LophiBio Gains Attention as a Biosimilar Drug Developer

Dr. Hong Seung-seo, Former CEO of Celltrion Healthcare, Recruited
Advancing Ailia Biosimilar into Global Phase 3 Clinical Trials

Amicogen announced on the 9th that it has recruited Dr. Hong Seung-seo as the sole CEO of its affiliate, Rophibio.

Hong Seung-seo, the new CEO of Rophibio, graduated from the Department of Agricultural Chemistry at Seoul National University and earned a Ph.D. in Food Engineering from the same university's graduate school. He then completed a postdoctoral course at the University of Wisconsin in the United States. After serving as the head of the Samyang Group Bio Research Institute, he worked at the Celltrion Group from 2002 to 2019. He led the Biotechnology Research Institute and spearheaded the development of biosimilars such as Remsima, and in December 2014, he moved to become the president of Celltrion Healthcare.

Founded in 2015, Rophibio develops new biopharmaceuticals and biosimilar drugs such as gene and cell therapies using advanced gene- and cell-based technology platforms. Amicogen, which is promoting the biopharmaceutical CDMO business, acquired Rophibio in 2021. In September 2021, it signed a technology transfer contract worth a total of 30 billion KRW with a global biosimilar company, Company E, based in Taiwan. It is pursuing technology transfer contracts for the United States and Europe. Significant results are expected to appear starting next year.

Rophibio has completed the development of the biosimilar for Aflibercept (Eylea) from Regeneron, a U.S. company that achieved sales of 11.3 billion USD (14 trillion KRW) in 2022, and is preparing for global Phase 3 clinical trial IND (approval). Rophibio's Aflibercept biosimilar is known to have equivalent efficacy to the original drug while securing sufficient price competitiveness with productivity up to 4 to 5 times higher than competitors. The market for macular degeneration treatments, which is the leading cause of blindness in adults over 55 in major advanced countries and requires early diagnosis and treatment, is expected to reach 18.7 billion USD (approximately 24 trillion KRW) by 2028.

Rophibio signed a contract with C&Research, which has conducted over 300 regulatory Phase 3 clinical trials, to conduct the global Phase 3 clinical trial for the Aflibercept biosimilar. The trial is expected to be completed in 2025, with sales approval applications planned for the United States, Europe, and other regions in 2026. Yoon Moon-tae, CEO of C&Research, said, "We decided to partner as the clinical partner because we judged that the likelihood of success for Rophibio's Aflibercept biosimilar Phase 3 clinical trial is high."

Based on Amicogen's stable process and production technology, Rophibio currently holds six biosimilar drug development pipelines. It aims to become a global leader in biosimilar development by additionally developing commercially viable biosimilar pipelines. The company plans to list on the KOSDAQ market around 2026 to secure research and development (R&D) funds.

The global biosimilar market is expected to grow from approximately 26 trillion KRW in 2021 to over 100 trillion KRW by 2030, more than tripling in size. Governments worldwide are encouraging prescription policies for biosimilar drugs, which are at least 30% cheaper than original drugs, to reduce medical insurance deficits caused by global aging. Within the next 10 years, more than 55 blockbuster drugs with sales exceeding 1 billion USD will have patents expiring and biosimilar drugs available for launch.