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Celltrion (068270.KS) is set to unveil preclinical results for its next-generation obesity treatment and early clinical data for antibody-drug conjugate (ADC) candidates in succession, bringing its new drug development progress into full view. The company aims to cultivate new drugs as a fresh growth pillar, drawing on the cash-generating power and research, development and commercialization capabilities it has built through its biosimilar business
Celltrion recently held an in-house research and development briefing and said on the 29th that it plans to disclose the preclinical results of its quadruple-action obesity treatment “CT-G32” at an academic conference this November. The company plans to complete Good Laboratory Practice (GLP) toxicity testing within this year, submit a Phase 1 investigational new drug (IND) application in February next year, and begin first patient dosing in the second quarter of the same year
CT-G32 is an obesity treatment candidate designed to act on four targets simultaneously, the first of its kind in the world. Celltrion explained that in earlier preclinical trials, it confirmed a higher weight-loss effect and the potential to preserve lean mass, including muscle, compared with triple-action agents being developed by global pharmaceutical firms. In addition, the company is developing a multi-action oral obesity treatment, targeting an IND filing in the second half of 2028. Celltrion is also pursuing a product lifecycle management strategy by expanding its research to long-acting obesity treatments and metabolic disease treatments for conditions such as sarcopenia and diabetes.
The development of cancer drugs is also picking up pace. The ADC candidates CT-P70, CT-P71 and CT-P73, along with the multi-antibody candidate CT-P72, have entered the Phase 1 patient dosing stage. Among these, two ADCs are set to complete Part 1 of Phase 1 within this year and disclose early results sequentially starting in the first half of next year
CT-P70, the fastest in development, aims to enter Part 2 of Phase 1 for dose optimization in March next year. The main indications for each candidate are: CT-P70 for non-small cell lung cancer and colorectal cancer; CT-P71 for urothelial cancer, breast cancer and prostate cancer; CT-P73 for cervical cancer and head and neck cancer; and CT-P72 for gastric cancer and breast cancer. CT-P70 and CT-P71 have each received Fast Track designation from the U.S. Food and Drug Administration (FDA). Fast Track designation grants the right to consult with the FDA quickly throughout the entire clinical cycle.
Celltrion has secured a total of 25 new drug candidates through its own research and development and open innovation, and is continuing their development. The company plans to increase the number of candidates in the clinical stage to five by the end of this year and to eight next year, expanding to more than triple the year-end level by 2028. It has selected oncology, obesity and metabolic diseases, and autoimmune diseases as core areas of new drug development
To this end, the company invested about 482.4 billion won in research and development last year. Going forward, it plans to reinvest the cash generated from its biosimilar business into new drug development and to raise its commercialization prospects by leveraging its in-house capabilities spanning antibody development, clinical trials, approval, production and sales
A Celltrion official stressed, “Starting with the preclinical results for the obesity treatment at the end of this year, the clinical progress of the anti-cancer ADC candidates will materialize sequentially in the first half of next year.” The official added, “We will use the technology accumulated in biosimilars and our global clinical, production and sales capabilities to make new drugs a new growth pillar for our mid- to long-term corporate value.”
#Celltrion#ObesityDrug#ADC#NewDrug#Biotech#FDAFastTrack#Pharma
Original reporting by Lee Yeon-soo for Seoul Economic Daily
AI-translated from Korean. Quotes from foreignxact original wording
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