Korean pharmaceutical and biotech companies are preparing to release Phase 3 clinical trial results for major drug pipelines. As Phase 3 is the final stage in drug development that determines product approval and commercialization potential, analysts say the results could lead to upward revisions in sales forecasts and corporate valuation reassessments.
According to industry sources on the 21st, Kolon TissueGene will release the topline results of its U.S. Phase 3 clinical trial for the osteoarthritis treatment "TG-C" in July this year. "TG-C" completed Phase 3 dosing in 2024 and is currently undergoing a two-year follow-up observation. Unlike existing treatments centered on temporary pain relief such as analgesics, it is being developed as a knee osteoarthritis treatment that also reduces cartilage damage. If the trial demonstrates both pain reduction and functional improvement, it could establish itself as the first disease-modifying osteoarthritis drug (DMOAD) to fundamentally improve the condition. Competitor Biosplice's knee osteoarthritis treatment "Lorecivivint" failed to meet its primary endpoint in an earlier Phase 3 trial. "If satisfactory Phase 3 results emerge, TG-C's approval and launch are expected in 2028," said Wi Hae-ju, an analyst at Korea Investment & Securities. "By 2037, the 10th year after launch, sales are projected to reach approximately 17.93 trillion won."
AriBio will also release the topline results of its Phase 3 clinical trial for the oral dementia treatment "AR1001" in September this year. AR1001 is a PDE-5 inhibitor-class Alzheimer's disease treatment, currently undergoing a global clinical trial in 13 countries with 1,535 patients. The company aims to complete dosing for the last patient in June this year. Alzheimer's treatments recently approved by the U.S. Food and Drug Administration (FDA), including Aduhelm, Leqembi, and Kisunla, are all intravenous antibody therapies. In contrast, AR1001 is being developed as an oral small-molecule drug, offering greater dosing convenience as a key differentiator. "We will achieve annual sales of 1 trillion won by 2030," an AriBio official said.
JW Pharmaceutical will produce a clinical study report (CSR) for the Phase 3 trial of its gout treatment "Epaminurad" within this year. Epaminurad is an oral treatment that selectively inhibits "hURAT1," a protein involved in uric acid reabsorption. The company is conducting Phase 3 trials in five Asian countries including Korea and recently completed dosing for the last patient. The global gout treatment market is estimated at approximately 4 trillion won. Currently, uric acid production inhibitors such as allopurinol and febuxostat are mainly used for gout treatment, but there are concerns about insufficient efficacy or safety issues, raising the possibility that Epaminurad could emerge as a best-in-class drug with improved efficacy and safety over existing treatments. "Korea's gout treatment market is worth several hundred billion won," an industry official said. "If a domestic new drug with improved efficacy and safety over existing treatments is launched, it could generate meaningful sales based on prescription switching demand."
Handok is preparing to release Phase 3 trial results in the second half of this year for "RZ358," a tumor-induced hyperinsulinism treatment being developed by its affiliate Rezolute. Handok holds the domestic development and commercialization rights for the drug and also held an 8.8% stake in Rezolute as of the end of last year. As a result, changes in the share price and corporate value of Nasdaq-listed Rezolute based on the clinical results are also affecting Handok's investment value.
Daewon Pharmaceutical is conducting Phase 3 clinical trials for "Padoprazan," a gastroesophageal reflux disease treatment in the potassium-competitive acid blocker (P-CAB) class. It is being developed as the fourth domestic P-CAB new drug, following HK inno.N's "K-CAB," Daewoong Pharmaceutical's "Fexuclue," and Onconic Therapeutics' "Jaqbo." As Korea's peptic ulcer treatment market is being reshaped from proton pump inhibitor (PPI) dominance to the P-CAB class, the strategy is to target the growing P-CAB market despite being a latecomer.
Korean companies developing obesity drugs are also accelerating late-stage trials and commercialization. Hanmi Pharmaceutical last year completed Phase 3 trials for "Efpeglenatide," which is being developed as Korea's first glucagon-like peptide (GLP)-1 class obesity treatment, and applied for domestic product approval. In April this year, the company began dosing the first patient in a Phase 3 trial to expand the drug's indication to diabetes. HK inno.N is also conducting domestic Phase 3 trials for the GLP-1 class obesity treatment "IN-B00009" and plans to apply for product approval based on clinical results after completing 40 weeks of dosing within this year.
Each company is also strengthening its commercialization capabilities in line with trial completion and approval timelines. Kolon TissueGene recently held a board meeting to review commercialization strategies, including building local sales and marketing organizations for TG-C. AriBio is in discussions with Fosun Pharma, its global licensing partner for the dementia drug, on building production and supply chains. Hanmi Pharmaceutical recently established an "Innovative Growth Division" and integrated its marketing center, Pyeongtaek manufacturing center, and overseas sales team to ensure the successful launch of its obesity drug at home and abroad.
