Celltrion

Celltrion has successfully completed the pivotal regulatory clinical trial for Herzuma SC and plans to submit marketing authorization applications within the next three months, starting with Europe and Korea, its largest markets for SC formulation products.The trial demonstrated pharmacokinetic (PK) equivalence as well as comparable safety and immunogenicity to the reference product, and Herzuma SC is expected to reduce administration time to approximately five minutes.Celltrion plans to leverage its hyaluronidase-based SC formulation platform for subsequent pipeline candidates as well as for the development of novel drug programs.By establishing a full SC value chain spanning development, regulatory approval, manufacturing, and commercialization, Celltrion has secured differentiated competitiveness beyond simple technology out-licensing models.Building on its advanced SC formulation capabilities, Celltrion also aims to expand its business scope into formulation-change CMO services. INCHEON, South Korea- Celltrion announced today that it has successfully completed the regulatory clinical trial for ‘Herzuma SC(CT-P6 SC)’, the subcutaneous (SC) formulation of the breast cancer treatment ‘Herzuma (trastuzumab)’, plans to submit marketing authorization applications to regulatory authorities in Europe and Korea within the next three months. In the recently completed pivotal trial for CT-P6 SC, Celltrion directly compared CT-P6 SC with the reference product’s SC formulation and successfully demonstrated pharmacokinetic (PK) equivalence, the primary endpoint of the study. Furthermore, it confirmed equivalence to the originator product in safety and immunogenicity assessments. With this, Celltrion has once again demonstrated its unparalleled development capabilities. Following the successful development and commercialization of the biosimilar Herzuma, it has now successfully completed the regulatory clinical trial for an SC formulation biosimilar incorporating the enzyme hyaluronidase. The company has secured sufficient data on quality and PK equivalence compared to the original product. Accordingly, following prior consultations with regulatory authorities, it plans to apply for marketing authorization for Herzuma SC in Europe and domestically within three months without conducting additional clinical trials. Europe and Korea currently represent Celltrion’s largest markets for SC formulation products. Celltrion developed Herzuma SC by internalizing hyaluronidase-based SC formulation technology. This technology temporarily breaks down hyaluronic acid within subcutaneous tissue, enabling the SC administration of high-concentration, high-dose pharmaceuticals, which offers high safety and scalability. Additionally, Herzuma SC is expected to maximize patient convenience by reducing the administration time from approximately 90 minutes (including a 30-minute maintenance period) for the existing intravenous (IV) formulation to within about 5 minutes, while also broadening the options available to healthcare providers. Upon approval, Celltrion is expected to accelerate its expansion of global market share by securing a full product lineup encompassing both IV and SC formulations. According to IQVIA, the global trastuzumab market size reached approximately $3.561 billion as of 2024. Celltrion has completed its own integrated development platform spanning the entire SC formulation development lifecycle, establishing Korea's only full SC value chain encompassing development, approval, mass production, and global supply starting with this Herzuma SC. Unlike the license-out (L/O) approach, which transfers only partial technology externally, this structure enables direct control over the entire cycle from development to commercialization and sales. It is evaluated as securing a differentiated structural competitive advantage in terms of long-term profitability and strategic flexibility. It also holds significant strategic meaning in establishing a mid-to-long-term growth platform leveraging SC formulation technology, going beyond the success of a single product. Once the development of Herzuma SC is completed, Celltrion is expected to join the ranks of ‘first movers’ by being the first to apply hyaluronidase to a biosimilar, establishing itself as a leading example for biosimilars in this formulation. As this milestone is anticipated to secure a market advantage, the company expects to maximize both product competitiveness and profitability. Celltrion plans to actively consider applying the SC formulation to its own biosimilars as well as new drugs under development in the future, if necessary. Celltrion has already demonstrated its capability to commercialize SC formulations through Remsima SC (US product name: Zymfentra). Building on this, the company plans to expand into contract manufacturing (CMO) services for formulation changes, offering its SC formulation modification expertise to external clients as well. “Following the world’s first commercialization of infliximab SC, we have now secured hyaluronidase-based SC formulation technology, completing global-level SC formulation capabilities,” said an official at Celltrion. “Beyond this, we will accelerate global market share expansion and new business growth such as contract development and manufacturing (CDMO), based on our overwhelming competitive advantage of full-cycle SC formulation development internalization—from productization to manufacturing and supply.”

