Celltrion is accelerating its transition from a biosimilar-focused strategy to full-scale new drug development. With successive approvals for clinical trial applications (INDs) in Korea and abroad, the company is rapidly expanding its pipeline of novel drug candidates.
According to the biopharmaceutical industry on July 7, Celltrion recently received approval from the Ministry of Food and Drug Safety for a Phase 1 clinical trial of ‘CT-P71.’ The trial will be conducted primarily at major Korean hospitals, including Asan Medical Center and Severance Hospital at Yonsei University. The study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CT-P71 in adult patients with advanced solid tumors.
CT-P71 is an antibody-drug conjugate (ADC) under development for the treatment of solid tumors, including bladder cancer. It targets nectin-4, a tumor-associated antigen, and has demonstrated tumor suppression in bladder, breast, and lung cancers in preclinical studies. Toxicology data have also confirmed its safety. The company notes CT-P71 could offer superior treatment benefits compared to existing nectin-4-targeting ADCs.
Celltrion officially declared its new drug development ambitions last year. At the 2024 J.P. Morgan Healthcare Conference, it unveiled its strategy and this year, it presented a more detailed roadmap of its pipeline. While previously focused on a long-term vision centered on biosimilars, the company has now made a clear shift toward becoming an innovator in novel drug development.
Reflecting this change, Celltrion's R&D spending has increased. In 2023, the company spent KRW 434.6 billion on R&D on a consolidated basis, up about 27% from KRW 342.7 billion in 2022—comparable to the annual revenue of a mid-sized pharmaceutical company. In the first quarter of 2024 alone, R&D expenditures rose 28% year-over-year to KRW 103.1 billion.
This year marks a turning point, with several drug candidates entering the clinical stage. In March, Celltrion received U.S. FDA approval to begin a Phase 1 trial for ‘CT-P70,’ a non-small cell lung cancer therapy. In May, the same compound was also cleared for clinical testing by the Korean regulatory agency. These approvals are enabling faster clinical advancement both domestically and globally.
In addition to CT-P70, Celltrion plans to sequentially submit INDs in the U.S. for CT-P71, CT-P72, and CT-P73 within the year, initiating a series of clinical trials for its next-generation drug pipeline.
A company official stated, “We aim to develop a total of 13 new drug candidates by 2028, including nine ADCs and four multispecific antibodies, significantly expanding our new drug pipeline.”
Celltrion's robust biosimilar business has provided the financial stability to support aggressive investment in novel drug development. Its autoimmune drug ‘Remsima’ holds around 62% market share in Europe, while oncology biosimilar ‘Herzuma’ also maintains a leading position in the region. In the U.S., prescriptions of ‘Zymfentra’ (Remsima SC) continue to increase. Celltrion’s biologics revenue surged from KRW 1.0787 trillion in 2022 to KRW 1.971 trillion in 2023, and reached KRW 3.109 trillion last year.
“The steady growth of our biosimilar portfolio and the launch of new products that significantly broaden our treatment coverage are expanding our market presence,” the Celltrion representative added. “We are laying the foundation for sustainable growth through next-generation drug development, including ADCs and multispecific antibodies, and aim to further strengthen our global position as a top-tier pharmaceutical company.”
