Celltrion declared a full-fledged shift from biosimilars to an innovative new drug development corporations.
Seo Jin-Seok, head of Celltrion's business management division, said in a main track presentation at the 44th JP Morgan Healthcare Conference (JPMHC2026) held 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 Celltrion Chair Seo Jung-Jin. Seo had taken the JPMHC stage for two years starting in 2024, but on this day appeared on stage 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. manufacturing facilities, drawing interest from global investors. Seo said, "Based on the stable cash flow secured through the biosimilar business and the antibody technology accumulated over the years, we are expanding new drug development in earnest."
Regarding 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, "Accordingly, the size of the global market we can target will expand more than fourfold from last year to exceed 400 trillion won."
Celltrion's current biosimilar portfolio spans a wide range of therapeutic areas, including autoimmune diseases, oncology, bone disorders, and eye diseases. It then unveiled a development roadmap for 16 new drug pipelines, including 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 the multi-specific antibody candidate CT-P72 all obtained investigational new drug (IND) approval last year and entered phase 1 trials. Key results from these four pipelines are expected to come out sequentially starting in the second half of this year.
In particular, CT-P70 recently received Fast Track designation from 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, the new ADC candidate CT-P74 and the FcRn inhibitor CT-P77 are scheduled to submit an IND application 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 potent anticancer effects," adding, "Celltrion is the only corporations in Korea to have advanced a TOP1-based ADC, developed in-house, into the clinical stage." The company explained that the ADC payload showed more than a 10-fold improvement in safety and efficacy compared with existing MMA-based ones.
The company also presented a development roadmap for the next-generation obesity treatment candidate CT-G32. Celltrion is developing CT-G32 as a quadruple agonist, with the core goal of differentiating by improving interindividual variability in treatment effect and muscle loss side effects that have been pointed out as limitations of existing therapies. CT-G32 is being developed rapidly with the goal of submitting an IND in the second half of next year.
Celltrion also set a goal of continuously submitting 4 to 5 INDs each year to build a strong new drug pipeline by 2028. Seo said, "Along with our in-house research and development (R&D) capabilities, we are accelerating new drug development through collaboration with global biotech corporations," adding, "Celltrion's position as a new drug development corporations will become even stronger."
Lee Hyuk-Jae, Celltrion's executive vice president, highlighted the competitiveness of the Branchburg, New Jersey, manufacturing facility in the United States, whose acquisition was completed last year, and presented plans to expand facility investments.
Lee said, "By securing a production base in the United States, we resolved tariff risks and strengthened global supply stability to meet the expanding product portfolio and production demand," adding, "Starting this year, the facility will be able to generate revenue through contract manufacturing (CMO), becoming a new growth engine." He said, "If we had built this 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 current 66,000-liter drug substance (DS) manufacturing capacity to 99,000 liters by 2028, and add another 33,000 liters by 2030 to reach a total of 132,000 liters. In addition, the company plans to establish drug product (DP) manufacturing to complete an end-to-end supply chain in the United States.
Celltrion plans to foster the Branchburg manufacturing facility as the foundation for a research center to be built in the United States and as a core hub for its global contract development and manufacturing (CDMO) business. Through this, the company aims to further strengthen its dominance in the global market by using its Songdo headquarters in Korea and its local U.S. production base as two pillars, and to maximize synergy with local research labs.
Executive Vice President Lee Hyuk-Jae said, "We plan to build the U.S. manufacturing facility into a core production hub that not only supplies Celltrion products to the North American market but also contract-manufactures products for global pharmaceutical companies to generate revenue," adding, "Through this, we will strengthen both global supply chain stability and operational efficiency."
He added, "After securing the manufacturing facility, we will also push to create a global R&D center linked with local bio clusters to secure top talent and further strengthen our development competitiveness."
Celltrion said that beyond its official announcements, 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 recorded an average annual growth rate of about 20% over the past 10 years, and sales in 2024 reached about $3 billion. The company predicted that this growth trend will continue this year and next.