Celltrion

- The FDA’s move to streamline PK testing and expand the use of non-U.S.-licensed comparator products is expected to reduce total clinical development costs by up to 25%.- Leveraging its internalized capabilities, Celltrion plans to expand its portfolio to include products targeting small and mid-sized markets, further strengthening economies of scale.- Celltrion plans to expand its biosimilar portfolio to 41 products by 2038, with the number of products under development expected to increase rapidly.- With capabilities spanning development, manufacturing and direct sales, Celltrion is well positioned to benefit from the regulatory changes. INCHEON, South Korea – Celltrion announced today that it will immediately incorporate newly announced global regulatory updates aimed at streamlining biosimilar development into its ongoing pipeline programs, with the goal of significantly reducing development costs and timelines. The company expects that the latest policy changes, combined with its expanding multi-product portfolio, will serve as a catalyst for achieving unprecedented economies of scale across its biosimilar business.The U.S. Food and Drug Administration (FDA) recently announced the fourth revision of the “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act,” aimed at streamlining the biosimilar development process. The revised draft guidance recommends streamlining clinical pharmacokinetic (PK) testing typically conducted during Phase 1 trials when scientifically justified. One of the most notable revisions involves the relaxation of comparator product requirements. Previously, biosimilar developers seeking approval in the United States were required to conduct direct PK comparison studies using a U.S.-licensed reference product. Under the updated guidance, however, comparative clinical data generated using a comparator product approved outside the United States may also be accepted to support a demonstration of biosimilarity. This change is expected to significantly reduce development costs, particularly in the immuno-oncology field where reference biologics are extremely expensive. Celltrion maintains strong competitiveness in this area with multiple products currently under development. The company therefore expects this measure alone could reduce overall clinical development costs by up to 25%. When combined with the FDA’s draft guidance issued in October last year aimed at reducing or waiving certain Phase 3 clinical studies, the overall cost-saving effect across the development process is expected to increase further. Although the revised guidance remains in draft form, Celltrion believes it reflects the FDA’s latest perspective, and plans to immediately apply the updated regulatory approach to its ongoing development programs to significantly shorten development timelines and reduce costs. Even prior to the regulatory changes, Celltrion has maintained industry-leading cost competitiveness through its integrated capabilities spanning development, manufacturing and direct sales. With a direct sales network already established across most key markets and additional savings expected from reduced clinical and comparator product costs, this cost advantage is expected to strengthen further. Celltrion also views the regulatory streamlining not merely as a cost-reducing measure, but as a strategic lever to achieve larger economies of scale across its entire product portfolio. By reinvesting resources saved through streamlined clinical requirements into additional pipeline development, the company expects to accelerate the expansion of its mid- to long-term product portfolio, including products targeting small and mid-sized markets that were previously difficult to pursue due to high clinical development costs. Streamlined regulatory requirements for clinical data and approval procedures are elevating the importance of expertise in antibody analytics, comparability assessment and process development, thereby favorably positioning companies like Celltrion who possess robust early-stage development capabilities. Beyond the 11 biosimilar products currently marketed globally, Celltrion plans to expand its portfolio to 41 products by 2038. Through this expansion, the company expects to target a global market projected to exceed KRW 400 trillion, more than four times larger than the KRW 85 trillion addressable market recorded last year. Celltrion believes that the recent global trend toward regulatory streamlining could support a further expansion of its product development plans. Key disclosed pipeline programs include CT-P53 (Ocrevus biosimilar), CT-P55 (Cosentyx biosimilar), CT-P52 (Taltz biosimilar) in autoimmune diseases, as well as CT-P51 (Keytruda biosimilar) and CT-P44 (Darzalex biosimilar) in oncology. In addition, more than 20 additional pipeline programs remain undisclosed. Notably, Celltrion recently reduced Phase 3 clinical trial enrollment for CT-P55 from 375 patients to 153, reflecting the impact of regulatory streamlining and suggesting the potential for faster development timelines. “The global trend toward regulatory streamlining presents a significant opportunity for Celltrion, which possesses strong early-stage development capabilities, large-scale manufacturing capacity and a global direct sales network,” a Celltrion official said. “By reinvesting the cost savings to further expand our pipeline, we aim to achieve greater economies of scale and strengthen our cost competitiveness as we continue advancing toward becoming a leading global biopharmaceutical company.”

