Celltrion's ADC New Drug 'CT-P71' Designated for Fast Track by U.S. FDA

Just Four Months After CT-P70: Anticancer Efficacy Confirmed in Preclinical Studies
Two Additional Drug Candidates to Apply for Fast Track Within the Year

Celltrion announced on April 9 that its antibody-drug conjugate (ADC)-based anticancer drug candidate, CT-P71, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma.

This approval comes just four months after CT-P70 received Fast Track designation for the indication of metastatic non-squamous non-small cell lung cancer (NSCLC) in December of last year. With this, Celltrion has been recognized for the value of its ADC new drug pipeline in high-risk cancers with high unmet medical needs, such as lung cancer and urothelial carcinoma, laying an early foundation to become a global new drug development company.

The FDA's Fast Track program allows for expedited consultations between the developer and the FDA throughout the clinical development lifecycle for serious conditions where existing treatments are insufficient. Upon receiving Fast Track designation, developers gain benefits such as: ▲ establishing continuous communication channels with the FDA ▲ early discussions on clinical trial design and development strategies ▲ increased potential for priority review and accelerated approval.

In particular, the designation grants the right to 'Rolling Review,' whereby documents can be submitted and reviewed as they become ready, greatly maximizing overall development efficiency and significantly shortening the total timeline from development to new drug approval.

CT-P71 is an ADC drug candidate under development for the treatment of urothelial carcinoma. It targets nectin-4, which is observed in tumor cells, and has shown superior anticancer efficacy compared to the existing treatment, Padcev (active ingredient: enfortumab vedotin), in preceding nonclinical studies.

Its main strength lies in its differentiated mechanism of action, which induces damage during the DNA replication process in cancer cells, demonstrating robust efficacy even in resistance models to existing therapies. Additionally, nonclinical evaluation in primates confirmed significantly superior safety results compared to existing treatments.

Based on the verified safety and efficacy of CT-P71, Celltrion plans to develop it as a best-in-class drug within its mechanism. In September of last year, Celltrion began the first Phase 1 clinical trial dosing of CT-P71 in patients with solid tumors with limited treatment options, including urothelial carcinoma, and the clinical trial is progressing smoothly. The expected market size for the ADC modality targeted by CT-P71 is projected to reach approximately 7.75 trillion won by 2032.

Celltrion intends to use Fast Track designation as a core strategy in the development of future new drug pipelines. Accordingly, it plans to complete Fast Track applications for subsequent drug candidates CT-P72 and CT-P73 within this year, and will actively utilize accelerated approval and priority review programs to dramatically advance the global market launch and commercialization timeline.

A Celltrion official stated, "Being granted Fast Track designation for both CT-P70 and now CT-P71 in such a short period reflects the recognition of Celltrion's new drug candidates as key therapies that can address unmet needs in the global medical field."

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