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Celltrion
Celltrion
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Celltrion Inc. is a South Korean company specializing in the research, development, manufacture, and commercialization of and innovative biologic medicines, with a focus on monoclonal antibodies for treating conditions such as autoimmune diseases, , and infectious diseases. Founded in February 2002 and headquartered in , , Celltrion has grown into one of the world's largest manufacturers, with annual revenues reaching 3.56 trillion KRW in and operating production facilities with a total capacity of 250,000 liters. The company pioneered the global biosimilars market by launching Remsima (infliximab), the world's first , which received approval from the (EMA) in 2013, the U.S. (FDA) in 2016, and the Korean Ministry of Food and Drug Safety (MFDS) in 2012, marking a significant advancement in affordable biologic therapies. Celltrion's portfolio has since expanded to include other key such as Truxima (rituximab, approved by EMA in 2017 and FDA in 2018), Herzuma (, approved by EMA in 2018 and FDA in 2018), Yuflyma (, approved by EMA in 2021 and FDA in 2023), and Vegzelma (, approved by EMA and FDA in 2022), with products now approved in approximately 100 countries and sales accounting for about 87% of its revenue. Celltrion invests approximately 20% of its revenue in research and development, with about 30% of its workforce dedicated to R&D, around 33% of employees holding advanced degrees, and maintains cGMP-certified facilities approved by the FDA and EMA since 2007 and 2015, respectively, enabling high-efficiency production. Its global footprint includes subsidiaries like Celltrion USA (established 2018) and operations across Europe, Asia, and the Americas, supporting one-stop solutions from clinical trials to commercialization; in 2025, it acquired a biopharmaceutical manufacturing facility in New Jersey from Eli Lilly and Co. for US$330 million. In recent years, the company has diversified through mergers, such as the 2023 integration of Celltrion Healthcare, and strategic acquisitions, including Takeda's primary care assets in 2020, while continuing to develop novel therapies like Regkirona (regdanvimab) for COVID-19, approved by the EMA in 2021.

History

Founding and early development

Celltrion was founded in February 2002 by Seo Jung-jin in , , as a startup specializing in the development of biosimilars. The company emerged from a involving Korean investors, including Nexol Co., Ltd., and the U.S.-based VaxGen, Inc., which provided expertise in CHO cell-based monoclonal antibody production. Headquartered in Yeonsu-gu, , Celltrion aimed to address the growing demand for affordable biologic alternatives through innovative manufacturing and research. The precursor to Celltrion's marketing arm was Nexol, Inc., established in 1999 as a global business firm by Seo and former colleagues from . Nexol evolved to support ventures and later rebranded as Celltrion Healthcare Co., Ltd. in 2009, focusing on the commercialization and distribution of Celltrion's products. In its early years, Celltrion prioritized operations as a (CMO), securing key agreements such as a supply deal with Bristol-Myers Squibb in 2005 to produce biologics. The company also invested heavily in R&D for monoclonal antibodies, completing its first 50,000-liter production plant in 2005 and obtaining U.S. FDA cGMP approval for the facility in 2007. A pivotal early achievement came in 2008 when Celltrion, through its IPO on the , raised capital to fuel expansion and established a global distribution agreement with Nexol (later Celltrion Healthcare) to market its worldwide. This partnership laid the groundwork for international outreach, enabling distribution channels in regions like and by 2009. Building on these foundations, Celltrion advanced its product development, culminating in the July 2012 approval by the Korean Ministry of Food and Drug Safety (MFDS) for Remsima, its version of , marking the first such approved in Korea.

