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[Bio USA] Samsung Biologics doubles down on CDMO leadership after biosimilar spinoff
[Bio USA] Samsung Biologics doubles down on CDMO leadership after biosimilar spinoff

Korea Herald

time5 days ago

  • Business
  • Korea Herald

[Bio USA] Samsung Biologics doubles down on CDMO leadership after biosimilar spinoff

CEO John Rim says Bioepis separation unlocks transparency, enhances investor clarity, sharpens strategic focus BOSTON — Samsung Biologics CEO John Rim unveiled an ambitious road map to strengthen the company's position as a global leader in CDMO during a press conference held on the sidelines of this year's Bio USA on Tuesday, emphasizing sharpened focus, expanded capabilities and accelerated global expansion. At the center of the announcement was Samsung Biologics' recent corporate split, which fully separates its CDMO operations from Samsung Bioepis, its former biosimilar arm. Rim described the move as a milestone that allows Samsung Biologics to operate as a 'pure-play CDMO.' 'By becoming a stand-alone CDMO, we can focus entirely on our core mission—delivering best-in-class biomanufacturing and development services while enhancing transparency and trust with our global partners,' said Rim. 'This also enables investors to evaluate each business based on its own strategic value and growth potential.' The strategic restructuring is expected to unlock hidden value within Samsung's portfolio and further elevate shareholder value by making the distinct business models more visible and investable. Highlighting strong sector fundamentals, Rim pointed to rising global demand for biologics manufacturing, driven by expanding indications for blockbuster drugs and the development of new modalities, such as ADCs, AOCs and gene therapies. "Following the corporate split, our overseas clients responded positively, as it eliminated any perceived conflicts of interest," Rim emphasized. "Samsung Biologics will continue to fuel its growth by advancing its three core pillars: Geographic expansion, increased capacity and diversification of modalities." According to market research firm Frost & Sullivan, the global biologics CDMO market is projected to grow at a CAGR of 15 percent from $21.8 billion in 2024 to $43.9 billion in 2029. Despite some pharma companies announcing in-house capacity expansions, CMO outsourcing demand continues to rise as pharma remains cautious with internal investments. "Just three years ago, there were industry-wide concerns about potential oversupply in the CDMO market. However, we've since witnessed consistent double-digit growth, and with continued category expansion — particularly in the antibody segment — the outlook for CDMOs appears stronger than ever," Rim explained. Samsung Biologics is doubling down on its global client outreach. The company currently serves 17 of the top 20 global pharmaceutical companies and has intensified efforts to expand its reach among the top 40. In addition to sales offices in New Jersey and Boston, it opened a Tokyo office earlier this year to improve engagement with Asia-based clients. 'Our global clients trust Samsung for both scale and speed. As we expand geographically and technologically, we are committed to offering localized support with global excellence,' Rim emphasized. As of June 2025, Samsung Biologics has secured five new contracts this year totaling 3.35 trillion won ($2.58 billion), surpassing 60 percent of last year's full-year bookings of 5.4 trillion won. The company's cumulative order value since inception now stands at $18.7 billion. 'Despite macroeconomic uncertainties, our pipeline remains strong, and we maintain our full-year revenue guidance of 20–25 percent growth,' said Rim. 'We expect to see continued momentum as we deepen global partnerships and reinforce our role as a full-service biopharma enabler.' Meanwhile, Samsung Biologics is investing heavily in modality diversification to meet evolving customer needs. It recently launched a dedicated facility for ADCs, supporting full development and GMP production, with capabilities ranging from 2 milliliters to 500 liters. The company plans to introduce a dedicated ADC DP line by Q1 2027, completing an end-to-end solution within its Songdo site in Incheon. 'The more competitors there are, the more positive impact it has on patients, so we fully welcome competition. Of course, when it comes to winning contracts, we believe we possess the best internal competitiveness. We are confident that not only our infrastructure but also the strength of our workforce are our greatest assets.'

Samsung Biologics launches organoid platform to boost early-stage drug discovery
Samsung Biologics launches organoid platform to boost early-stage drug discovery

Korea Herald

time7 days ago

  • Business
  • Korea Herald

Samsung Biologics launches organoid platform to boost early-stage drug discovery

South Korea's leading contract development and manufacturing organization, Samsung Biologics, announced Monday the launch of Samsung Organoids, a cutting-edge drug screening service designed to support corporate clients throughout drug discovery and development. Organoids are three-dimensional cell culture systems engineered to closely replicate the structure and function of human organs. Due to their high physiological relevance, organoids are rapidly emerging as a next-generation research model in drug development. They offer clinically meaningful insights into drug responses, making them valuable tools for lead compound selection, biomarker discovery and efficacy prediction. 'The latest service launch reflects our unwavering commitment to driving innovation by improving drug success rates and creating new possibilities in personalized medicine,' said John Rim, CEO and president of Samsung Biologics. 'The addition of research services is a significant move for us to create added value for clients by supporting the drug life cycle from start to finish with thorough therapeutic analysis.' Samsung Organoids will enable precision screening to predict patient-specific drug responses, streamline preclinical development and accelerate timelines for investigational new drug filings. The platform uses data-driven analysis to assess the characteristics and mechanisms of drug candidates, offering multi-modal insights that enhance decision-making. Through the expansion, Samsung Biologics broadens its service portfolio to include preclinical research, covering the full spectrum from target discovery and lead identification to preclinical studies and clinical trial planning. By leveraging its expertise in drug development and manufacturing, the company aims to help clients overcome early-stage development hurdles and improve clinical outcomes.

Samsung Biologics splits biosimilar business to boost CDMO, investment flexibility
Samsung Biologics splits biosimilar business to boost CDMO, investment flexibility

Korea Herald

time22-05-2025

  • 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.

