Celltrion

A new post-hoc analysis from the LIBERTY studies, presented at ECCO 2026, demonstrated that initiating subcutaneous (SC) infliximab (Remsima™ SC) after a treatment interruption following intravenous (IV) infliximab induction helps patients with Crohn’s disease (CD) and ulcerative colitis (UC) recapture and maintain disease control1The results demonstrated that SC infliximab provides an effective and safe option to regain clinical control after a planned or unplanned treatment interruptionMore than a total of 30 accepted abstracts including one oral and one digital oral presentation and eight posters, reinforce Celltrion’s commitment to inflammatory bowel disease (IBD) research aimed at enhancing patient outcomes INCHEON, South Korea - Celltrion, Inc. today announced new data from a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), showing that subcutaneous (SC) infliximab restored and maintained response in most Crohn’s disease (CD) and ulcerative colitis (UC) patients with sustained efficacy, safety, and persistence through to Week 102.1 The data will be presented as a poster presentation at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO), to be held from February 18-21 in Stockholm, Sweden. “As immunogenicity is the most significant concern when restarting treatment with infliximab after an interruption, these results suggest that treatment persistence was maintained even in patients with immunogenicity,” said Dr. Marla Dubinsky, Professor of Pediatrics and Director of the IBD Center at the Icahn School of Medicine at Mount Sinai. “It's reassuring to see that not only can we effectively recapture disease control with a convenient subcutaneous option, but that this response was seen early and was shown to be maintained through Week 102 in a post-hoc analysis from the pivotal LIBERTY studies. This is a significant finding for patients, as it offers a potentially reliable strategy for providers and transformative opportunity for patients to manage their IBD journey even when treatment is interrupted.” “In clinical practice, patients may experience treatment interruption for clinical and non-clinical reasons, and initiation of treatment demands careful consideration of the risks,” said Professor Stefan Schreiber, University Hospital Schleswig-Holstein, Department of Medicine I, Kiel, Germany. “This data provides evidence that subcutaneous infliximab can effectively and safely recapture disease control, offering a viable treatment option for both clinicians and patients.” The analysis evaluated the efficacy and safety of starting SC infliximab 240mg in patients, randomised to the placebo maintenance arm in the Phase 3 LIBERTY studies, who had previously completed intravenous (IV) infliximab induction and subsequently experienced a drug holiday of 16 weeks or more before starting SC infliximab due to disease progression. Among 51 CD and 77 UC patients who initiated treatment with SC infliximab, clinical response was observed early by 8±2 weeks and was maintained through the study. At the end of the treatment, 61.1% in CD and 65.2% in UC patients achieved faecal calprotectin remission, and 64.0% in CD and 68.8% in UC patients achieved endoscopic response/ improvement. Persistence in treatment end was 72.3% of CD patients and 61.9% of UC patients. Serum infliximab levels increased after initiating SC infliximab and remained stable through Week 102, with no new safety concerns observed. The results demonstrated that initiation of treatment with SC infliximab 240 mg was effective to recapture and maintain disease control for Crohn’s disease (CD) and ulcerative colitis (UC) patients, suggesting SC infliximab provides an effective and safe option to regain clinical control after a planned or unplanned treatment interruption. Additionally, Celltrion will host a satellite symposium titled, “Enhancing Patient Management with Subcutaneous Infliximab: Practical Insights & Discussion.” on Friday, February 20 from 12:45 to 13:25, in Room A12 at Stockholmsmässan. Chaired by Professor Jean-Frédéric Colombel, the symposium will feature presentations from Professor Anthony Buisson and Professor Axel Dignass. “The comprehensive data from the studies reinforces the growing body of evidence supporting subcutaneous infliximab as a critical treatment option for the gastroenterology community,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “The data presented at ECCO 2026 further demonstrate our leadership and long-standing commitment to raising standards of care in gastroenterology and to improving the lives of people with Inflammatory Bowel Disease.” Notes to Editors: About the subcutaneous (SC) formulation of CT-P13CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.2,3 In July 2024, CT-P13 SC received final approval from the European Commission for an additional dosing regimen and dose escalation, which allows 3-intraveneous (IV) induction dosing regimen and dose escalation of subcutaneous maintenance dose from CT-P13 SC 120 mg Q2W to 240 mg Q2W for patients with loss of response.4 Long term data from two-year extension of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) have demonstrated sustained efficacy and safety of CT-P13 SC, with clinical remission, response, and corticosteroid-free remission generally maintained through Week 102.5 About CelltrionCelltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", “anticipates”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. References____________________1 Colombel JF et al., Recapturing disease control with subcutaneous infliximab after a drug holiday following intravenous infliximab induction: A post hoc analysis of LIBERTY-CD and -UC studies. Poster Presentation (P0832) at ECCO 2026.2 Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353.3 Westhovens R et al., Rheumatology. 2021;60(5):2277-2287.4 European Medicines Agency. Remsima - Summary of Product Characteristics (SmPC). [Accessed January 2026]5 Colombel JF et al., Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Crohn’s Disease and Ulcerative Colitis: 2-Year Results from Open Label Extensions of Two Randomized Controlled Trials (LIBERTY). Journal of Crohn’s and Colitis. 2025;19(6):jjaf060.