Celltrion outlines a blueprint for innovative drug development built on its antibody expertiseThe company highlights its business strategy to scale U.S. manufacturing and R&D capabilities, strengthening its global supply chain, production and operations INCHEON, South Korea, Jan. 13, 2026 /PRNewswire/ -- Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today presented key strategic priorities and clinical development updates for its innovative drug pipelines including antibody-drug conjugates (ADCs) and multi-specific antibodies (msAbs) at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California. The company also highlighted plans to expand its manufacturing and R&D capabilities to support long-term growth, enhance supply resilience and reinforce its long-term commitment to the U.S. market. The presentation, composed of two sections— 'From Biosimilar Excellence to Next-Gen Innovative Therapeutics' and 'Scaling Our U.S. Presence with a Next-Gen Manufacturing and R&D Hub'—was delivered on the conference's Main Track. Celltrion's Chief Executive Officer Jin-Seok Seo and Senior Executive Vice President Hyuk-Jae Lee outlined the company's innovative drug pipeline, with plans to submit up to 16 investigational new drug (IND) applications by 2028, including up to 10 ADCs, 4 msAbs, 1 recombinant protein, and 1 peptide. In its biosimilar business, Celltrion aims to commercialize up to 18 products by 2030 and 41 products by 2038. The company's ADC candidates are designed to target solid tumor cancers; with IND applications for CT-P70, CT-P71 and CT-P73 accepted by the U.S. Food and Drug Administration (FDA) in 2025. CT-P70, a novel ADC candidate being developed for the treatment of non-small cell lung cancer (NSCLC), recently received Fast Track designation from the U.S. FDA, enabling expedited interactions throughout the development process and the potential for accelerated regulatory review. Celltrion is advancing a portfolio of msAbs that are designed to selectively target cancer cells or are activated only under specific conditions. Celltrion received an IND approval from the U.S. FDA for CT-P72, a tetravalent bispecific antibody being developed to target human epithelial growth factor receptor 2 (HER2) and cluster of differentiation 3 (CD3). "We have made significant progress and see compelling opportunities ahead. Building on our company's global footprint in biosimilar excellence, Celltrion is accelerating its transition toward next-generation innovative therapeutics," said Jin-Seok Seo, Chief Executive Officer at Celltrion. "Our expanding pipeline of ADCs and msAbs, grounded in deep antibody expertise, underscores our commitment to delivering meaningful value to patients worldwide. We aim to redefine the standard of care in oncology and beyond, while creating long-term sustainable value through scientific excellence and bold innovation." To reinforce the company's U.S. manufacturing capabilities, Celltrion recently completed the strategic acquisition of a former Eli Lilly manufacturing facility located in Branchburg, New Jersey, securing 66,000L of drug substance (DS) capacity.  The company plans to sequentially increase capacity to a total of 132,000L by 2030, while also extending its capabilities to include drug product (DP) facilities. Through this acquisition, Celltrion plans to ensure long-term supply chain resilience eliminating the tariff and trade risks, ultimately strengthening its competitiveness in the U.S. market. "The acquisition of the U.S. manufacturing facility represents a pivotal step in strengthening our global supply chain and solidifying our presence in the U.S. market," said Hyuk-Jae Lee, Senior Executive Vice President at Celltrion. "By securing large-scale DS capacity in the U.S., we are enhancing supply stability, mitigating trade and tariff risks, and establishing a solid foundation for expanded R&D collaboration and innovation in the region." About Celltrion, Inc.Celltrion, Inc. is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion, Inc. 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, hematology, ophthalmology and endocrinology. Built on trust through our fully integrated capabilities – from advanced R&D and in-house manufacturing to a reliable global supply network – we continue moving toward innovation as we work to ensure consistent availability of affordable, trusted, and high-quality biosimilars and biologics for patients and healthcare systems across the globe.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.

INCHEON, South Korea, Jan. 6, 2026 - Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today announced that Jin-Seok Seo, Chief Executive Officer and Hyuk-Jae Lee, Senior Executive Vice President at Celltrion, will present at the 44th Annual J.P. Morgan Healthcare Conference taking place in San Francisco, California on January 12–15, 2026. Celltrion's presentation and fireside chat are scheduled for Tuesday, January 13, 2026, from 3:45 PM to 4:25 PM (PT) at the Grand Ballroom, The Westin St. Francis San Francisco Union Square. About Celltrion, Inc. Celltrion, Inc. is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion, Inc. 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, hematology, ophthalmology and endocrinology. Built on trust through our fully integrated capabilities – from advanced R&D and in-house manufacturing to a reliable global supply network – we continue moving toward innovation as we work to ensure consistent availability of affordable, trusted, and high-quality biosimilars and biologics for patients and healthcare systems across the globe. 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. US--25-00145 For further information please contact: Global PR Teamglobalpr@celltrion.com