Major milestones and expansions

Celltrion achieved a significant breakthrough in 2013 when the (EMA) granted marketing authorization for Remsima (), marking it as the world's first approved for treating autoimmune diseases such as and . This approval, issued on September 10, 2013, alongside the similar product Inflectra, demonstrated the feasibility of development for complex biologics and paved the way for broader market access to affordable treatments. In October 2023, the U.S. (FDA) approved Zymfentra (-dyyb), a subcutaneous formulation of Celltrion's , for maintenance therapy in adult patients with moderately to severely active or who responded to intravenous induction therapy. This marked the first FDA approval for a subcutaneous product, offering greater convenience for patients by reducing the need for visits. Celltrion completed a major internal merger on December 28, 2023, integrating Celltrion Inc. with its subsidiary Celltrion Healthcare to streamline , , and global operations for enhanced efficiency in the biosimilars market. The merger, approved by shareholders in October 2023, aimed to consolidate resources and boost competitiveness amid growing global demand. In 2024, Celltrion expanded its Southeast Asian footprint by establishing a local , Celltrion Vietnam Corporation, on September 30, to facilitate regulatory approvals and distribution of key biosimilars like Remsima and Herzuma in the region's burgeoning market. Later that year, on October 22, the company secured a $72.8 million contract development and manufacturing organization (CDMO) agreement with for the production of Ajovy (), a treatment, underscoring its growing role in biologics contract services. Celltrion further strengthened its European presence in November 2024 by acquiring iQone Healthcare , a specialty pharmaceutical , for approximately $21.3 million, with the deal closing in the fourth quarter to enhance distribution networks for its biosimilars across key markets. In September 2025, Celltrion signed an agreement to acquire Eli Lilly's facility in , for $330 million, aiming to bolster its North American production capacity and support partnerships. The acquisition, completed by November 2025 following regulatory approvals, includes an ongoing CMO with Lilly to ensure immediate revenue generation and mitigate risks in the U.S.

Business operations

Research and development

Celltrion's efforts emphasize the creation of and novel biologics, building on over two decades of investment in platforms since the company's founding in 2002. As a pioneer in the industry, Celltrion has focused on developing high-quality alternatives to originator biologics, particularly in and , while expanding into innovative therapeutics to address unmet medical needs. This long-term commitment has enabled the company to launch the world's first and establish a robust pipeline of next-generation biologics. Key technologies developed by Celltrion include the CT-P13 platform, which underpins its infliximab biosimilars such as Remsima and Inflectra, demonstrating comparable efficacy and safety to the reference product in and other indications. The company has also advanced subcutaneous formulations to improve convenience and treatment adherence; for instance, CT-P13 SC represents the first subcutaneous approved in multiple regions, supported by Phase III data showing sustained remission in patients. These innovations in delivery systems, including high-concentration formulations, facilitate easier administration outside clinical settings. Celltrion collaborates with global partners to conduct clinical trials, including Phase III studies in and . For example, partnerships with companies like Kaigene and MustBio support the development of novel antibodies for autoimmune diseases and multispecific immunotherapies, respectively, through joint R&D agreements that leverage combined expertise in preclinical and clinical phases. These collaborations have facilitated large-scale trials, such as the Phase III study for its Avtozma, which confirmed efficacy in . The company invests heavily in emerging drug platforms, including antibody-drug conjugates (ADCs) and bispecific antibodies, with plans to submit applications for 13 novel candidates by 2028—nine ADCs and four multispecific antibodies targeting solid tumors and immune disorders. This strategic shift builds on in-house antibody engineering and external licensing deals, such as the preclinical tetravalent bispecific antibody CT-P72/ABP-102 developed with Abpro for HER2-positive cancers. Celltrion operates its primary R&D center in , , with additional global facilities supporting international research activities, and allocates approximately 20% of its annual revenue to , funding advancements in biologics and platform technologies. A notable outcome of these efforts is the 2025 U.S. FDA designation of interchangeability for Celltrion's biosimilars, Stoboclo and Osenvelt, allowing substitution for Prolia and Xgeva in and treatments based on Phase III evidence of equivalent and .

Manufacturing and global facilities

Celltrion's headquarters and primary manufacturing operations are based in , , where the company maintains multiple (GMP)-certified plants dedicated to biologics production. These facilities, located in the International Business District, support large-scale production of monoclonal antibodies, including fill-finish operations, with a total capacity of 250,000 liters across three main plants: Plant 1 (100,000 liters), Plant 2 (90,000 liters), and Plant 3 (60,000 liters). The sites hold certifications from the U.S. Food and Drug Administration (FDA) and the (EMA) for current GMP compliance, achieving a production success rate exceeding 99%. In February 2025, Celltrion received approval to construct a new drug product manufacturing plant in , aimed at advancing bioprocessing capabilities and increasing overall capacity to meet global demand. To enhance its Asia-Pacific supply chain, Celltrion established a local subsidiary in Vietnam in 2024, enabling improved distribution and market penetration for its biologics portfolio in the region; in August 2025, the company launched key biosimilars including trastuzumab (Herzuma) and infliximab (Remsima) in Vietnam. In a strategic move to localize production and address potential U.S. risks, Celltrion completed the acquisition of and Company's manufacturing facility in , on November 11, 2025, for approximately $330 million. This 45,000-square-meter campus represents the company's first U.S.-based biologics plant, with existing FDA approvals facilitating a swift integration into operations and plans for further investments exceeding $500 million to expand capacity. Beyond internal production, Celltrion offers contract development and manufacturing organization (CDMO) services to partners like , prioritizing stringent quality control and scalable processes for biologics. A notable example is the October 2024 agreement with Teva worth $72.8 million for the development and manufacturing of a treatment.