- Celltrion will proactively amend its Articles of Incorporation to reflect the intent of the pending Commercial Act revision and submit a proposal for the cancellation and utilization of treasury shares at the upcoming AGM.- The Company plans to cancel 65% of its treasury shares, excluding those reserved for employee compensation, while the remaining 35% will be utilized to secure future growth drivers.- The planned cancellation of 6.11 million shares exceeds the volume of treasury shares repurchased in 2024–2025, demonstrating the Company’s commitment to responsible shareholder returns.- Celltrion will also adopt cumulative voting, an independent director system, an expanded number of separately elected outside directors, and electronic shareholders’ meetings in advance to strengthen shareholder rights protection. INCHEON, South Korea - Celltrion announced today that it will submit agenda items to its upcoming Annual General Meeting of Shareholders (AGM) to manage the cancellation, retention, and utilization of treasury shares under a structured framework, as part of its effort to strengthen corporate competitiveness and enhance shareholder value. In its notice of convocation, the company disclosed that it will hold its 35th Annual General Meeting of Shareholders on March 24 and submit agenda items including approval of the treasury share cancellation and disposal plan, partial amendments to the Articles of Incorporation, appointment of directors, and approval of the financial statements including a cash dividend of KRW 750 per share. Celltrion plans to revise its Articles of Incorporation and obtain shareholder approval to clarify the legal basis for treasury share cancellation and disposal. The Company also aims to eliminate potential market uncertainty and maintain a transparent disclosure framework. In addition, the amendments will proactively incorporate the intent of the government-proposed Commercial Act revision by introducing an independent director system, mandatory cumulative voting, an increased number of separately elected outside directors, and electronic shareholders’ meetings, thereby strengthening shareholder rights protection. Celltrion intends to retain approximately 3 million shares out of its current treasury holdings of approximately 12.34 million shares for employee compensation purposes, including stock options already granted. This measure reflects shareholders’ requests to utilize treasury shares instead of issuing new shares for stock option exercises. Excluding the portion retained for stock option purposes, approximately 6.11 million shares, representing 65% of the Company’s treasury share holdings, will be cancelled, while the remaining approximately 3.23 million shares (35%) will be utilized to secure future growth drivers. After announcing that it would cancel all treasury shares acquired in 2025, Celltrion has already cancelled approximately 1.96 million shares. If the additional cancellation of 6.11 million shares is finalized, the total will exceed the entire amount repurchased in 2024 (2.39 million shares) and the remaining 2025 repurchases (2.98 million shares), and will also include shares acquired prior to 2023. The additional 6.11 million shares scheduled for cancellation correspond to approximately KRW 1.4633 trillion based on the closing price as of February 11. Funds secured through monetization will be utilized to strengthen capabilities necessary for Celltrion’s future growth, including development and acquisition of new technologies and investment in manufacturing facilities. Given the nature of the biopharmaceutical industry, where new drug development significantly impacts corporate value, the Company plans to deploy these resources as strategic investments to enhance mid- to long-term competitiveness. “This treasury share proposal reflects our commitment to embracing the intent of the Commercial Act revision currently under discussion in the National Assembly, establishing a transparent treasury share management framework, and prioritizing shareholder value,” a Celltrion official said. “We will remain committed to shareholders while securing future growth drivers and advancing toward becoming a global biopharmaceutical leader.” 

