K-made new drug production reached KRW 800B

The production amount of domestically developed new drugs amounted to KRW 794.6 billion last year…47%↑ over two years

K-CAB production surpassed KRW 200 billion…Fexuclue·Leclaza KRW 100 billion

Three domestically developed new drugs were approved this year…the highest in 4 years

Last year, the production amount of domestically developed new drugs in South Korea was the highest in history. With a variety of hit products having been introduced to the prescription market, the production growth rate has neared 50% over the past two years. Annual production for HK inno.N's K-CAB, Daewoong Pharmaceutical’s Fexuclue, and Yuhan Corporation’s Leclaza each surpassed KRW 100 billion. Additionally, three domestically developed new drugs passed commercialization hurdles this year. This year has seen the highest output of new drugs in four years since 2021.

Korea-made new drug production amounted to KRW 794.6B, up 47% in 2 years...K-CAB first to surpass KRW 200B

According to the Ministry of Food and Drug Safety (MFDS) on December 30, domestically developed new drugs combined for a total production value of KRW 794.6 billion last year. This represents a 16.1% increase from the KRW 684.6 billion recorded in 2023, the highested in history. Compared to the 2022 production figure of KRW 540.5 billion, the sector has expanded by 47.0% in just two years.

2024 Production Amount of Domestically Developed New Drugs in South Korea(unit: number of items, sources: MOHW, MFDS): (from top) K-CAB, Fexuclue, Leclaza, Pelubi, Kanarb, Zemiglo, Noltec, Duvie, Suganon, Envlo, Supect, Rolontis, Zydena, Pyramax, Mvix, Jaqbo, Besivo, Factive, Easyef SOLN, RG-Q, Revanex

K-CAB, Fexuclue, and Leclaza represent key commercial successes among Korea-made drugs, each recording annual production exceeding KRW 100 billion.

HK inno.N's K-CAB recorded the highest production last year at KRW 231.0 billion. K-CAB is the first potassium-competitive acid blocker (P-CAB) developed by a Korean company for the treatment of gastroesophageal reflux disease (GERD). K-CAB recorded production performance of KRW 171.9 billion in 2022 and KRW 173.9 billion in 2023. Last year, its production increased by 32.8% year-on-year, surpassing the KRW 200 billion mark. K-CAB is the first domestically developed new drug to exceed KRW 200 billion in annual production.

K-CAB continues its high growth by highlighting advantages such as a faster onset of action compared to conventional proton pump inhibitor (PPI) products and the ability to be taken regardless of mealtime. In addition to the tablet form, two types of orally disintegrating tablets (ODT) have also been approved. KRW 28.2 billion-worth ODT formulation was produced last year.

The production of Daewoong Pharmaceutical's GERD treatment, Fexuclue, reached KRW 118.1 billion last year, a 66.0% increase from the previous year. Fexuclue is a P-CAB class treatment similar to K-CAB. It received marketing authorization in December 2021 and began full-scale sales in July 2022 upon being listed on the national health insurance (NHI) reimbursement list.

Fexuclue rapidly penetrated the market by demonstrated excellence in areas such as ▲rapid onset of action ▲fast and superior symptom improvement ▲ effective nighttime symptom relie ▲dosing convenience ▲low drug-drug interactions and consistent efficacy. Fexuclue's production was KRW 27.4 billion in its launch year (2022), then rose sharply to KRW 71.2 billion in 2023, and surpassed KRW 100 billion last year.

Yuhan Corporation's Leclaza recorded a production value of KRW 105.8 billion last year. Leclaza is a treatment for non-small cell lung cancer (NSCLC) approved in January 2021 as Korea's 31st domestically developed new drug. Leclaza entered the prescription market following its listing on the NHI reimbursement list in July 2021.

Leclaza's initial production in 2021 was KRW 9.8 billion, which expanded to KRW 39.3 billion in 2022. It surpassed the KRW 100 billion in 2023 with KRW 112.2 billion in production, only three years after launch, and has maintained production levels above KRW 100 billion for two consecutive years.

Analysis suggests that the surge in demand is due to the expanded scope of NHI reimbursement for Leclaza as a first-line treatment. Leclaza was initially approved as a second-line treatment for locally advanced or metastatic NSCLC with specific gene (T790M) resistance following the administration of 1st or 2nd generation EGFR Tyrosine Kinase Inhibitors (TKIs). In June 2023, the MFDS approved changes of approval for Leclaza to include the 'first-line treatment of NSCLC'. Since January of last year, scope of reimbursement was expanded to include the 'first-line treatment of locally advanced or metastatic NSCLC with specific genetic mutations'.

These three new drugs, K-CAB, Fexuclue, and Leclaza, combined for a total production of KRW 454.9 billion last year. They accounted for 57.3% of the total production value of all domestically developed new drugs, leading the commercial success of the sector.

