New Drug Development 'Lung' Ownership Battle... Daewoong Pharmaceutical, Chongkundang, and Others Accelerate

Challenge for New Drug in Idiopathic Pulmonary Fibrosis
Daewoong Selected for FDA Fast Track
Chongkundang Preparing Late Phase 2
Passion for Development in Domestic Pharmaceutical Industry

[Asia Economy Reporter Lee Gwan-joo] The domestic pharmaceutical industry is increasingly stepping up efforts to develop new drugs for idiopathic pulmonary fibrosis (IPF). IPF is a rare disease characterized by the hardening of the lungs and deterioration of lung function, with its exact cause still unknown. Particularly, the 5-year survival rate is only 40%, creating a high demand for effective new treatments.

According to the pharmaceutical and biotech industry on the 20th, more than five domestic pharmaceutical companies are developing new drugs targeting idiopathic pulmonary fibrosis. The leading companies in this field are Daewoong Pharmaceutical and Chong Kun Dang Pharmaceutical.

First, Daewoong Pharmaceutical’s self-developed new drug for IPF, ‘DWN12088,’ was recently designated as a Fast Track development item by the U.S. Food and Drug Administration (FDA). Being designated as Fast Track allows close consultation with the FDA at each development stage and enables accelerated approval and priority review applications after Phase 2 clinical trials, speeding up the drug development process. DWN12088 is the world’s first PRS (Prolyl-tRNA Synthetase) inhibitor antifibrotic drug. It works by reducing the activity of the PRS protein, which affects collagen production, thereby inhibiting the excessive collagen formation that causes fibrosis. Last month, DWN12088 received FDA approval for its Phase 2 clinical trial plan (IND) for idiopathic pulmonary fibrosis and is set to enter full-scale clinical trials.

Chong Kun Dang is exploring the potential of its new drug ‘CKD-506,’ developed for autoimmune diseases, as a treatment for idiopathic pulmonary fibrosis. CKD-506 is an HDAC6 (histone deacetylase 6) inhibitor that reduces inflammation by inhibiting HDAC6, which affects various inflammatory diseases, and maintains immune homeostasis by enhancing T cell function. In a Phase 2a clinical trial conducted in five European countries for rheumatoid arthritis, the potential of CKD-506 as an IPF drug was confirmed, and preparations are underway to enter late Phase 2 trials.

Hanmi Pharmaceutical’s innovative biopharmaceutical ‘LAPS Triple Agonist (Lapseuteuripleagonist·HM15211)’ was designated as an orphan drug for the treatment of idiopathic pulmonary fibrosis by the European Medicines Agency (EMA) following the FDA’s designation last year. Orphan drug designation in Europe provides benefits such as reduced application fees and a 10-year market exclusivity period for the first approved product in the same class. LAPS Triple Agonist is a triple agonist that simultaneously activates GLP-1 receptor, glucagon receptor, and GIP receptor, demonstrating anti-inflammatory and antifibrotic effects in animal models of idiopathic pulmonary fibrosis.

Bridge Biotherapeutics is also accelerating its development of treatments for idiopathic pulmonary fibrosis. ‘BBT-877,’ developed as an autotaxin inhibitor, is currently under discussion with the FDA for entry into Phase 2 clinical trials. In April, Bridge Biotherapeutics acquired ‘BBT-209,’ an oral IPF candidate drug from the biotech company Shaperon. SK Chemicals, in collaboration with Dr. Noah, which possesses an artificial intelligence (AI) drug platform, has also discovered candidate substances for IPF treatment and filed patents.

The reason the domestic pharmaceutical industry is actively developing treatments for idiopathic pulmonary fibrosis is that there are no effective drugs relative to the market size. According to the global market research firm IMARC, the IPF treatment market is expected to grow at an average annual rate of 7.9%, reaching $5.268 billion (approximately 7 trillion KRW) by 2027. An industry insider stated, "Although there are existing approved treatments, their effects are limited to slowing disease progression," adding, "Due to the significant unmet medical needs, challenges in developing IPF treatments are expected to continue for the foreseeable future."

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