Latest news with #KimKyung-ah
Korea Herald
09-06-2025
- Business
- Korea Herald
Samsung Bioepis partners with Nipro for Japan market entry
Samsung Bioepis, the biosimilar unit of Samsung Group, announced Monday that it has signed a commercialization agreement with Japan-based pharmaceutical and medical device company Nipro to enter the Japanese market. The deal covers the licensing, development and commercialization of multiple biosimilars, including SB17, a biosimilar referencing Stelara (ustekinumab), used to treat autoimmune conditions. This marks the company's first partnership with a Japanese pharmaceutical company. Under the agreement, Samsung Bioepis will oversee development, manufacturing and supply, while Nipro will manage sales and distribution in Japan. 'The partnership is a major milestone for our entry into Japan,' said Samsung Bioepis CEO Kim Kyung-ah. 'We aim to enhance patient access to high-quality biopharmaceuticals through close collaboration with local partners.' SB17 is a biosimilar to Janssen's Stelara, which treats inflammatory diseases such as psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. Samsung Bioepis launched its proprietary Stelara biosimilar, Pyzchiva, in the US earlier this year, followed by an increased market competition after Stelara's US patent expiry in 2023. After receiving approval in Europe last year, Pyzchiva went on to secure a 43 percent market share, emerging as a leading product in the region's biosimilar market. Founded in 2012, Samsung Bioepis has gained approval for 11 blockbuster biosimilar products and posted 1.54 trillion won ($1.13 billion) in revenue in 2024. Meanwhile, Samsung Bioepis is scheduled to separate from its parent company, Samsung Biologics, in October to operate as a new holding company, a strategic move aimed at easing client concerns over potential conflicts of interest between Samsung Biologics' contract development and manufacturing business and Samsung Bioepis' biosimilar unit.
Korea Herald
22-05-2025
- Business
- Korea Herald
Samsung Biologics splits biosimilar business to boost CDMO, investment flexibility
Spin-off aims to sharpen operational focus, build client trust, enhance shareholder value Samsung Biologics, the biotech arm of Samsung Group, announced Thursday that it will spin off its biosimilar operations into a new holding company, separating them from its contract development and manufacturing organization business to sharpen the strategic focus of each unit. Through the structural realignment, Samsung Biologics will concentrate solely on its CDMO business, while the newly created holding company, tentatively called Samsung Epis Holdings, will oversee the biosimilar unit Samsung Bioepis. Kim Kyung-ah, CEO of Samsung Bioepis, will concurrently serve as CEO of the new holding company. Samsung Bioepis was established in 2012 as a joint venture between Samsung Biologics and US-based Biogen, with Samsung initially holding an 85 percent stake. In 2022, Samsung Biologics acquired Biogen's remaining shares for $2.3 billion. 'This split reflects our decision to enhance competitiveness by responding swiftly to global changes and sharpening strategic focus,' said Samsung Biologics CEO John Rim. 'Both entities will accelerate their growth and are well-positioned to establish themselves as global leaders in biopharma.' Samsung Biologics clarified that the creation of Samsung Epis Holdings through the spin-off bears no relation to the governance structure of Samsung Group. The separation also aims to address concerns from CDMO clients regarding the in-house biosimilar unit. The dual-track model had raised conflict-of-interest concerns, particularly related to potential technology leakage. 'We've invested significant time and resources to ease these concerns, yet it's realistically difficult to eliminate all worries across our client base,' said Ryu Seung-ho, executive vice president of Samsung Biologics, at a press conference on Thursday. 'This restructuring will further allow each business to be properly valued in the market and give shareholders more flexibility to invest based on their own strategies," he added. Under the deal, shareholders will receive shares in both companies based on current book values — approximately 0.65 shares in Samsung Biologics and 0.35 shares in Samsung Epis Holdings for each share held. With the restructuring expected to fuel focused growth, both entities have outlined distinct long-term goals. Samsung Biologics will double down on its ambition to become a global top-tier CDMO by investing in three key areas: expanding production capacity, diversifying its service portfolio, and widening its international footprint. New initiatives will target next-generation biomanufacturing technologies, including antibody-drug conjugates or ADCs, adeno-associated viruses or AAVs, and pre-filled syringes. Samsung Epis Holdings will focus on expanding Samsung Bioepis's biosimilar portfolio to over 20 products, while also developing platform technologies and exploring investment opportunities in emerging technologies and global markets. 'Samsung Epis Holdings plans to establish new subsidiaries in addition to managing the existing Samsung Bioepis,' said Kim Hyoung-joon, vice president of Samsung Bioepis, at the press conference. 'These new entities will focus on developing platform technologies for future growth. We also aim to generate revenue through investments in domestic and global companies,' he added. Regarding the upcoming procedures, the company will submit a registration statement on July 29, followed by a shareholder meeting for approval on Sept. 16. Upon completion of the spin-off, effective Oct. 1, Samsung Epis Holdings will make Samsung Bioepis its wholly owned subsidiary. Both Samsung Biologics and Samsung Epis Holdings are scheduled to be relisted on Oct. 29. Trading of Samsung Biologics shares will be temporarily suspended from Sept. 29 through Oct. 28.
