| MFDS reorganizes the system for biopharmaceutical licensing and review across the headquarters and affiliated agencies
| JNPMEDI provides customized strategies reflecting country-specific data standards and regulatory environments for companies expanding globally
| Samsung Biologics moves to secure 'super-gap' competitiveness in Contract Research, Development, and Manufacturing Organization (CRDMO)
| Celltrion establishes a full value chain for SC—the only one in Korea capable of development, licensing, mass production, and global supply—starting with Herzuma SC
The domestic bio-pharmaceutical industry is accelerating the enhancement of the full lifecycle of drug research and development (R&D) along with institutional support from the government. Last January, the Ministry of Food and Drug Safety (MFDS) reorganized the system dedicated to biopharmaceutical licensing and review across its headquarters and affiliated agencies. This administrative foundation allows for more consistent support throughout the entire lifecycle—from development to licensing and review—through organic role-sharing between the Biopharmaceuticals and Herbal Medicine Bureau at the headquarters and the National Institute of Food and Drug Safety Evaluation.
Unlike traditional contract research organizations (CROs) or simple clinical IT companies, JNPMEDI has built a structure that manages the entire clinical trial process as a single digital flow. It features integrated support for each stage, ranging from early strategy establishment for drug and medical device R&D to Investigational New Drug (IND) preparation, clinical operation, pre-clinical/clinical design, regulatory strategy, and marketing authorization roadmaps. As a result, the company has successfully structurally reduced the administrative burden and data management inefficiencies that repeatedly occur at clinical sites.
In particular, for companies aiming for global expansion, it is broadening the scope of its solution applications by presenting customized strategies that reflect country-specific data standards and regulatory environments, such as those of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Samsung Biologics is moving to secure 'super-gap' competitiveness in the CRDMO business based on its contract manufacturing (CMO) competitiveness. Its strategy is to satisfy diverse customer demands and provide end-to-end services through business portfolio expansion.
Since the launch of its CDO business in 2018, Samsung Biologics has signed a cumulative total of 164 contracts over eight years, including five for ADCs (Antibody-Drug Conjugates). By type, complex molecular modalities account for a high proportion, with bispecific antibodies at 20%, ADCs at 15%, and fusion proteins at 14%. It has recorded 49 IND approvals. For 2026, it presented ‘Technology-Centered Leadership’ as the keyword for its CDO strategy. With securing early partnerships, data-driven operation, and creating high added value as the three main pillars, the company plans to strengthen its global technology leadership as a data-centric CDO that combines AI, automation, and data.
Celltrion recently announced the successful completion of clinical trials for the licensing of 'Herzuma SC (development name CT-P6 SC),' a subcutaneous (SC) formulation of the breast cancer treatment 'Herzuma (ingredient name: trastuzumab),' and plans to apply for approval to European and domestic regulatory agencies within three months. Starting with Herzuma SC, Celltrion has established a full value chain for SC—the only one in Korea to cover development, licensing, mass production, and global supply—completing its own integrated development platform across the entire lifecycle of SC formulation development. This is evaluated as having secured a differentiated structural competitive advantage in terms of long-term profitability and strategic flexibility, as it is a structure that directly controls the entire lifecycle from development to commercialization and sales, unlike the license-out (L/O) method where only certain technologies are transferred externally.
Meanwhile, in September last year, Celltrion acquired a biopharmaceutical production plant from global big pharma Eli Lilly, enabling it to establish a one-stop supply chain in the market covering the entire drug production process from product production to sales. In addition, local product production is expected to significantly strengthen product competitiveness in the U.S. by significantly reducing production costs compared to outsourced CMOs, as well as existing logistics costs to the U.S. An investment of at least 1.4 trillion KRW will be made for the acquisition of the plant, initial operating expenses, and expansion of production facilities.
| MFDS reorganizes the system for biopharmaceutical licensing and review across the headquarters and affiliated agencies
| JNPMEDI provides customized strategies reflecting country-specific data standards and regulatory environments for companies expanding globally
| Samsung Biologics moves to secure 'super-gap' competitiveness in Contract Research, Development, and Manufacturing Organization (CRDMO)
| Celltrion establishes a full value chain for SC—the only one in Korea capable of development, licensing, mass production, and global supply—starting with Herzuma SC
The domestic bio-pharmaceutical industry is accelerating the enhancement of the full lifecycle of drug research and development (R&D) along with institutional support from the government. Last January, the Ministry of Food and Drug Safety (MFDS) reorganized the system dedicated to biopharmaceutical licensing and review across its headquarters and affiliated agencies. This administrative foundation allows for more consistent support throughout the entire lifecycle—from development to licensing and review—through organic role-sharing between the Biopharmaceuticals and Herbal Medicine Bureau at the headquarters and the National Institute of Food and Drug Safety Evaluation.
Unlike traditional contract research organizations (CROs) or simple clinical IT companies, JNPMEDI has built a structure that manages the entire clinical trial process as a single digital flow. It features integrated support for each stage, ranging from early strategy establishment for drug and medical device R&D to Investigational New Drug (IND) preparation, clinical operation, pre-clinical/clinical design, regulatory strategy, and marketing authorization roadmaps. As a result, the company has successfully structurally reduced the administrative burden and data management inefficiencies that repeatedly occur at clinical sites.
In particular, for companies aiming for global expansion, it is broadening the scope of its solution applications by presenting customized strategies that reflect country-specific data standards and regulatory environments, such as those of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Samsung Biologics is moving to secure 'super-gap' competitiveness in the CRDMO business based on its contract manufacturing (CMO) competitiveness. Its strategy is to satisfy diverse customer demands and provide end-to-end services through business portfolio expansion.
Since the launch of its CDO business in 2018, Samsung Biologics has signed a cumulative total of 164 contracts over eight years, including five for ADCs (Antibody-Drug Conjugates). By type, complex molecular modalities account for a high proportion, with bispecific antibodies at 20%, ADCs at 15%, and fusion proteins at 14%. It has recorded 49 IND approvals. For 2026, it presented ‘Technology-Centered Leadership’ as the keyword for its CDO strategy. With securing early partnerships, data-driven operation, and creating high added value as the three main pillars, the company plans to strengthen its global technology leadership as a data-centric CDO that combines AI, automation, and data.
Celltrion recently announced the successful completion of clinical trials for the licensing of 'Herzuma SC (development name CT-P6 SC),' a subcutaneous (SC) formulation of the breast cancer treatment 'Herzuma (ingredient name: trastuzumab),' and plans to apply for approval to European and domestic regulatory agencies within three months. Starting with Herzuma SC, Celltrion has established a full value chain for SC—the only one in Korea to cover development, licensing, mass production, and global supply—completing its own integrated development platform across the entire lifecycle of SC formulation development. This is evaluated as having secured a differentiated structural competitive advantage in terms of long-term profitability and strategic flexibility, as it is a structure that directly controls the entire lifecycle from development to commercialization and sales, unlike the license-out (L/O) method where only certain technologies are transferred externally.
Meanwhile, in September last year, Celltrion acquired a biopharmaceutical production plant from global big pharma Eli Lilly, enabling it to establish a one-stop supply chain in the market covering the entire drug production process from product production to sales. In addition, local product production is expected to significantly strengthen product competitiveness in the U.S. by significantly reducing production costs compared to outsourced CMOs, as well as existing logistics costs to the U.S. An investment of at least 1.4 trillion KRW will be made for the acquisition of the plant, initial operating expenses, and expansion of production facilities.