Celltrion Advances All Three ADC-Based Anticancer Drug Candidates to Patient Dosing Stage

Multi-Antibody Candidate 'CT-P72' Enters Patient Recruitment Phase
CT-P70 and CT-P71 Receive FDA Fast Track Designation

Celltrion announced on April 23 that all three of its antibody-drug conjugate (ADC)-based anticancer drug candidates have advanced to the patient dosing stage.

The new drug candidates currently being administered to patients are CT-P70, CT-P71, and CT-P73—all of which received Investigational New Drug (IND) approval for Phase 1 clinical trials from the U.S. Food and Drug Administration (FDA) last year. Following the initiation of clinical trial procedures, CT-P70 and CT-P71 began patient dosing in the second half of last year, while CT-P73 started patient dosing in the first quarter of this year.

According to Celltrion, these ADC drug candidates demonstrated differentiated mechanisms of action and excellent safety profiles during preclinical studies. Building on this, the company plans to assess safety across various dosage levels and pharmacokinetic characteristics in the Phase 1 clinical trials.

The multi-antibody drug candidate CT-P72 has entered the patient recruitment phase through clinical trial institutions, and the first patient dosing is expected to begin as early as next month.

With multi-antibody drug candidates now also entering full-scale human clinical trials following the ADC pipeline, Celltrion is being evaluated as having successfully entered the main track of next-generation new drug pipeline development.

The indications for each drug candidate are as follows: CT-P70 is being developed for non-small cell lung cancer, colorectal cancer, and gastroesophageal cancer; CT-P71 targets urothelial carcinoma, breast cancer, and prostate cancer; CT-P73 focuses on cervical cancer, head and neck cancer, colorectal cancer, and endometrial cancer; and CT-P72 targets bladder cancer, breast cancer, colorectal cancer, endometrial cancer, and gastric cancer.

Given that all four new drug candidates address high unmet medical needs in the oncology field, Celltrion has made Fast Track Designation by the FDA its fundamental strategy for accelerating commercialization. CT-P70 received FDA Fast Track Designation in December last year, and CT-P71 received it this month. The company also plans to submit Fast Track applications for CT-P72 and CT-P73 within this year. Fast Track is a system that allows expedited cooperation between the developer and the FDA for severe diseases where conventional therapies are insufficient, granting rolling review eligibility, which enables submission of documents for review as soon as they are ready.

The company plans to leverage its accumulated research and development capabilities from the biosimilar business and global regulatory experience to accelerate its transformation into a global new drug company. In particular, Celltrion aims to sequentially obtain interim clinical results for the four anticancer drug candidates currently in Phase 1 trials, thereby securing early clinical data.

A Celltrion representative stated, "All ADC drug candidates have entered the patient dosing phase, and the multi-antibody pipeline has reached the patient recruitment stage, marking significant progress in development. Along with visible achievements from the next-generation new drug pipeline, the global market share of our existing biosimilar products remains robust, providing a foundation for the company's continued growth."

The representative added, "The first earnings report for this year, covering the first-quarter results, will be released to the market in early to mid-next month upon completion of the relevant procedures. This announcement will provide a concrete measure of the company's growth indicators."

This content was produced with the assistance of AI translation services.