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South Korean biopharmaceutical firm Celltrion has unveiled its strategic priorities, which include expanding its manufacturing and research and development (R&D) capabilities in the US. The company aims to submit up to 16 investigational new drug applications by 2028, including up to 10 antibody-drug conjugates (ADCs), four multi-specific antibodies (msAbs), a recombinant protein, and a peptide. It has also acquired a former Eli Lilly manufacturing facility in New Jersey, to strengthen its U.S. supply chain against trade and tariff risks.
Celltrion’s Innovative Drug Development Strategy and U.S. Expansion
Biopharmaceutical leader, Celltrion, Inc. (068270.KS), showcased its updated strategic priorities and clinical development at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. The firm’s focus is on expanding its innovative drug pipelines, such as antibody-drug conjugates (ADCs) and multi-specific antibodies (msAbs), while bolstering its manufacturing and R&D capabilities in the U.S.
From Biosimilar Excellence to Innovative Therapeutics
In a presentation titled ‘From Biosimilar Excellence to Next-Gen Innovative Therapeutics’, Celltrion’s CEOs outlined plans to submit up to 16 investigational new drug (IND) applications by 2028. The company targets commercializing up to 18 products by 2030 and 41 products by 2038 in its biosimilar business.
Celltrion’s ADC candidates, aiming to target solid tumor cancers, have received IND application acceptance by the U.S. FDA for CT-P70, CT-P71, and CT-P73. Specifically, CT-P70 is under development for treating non-small cell lung cancer (NSCLC) and received Fast Track designation from the U.S. FDA.
The Potential of msAbs in Cancer Treatment
Celltrion is progressing with a portfolio of msAbs designed to selectively target cancer cells. The U.S. FDA has given IND approval for CT-P72, a bispecific antibody in development to target human epithelial growth factor receptor 2 (HER2) and cluster of differentiation 3 (CD3).
“We aim to redefine oncology care standards, creating sustainable value through scientific excellence and innovation,” said Jin-Seok Seo, Celltrion’s CEO. “Our expanding pipeline of ADCs and msAbs is a testament to our commitment to providing significant value to patients globally.”
Increasing U.S. Presence
Celltrion recently acquired a former Eli Lilly manufacturing facility in Branchburg, New Jersey, enhancing its U.S. manufacturing capabilities. The company plans to increase capacity to 132,000L by 2030, and extend its capabilities to include drug product (DP) facilities, ensuring long-term supply chain resilience and reinforcing its U.S. market presence.
“The U.S. facility acquisition is a pivotal step in fortifying our global supply chain and presence in the U.S. market,” said Hyuk-Jae Lee, Senior Executive Vice President at Celltrion. “By securing large-scale DS capacity in the U.S., we are boosting supply stability and laying the groundwork for expanded R&D collaboration and innovation.”
About Celltrion, Inc.
Celltrion, Inc., a biopharmaceutical pioneer, specializes in developing, manufacturing, and marketing innovative therapeutics globally. Notably, Celltrion launched the world’s first monoclonal antibody biosimilar. Their pharmaceutical portfolio addresses various therapeutic areas including immunology, oncology, hematology, ophthalmology, and endocrinology. For more information, visit www.celltrion.com/en-us and follow their latest news on LinkedIn, Instagram, and Facebook.
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