32 Years Since the Birth of 'Guksan New Drug', Will the 35th Next-Generation New Drug Emerge This Year?

Since SK Chemicals' 'Sunplazju' in 1999, up to No. 34 released
Main products leading the future of each pharmaceutical company
Daewoong Pharmaceutical announces Phase 3 clinical trial for new diabetes drug... Approval expected for 2 consecutive years

[Asia Economy Reporter Lee Gwan-joo] This year marks 32 years since the birth of the first ‘domestically developed new drug’ created purely with Korean technology, and attention is focused on whether the 35th domestic new drug can be born. Daewoong Pharmaceutical’s diabetes drug ‘Inavogliflozin,’ considered a leading candidate, has already completed its marketing authorization application, and if approval is granted within the year, it could set a record of new drug approvals for two consecutive years.

According to the pharmaceutical and bio industry on the 14th, the first domestic new drug was SK Chemicals’ anticancer drug ‘Sunpla-ju,’ which obtained marketing authorization in July 1999. With stomach cancer as its indication, 8.1 billion KRW was invested over 10 years of research, opening the curtain for domestic new drugs.

Since then, recognizing the importance of new drug development, the pharmaceutical industry has significantly increased its research and development (R&D) investment, successfully obtaining approval for more than one new drug almost every year. Especially last year, a remarkable achievement was made with the birth of the 31st to 34th domestic new drugs, starting with Yuhan Corporation’s non-small cell lung cancer treatment ‘Reclaza,’ followed by Celltrion’s COVID-19 antibody treatment ‘Rekkirona,’ Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis,’ and Daewoong Pharmaceutical’s gastroesophageal reflux disease treatment ‘Pexuclu.’

These developed domestic new drugs are growing into key products that will lead the future of each pharmaceutical company. Reclaza surpassed cumulative sales of 10 billion KRW within a year after being covered by insurance in July last year, and Rolontis became the sixth domestic new drug to receive approval from the U.S. Food and Drug Administration (FDA). Pexuclu is also expanding its indications and accelerating its entry into overseas markets, growing into a future blockbuster.

Daewoong Pharmaceutical's Pexuclu, the 34th domestic new drug approved last December.
[Photo by Daewoong Pharmaceutical]

The product currently attracting attention as the next domestic new drug is Inavogliflozin, an SGLT-2 (sodium-glucose co-transporter-2) inhibitor class diabetes drug developed for the first time in Korea by Daewoong Pharmaceutical. According to the Phase 3 clinical trial results recently presented by Daewoong Pharmaceutical at the Korean Diabetes Association International Conference, Inavogliflozin demonstrated excellent blood sugar-lowering effects and safety in monotherapy, dual combination therapy, and triple combination therapy.

SGLT-2 is present in the proximal tubules of the kidney and is involved in glucose reabsorption; by inhibiting it, glucose is directly excreted in the urine, thereby lowering blood sugar levels. After being designated as the first expedited review drug in Korea in 2020, the marketing authorization application was submitted to the Ministry of Food and Drug Safety at the end of March this year.

Since statistical significance was secured through Phase 3 clinical trials, expectations for Inavogliflozin’s marketing authorization are high. Daewoong Pharmaceutical aims for approval within the year and domestic launch in the first half of next year. If approved, Daewoong Pharmaceutical will set a new record of consecutive domestic new drug approvals for two years in a row, following Pexuclu. No pharmaceutical company has achieved consecutive domestic new drug approvals over the past 32 years.

Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, “We are developing Inavogliflozin, which has excellent blood sugar-lowering effects, as the best-in-class drug in its category,” adding, “We hope to quickly launch this next-generation new drug to improve the quality of life for patients suffering from diabetes.”

This content was produced with the assistance of AI translation services.