Celltrion Outlines Plans For Up to 16 IND Filings By 2028

COMPANY PROFILE
  • Celltrion presented updates on its ADC and multispecific antibody pipelines at the 44th Annual J.P. Morgan Healthcare Conference, with plans for up to 16 IND submissions by 2028.
  • The company outlined plans to expand U.S. manufacturing capacity following the acquisition of a New Jersey facility, targeting 132,000L of drug substance capacity by 2030.

Celltrion, Inc. presented its strategic priorities and clinical development updates at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, outlining progress across its innovative drug pipeline and plans to expand manufacturing and R&D capabilities in the United States.

During the main track presentation, Chief Executive Officer Jin-Seok Seo and Senior Executive Vice President Hyuk-Jae Lee detailed the company’s transition from a biosimilar-focused business towards next-generation therapeutics. Celltrion plans to submit up to 16 investigational new drug applications by 2028, including up to 10 antibody-drug conjugates, four multispecific antibodies, one recombinant protein and one peptide. In parallel, the company aims to commercialise up to 18 biosimilar products by 2030 and 41 by 2038.

The company highlighted progress within its oncology pipeline. Several ADC candidates targeting solid tumours have advanced, with IND applications for CT-P70, CT-P71 and CT-P73 accepted by the U.S. Food and Drug Administration in 2025. CT-P70, which is being developed for non-small cell lung cancer, has also received Fast Track designation. In addition, Celltrion received FDA IND approval for CT-P72, a tetravalent bispecific antibody designed to target HER2 and CD3.

“Building on our company’s global footprint in biosimilar excellence, Celltrion is accelerating its transition toward next-generation innovative therapeutics.”

Jin-Seok Seo, Chief Executive Officer, Celltrion

To support long-term growth and supply resilience, Celltrion recently completed the acquisition of a former Eli Lilly manufacturing facility in Branchburg, New Jersey. The site provides 66,000 litres of drug substance capacity, with plans to increase this to 132,000 litres by 2030 and add drug product manufacturing capabilities. The company stated that the expansion is intended to strengthen its U.S. supply chain and support future R&D activities in the region.

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