Celltrion, Poised for US New Drug Launch, Also Expected to Grow by Securities Firms

Expectations from the securities industry are growing for Celltrion, which has successfully completed the merger with Celltrion Healthcare. Analysts predict continuous growth as the autoimmune disease treatment new drug Jimpendra is set to be launched in the U.S. soon, followed by the expansion of a diverse biosimilar product portfolio.

Celltrion's new autoimmune disease treatment drug Jimpendra
[Photo by Celltrion]

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On the 22nd, according to the securities and pharmaceutical/bio industries, numerous domestic and international securities firms, including Japan's Nomura Securities, KB Securities, and DS Investment & Securities, have recently expressed positive opinions about the integrated Celltrion.

Nomura Securities projected Celltrion's sales this year to be 3.455 trillion KRW in a report published last month. While Celltrion's performance for last year has not yet been announced, Nomura analyzed that this would represent a 43% increase compared to the estimated annual sales of 2.4167 trillion KRW for last year. Furthermore, they expect sales to increase by another 33% next year to 4.584 trillion KRW.

The core of this rapid growth is Jimpendra, which will be introduced to the U.S. market on the 29th. Among infliximab-based drugs that have long been used in the autoimmune disease treatment market, it is the only subcutaneous injection formulation that can be self-administered. In Europe, it is already marketed as the biosimilar Remsima SC. In the U.S., the Food and Drug Administration (FDA) approved it as a new drug, recognizing the possibility of formulation change, allowing a price approximately four times higher than in Europe, which is expected to lead to continuous sales growth.

In particular, domestic securities firms expect the integrated Celltrion to continue its performance growth by actively expanding its biosimilar portfolio in addition to Jimpendra. KB Securities researcher Kim Hyemin stated, "Celltrion will establish a consistent system through the merged corporation to carry out effective and efficient development, manufacturing, and sales," adding, "As the subcutaneous injection formulation is gaining global attention, Jimpendra will lead the way with an excellent pricing strategy." However, she noted, "In the short term, costs related to the merged corporation may be a concern," but analyzed that "through various biosimilar products such as Stelara, Xolair, and Eylea, even better growth will be demonstrated."

DS Investment & Securities recently cited the expiration of patents for blockbuster drugs as a positive factor. The patents for autoimmune disease treatments Humira and Stelara have recently expired, and the blockbuster ophthalmic drug Eylea's patent will expire within this year. They pointed out, "Due to the successive patent expirations of blockbuster drugs, biosimilar products are gaining attention," identifying Celltrion as a direct beneficiary. Especially, through the recent merger, the previously separated tasks of development and production (Celltrion) and sales and distribution (Celltrion Healthcare) have been unified, enhancing cost competitiveness and sales power. DS Investment & Securities researcher Kim Minjung said, "With the overall monetary policy shifting to interest rate cuts this year, the pharmaceutical and bio sector is receiving attention as a representative beneficiary," and forecasted, "The integrated Celltrion will achieve meaningful performance improvement through biosimilar market recovery and the launch of Jimpendra."

Korea Investment & Securities also projected Jimpendra sales to grow from $191 million (approximately 255 billion KRW) in its first year this year to $440 million (approximately 587.5 billion KRW) next year, judging that "it is now time to focus on potential rather than concerns" regarding the integrated Celltrion.

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Celltrion is pursuing a 'Third Wave' strategy to build a portfolio of 22 blockbuster biosimilars by 2030, aiming to achieve annual sales of 12 trillion KRW. First, by 2025, it plans to complete an intermediate stage called the 'Second Wave' with 11 biosimilar product groups. To this end, from May last year to this month, it has completed regulatory submissions for five biosimilars, including Stelara (CT-P43), Eylea (CT-P42), and the rheumatoid arthritis treatment Actemra (CT-P47), in the U.S. and Europe.

Additionally, leveraging the merger, Celltrion is actively expanding new business areas through selection and concentration. It is developing new drugs with various modalities (therapeutic approaches) such as oral antibody therapeutics, antibody-drug conjugate (ADC) anticancer drugs, multi-antibodies, and microbiomes. At the JP Morgan Healthcare Conference held last month in San Francisco, U.S., it introduced not only new drug and biosimilar pipelines but also a data bank project. Named the 'Celltrion Healthcare Intelligence Bank,' this project utilizes Celltrion's accumulated proprietary clinical data and external data. It aims to create synergy with existing businesses while providing services to patients and doctors that were previously unavailable through conventional methods.

Seo Jin-seok, CEO of Celltrion, and Seo Jung-jin, Chairman of Celltrion Group (from left), are conducting a Q&A session at the JP Morgan Healthcare Conference (JPMHC) held last month in San Francisco, California, USA.
[Photo by Celltrion]

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A representative of the Celltrion Group said, "Based on the know-how and global competitiveness accumulated by the integrated Celltrion, this year we plan to fully realize achievements in various areas, including the new drug Jimpendra," adding, "We will do our best to leap into a global big pharma company based on the rapidly expanding product portfolio."

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