug and antibody-drug conjugate (ADC) pipeline.

The company said Wednesday it held an internal R&D briefing at which it outlined plans to release preclinical data on its next-generation obesity drug candidate before year-end and to publish initial clinical results from its oncology ADC candidates in Phase 1 trials sequentially from the first half of next year. The strategy is to carry the lessons of its biosimilar success into the new-drug arena and expand the company's medium- to long-term growth engine.

The pipeline closest to delivering visible results is CT-G32, a quad-action obesity drug candidate that Celltrion says would be the world's first to act simultaneously on four targets. The company is conducting GLP toxicology studies — involving 252 rats and 48 monkeys — to establish the appropriate dosage and confirm safety. It expects to complete the studies before year-end and present the findings at an academic conference in November. Celltrion aims to submit an investigational new drug (IND) application for a Phase 1 trial by February next year and begin dosing the first patient within the second quarter.

In earlier separate preclinical studies, CT-G32 demonstrated superior weight-loss efficacy and lean body mass (LBM) preservation compared with triple-action candidates under development by global pharmaceutical companies. Celltrion is also developing a multi-action oral obesity drug, targeting IND submission in the second half of 2028, and plans to maximize its lifecycle management strategy through long-acting formulations with extended dosing intervals and treatments for metabolic conditions such as sarcopenia and diabetes.

Patient dosing is also progressing smoothly across the oncology pipeline. All four candidates in Phase 1 trials — three ADCs (CT-P70, CT-P71 and CT-P73) and one multi-specific antibody (CT-P72) — have begun patient dosing. Two of the ADC candidates are on track to complete Part 1 of their Phase 1 trials before year-end, with top-line results to follow sequentially from the first half of next year. CT-P70, the most advanced candidate targeting non-small cell lung cancer and colorectal cancer, is set to enter Part 2 dose-optimization trials in March next year.

The shift from a pure biosimilar generics company to a high-value new-drug developer marks a strategic inflection point, as Celltrion looks to leverage its stable cash generation to stake out early positions in the high-complexity ADC and metabolic disease markets and earn a revaluation of its long-term enterprise worth.

By indication, CT-P70 targets non-small cell lung cancer and colorectal cancer; CT-P71 targets urothelial cancer, breast cancer and prostate cancer; CT-P73 targets cervical cancer and head and neck cancer; and CT-P72 targets gastric cancer and breast cancer — all tumor types with significant unmet medical need. Celltrion is actively pursuing FDA fast track designation: CT-P70 and CT-P71 have already received it, and the company plans to apply for the same designation for its two remaining candidates before year-end.

Through in-house R&D and open innovation, Celltrion is developing a total of 25 new drug candidates. It plans to expand its clinical pipeline to five candidates by year-end, eight by next year, and more than triple the current year-end count by 2028. Having invested 482.4 billion won ($329 million) in R&D last year alone, the company has built a virtuous cycle of reinvesting biosimilar revenue into drug development, while broadening partnerships with AI deep tech and microbiome firms.

"We are channeling the antibody technology and global clinical, production, regulatory and commercial capabilities built through our biosimilar business into new drug development," a Celltrion official said. "We will generate development results early and make the leap to becoming a global new-drug company."


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