Celltrion

• Celltrion looks beyond biosimilars to bring value to healthcare and to pioneer innovation
• Company outlines key business strategies, including expanded product pipeline and healthcare intelligence bank, building upon groundbreaking legacy of success in biosimilars

• Company highlights its target of 22 products by 2030 and projects five-fold growth

   

INCHEON, South Korea, Jan. 10, 2024 /PRNewswire/ -- Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today announced the next phase of its strategic transformation from a developer of the world's first monoclonal antibody biosimilar to an innovative company focused on new drug development at the 42^nd Annual J.P. Morgan Healthcare Conference in San Francisco, Calif.

Celltrion's presentation, titled 'From Pioneer to Innovator,' took place at the main track on Wednesday, January 10. Celltrion's Chairman Jung-Jin Seo and CEO Jin-Seok Seo discussed the company's strategic priorities and progress, including the company's vision to move beyond biosimilars through the 2024 launch of ZYMFENTRA™ in the U.S. and expansion into digital healthcare.

Jin-Seok Seo highlighted Celltrion's solid business results from the approval of the world's first monoclonal antibody biosimilar REMSIMA^® (branded INFLECTRA^® in the U.S.) to the successful transition to a direct sales model. He also shared insights and trends on the biosimilar industry and how the market landscape is impacting Celltrion's strategy.

Celltrion will continue to develop a diverse pipeline of biosimilars that treat different diseases and disorders through multiple therapeutic modalities, including antibody-drug conjugates, immune checkpoint inhibitors and multi-specific (bi/tri-specific) antibody drugs. The company currently has six biosimilars on the market and aims to have a portfolio of 11 drugs by 2025 and a total of 22 drugs by 2030.  The biosimilar-focused portfolio also features ZYMFENTRA, which is the first and only FDA-approved subcutaneous formulation of infliximab and approved by the FDA as a new drug pathway under section 351 of the Public Health Service (PHS) Act.

Jin-Seok Seo also shared plans to expand into digital healthcare by building an independent data bank that utilizes artificial intelligence to synthesize Celltrion's vast clinical and genomic data.

Jin-Seok Seo said, ''Celltrion has the potential to grow its revenue by at least fivefold in 2030, once our 22-drug portfolio is commercialized. We will foster innovation and demonstrate the value of our therapies to payers, providers and patients in order to contribute to the sustainability of healthcare systems."

Jung-Jin Seo said, ''The launch of ZYMFENTRA in the U.S. this year will mark a key step amongst many groundbreaking scientific discoveries and milestones by leveraging our global competitiveness. Celltrion remains committed to pursuing its goal in promoting the health and well-being of patients."

About ZYMFENTRA^™ (infliximab-dyyb)

ZYMFENTRA™ is the first and only FDA-approved subcutaneous (SC) administration form of infliximab. ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. Following the submission of a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA) in December 2022, the FDA approved ZYMFENTRA based on the phase III pivotal data results of the LIBERTY UC and LIBERTY CD studies. 

The infliximab biosimilar developed and manufactured by Celltrion was the world's first monoclonal antibody biosimilar. It is indicated for the treatment of eight autoimmune diseases including Crohn's disease (CD) and ulcerative colitis (UC). It was approved by the European Commission under the trade name REMSIMA^® in September 2013 and launched in major EU countries in early 2015. The U.S. Food and Drug Administration approved the biosimilar in April 2016 under the trade name INFLECTRA^®. 

Subcutaneous (SC) infliximab (trademarked as REMSIMA^® SC in the EU) has received EU marketing authorization for the treatment of people with CD, UC, rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis in adult patients. In the U.S., ZYMFENTRA has received FDA approval for the maintenance treatment of adult patients with moderately to severely active UC and CD. The recommended dose of ZYMFENTRA for maintenance treatment is 120 mg every two weeks.

About Celltrion

Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specializes in researching, developing and manufacturing innovative therapeutics that improve people's lives worldwide. The company's solutions include world-class monoclonal antibody biosimilars such as REMSIMA^®, TRUXIMA^® and HERZUMA^®, providing broader patient access globally. Celltrion has also received U.S. FDA and EMA approval for VEGZELMA^® and YUFLYMA^®, FDA approval for ZYMFENTRA™, and EMA approval for REMSIMA^®SC.

Celltrion pursues sustainable growth by leveraging its experience and assets in the successful biosimilar business to develop new medicines and healthcare platform technologies. The company works with a sense of duty to advance patients' wellness and provide them with enhanced access to reliable healthcare. To accomplish this, Celltrion adheres to strong internal ethical standards in its daily operations. To learn more, please visit www.celltrion.com/en-us.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion that may constitute forward-looking statements under pertinent securities laws.

These statements may be 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," 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's 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 result expressed or implied by such forward-looking statements.

Such Risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.