[Edaily Reporter Hong Ju-yeon ] Celltrion(068270)is aiming to leap forward from a biosimilar company to a global innovator by expanding its new drug pipeline. Celltrion announced on the 29th that, during a recent internal R&D status briefing, it plans to disclose preclinical results for a next-generation obesity treatment candidate by the end of this year and to sequentially announce initial clinical results for an antibody-drug conjugate (ADC) candidate currently in Phase 1 clinical trials starting in the first half of next year.

According to Celltrion, the pipeline expected to yield the first tangible research results is “CT-G32,” a quadruple-action obesity treatment candidate. Celltrion is currently conducting GLP toxicity tests to determine the optimal dosage and ensure the safety of “CT-G32,” the world’s first next-generation obesity treatment candidate to simultaneously target four different targets. The company plans to complete toxicity testing on 252 mice and 48 monkeys by the end of this year and present the results at a relevant academic conference this November. Based on these results, the company aims to complete the submission of an Investigational New Drug (IND) application for a Phase 1 clinical trial by February of next year and, assuming the approval process proceeds without a hitch, begin administering the drug to the first patients within the second quarter of next year.

At the same time, the company is concurrently developing a multi-action oral obesity treatment. Development of the oral candidate is underway with the goal of submitting an IND in the second half of 2028. Celltrion has already begun developing treatments for various metabolic diseases—including a long-acting obesity treatment with an extended dosing interval, as well as treatments for sarcopenia and diabetes—and plans to maximize its new drug lifecycle management (LCM) strategy through these efforts.

The company is also accelerating the development of ADCs and multi-antibody therapies that have entered the clinical phase. All four candidates—three ADCs (CT-P70, CT-P71, CT-P73) and one multi-antibody candidate (CT-P72)—that have already entered Phase 1 clinical trials have begun patient dosing. In particular, two of these ADC candidates are scheduled to complete Part 1 of their Phase 1 clinical trials by the end of this year, with topline results to be announced sequentially starting in the first half of next year. Additionally, the company plans to initiate Part 2 clinical trials for dose optimization in the first half of next year; among these, “CT-P70,” which is progressing the fastest, aims to enter Part 2 in March of next year.

The main indications for each candidate are as follows: ▲CT-P70 for non-small cell lung cancer and colorectal cancer; ▲CT-P71 for urothelial carcinoma, breast cancer, and prostate cancer; ▲CT-P73 for cervical cancer and head and neck cancer; and ▲CT-P72 for gastric cancer and breast cancer. Since all of these candidates target cancer types with high unmet medical needs, Celltrion’s strategy is to actively utilize the U.S. Food and Drug Administration’s (FDA) Fast Track designation to significantly accelerate their commercialization timeline.

In fact, CT-P70 received Fast Track designation from the FDA last year, and CT-P71 received it this year, demonstrating the company’s technological capabilities. Fast Track designation is a program designed for serious diseases where existing treatments are not sufficiently effective; it allows for expedited consultation between the developer and the FDA throughout the entire clinical development cycle.

The company plans to apply for Fast Track designation within the year for two follow-up candidates currently in Phase 1 clinical trials and intends to further accelerate its entry into the global market by actively utilizing clinical trial regulatory relief programs and accelerated approval pathways in various countries.

Through in-house R&D and open innovation, Celltrion is currently developing a total of 25 new drug candidates. By the end of this year, a total of five candidates are expected to enter the clinical phase, and next year, the number of clinical-stage candidates is projected to expand to eight. Starting in 2028, the number of candidates entering the clinical phase is expected to increase to more than three times the number at the end of this year.

The company has identified oncology, obesity and metabolic diseases, and autoimmune diseases as the core pillars of its new drug development strategy and is pursuing a dual approach of in-house development and the acquisition of external technologies through open innovation. It is also expanding its candidate discovery capabilities and technological foundation by collaborating with AI deep tech firms, as well as companies specializing in microbiome and antibody-based new drugs.

Celltrion is accelerating its new drug development by continuing to make bold investments, having allocated approximately 482.4 billion won to research and development last year alone. Moving forward, the company plans to continue investing in new drug R&D based on the stable cash flow generated by its biosimilar business, while gradually increasing the value of its new drug division by securing clinical data and enhancing its pipeline.

A Celltrion official stated, “Starting with the release of preclinical results for our next-generation obesity treatment at the end of this year, key clinical results for our anti-cancer ADC candidates are expected to be unveiled sequentially in the first half of next year,” adding, “This will mark a significant turning point for the market to recognize Celltrion’s new drug development capabilities and the potential of our pipeline.”