Products and pipeline

Approved biosimilars

Celltrion's approved biosimilars represent a significant portion of its portfolio, focusing on high-impact biologic therapies for autoimmune diseases, , and . These products have gained regulatory approvals across major markets, demonstrating comparable , , and to their biologics through rigorous clinical studies. By 2025, the company has secured approvals for multiple biosimilars, contributing to expanded access and cost savings in treatment regimens. Remsima/Inflectra (infliximab-dyyb) is Celltrion's flagship to Janssen's Remicade, approved in in 2012 by the Ministry of Food and Drug Safety, by the (EMA) in September 2013 under the name Remsima, and by the U.S. (FDA) in April 2016 as Inflectra. It is indicated for the treatment of , , and , among other inflammatory conditions, administered via intravenous infusion. Herzuma (trastuzumab-pkrb), a to Roche's Herceptin, received FDA approval in December 2018. It targets HER2-positive and gastric cancer, offering an alternative for patients requiring targeted . Truxima (rituximab-abbs), referencing Roche's Rituxan, was approved by the EMA in February 2017 and by the FDA in November 2018. This is used for and , providing options for B-cell depletion in and autoimmune settings. Vegzelma (bevacizumab-adcd), a to /Genentech's Avastin, received FDA approval in September 2022. It is indicated for metastatic , non-squamous non-small cell , , , , and epithelial ovarian/fallopian tube/primary peritoneal cancer, administered via intravenous infusion. Yuflyma (adalimumab-aaty), a high-concentration, citrate-free to AbbVie's Humira, earned FDA approval in May 2023. It addresses autoimmune diseases including plaque and , with for improved patient convenience. Zymfentra (infliximab-dyyb SC) is a subcutaneous of , approved by the FDA in October 2023 specifically for maintenance therapy in adults with moderately to severely active and . This innovation allows for at-home self-administration following induction with intravenous infliximab, enhancing treatment adherence in management. Steqeyma (ustekinumab-stba), to Janssen's Stelara, was approved by the FDA in December 2024, with an additional 45 mg/0.5 mL single-dose for pediatric use approved in June 2025. Indications include moderate-to-severe plaque psoriasis and active in both adults and children aged 6 years and older. Avtozma (tocilizumab-anoh), a to Genentech's Actemra, received FDA approval in January 2025 for intravenous and subcutaneous formulations. It is indicated for , , systemic , and associated with CAR T-cell therapy, among other conditions. Omlyclo (omalizumab-igec), a to Novartis/Genentech's Xolair with interchangeability designation, was approved by the FDA in March 2025. It is indicated for moderate-to-severe persistent , chronic with nasal polyposis, , and IgE-mediated , administered subcutaneously. Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), biosimilars referencing Amgen's Prolia and Xgeva, respectively, were approved by the FDA on February 28, 2025, with interchangeability designation granted on October 30, 2025. Stoboclo is indicated for increasing bone mass in postmenopausal women with at high risk for and in men with ; Osenvelt for prevention of skeletal-related events in patients with and bone metastases from solid tumors. Both are administered subcutaneously. EYDENZELT (aflibercept-boav), referencing Regeneron/Bayer's Eylea, received FDA approval in October 2025 as the company's first ophthalmic . It is indicated for wet age-related , diabetic macular edema, and other retinal vascular conditions, administered via intravitreal injection to inhibit . By November 2025, Celltrion has achieved 12 FDA-approved , establishing global sales leadership in categories such as and rituximab biosimilars, driven by strong in Europe and the U.S. These products have facilitated broader access to affordable biologics, with notable uptake in high-volume indications like and .

