Celltrion(068270) is accelerating efforts to strengthen its mid- to long-term growth base by simultaneously expanding its biosimilar product lineup and nurturing its new-drug pipeline.
Based on the profitability secured in its existing biosimilar (biosimilar) business, the company plans to expand its next-generation product portfolio while investing in new-drug development, including antibody-drug conjugates (ADCs), multispecific antibodies and obesity treatments, to diversify its growth pillars.
According to the industry on the 13th, Celltrion said in a recent provisional earnings filing that it posted record quarterly results in the second quarter of this year, with sales of 1.3 trillion won and operating profit of 430 billion won on a consolidation basis. The company noted that performance has continued to improve as the share of high-margin new biosimilar sales has increased.
In the biosimilar business, the expansion of the follow-up pipeline centered on autoimmune disease treatments is in full swing.
Celltrion filed for approval of the biosimilar CT-P55 to "Cosentyx" (ingredient secukinumab), an autoimmune disease treatment, in Canada in May and in Korea in June. It plans to sequentially apply for approval in major markets, including the United States and Europe, to push for global commercialization. Cosentyx, an interleukin (IL)-17A inhibitor, is a blockbuster drug that recorded about 10 trillion won in global sales last year.
CT-P45, a biosimilar to "Entyvio" (ingredient vedolizumab), another autoimmune disease treatment, won phase 1 investigational new drug (IND) approvals in the United States and Korea in the first half of this year. CT-P45 is an integrin-class therapy that inhibits the migration of immune cells to the gut, a mechanism different from existing tumor necrosis factor-alpha (TNF-α) inhibitors or interleukin inhibitors. Unlike existing therapies that induce systemic immunosuppression, it features high target selectivity and a relatively lower risk of systemic infection.
Celltrion has built a lineup of TNF-α inhibitors and interleukin inhibitors around Remsima, Remsima SC (U.S. product name Zymfentra), Yuflyma, Steqeyma and Abtozma. It plans to further expand its autoimmune disease portfolio by adding CT-P55 and CT-P45.
The company's goals are also specific. It presented a blueprint to increase its biosimilar product portfolio from 11 now to 18 by 2030 and 41 by 2038.
The market environment is also turning favorable. After the U.S. government excluded biosimilars from its biopharmaceutical tariff policy, a U.S. Senate committee unanimously passed the "Biosimilar Deregulation Act" to lower barriers to entry into the biosimilar market, raising expectations for global market expansion.
New-drug development is also picking up speed. Celltrion presented ADCs, multispecific antibodies, neonatal Fc receptor (FcRn) agents and obesity treatments as next-generation core new-drug pipelines at the JPMorgan Healthcare Conference early this year. In the first half of this year, major candidates made consecutive progress in clinical and nonclinical stages.
The ADC anticancer new-drug candidates CT-P70, CT-P71 and CT-P73 have all begun dosing patients and entered the clinical stage. The multispecific antibody candidate CT-P72 presented various potential treatments for solid tumors by announcing interim study results at the "World Bispecific Antibody & T Cell Engager Summit South Korea" last month. The next-generation obesity treatment candidate CT-G32 also began primate toxicity studies, entering the final phase of nonclinical development.
The development strategy is also being differentiated. Celltrion is actively using the Fast Track Designation system, which allows close consultation with the U.S. Food and Drug Administration (FDA) from the early stages of development. CT-P70 and CT-P71 have already received fast-track designation, and the company plans to apply for fast-track designation for CT-P72 and CT-P73 within the year.
A Celltrion official said, "The company will continue to expand the development of next-generation biosimilars, including autoimmune disease treatments where it has strengths, to maintain growth," adding, "Based on the global development and production capabilities accumulated through the biosimilar business, we will also continue to expand our new-drug pipeline, including ADCs, multispecific antibodies and obesity treatments, to strengthen our mid- to long-term growth engines."