Four oncology pipelines, including antibody-drug conjugates (ADCs), advancing through clinical development
Company aims to more than triple its clinical-stage novel drug pipeline by 2028
Celltrion is accelerating its transformation from a biosimilar-focused company into a global innovator in novel therapeutics, with key milestones expected for its obesity and oncology drug pipelines over the next year. As several lead candidates move into advanced stages of development, the company is positioning novel medicines as a new long-term growth engine alongside its established biosimilar business.
Celltrion announced on July 29 that it plans to unveil preclinical results for its next-generation obesity drug candidate later this year, while releasing initial clinical data for several antibody-drug conjugate (ADC) candidates beginning in the first half of next year.
The company's most advanced obesity program is CT-G32, a quadruple-action obesity drug candidate designed to simultaneously target four biological pathways.
Celltrion is currently conducting Good Laboratory Practice (GLP) toxicology studies to establish the optimal dosing regimen and safety profile of CT-G32. The company plans to complete the studies by the end of this year and present the findings at a scientific conference in November. Based on those results, Celltrion intends to submit an Investigational New Drug (IND) application by February next year and begin dosing the first patient in Phase 1 clinical trials during the second quarter, subject to regulatory approval.
According to the company, earlier preclinical studies showed that CT-G32 demonstrated greater weight-loss efficacy and superior preservation of lean body mass compared with triple-agonist obesity therapies currently being developed by global pharmaceutical companies.
In parallel, Celltrion is developing an oral multi-action obesity therapy, with an IND submission targeted for the second half of 2028. The company is also expanding its metabolic disease portfolio to include long-acting obesity therapies as well as treatments for sarcopenia and diabetes, reflecting a broader life-cycle management strategy.
Celltrion is also making steady progress in oncology.
Four clinical-stage candidates—including three ADCs (CT-P70, CT-P71, and CT-P73) and one multispecific antibody (CT-P72)—have all entered patient dosing in Phase 1 clinical trials.
Among them, CT-P70 and CT-P71 are expected to complete Part 1 of their Phase 1 studies by the end of this year, with topline data scheduled for release during the first half of next year. CT-P70 is expected to enter Part 2, focusing on dose optimization, as early as March next year.
The candidates target cancers with significant unmet medical needs, including non-small cell lung cancer, colorectal cancer, urothelial carcinoma, breast cancer, prostate cancer, cervical cancer, head and neck cancer, and gastric cancer.
CT-P70 and CT-P71 have already received Fast Track designation from the U.S. Food and Drug Administration (FDA), allowing closer regulatory interaction and the potential for accelerated development. Celltrion plans to seek Fast Track designation for additional candidates while utilizing expedited regulatory pathways in multiple markets to shorten development timelines.
Beyond its lead assets, Celltrion is steadily expanding its overall research pipeline.
The company is currently developing 25 novel drug candidates through a combination of in-house research and open innovation partnerships. Five candidates are expected to be in clinical development by the end of this year, increasing to eight next year. By 2028, Celltrion expects the number of clinical-stage programs to be more than three times higher than at the end of 2026.
The company's R&D strategy focuses on oncology, obesity and metabolic disorders, and autoimmune diseases. In addition to internal research, Celltrion is collaborating with AI-driven biotechnology companies, microbiome specialists, and antibody discovery firms to broaden its technology platform and accelerate candidate discovery.
Celltrion invested approximately KRW 482.4 billion in research and development last year and plans to continue increasing investment using the stable cash flow generated by its biosimilar business. The company aims to strengthen the value of its novel drug portfolio through continued clinical development and pipeline expansion.
Industry observers note that Celltrion's greatest advantage lies in the integrated capabilities it has built through its biosimilar business. Unlike many emerging biotechnology companies, Celltrion possesses end-to-end expertise spanning antibody discovery, clinical development, regulatory approval, large-scale manufacturing, and global commercialization.
As more pipeline candidates generate clinical data over the coming year, the company is expected to face an important milestone in demonstrating that its accumulated capabilities can successfully support the transition from a biosimilar leader to a global developer of innovative medicines.
A Celltrion official said, "Beginning with the release of preclinical results for our next-generation obesity therapy later this year, key clinical data from our ADC candidates will become available sequentially during the first half of next year. These milestones are expected to demonstrate the strength of our novel drug pipeline and mark an important step in our evolution into a global innovative biopharmaceutical company."