- Early performance demonstrated with national tender wins in Norway and Denmark… Secured 35% share of the IV market in the Netherlands- The world’s first and only infliximab liquid formulation… Patent registrations completed across most European countries including the EU5- Continued field-friendly marketing activities through formulation innovation reflecting clinical needs… Enhancing brand value- The world’s first and only full infliximab portfolio of IV and SC formulations… “Will continue innovation in biosimilar products” [March 11, 2026, KST] Celltrion today announced the European launch of the liquid formulation of Remsima (infliximab), strengthening its leadership in the infliximab market. The infliximab liquid formulation is uniquely held by Celltrion globally and is supported by registered patents. As a newly introduced formulation reflecting clinical needs, it is expected to further reinforce Remsima’s influence through enhanced product competitiveness and expanded market impact. Celltrion’s Nordic affiliate achieved early success by securing contracts with the Remsima intravenous (IV) liquid formulation in infliximab national tenders held in Denmark and Norway. Following the European approval of the Remsima IV liquid formulation in November last year, the local affiliate had prepared in advance to ensure product distribution through key national tenders. As a result, sales in Norway began immediately after the tender award, with supply planned through January 2028. Through this, the product is expected to secure approximately 35% share of the infliximab IV market in Norway. The Remsima liquid formulation expands treatment options by reflecting clinical needs, alongside the existing Remsima IV (100 mg lyophilized formulation) and Remsima SC. In European clinical settings, there has been continuous demand for a multi-dose liquid formulation that enables more efficient storage and management while reducing the complexity of the preparation process. Reflecting these needs, Celltrion has introduced the Remsima 350 mg liquid formulation, while continuing to strengthen field-focused sales and marketing activities. With the field-friendly Remsima liquid formulation, healthcare institutions are expected to benefit from administrative and cost efficiencies, further strengthening the competitiveness of the Remsima portfolio. Compared with the lyophilized formulation, the liquid formulation can reduce preparation time by approximately 50%, while lowering labor and consumable costs by around 20% during drug preparation. In addition, storage space and related storage costs can be reduced by up to 70%, generating strong interest across Europe from the early stage of launch. The recent national tender award in Norway also reflects recognition of these advantages and is expected to serve as a new competitive strength for Remsima in Europe, where tender markets represent a significant portion of demand. Celltrion has also filed patents for the Remsima liquid formulation and has completed patent registrations in most European countries, including the EU5 markets such as the UK, Germany and France. As Remsima is the only infliximab product available in a liquid formulation, its differentiated competitiveness is expected to further strengthen its influence in the infliximab market. Following the development and commercialization of the world’s first infliximab SC formulation, Celltrion has now secured the IV liquid formulation, becoming the only company globally to establish a full portfolio of infliximab IV (lyophilized and liquid) and SC formulations. Based on this, the company aims to further strengthen brand trust in Remsima in the infliximab market, expand prescriptions across both Remsima IV and SC, and enhance profitability. In addition, Celltrion plans to continue product innovation reflecting clinical needs while reinforcing its differentiated corporate image with unique competitiveness in the biosimilar market. Starting with the Nordic region, Celltrion plans to expand the launch of the Remsima liquid formulation across Europe this year, including France, the Netherlands and the Czech Republic, further strengthening its leadership in the infliximab market. According to pharmaceutical market research firm IQVIA, the Remsima portfolio (IV and SC) maintained the No.1 position in infliximab prescriptions in Europe with a 68% market share as of Q3 last year. Based on the strengthened Remsima portfolio with a full formulation lineup, Celltrion plans to continue strengthening its market position while addressing diverse clinical needs. “As trust in Celltrion continues to build in the European biosimilar market, the Remsima liquid formulation reflects clinical needs and has demonstrated its competitiveness by securing tender wins immediately after launch," said Seung-doo Baek, Head of Celltrion’s Nordic affiliate. "Going forward, we will continue field-focused sales and marketing activities to provide better treatment options for patients and healthcare professionals in Europe while further expanding prescriptions.”