Samsung Biologics boosts contract wins with $513m US deal
Samsung Biologics boosts contract wins with $513m US deal

Korea Herald

time28-04-2025

  • Business
  • Korea Herald

Samsung Biologics boosts contract wins with $513m US deal

Samsung Biologics, the biotech arm of Samsung Group, has secured its second contract manufacturing deal this year, signing a major agreement worth 737.3 billion won ($513 million) with a US-based pharmaceutical company. In a regulatory filing Monday, the company said the new contract with the undisclosed partner will run through the end of 2031. The deal is equivalent to 16.2 percent of Samsung Biologics' revenue in 2024. This latest win follows Samsung Biologics' largest-ever contract manufacturing agreement, a 2.07 trillion won deal signed in January with a European pharmaceutical firm. With the two deals combined, Samsung Biologics' total cumulative contracts for the year have reached 2.8 trillion won, accounting for more than 50 percent of last year's total deal value of 5.4 trillion won. The company's total annual contract volume last year was driven by three major deals, each valued at over 1 trillion won. Samsung Biologics now counts 17 of the world's top 20 pharmaceutical companies as clients. Last year, on a consolidated basis, the company posted record sales of 4.54 trillion won, up 23 percent from the previous year, while operating profit rose 19 percent to 1.32 trillion won. For the first quarter of this year, Samsung Biologics' operating profit more than doubled to 486.7 billion won, compared to 221.3 billion won a year earlier, while sales rose 37.1 percent to 1.29 trillion won. 'We sustained solid momentum in the first quarter, supported by the efficient operations across all our plants and continued partnerships with our clients,' said CEO John Rim. To meet the growing demand for biologics, Samsung Biologics has been expanding its production capacity. The company currently operates five production plants in Songdo, Incheon, and plans to expand to eight by 2032, targeting a combined production capacity of around 1.32 million liters. Starting this month, it began operations at its fifth plant, bringing its total capacity to 784,000 liters — the largest biomanufacturing capacity in the world. 'The launch of the fifth plant and our dedicated antibody-drug conjugate facility marks another milestone in expanding our capacity to cater to diverse client demands,' Rim said, explaining the company's commitment to delivering long-term value for clients and shareholders through strategic investments in technology. Samsung Biologics plans to continue bolstering its contract pipeline throughout the year. While operating a dedicated facility for antibody-drug conjugates as part of its strategic move into the next-generation cancer therapeutics market, the company also recently opened a sales office in Japan, adding to its existing locations in New Jersey and Boston to strengthen relationships across key global markets.

Samsung Biologics turns 14, eyes W5tr milestone on global expansion
Samsung Biologics turns 14, eyes W5tr milestone on global expansion

Korea Herald

time21-04-2025

  • Business
  • Korea Herald

Samsung Biologics turns 14, eyes W5tr milestone on global expansion

Founded in 2011, Samsung Biologics has rapidly ascended to become a top-tier global CDMO, with further capacity and portfolio expansion on the horizon Samsung Biologics, the biotech arm of Samsung Group, celebrated its 14th anniversary on Monday and reaffirmed its commitment to global biopharmaceutical leadership, guided by a growth strategy built on three pillars: production capacity, portfolio diversification and global expansion. After posting a record 4.5 trillion won ($3.2 billion) in sales last year, the company is now aiming for 5 trillion won this year — just five years after it first crossed the 1 trillion won mark in 2020. 'Over the past 14 years, Samsung Biologics has provided top-quality service to global clients and led the contract development and manufacturing organization market,' said CEO John Rim. 'We will continue to make proactive investments to enhance our competitiveness as we work together to realize our vision of enriching human life.' Since entering the biopharmaceutical CDMO market in 2011 as a latecomer, Samsung Biologics has swiftly risen to industry leadership through aggressive capacity expansion and a rigorous focus on quality. Its growth momentum was accelerated under the leadership of John Rim, who took the helm as CEO in late 2020. His 35 years of experience in the biopharmaceutical industry, along with an extensive global network, has helped the company break records in both orders and sales. The production scale of the Korean biopharmaceutical company is now at an all-time high. The company currently holds the world's largest biomanufacturing capacity at 784,000 liters, while maintaining top-tier inspection pass rates and securing more than 350 manufacturing approvals from global regulatory authorities. With the completion of its fifth plant this month, which would add 180,000 liters of capacity, the company plans to build three additional facilities of similar scale by 2032, aiming for a total production capacity of approximately 1.32 million liters. The company's expanded capacity is closely tied to its high volume of contract deals. With 17 of the world's top 20 pharmaceutical companies now among its clients, the company has been bringing its presence closer to key partners through overseas offices in places such as New Jersey and Tokyo. Since its founding, the company has secured 99 contract manufacturing agreements and 133 contract development deals, with cumulative orders totaling $16.3 billion. Samsung Biologics surpassed 5 trillion won in total annual contract volume last year, driven in part by three major deals, each valued at over 1 trillion won. In January, the company secured its largest-ever contract manufacturing agreement worth 2.07 trillion won. Samsung Biologics is also broadening its portfolio as part of its efforts to expand its global footprint. In March, the company began operating a dedicated facility for antibody-drug conjugates, marking a strategic move into the market for next-generation cancer therapeutics. Future investments, the company said, will focus on new modalities, particularly in cell and gene therapies. Beyond its commercial growth, the company remains committed to environmental, social and corporate governance initiatives within the biopharma sector. In February, the company received the "Leadership" designation (A- rating) from the Carbon Disclosure Project in recognition of its efforts to mitigate climate-related risks. According to the company, CEO John Rim is currently involved in the Sustainable Markets Initiative — a platform led by King Charles III to advance a sustainable future — which aims to decarbonize health care systems in collaboration with global partners.

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