South Korean pharmaceutical and chemical company headquartered in Seoul, established in 1926 by New Il-han; one of Korea's oldest and most prominent pharmaceutical companies. Listed on the Korea Exchange (KRX: 000100) since 1962.
Clinical Trials
19
3 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1926
Active, not recruiting
2
10.5%
Completed
11
57.9%
Not yet recruiting
1
5.3%
Recruiting
5
26.3%
No approval data available
- Yuhan registered a U.S. patent on July 21 covering bicyclic fused ring derivatives that inhibit the LOX enzyme family, a preclinical small-molecule anti-fibrosis candidate. - The patent lists idiopathic pulmonary fibrosis, MASH, chronic kidney disease and liver cirrhosis as target indications, positioning the asset across multiple organ fibrosis markets. - The LOX inhibitor differs mechanistically from Yuhan's disclosed MASH candidate YH25724, which acts on FGF21 and GLP-1 and entered domestic Phase 1 planning in May. - Industry analysts see potential licensing value as global fibrosis and MASH dealmaking accelerates, though Yuhan cautions the candidate remains preclinical and success is unproven.
- South Korea lowered the national health insurance reimbursement rate for generic drugs to 45 percent of the original drug's price, down from 53.55 percent, effective Aug. 1. - Industry groups estimate the overhaul could result in as much as 3.6 trillion won in lost sales and 14,800 fewer jobs across the pharmaceutical and biotech sector. - Korean drugmakers including Ildong Pharmaceutical and Chong Kun Dang have declared emergency management systems, consolidated sales organizations, and cut R&D budgets in response. - The government designed the cuts to reduce reliance on generics and encourage innovation, offering preferential rates of 60 percent and 50 percent to innovative and quasi-innovative companies.
- South Korean pharmaceutical companies are investing heavily in digital healthcare as a new growth engine amid mounting profitability pressure from generic drug price cuts. - Daewoong Pharmaceutical's digital healthcare revenue more than tripled from 4.8 billion won in Q1 2024 to 17 billion won in Q1 2025, with annual revenue forecast to approach 100 billion won. - Dong-A ST's digital health revenue rose 220.4% year-over-year to 5 billion won in the first half, while Daewon Pharmaceutical plans to launch a corporate venture capital arm this year. - Drugmakers are leveraging existing hospital and clinic sales networks to accelerate commercialization of digital therapeutics, remote monitoring, and AI diagnostic solutions.
- Kwangdong Pharmaceutical obtained first generic exclusivity for its osimertinib product 'Ktinib Tab' on April 30, becoming the second company after Chong Kun Dang to achieve this milestone. - Both companies successfully circumvented Tagrisso's formulation patent (expiring January 2035) and will hold roughly 9-month market exclusivity starting from the substance patent expiry in 2033. - The domestic NSCLC market, currently dominated by AstraZeneca's Tagrisso and Yuhan's Leclaza, is expected to see intensified competition when generics launch in 2033. - The exclusivity period for Ktinib runs from December 28, 2033, to September 27, 2034, during which sales of identical drugs are restricted.
- South Korean biopharmaceutical companies have secured approximately $4.2 billion in biologics licensing agreements, demonstrating increased activity in advanced therapeutic areas including antibody-drug conjugates and cell and gene therapies. - Major deals include GlaxoSmithKline's $2.5 billion agreement with ABL Bio for blood-brain barrier-crossing treatments and LigaChem Biosciences' $1.7 billion partnership with J&J Innovative Medicine. - The sector's growth is supported by $2 billion in public funding through the Korea Drug Development Fund and around 40 biotech IPOs on KOSDAQ since 2018. - Korean companies are increasingly participating in global regulatory submissions and multiregional clinical trials, with major firms showcasing capabilities at the J.P. Morgan Healthcare Conference.
- The phase 3 PALOMA-3 trial showed subcutaneous amivantamab was noninferior to intravenous administration based on pharmacokinetics and objective response rates in patients with refractory EGFR-mutated advanced NSCLC. - Subcutaneous delivery significantly improved overall survival with a hazard ratio of 0.62 and reduced infusion-related reactions five-fold compared to IV administration. - Treatment administration time was dramatically reduced from 5 hours to less than 5 minutes with subcutaneous delivery, with 85% of patients rating it as convenient or very convenient. - Prophylactic anticoagulation reduced venous thromboembolism rates from 21% to 10% in patients receiving amivantamab plus lazertinib combination therapy.