The production of ​Daewon Pharmaceutical's analgesic drug Pelubi reached KRW 76.9 billion last year, a 58.3% increase year-on-year. Approved in 2007 as Korea's 15th new drug, Pelubi is a non-steroidal anti-inflammatory drug (NSAID) with indications for osteoarthritis, rheumatoid arthritis, low back pain, and fever reduction in acute upper respiratory infections. Pelubi’s production surged as its prescription volume expanded significantly through the COVID-19 pandemic and endemic phases.

Boryung's hypertension treatment Kanarb, LG Chem's diabetes treatment Zemiglo, and Il-Yang Pharm's anti-ulcer agent Noltec all recorded production values exceeding KRW 50 billion last year.

Products recording over KRW 10 billion in production last year included Chong Kun Dang's diabetes treatment Duvie, Dong-A ST's diabetes treatment Suganon, Daewoong Pharmaceutical's diabetes treatment Envlo, Il-Yang Pharm's leukemia treatment Supect, and Hanmi Pharmaceutical's neutropenia treatment Rolontis. 

Of the 38 new drugs approved through last year, 21 products recorded production figures. Approximately half of the new drugs approved by the MFDS were found to have no production.

Three Korea-made new drugs approved this year…highest since 2021

This year, three domestically developed new drugs, GC Biopharma's Barythrax, Medytox's Nuviju, and Dong-A ST's Xcopri, received marketing authorization.

List of Newly Approved Domestically Developed Drugs: 1. Sunpla Inj (SK Chemicals) 2. Easyef SOLN (Daewoong Pharmaceuticals) 3. Milican inj (Dong Wha) 4. Q-roxin Tab (JW Pharmaceutical) 5. Factive Tab (LG Chem) 6. Apitoxin Inj (BCWORLD PHARM) 7. Pseudobaccine (CJ CheilJedang) 8. Camtobell (Chong Kun Dang Pharm) 9. Revanex (Yuhan Corp) 10. Zydena (DONG-A ST) 11. Levovir (Bukwang Pharm) 12. Pelubi (Daewon Pharm) 13. Mvix (SK Chemicals) 14. Noltec Tab (IL-YANG PHARM) 15. Kanarb Tab (Boryung) 16. Pyramax Tab (SHIN POONG PHARM) 17. Zepeed Tab (JW Pharmaceutical) 18. Supect Capsule (IL-YANG PHARM) 19. Zemiglo (LG Chem) 20. Duvie Tab (Chong Kun Dang Pharm) 21. RIAVAX (GemVax & KAEL) 22. Acelex Cap (CrystalGenomics) 23. Zaborlante Tab (Dongwha Pharm) 26. Suganon tab (DONG-A ST) 27. Olita Tab (Hanmi Pharm) 28. Besivo Tab (Ildong Pharmaceutical)29. Alzavue Inj (Future Chem) 30. K-CAB (HK inno.N) 31. Leclaza (YUHAN Corp) 32. Regkirona Inj (CELLTRION) 33. Rolontis (Hanmi Pharm) 34. Fexuclue Tab (Daewoong Pharmaceuticals)35. SkyCovione Multi Injection (SK bioscience) 36. Envlo (Daewoong Pharmaceuticals)37. JAQBO Tab (Onconic Therapeutics) 38. Unafra Inj (VIVOZON PHARMACEUTICAL)39. Barythrax (Green Cross) 40. NUVIJU Inj (Medytox) 41. Xcopri tab (DONG-A ST).

In April, GC Biopharma's recombinant anthrax vaccine, Barythrax, was approved as Korea's 39th new drug. Barythrax is a vaccine designed for the pre-exposure prophylaxis of anthrax in adults. It uses recombinant technology to manufacture the protective antigen (PA) protein, a major component of the anthrax toxin, to induce antibodies that prevent infection. 

Barythrax was co-developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA) and was approved 18 months after the application was filed in October 2023.

In September, Medytox's Nuviju was approved as the 40th domestically developed new drug. Nuviju is a treatment that reduces submental subcutaneous fat by inducing adipocyte lysis through the disruption of the cell membrane's lipid bilayer via surfactant action. It is approved for adult patients seeking to improve moderate to severe submental fullness or excessive fat. 

Nuviju is Medytox's first chemical drug and the world's first next-generation fat-dissolving injectable developed with cholic acid as the main ingredient. Cholic acid is a type of bile acid synthesized in the liver and secreted into the bile.

This year, the highest number of domestically developed new drugs reached the commercialization stage in four years, following the four drugs approved in 2021. In 2021, Yuhan Corporation's oncology drug Leclaza, Celltrion's COVID-19 treatment Regkirona, Hanmi Pharmaceutical's neutropenia treatment Rolontis, and Daewoong Pharmaceutical's GERD treatment Fexuclue obtained new drug approval.