Celltrion's New Drug Pipeline Achievements in Obesity and ADCs Become Increasingly Visible

Clinical Results for Obesity Treatments and Oncology ADCs
To Be Announced Sequentially Later This Year and Early Next Year

Celltrion announced on July 29 that it plans to release preclinical results for its next-generation obesity drug candidate within this year at an internal research and development status meeting. The company also plans to sequentially announce initial clinical results for its antibody-drug conjugate (ADC) candidates, currently in Phase 1 clinical trials, starting from the first half of next year. Leveraging its antibody development technology accumulated through its biosimilar business and its global clinical, manufacturing, regulatory, and commercialization capabilities, Celltrion aims to maximize the speed and success rate of its new drug development, expanding the company's growth foundation to the new drug sector.

Preclinical Results of Quadruple-Action Obesity Drug to Be Released Within the Year

The pipeline expected to yield visible research achievements first is the quadruple-action obesity drug candidate 'CT-G32'.

Celltrion is conducting GLP toxicity studies to determine the optimal dosage and establish the safety of the world's first next-generation obesity drug candidate, 'CT-G32', which acts on four targets simultaneously. Toxicity validation is being conducted on 252 rats and 48 monkeys and is scheduled to be finished within the year; the results will be presented at a related academic conference in November. Based on these results, the company aims to submit a Phase 1 clinical trial IND (Investigational New Drug) application by February of next year. If approval proceeds as planned, the first patient dosing is targeted for within the second quarter of 2027.

Aerial view of Celltrion Plant 2 in Songdo, Incheon. / Incheon – Photo by Hyunmin Kim kimhyun81@

In an earlier independent preclinical study, CT-G32 demonstrated superior weight loss effects and preservation of lean body mass (LBM), including muscle, compared to the triple-targeting agents currently being developed by global pharmaceutical companies. Celltrion plans to develop this as a differentiated new obesity treatment compared to existing products.

Simultaneously, Celltrion is also developing a multi-action oral obesity treatment. The oral candidate is being developed with the goal of submitting an IND in the second half of 2028. In addition, Celltrion has already begun the development of long-acting formulations with extended dosing intervals, as well as therapeutics targeting other metabolic diseases such as sarcopenia and diabetes. Through these efforts, the company aims to maximize its life cycle management (LCM) strategy for new drug products.

Four ADC and Multi-Antibody Drugs Progressing Smoothly with Patient Dosing Underway

Development of ADCs and multi-antibody therapeutics in the clinical phase is also accelerating. All four candidates—three ADCs (CT-P70, CT-P71, CT-P73) and one multi-antibody drug (CT-P72)—have entered the patient dosing stage in their respective Phase 1 trials and are progressing smoothly.

Notably, two of the ADC candidates are set to complete Part 1 of Phase 1 clinical trials within this year, with topline results to be announced sequentially from the first half of next year. In addition, plans are in place to initiate Part 2 of the trials within the first half for dose optimization, with 'CT-P70' aiming to enter Part 2 as early as March next year, as it is progressing the fastest.

The main indications by candidate are: ▲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. As 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 (FDA) Fast Track system to significantly accelerate the timeline to commercialization.

In fact, CT-P70 secured Fast Track designation from the FDA last year, and CT-P71 followed with designation this year, demonstrating the company's technological prowess. Fast Track designation is a system that allows expedited communication and review between developers and the FDA during the entire clinical timeline for severe diseases where existing treatments are insufficient.

The company is also planning to apply for Fast Track designation for two additional candidates currently in Phase 1 within this year and will actively use regulatory easing and accelerated approval pathways in each country to further speed global market entry.

Total of 25 New Drug Candidates in Development, Clinical-Stage Pipeline to More Than Triple by 2028

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 will have entered the clinical stage, and next year the number of clinical-stage candidates is expected to expand to eight. Starting in 2028, the number of candidates in the clinical stage is expected to more than triple compared to the end of this year. With the new drug pipeline rapidly moving from a preclinical to a clinical development focus, the share of new drugs in Celltrion's overall research and development portfolio is expected to continue to rise.

The company has positioned oncology, obesity and metabolic diseases, and autoimmune diseases as core pillars of its new drug development strategy, pursuing both in-house development and external technology acquisition through open innovation. Celltrion is also expanding its scope and technological base for candidate discovery by collaborating with AI deep tech companies and firms specializing in microbiome and antibody therapeutics.

Celltrion has continued bold investments in new drug development, investing approximately 482.4 billion won in R&D last year alone. The company plans to maintain its R&D investment for new drugs based on stable cash flow generated from the biosimilar business and will systematically enhance the value of its new drug sector by securing clinical data and further advancing its pipeline.

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