Stoboclo listed as a preferred product on the CVS Caremark formulary, with originator products excluded, supporting accelerated uptakeOsenvelt, previously listed on CVS Caremark, secures a competitive advantage as the only biosimilar designated as a preferred productListings secured with three major PBMs within seven months of launch, achieving over 60% reimbursement coverage in the U.S.Celltrion remains focused on accelerating sales through a field-based direct sales strategy and strong product competitiveness INCHEON, South Korea-  Celltrion announced today that Stoboclo (denosumab), its biosimilar treatment for bone-related diseases, has been listed as a preferred product on the formulary of CVS Caremark, one of the three largest pharmacy benefit managers (PBMs) in the United States. With this listing, Celltrion has successfully completed preferred formulary placement on CVS Caremark for both biosimilars referencing Prolia and XGEVA. As a result of its preferred status, patient reimbursement for Stoboclo will commence on April 1 (local time), providing a solid foundation for expanding market share in the U.S. In particular, the listing of Stoboclo has been accompanied by the exclusion of the originator products from the CVS Caremark formulary, which is expected to further accelerate prescribing. The decision reflects CVS Caremark’s assessment of Stoboclo’s product competitiveness and is expected to have a positive impact on ongoing formulary discussions with other PBMs and insurers. Meanwhile, Osenvelt, which was listed on the CVS Caremark formulary ahead of Stoboclo, has been designated as the sole biosimilar preferred product, securing a clear competitive advantage. As the only reimbursed biosimilar for CVS Caremark members in its oncology indication, Osenvelt is expected to further strengthen its market position and drive prescription growth. With both Stoboclo and Osenvelt listed on CVS Caremark, Celltrion expects favorable prescribing conditions to extend across healthcare services under CVS Health, the parent company of CVS Caremark. CVS Health is one of the leading integrated healthcare companies in the U.S., operating across PBMs, pharmacy networks, health insurance, and healthcare services, and holds significant influence across the healthcare value chain. Through this achievement, Stoboclo and Osenvelt have been listed as preferred products on formularies managed by three major PBMs, including two of the three largest PBMs in the U.S. and another large PBM ranked among the top five by market share. This milestone was achieved within approximately seven months of their launch in July 2025, and is estimated to have secured reimbursement coverage exceeding 60% of the U.S. market. The outcome is largely attributable to Celltrion USA’s field-oriented commercial strategy, which focused on targeted engagement with PBMs, healthcare professionals, and key institutions from the early stages of launch. In parallel, Celltrion plans to continue expanding its presence in the U.S. open market, which accounts for approximately 30% of the total denosumab market. The open market primarily comprises healthcare institutions supported by U.S. government programs, where pharmaceutical companies’ sales capabilities and product value play a decisive role. Building on its experience from the successful direct sales of its oncology biosimilar Vegzelma (bevacizumab), Celltrion intends to actively leverage its accumulated commercial expertise to support the uptake of Stoboclo and Osenvelt. “The preferred formulary listing of Stoboclo and Osenvelt with CVS Caremark has established a stable prescribing foundation that supports sales expansion. As Celltrion continues to receive positive evaluations from multiple major U.S. PBMs, we will actively leverage the local commercial networks built through our existing product portfolio to strengthen the early market positioning of Stoboclo and Osenvelt.”said an official at Celltrion. Meanwhile, Stoboclo and Osenvelt received FDA approval in March 2025 for all approved indications (full label), consistent with those of the reference products. The originator products recorded combined global sales of approximately USD 6.6 billion in 2024, of which approximately USD 4.4 billion, or 67%, was generated in the U.S. market.