This is 69 Newsletter for November 2025.
This article we focus at the growing gap between how much global pharma is investing in Korean R&D and how little Korean patients still access new medicines. In 2024, global companies ran 1,691 clinical trials in Korea with ₩1.03 trillion in R&D spending, yet new drug availability remains only about 25% of the OECD average. We review KRPIA’s proposals for faster approvals, legalization of decentralized clinical trials, and pricing reforms to close this gap. We also highlight Seoul National University Hospital’s use of an AI-enabled kidney stone removal robot, the US FDA’s streamlined biosimilar pathway, Korea’s ₩940.8 billion advanced medical device R&D program, and key regulatory risks in the rapidly expanding advanced regenerative medicine market.
Global pharma invested $726 mil. in Korean R&D last year, up 18.8%: KRPIA
Global pharma invested ₩1.03T in Korea R&D 2024 (+18.8%), ran 1,691 trials (69% oncology), hired 2,470 researchers. Yet new drug access is only ~25% of OECD average. KRPIA calls for faster approvals, DCT legalization, and pricing reform.
US FDA eased biosimilar regulations, raising pharma industry’s hopes for lower drug prices, larger access
FDA eases biosimilar approval by cutting comparative efficacy studies, relying on analytical/PK data. Saves 1-3 years & $24M per drug, boosts competition. Biologics = 51% U.S. spend despite 5% prescriptions. Korean firms gain faster, cheaper U.S. entry.
SNU Hospital adopts AI-backed kidney stone-removal robot for new training center
Company A supplied AI kidney stone robot Zamenix to SNUH robotic training center—the first Korean system there. Hands-on training starts Nov. 20; 2022 trial showed 93.5% stone removal rate.
Korea to Invest KRW 940 Billion in Advanced Medical Device R&D Over Seven Years
Four ministries will invest ₩940.8B (2026–2032) in Phase 2 of the Advanced Medical Device R&D Program to develop 6 world-first devices and localize 13 essential ones. Full-cycle support from basic research to approval will focus on AI/robotics devices. Phase 1 (2020–2024) yielded 433 approvals, 72 tech transfers, and 254 commercializations.
Ambiguity in advanced regenerative medicine law sparks concern over misuse, insurance strain
Korea’s advanced regenerative medicine market grows rapidly (112 institutions in 2024 → 160 in 2025), but non-reimbursed treatments show huge price gaps. KIRI warns of indemnity insurance instability and potential abuse without clear “intractable disease” definitions and cost regulation.
Regulatory roadblocks threaten European healthcare investment and market access in Korea: ECCK
ECCK 2024: Korea’s pricing, HIRA conservatism, and local favoritism delay European drugs/devices, risking “Korea-passing.” Urges transparent pricing, indication-based valuation, and EU-Korea GMP mutual recognition.
