Production of domestically developed new drugs in Korea has surpassed 700 billion won for the first time. With potassium-competitive acid blocker (P-CAB) treatments for gastroesophageal reflux disease and anticancer drugs driving growth, analysts say Korean new drugs are now delivering results not only in research and development but also at the commercialization stage.
Production of Korean new drugs reached 738.5 billion won last year, according to the "2025 Domestic Pharmaceutical Production Records" the Ministry of Food and Drug Safety (MFDS) submitted to the office of Rep. Han Ji-ah of the People Power Party on the 8th. This represents an increase of approximately 31% from 2023 (563.2 billion won) and a rise of about 7% from 2024 (648.1 billion won). Korean new drugs are medicines approved by the MFDS through independent domestic research and development, with a total of 43 products registered as of that day. Production records are calculated by multiplying the production volume of drugs manufactured and shipped domestically by their shipment prices, serving as an indicator of actual domestic manufacturing scale.
By product, the strong performance of the P-CAB class stood out. Production of three P-CAB products—K-CAB, Fexuclue, and Jaqbo—totaled 330.3 billion won, accounting for 44.7% of total Korean new drug production. K-CAB, approved as the 30th Korean new drug, reached 185.9 billion won, recording the largest production value among all Korean new drugs. Fexuclue, the 34th Korean new drug, followed with 117.3 billion won. Jaqbo, the 37th Korean new drug and the most recently approved among the P-CAB class, recorded 27.1 billion won. That marks a 544.5% increase from 2024 (4.2 billion won), the highest growth rate among all Korean new drugs.
Anticancer drugs also showed growth. Leclaza, a non-small cell lung cancer treatment from Yuhan (000100.KS), reached 150.2 billion won, up 41.9% from 2024 (105.9 billion won). Production of diabetes treatments also increased. Zemiglo tablets from LG Chem (051910.KS) recorded 58.2 billion won, rising 12.8% over the same period.
In contrast, among the 41 Korean new drugs registered as of the end of last year, 10 products saw production decline from the previous year. By product, production of the anti-inflammatory analgesic Pelubi fell 39.0% to 21.9 billion won from 35.9 billion won a year earlier, while Noltec, a proton pump inhibitor (PPI) treatment for gastroesophageal reflux disease, decreased 29.9%. Production of the diabetes drug Suganon dropped 51.2%, and the erectile dysfunction treatment Zydena fell by as much as 77.2% depending on dosage.
Beyond production declines, some drugs have exited the market entirely. Last year, Celltrion (068270.KS) decided to voluntarily withdraw Regkirona, a COVID-19 antibody treatment approved as the 32nd Korean new drug. Previously, five products—including HK inno.N's (195940.KQ) Pseudovaccine injection (2010), Dongwha Pharm's (000020.KS) Milican injection (2012), and JW Pharmaceutical's (001060.KS) Zepeed tablets (2022)—were voluntarily withdrawn by their manufacturers due to declining business viability. Olita tablets, the 27th Korean new drug from Hanmi Pharmaceutical (128940.KS), had its approval revoked in 2018 over safety issues in global clinical trials.
"Zepeed tablets, an erectile dysfunction treatment, was launched in 2011 as the 17th Korean new drug, but as various competing products and inexpensive generics of original drugs entered the market, its position weakened, and we decided to voluntarily withdraw it in 2022," a JW Pharmaceutical official explained.
As of last year, drugs that had reached the expiration of their approval period or halted production due to marketability and economic concerns included Sunpla injection from SK Chemicals (285130.KS)—Korea's first domestically developed new drug, whose approval expired in 2023—as well as JW Pharmaceutical's Q-Roxin tablets, Dongwha Pharm's Zabolante tablets, and SK bioscience's (302440.KS) SKYCovione, all of which have ceased production.
"The commercial success of Korean new drugs is likely to depend on market entry strategies and securing global partnerships rather than simple development achievements," said Jung Hye-yoon, senior researcher at the Bio-Health Policy Research Center of the Korea Health Industry Development Institute. "An approach that simultaneously establishes competitiveness verification and business strategy at the clinical and commercialization stages is important," she stressed.
