Celltrion's 3 ADC drug candidates all receive FDA fast track designation

Celltrion announced Thursday that its antibody-drug conjugate cancer drug candidate CT-P73 has received fast track designation from the US Food and Drug Administration, completing fast track status for all three of its clinical-stage ADC candidates — CT-P70, CT-P71 and CT-P73 — currently in Phase 1 trials.

The designation for CT-P73 covers treatment of recurrent and metastatic cervical cancer in patients who have previously undergone platinum-based chemotherapy. The FDA's fast track program is designed to accelerate the development and review of treatments for serious conditions. Designated drugs benefit from closer FDA consultation, rolling review — under which completed sections of an application can be submitted and reviewed sequentially — as well as expanded opportunities for priority review and accelerated approval.

Celltrion is conducting Phase 1 trials on three ADC candidates targeting c-MET, Nectin-4 and tissue factor, respectively. With fast track designation now secured across its entire ADC pipeline, the company plans to pursue a flexible commercialization strategy — evaluating clinical data and market potential to determine which candidates to commercialize directly and which to advance through licensing deals for early monetization.

CT-P73 is an ADC candidate targeting tissue factor, a protein overexpressed in various solid tumors. Preclinical research has shown superior antitumor efficacy and an improved safety profile compared with existing treatments, positioning it as a next-generation treatment option.

Phase 1 trials for all three ADC candidates are proceeding on schedule. Celltrion plans to complete Part 1 of the Phase 1 trials for two of the candidates by year-end and release top-line results sequentially from the first half of next year. CT-P70, the most advanced of the three, is targeting entry into Part 2 — focused on dose optimization — in March next year.

In addition, Celltrion plans to apply for FDA fast track designation for CT-P72, a multispecific antibody-based candidate, before the end of the year as it continues to expand its drug pipeline.

The designation carries broader significance as Celltrion shifts its portfolio away from biosimilars and into high-value proprietary drugs, marking formal recognition by a global regulator of the scientific validity and commercial potential of its new drug programs.

"With all three clinical-stage ADC candidates now holding fast track designation, we have laid the groundwork for close collaboration with the FDA," a Celltrion official said. "We will strategically choose between in-house development and commercialization or licensing deals to maximize both the long-term growth value of our new drugs and the potential for early returns."