Development pipeline

Celltrion's development pipeline encompasses over 20 candidates as of 2025, spanning biosimilars and biologics primarily in , , and , with a growing emphasis on innovative modalities such as antibody-drug conjugates (ADCs) and multispecific antibodies. Following the 2023 merger of Celltrion with its affiliate Celltrion Healthcare, the company has shifted strategically toward biologics, allocating merged resources for large-scale investments in new to diversify beyond biosimilars and enhance long-term growth. This evolution includes plans to submit 13 (IND) applications by 2028, focusing on nine ADCs and four multispecific antibodies to address unmet needs in these therapeutic areas. Celltrion is also co-developing next-generation VEGF-targeted therapies, such as a triple fusion combining PD-1, VEGF, and IL-2v targets, through a partnership with MustBio announced in 2025. In the novel pipeline, Celltrion is advancing bispecific antibodies for and autoimmune diseases, currently in early clinical or preclinical stages. For , CT-P72 (in collaboration with Abpro) is a tetravalent HER2×CD3 bispecific T-cell engager targeting solid tumors like breast and gastric cancer, with preclinical data presented at SITC 2025 and Phase I trials planned for 2026. In autoimmune indications, recent licensing deals include two preclinical bispecific or multispecific antibodies from Kaigene, valued at up to $744 million, aimed at inflammatory conditions with IND submissions targeted for 2026–2028. These efforts build on Celltrion's expertise, such as the recently approved CT-P47 (Avtozma®), which completed Phase III for and received FDA approval in early 2025, to inform novel bispecific designs.

Corporate structure

Governance and leadership

Celltrion's governance is led by its founder and honorary chairman, Seo Jung-jin, who established the company in 2002 and has guided its growth into a global leader. As of April 2025, Seo is ranked among South Korea's wealthiest individuals, with a of approximately US$6.3 billion, placing him fourth on ' list of Korea's 50 Richest. In recognition of his entrepreneurial achievements, Seo was awarded the EY World Entrepreneur of the Year in 2021, highlighting his role in pioneering development from modest beginnings with an initial investment of US$45,000. The company's operational leadership is headed by CEO Woo-sung Kee, who has served in the role since 2015 and assumed broader oversight following the 2023 merger of Celltrion with its sales affiliate, Celltrion Healthcare, which integrated key divisions under his direction. This merger streamlined , with Kee focusing on , R&D integration, and commercialization strategies. The 2025 corporate split separating the business from the R&D arm has reinforced this leadership structure by clarifying divisional accountabilities without altering top executive roles. Celltrion's comprises a balanced mix of internal executives and independent directors to ensure robust oversight. Key internal members include joint chairpersons Jung-jin Seo and Jin-seok Seo, CEO Woo-sung Kee, and co-CEO Hyoung-ki Kim, alongside independents such as Jae-sik Lee and Min-cheol Shin. The board operates through specialized committees, including those for audit, compensation, and R&D oversight, which review financial reporting, executive remuneration, and innovation pipelines to align with strategic objectives. Major shareholders include Celltrion Holdings Co., Ltd., holding 25.1% of shares, and the of Korea with 6.96%, providing stable institutional support for long-term . policies emphasize environmental, social, and governance (ESG) compliance, with annual reports disclosing performance metrics and commitments to sustainable practices. The company prioritizes ethical R&D through adherence to global standards like the Pharmaceutical Supply Chain Initiative, ensuring transparency in development processes, including disclosures and audits. In November 2025, minority shareholders initiated a campaign urging Chairman Seo Jung-jin to cancel treasury share purchases and address certain sales claims, reflecting ongoing discussions on .

Subsidiaries and acquisitions

Celltrion Healthcare Co., Ltd., historically responsible for the global marketing, sales, and distribution of Celltrion's biologics, was merged into the parent company Celltrion Inc. in December 2023 to streamline operations and enhance efficiency in the biosimilars market. Celltrion Pharm Inc., an affiliate focused on the development and commercialization of chemical-based pharmaceuticals and formulations in , had been slated for integration into Celltrion following the Healthcare merger, but the planned merger was canceled in August 2024 due to shareholder opposition. In the United States, Celltrion USA Inc., established in 2018 and headquartered in , manages North American operations, including regulatory interactions with the FDA and commercialization of biosimilars. This subsidiary acquired ImClone Systems LLC from in September 2025 for approximately $330 million, gaining a biologics manufacturing facility in , to bolster U.S. production capacity and mitigate potential trade tariffs. To strengthen its European footprint, Celltrion announced the acquisition of iQone Healthcare in November 2024 for around 30 billion won ($21 million); upon completion in Q4 2024, iQone became a wholly owned of Celltrion Healthcare Kft., enabling accelerated direct commercialization of biosimilars and to innovative therapies in . Celltrion has pursued strategic partnerships for co-development and licensing, notably an exclusive 2016 commercial collaboration with Teva Pharmaceutical Industries Ltd. to market Celltrion's biosimilars of rituximab (Truxima) and (Herzuma) in the U.S. and , involving an upfront payment of $160 million to Celltrion.

