Celltrion plans to sequentially announce the development results of its next-generation obesity treatment and antibody-drug conjugate (ADC) pipeline starting this year. The non-clinical results for the obesity treatment candidate will be disclosed by the end of this year, while initial clinical results for the ADC candidate currently in Phase 1 trials are expected to be revealed in the first half of next year.
On July 29, Celltrion shared these drug development plans during an internal research and development status report meeting.
Leveraging its antibody development technology accumulated through its biosimilar business, Celltrion aims to maximize the speed and success rate of new drug development, expanding its growth focus into the new drug sector.
The first pipeline to show research results will be the quadruple-action obesity treatment candidate, CT-G32.
Celltrion is conducting GLP toxicology tests to determine the appropriate dosage and ensure safety for CT-G32, the world’s first next-generation obesity treatment candidate that acts on four targets simultaneously.
Based on these results, the company plans to submit an Investigational New Drug (IND) application for Phase 1 clinical trials by February next year, with the goal of starting patient dosing in the second quarter of next year if the approval process proceeds as planned.
In previous non-clinical trials, CT-G32 demonstrated superior weight loss effects and preservation of lean body mass compared to a triple-target agent being developed by a global pharmaceutical company.
Additionally, Celltrion is developing a multi-action oral obesity treatment, aiming to submit an IND by the second half of 2028. The company has also initiated the development of long-acting obesity treatments and therapies for various metabolic diseases, including sarcopenia and diabetes, as part of its strategy to expand its new drug product lifecycle management.
Celltrion is accelerating the development of ADCs and multi-antibody treatments that have entered clinical stages. Four candidates, including three ADCs (CT-P70, CT-P71, CT-P73) and one multi-antibody candidate (CT-P72), have all entered the patient dosing phase.
Among these, two ADC candidates are expected to complete Part 1 of 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. Following this, the company plans to enter Part 2 clinical trials for dose optimization, with CT-P70, the fastest in development, aiming to enter Part 2 by March next year.
The main indications for each candidate include: 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 and breast cancer.
CT-P70 received FDA Fast Track designation last year, while CT-P71 received it this year. Celltrion plans to actively utilize the FDA's Fast Track program for these candidates, targeting cancers with high unmet medical needs to significantly accelerate commercialization timelines.
Currently, Celltrion is developing a total of 25 new drug candidates through its own research and open innovation. By the end of this year, five candidates are expected to enter clinical stages, with the total expected to expand to eight candidates next year.
A Celltrion official stated, "Starting with the disclosure of non-clinical results for the next-generation obesity treatment by the end of this year, key clinical results for the cancer ADC candidates will be sequentially revealed in the first half of next year. This will be an important turning point for the market to recognize the company's new drug development capabilities and pipeline potential."
Meanwhile, Celltrion announced on July 27 that it recorded consolidated sales of 1.3937 trillion won and an operating profit of 451.8 billion won for the second quarter.
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.