Celltrion is aggressively pursuing global clinical trials for a new antibody-drug conjugate (ADC) cancer treatment.
Celltrion submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) on 3rd for the global phase 1 trial of the ADC cancer treatment "CT-P70." CT-P70 is an ADC cancer treatment developed to target solid tumors, including non-small cell lung cancer, colorectal cancer, and gastric cancer. The target is the "cell growth factor receptor (cMET)" that promotes tumor growth in cancer cells.
CT-P70 previously demonstrated tumor suppression effects in solid tumors during preclinical studies. It shows superior efficacy even in low-expression tumors compared to existing cMET-targeted ADC cancer drugs, raising expectations for its effectiveness across various patient populations. Celltrion aims to start administering the drug to the first patient by mid-year.
This IND application comes about two weeks after Celltrion announced its "global new drug development corporate leap strategy" at the JPMorgan Healthcare Conference last month. Beginning with this IND application, Celltrion will accelerate the development of next-generation new drugs. The goal is to submit a total of four INDs, including three ADC new drugs and one multi-antibody new drug, this year.
Celltrion plans to expand its new drug portfolio starting with CT-P70. The company aims to solidify its position in the antibody drug market established through its existing biosimilar product line and the development of the new drug "Jimpentra." The company is scheduled to develop a total of 13 new drug candidates, including two ADC new drugs and two multi-antibody new drugs in 2026, three ADC new drugs in 2027, and one ADC new drug and one multi-antibody new drug in 2028.
A Celltrion official said, "Immediately after presenting our vision to leap as a global new drug development corporation at last month's U.S. JPM Conference, we swiftly submitted our first global clinical IND," and added, "We will do our utmost to continue developing innovative therapeutics that provide treatment benefits to patients and establish ourselves as a global new drug company."