This year, a variety of Korea-made medicines are aiming to enter the United States, the world's largest pharmaceutical market. There were no Korea-made new drugs that cleared the U.S. Food and Drug Administration (FDA) approval hurdle last year, but attention is on whether there will be FDA approval results this year. At the same time, for corporations already in the U.S. market, expanding product sales this year is expected to be a key indicator of each company's financial growth potential.
According to the KoreaBio Economic Research Center on the 9th, the FDA's Center for Drug Evaluation and Research (CDER) approved a total of 46 new drugs last year. They included 34 new molecular entities (NME) and 12 biologics license applications (BLA). No Korea-made medicines made the FDA's new drug approval list last year, while in 2024 Yuhan Corporation's lung cancer drug Leclaza (ingredient name Lazertinib) and HUGEL's botulinum toxin "Letybo" won FDA approval.
This year, HK inno.N's new drug for gastroesophageal reflux disease "K-CAB" will seek FDA approval. Securing FDA approval for K-CAB and entering Europe are the company's core tasks this year. According to the company, K-CAB's U.S. partner, Sebela, is in the final stages of preparing for U.S. approval and plans to submit a new drug application (NDA) to the FDA. The company said, "NDA submission is imminent," and noted, "The FDA new drug application preparation process is proceeding smoothly."
K-CAB, developed by HK inno.N, is a second-generation P-CAB (potassium-competitive acid blocker) therapy with strengths that improve on the shortcomings of first-generation reflux treatments, the PPI class. P-CAB drugs block the "proton pump," the acid secretion pathway in gastric parietal cells, to prevent excessive acid secretion. Unlike PPIs, P-CAB compounds self-activate and can be taken regardless of meals. They are resilient enough not to degrade easily even with acid exposure, allowing long-lasting efficacy.
It was launched in Korea in 2019 and has maintained the No. 1 position in out-of-hospital prescriptions in the domestic peptic ulcer drug (gastrointestinal medicine) market. It is currently sold in a total of 18 countries, including China, Malaysia, Peru, and Chile. The company secured positive results in U.S. phase 3 trials evaluating K-CAB's efficacy in patients with gastroesophageal reflux disease. Both the erosive esophagitis and non-erosive gastroesophageal reflux disease trials met their primary and secondary endpoints. Reflux esophagitis is classified into erosive and non-erosive types, with erosion referring to damage to the gastric mucosa.
HLB Group also plans to pursue a reapplication process for FDA new drug approval this year with the liver cancer treatment "Tualvegeo." This is a first-line combination therapy for liver cancer combining HLB's Rivoceranib with Hansoh Pharma's immune checkpoint inhibitor Camrelizumab.
Last year, HLB attempted to win FDA approval but came up short. The reason for the refusal was not the efficacy or safety of Rivoceranib, but issues with Camrelizumab's manufacturing processes and facilities. The FDA requested supplementation related to chemistry, manufacturing and controls (CMC). The company plans to address the cited issues and make another attempt at FDA product approval.
HLB Group last year appointed Kim Tae-han, former Samsung Biologics president, as chairman overseeing the bio business after Chair Jin Yang-gon stepped down as CEO. This is also a strategy to strengthen approval and commercialization capabilities. From Samsung Biologics' early days, Chair Kim oversaw manufacturing approvals from global regulators and the establishment of quality systems.
For corporations that have already cleared the FDA approval hurdle, commercial success and expanding market share are key tasks. Samsung Bioepis, Celltrion, Yuhan Corporation, GC Biopharma, SK Biopharm, and HUGEL are representative examples.
GC Biopharma's immunoglobulin product "Ariglo" received FDA approval in Dec. 2023 and was launched in the United States in the second half of 2024. In its first year on the market, sales were $36 million (about 52.1 billion won). Ahead of last year's annual results announcement, attention is on whether Ariglo's annual sales will reach the guidance presented at the start of the year of $100 million (about 144.6 billion won. The company set a goal of "$300 million in annual Ariglo sales in 2028."
Ariglo is an intravenous blood plasma product mainly used for primary immunodeficiency and is the first Korea-made plasma derivative to enter the U.S. market. Plasma derivatives are medicines made by separating and purifying various proteins contained in plasma by component, requiring complex manufacturing processes and advanced technologies.
GC Biopharma plans to improve profitability by securing plasma raw materials and expanding its distribution network in the United States. To that end, subsidiary ABO Holdings opened a plasma collection center in Texas in the third quarter of last year, and the company plans to open additional centers in the second half of this year. The company said that once eight plasma collection centers are in stable operation in the United States in 2027, it will be able to self-procure 80% of the plasma needed to manufacture Ariglo. This is intended to improve the cost ratio.
Yuhan Corporation's anticancer drug Leclaza (U.S. product name LAZCLUZE) received approval in Aug. 2024 as a combination therapy with Johnson & Johnson's anticancer drug Rybrevant for lung cancer treatment and was launched in the U.S. market. J&J disclosed that combined global sales of Leclaza and Rybrevant for the cumulative first to third quarters were $428 million (about 619.7 billion won). Last month, the FDA approved a subcutaneous (SC) formulation of Rybrevant that improves dosing convenience, leading to expectations that sales growth of the Leclaza–Rybrevant combination therapy will accelerate further.
HUGEL received FDA approval for its botulinum toxin "Letybo (domestic product name Botulax)" in Mar. 2024. The company plans to boost sales by strengthening marketing this year in the United States, which accounts for a large share of the global market, and expanding sales from the West Coast to the East Coast.
SK Biopharm aims to reach No. 1 in the U.S. market with its epilepsy drug Cenobamate (U.S. product name XCOPRI). From January to September last year, cumulative U.S. sales of XCOPRI were about 459.5 billion won, surpassing full-year 2024 sales.
In the securities industry, there is a projection that XCOPRI's U.S. annual sales last year reached about 680 billion won. Jung Jae-won, an iM Securities analyst, said, "This year, SK Biopharm can be expected to see top-line growth from increased U.S. prescriptions of XCOPRI and higher royalty revenue due to expanded sales regions."
Biosimilar corporations are also stepping up efforts to expand their U.S. market share.
Samsung Bioepis last year won U.S. approval for Ospomyv, a biosimilar to osteoporosis treatments Prolia and Xgeva, and Xbryk, bringing its number of FDA-approved biosimilars in the United States to 10. Last year, it also launched in the U.S. the autoimmune disease treatment Pruxizva, the rare disease treatment Epyscyli, and the ophthalmic disease treatments Byuvez and Ofuviz.
Celltrion has obtained FDA approval for 11 products, including 10 biosimilars and one biologic new drug. Celltrion's U.S. subsidiary plans to launch a subcutaneous (SC) formulation of the autoimmune disease treatment Abtozma in the first half of this year. Last year, the company launched in the U.S. market biosimilar products including the autoimmune disease treatments Abtozma and Steqeyma, and the osteoporosis treatment Stovoclo-Osenvelt.
A company official said, "The U.S. subsidiary has completed the expansion of specialized personnel to drive prescription growth in rheumatoid arthritis, a key indication for Abtozma," adding, "We plan to move quickly to secure first-mover advantage with stronger sales competitiveness and marketing capabilities."