Financial performance

Historical overview

Celltrion experienced early financial challenges in the , operating as a development-stage enterprise with significant losses due to substantial investments in , development, and production facilities following its founding in 2002. These losses were gradually offset in the through improved profitability, fueled by strategic global partnerships that facilitated market entry and of its biosimilars. A key milestone came with Celltrion's on the in 2008, which provided capital for facility expansions and R&D acceleration, though subsequent funding rounds and affiliate listings in the mid-2010s further supported growth. Between 2013 and 2018, the company's revenue surged due to major regulatory approvals, including the European Medicines Agency's endorsement of Remsima in 2013 and the U.S. Food and Drug Administration's approvals for Inflectra (Remsima's U.S. version) in 2016 and Truxima in 2018, enabling broader international sales. In 2017, Celltrion reported consolidated revenue of ₩949 billion, of ₩401 billion, and total assets of ₩3.46 trillion, reflecting strong momentum from initial market penetration. Prior to the 2023 merger of its affiliates, Celltrion Inc. primarily generated revenue from manufacturing and supplying biopharmaceuticals, while Celltrion Healthcare focused on royalties and distribution proceeds from global sales. The company's growth trajectory accelerated with biosimilar launches, culminating in consolidated group revenue exceeding ₩2 trillion by 2022, driven by robust sales of Remsima and Truxima in key markets like and the U.S. This historical foundation set the stage for post-2023 merger synergies, which integrated operations for enhanced efficiency.

Recent results and key metrics

In 2024, Celltrion achieved record annual revenue of 3.56 trillion (KRW), marking a 63.5% increase from the previous year, primarily driven by strong sales growth from the launch of its subcutaneous Zymfentra (infliximab-dyyb) and initial following the U.S. FDA approval of Steqeyma (ustekinumab-stba) in December 2024. For the third quarter of 2025 (ended September 30, 2025), Celltrion reported record quarterly revenue of 1.03 KRW (up 16% year-over-year), operating profit of 301 billion KRW (up 45% year-over-year), and net income of 331.9 billion KRW (up 294.7% year-over-year), driven by high-margin sales. The company projects full-year 2025 revenue exceeding 4 KRW, with internal targets reaching up to 5 KRW, supported by the completion of its U.S. manufacturing site acquisition from —agreement signed in September 2025 with regulatory approval completed in November 2025—and expanded sales of new such as Eydenzelt (aflibercept-boav), approved by the FDA in October 2025. Key performance metrics as of late 2025 include a surpassing 37 trillion KRW (over $27 billion USD), bolstered by a minor 1.04:1 in June 2025, and EBITDA margins approaching 40% for high-margin products, reflecting operational efficiency gains from portfolio optimization. Significant financial impacts in the period include a 100.4 billion KRW ($72.8 million USD) contract development and manufacturing organization (CDMO) deal signed with in October 2024 for the migraine drug Ajovy, expected to generate upfront and milestone revenues, and the $330 million USD acquisition of Eli Lilly's facility—agreement signed in September 2025 with regulatory approval completed in November 2025—financed through a combination of subsidiary equity contributions and planned bond issuances totaling approximately $500 million USD for acquisition and initial expansion. Celltrion's shares (KRX: 068270.KS) have shown volatility influenced by regulatory milestones, including a positive response to the FDA approval of Eydenzelt in October 2025, contributing to a year-to-date performance of approximately 1.5% as of 2025. Analyst price targets for Celltrion are typically for the next 12 months rather than specific long-term years such as 2026. As of late 2025, the consensus target prices are generally in the range of 200,000 to 250,000 KRW based on short-term forecasts. No specific consensus or analyst target price for 2026 is widely published in reliable sources, with longer-term projections varying by brokerage and often based on models such as discounted cash flow (DCF) or earnings growth assumptions.

References

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