- Celltrion plans to expand treasury share cancellation to 9.11 million shares by adding 3 million shares originally reserved for employee compensation to the previously announced 6.11 million shares.- The total treasury share cancellation amounts to KRW 1.9268 trillion, representing the cancellation of 74% of the company’s total treasury shares to enhance shareholder value.- The decision reflects a proactive response to market volatility amid rising geopolitical risks and uncertainties, while reaffirming the company’s commitment to prioritizing shareholder value.- “We are prioritizing shareholder value amid heightened uncertainties and will make every effort to achieve this year’s revenue target of KRW 5.3 trillion,” a Celltrion official said. INCHEON, South Korea – Celltrion announced today that it has decided to expand treasury share cancellation to approximately 9.11 million shares and disclosed a revision to the agenda for its upcoming annual general meeting of shareholders. Based on the closing price on March 5, the total value of the shares to be cancelled amounts to approximately KRW 1.9268 trillion[1].In the agenda for the 35th annual general meeting of shareholders previously disclosed, Celltrion proposed a resolution titled “Approval of Treasury Share Holding and Disposal Plan and Cancellation,” which included the cancellation of approximately 6.11 million treasury shares, excluding shares reserved for stock option compensation. The approximately 3 million shares excluded from cancellation had been retained to fulfill stock option grants already awarded to certain employees. Through this latest disclosure, Celltrion proposed revising the agenda to include these stock option-related treasury shares as well, thereby increasing the total cancellation volume to approximately 9.11 million shares. Employee stock option compensation will be managed through new share issuances. However, as the treasury shares will be cancelled first and new shares issued afterward, the company expects no impact on the total number of shares outstanding. The approximately 9.11 million shares to be cancelled represent about 74% of the total treasury shares held by Celltrion. The remaining 3.23 million shares, equivalent to about 26%, will be utilized to support future growth initiatives. Celltrion’s decision to cancel nearly three quarters of its treasury shares reflects its longstanding commitment to prioritizing shareholder value. The decision also reflects the company’s response to heightened market volatility driven by increasing geopolitical risks. In fact, Celltrion has continued to implement shareholder-friendly initiatives in 2024 and 2025, including treasury share purchases and cancellations, as well as providing updates to shareholders on the company’s response to rapidly changing market conditions. In addition, the company plans to proactively reflect the intent of the amended Commercial Act at this year’s shareholders’ meeting by introducing measures such as an independent director system, mandatory cumulative voting, an increase in separately elected outside directors, and the adoption of electronic shareholder meetings, further strengthening the protection of shareholder rights. Other agenda items to be presented at the shareholders’ meeting include partial amendments to the articles of incorporation, appointment of directors, and approval of financial statements including a cash dividend of KRW 750 per share. The director appointment agenda has been revised to nominate Shin Min-chul, Head of the Administration Unit and President, as an internal director, replacing Kim Hyoung-ki, Vice Chairman and Head of the Global Sales Business Group, who has decided to step down due to personal reasons. In addition, part of the statement of appropriation of retained earnings has been revised to secure surplus for the additional treasury share cancellation. “The decision to cancel 9.11 million treasury shares, representing 74% of the company’s total treasury holdings including the additional amount announced today, reflects our commitment to prioritizing the protection of shareholder interests amid an unstable market environment,” a Celltrion official said. “We will continue to respond to market changes while conducting our business responsibly and enhancing shareholder value, and will make every effort to achieve this year’s revenue target of KRW 5.3 trillion.” [1] Closing price on March 5, KRW 211,500