Pharmaceutical and Bio Industry Strengthening R&D... Daewoong Pharmaceutical "Securing Growth Engine Through New Drug Development"

Over 16% of Annual Sales Invested in R&D
Visible New Drug Development Achievements Continue
GERD Treatment 'Pexuclu Tablets'
Type 2 Diabetes Treatment 'Inavogliflozin'

[Asia Economy Reporter Lee Gwan-joo] The domestic pharmaceutical and bio industry is accelerating efforts to strengthen research and development (R&D) capabilities, including new drug development, to secure new growth engines. In fact, the ratio of R&D expenses to sales of listed pharmaceutical and bio companies in Korea reaches 10.7%.

Active R&D investment is also increasing the new drug pipeline. According to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, as of 2020, the new drug pipeline of domestic pharmaceutical and bio companies numbered 1,477, which is 2.6 times higher compared to 2018 (573). The scale of technology exports also recorded 13.372 trillion KRW last year, a 31.7% increase from the previous year.

Among traditional domestic pharmaceutical companies, Daewoong Pharmaceutical’s R&D achievements stand out. Daewoong Pharmaceutical invested 175.9 billion KRW in R&D last year, increasing the ratio of R&D expenses to sales to 16.7%. Amid such investment, visible results are also emerging in the field of new drug development.

Indigenously Developed Domestic New Drug, Gastroesophageal Reflux Disease Treatment ‘Pexuclu Tablets’

The most notable new drug from Daewoong Pharmaceutical is the indigenously developed gastroesophageal reflux disease treatment 'Pexuclu Tablets.' Approved as a domestic new drug by the Ministry of Food and Drug Safety last year, Pexuclu Tablets are a P-CAB (Potassium-Competitive Acid Blocker) formulation that reversibly blocks proton pumps that secrete gastric acid. It has been proven to relieve symptoms faster and maintain effectiveness longer than existing PPI-class treatments.

Based on this excellence, Pexuclu Tablets began technology exports to Mexico and Brazil in 2020, and last year secured export contracts successively with the United States, China, Latin America, and the Middle East, with the total contract value exceeding 1.1 trillion KRW. Recently, confidentiality agreements (NDAs) have been filed in four Latin American countries, and product approvals are underway in a total of eight countries worldwide. Domestically, after receiving product approval from the Ministry of Food and Drug Safety at the end of last year, the company aims to launch the product in the second half of this year.

Pexuclu Tablet Logo.

Type 2 Diabetes Treatment ‘Inavogliflozin’

Following Pexuclu Tablets, Daewoong Pharmaceutical is taking another step toward new drug launch with 'Inavogliflozin.' Inavogliflozin is an SGLT-2 inhibitor developed by Daewoong Pharmaceutical as a treatment for type 2 diabetes, characterized by superior blood sugar-lowering effects and safety compared to existing marketed drugs.

Earlier in the first quarter, topline results for phase 3 trials of Inavogliflozin monotherapy and dual and triple combination therapies were released. The trials involved about 630 Korean participants, confirming excellent blood sugar-lowering effects and safety, expected to aid blood sugar control in patients with mild to moderate diabetes.

Based on the phase 3 clinical results of Inavogliflozin monotherapy and combination therapies, Daewoong Pharmaceutical recently submitted and completed the product approval application to the Ministry of Food and Drug Safety. The company plans to complete domestic approval for Inavogliflozin in the second half of this year and launch both single and combination products in the first half of next year.

Additionally, Daewoong Pharmaceutical is developing 'DWN12088,' a first-in-class drug for pulmonary fibrosis treatment. DWN12088 is the world’s first fibrosis treatment that inhibits the production of the PRS (Prolyl-tRNA Synthetase) protein. Last year, it was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) for idiopathic pulmonary fibrosis and systemic sclerosis. Based on phase 1 clinical trials conducted in Australia, phase 2 clinical trial applications have been completed this year in Korea and the U.S., aiming for approval and launch of the pulmonary fibrosis treatment by 2026, with plans to expand into various fibrosis treatments.

A Daewoong Pharmaceutical official stated, “Through active R&D investment, Daewoong Pharmaceutical is showing visible new drug development achievements in various fields such as gastroesophageal reflux disease, diabetes, and pulmonary fibrosis,” and emphasized, “We will continue to focus on new drug development through differentiated technology and active open innovation to achieve a leap as a global healthcare company.”

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