Celltrion declared a full-fledged pivot from biosimilars to an innovative new drug developer.
Seo Jin-Seok, head of Celltrion's business management division, said in a main-track presentation at the 44th JPMorgan Healthcare Conference (JPMHC2026) at The Westin St. Francis in San Francisco on the 13th (local time), "Celltrion has entered a new growth phase as a new drug development corporations," adding, "Within the next two years, there will be visible progress in new drug development."
Seo is the eldest son of Seo Jung-Jin, chair of Celltrion. Seo had taken the JPMHC stage with Chair Seo for two years starting in 2024, but on this day appeared with Executive Vice President Lee Hyuk-Jae.
Celltrion unveiled a product pipeline roadmap that includes new drugs and next-generation biosimilars and highlighted the competitiveness of its U.S. production facilities, drawing interest from global investors. Seo said, "We are expanding new drug development in earnest on the back of the stable cash flow secured through the biosimilar business and the antibody technology we have accumulated."
On the biosimilar business, Seo said, "We plan to expand our biosimilar product portfolio from the current 11 to a total of 41 by 2038," adding, "As a result, the size of the global market we can target will expand to more than four times last year's level, surpassing 400 trillion won."
Celltrion's biosimilar portfolio currently spans a range of treatment areas, including autoimmune diseases, oncology, bone disorders, and eye diseases. It also revealed a development roadmap for 16 new drug pipelines packed with Antibody-Drug Conjugate (ADC), multi-specific antibodies, fetal Fc receptor (FcRn) inhibitors, and obesity treatments.
Among them, ADC candidates CT-P70, CT-P71, and CT-P73, and multi-specific antibody candidate CT-P72 all obtained investigational new drug (IND) approvals last year and entered phase 1 trials. Key readouts from these four pipelines are expected to come out sequentially starting in the second half of this year.
In particular, CT-P70 was recently granted Fast Track designation by the U.S. Food and Drug Administration (FDA), raising expectations that development could accelerate. Celltrion plans to seek Fast Track designation for other key pipelines, including CT-P71, CT-P72, and CT-P73. In addition, new ADC candidate CT-P74 and FcRn inhibitor CT-P77 are slated to submit IND applications early next year, and the company plans to submit INDs for a total of 12 new drug pipelines by 2028.
Seo said, "ADC candidates based on TOP1 inhibitors are drawing attention for high efficacy and strong anticancer effects," adding, "Among corporations in Korea, Celltrion is the only one that has advanced a TOP1-based ADC developed in-house into the clinical stage." The ADC payload in question showed more than a tenfold improvement in safety and efficacy compared with conventional MMA-based payloads, he said.
A development roadmap was also presented for next-generation obesity treatment candidate CT-G32. Celltrion is developing CT-G32 as a quadruple agonist and is making the reduction of interpatient variability in treatment effect and the mitigation of muscle loss side effects—long cited as limitations of existing therapies—the core goals of its differentiation strategy. CT-G32 is being advanced rapidly with a target of IND submission in the second half of next year.
Celltrion also set a goal to build a strong new drug pipeline by 2028 by steadily submitting four to five INDs each year. Seo said, "Along with our in-house research and development (R&D) capabilities, we are accelerating new drug development through collaborations with global biotech corporations," adding, "Celltrion's standing as a new drug development corporations will become even more solid."
Lee Hyuk-Jae, Celltrion's executive vice president, highlighted the competitiveness of the Branchburg, New Jersey, production facility in the United States, the acquisition of which was completed last year, and outlined plans to expand investment in the site.
Lee said, "By securing a production base in the United States, we have addressed tariff risks and strengthened global supply stability to meet our expanding product portfolio and production demand," adding, "Starting this year, the facility will be able to generate revenue through contract manufacturing organization (CMO) work, becoming a new growth engine." He said, "If we had built the facility from scratch, it would have required about three times the acquisition expense," adding, "Because it can be operated immediately, we plan to start the CMO business next month."
Through phased expansion, Celltrion plans to increase its drug substance (DS) manufacturing capacity from the current 66,000 liters to 99,000 liters by 2028, and add another 33,000 liters by 2030, bringing the total to 132,000 liters. It also plans to establish drug product (DP) manufacturing to complete an end-to-end supply chain in the United States.
Celltrion plans to develop the Branchburg facility into the foundation for a future U.S. research center and a key hub for its global contract development and manufacturing organization (CDMO) business. Through this, it aims to strengthen its dominance in the global market by making its headquarters in Songdo, Korea, and its U.S. production base the two pillars, while maximizing synergy with local research labs.
Executive Vice President Lee Hyuk-Jae said, "We plan to build the U.S. production facility into a core manufacturing hub that not only supplies Celltrion products to the North American market but also contract-manufactures products for global pharma companies to generate revenue," adding, "Through this, we will strengthen global supply chain stability and operational efficiency at the same time."
He added, "After securing the production facility, we will also pursue the creation of a global R&D center tied to local bio clusters to secure top talent and further strengthen our development competitiveness."
Celltrion said that beyond its official presentation, it is exploring various collaboration opportunities through meetings with numerous global pharmaceutical and biotech corporations and investment firms during the event.
Celltrion's biosimilar business has recorded an average annual growth rate of about 20% over the past 10 years, and sales in 2024 reached about $3 billion. The company projected that this growth trend will continue this year and next.