Bukwang Pharm Pushes for Global Phase 2 Clinical Trials of Parkinson’s Disease New Drug with 20 Billion Won Investment
Lakhvinder Singh Specialized Reporter
| 2026-10-24 17:39:35
Bukwang Pharm is accelerating its drive to secure mid-to-long-term growth engines through the development of a new Parkinson’s disease drug and the expansion of its Central Nervous System (CNS) therapeutics business.
In particular, the company is investing approximately 20 billion won into the global Phase 2 clinical trials for 'CP-012,' a candidate substance for Parkinson's disease morning akinesia. It is also strengthening its business portfolio by launching a specialized RNA therapeutics corporation and expanding its contract manufacturing organization (CMO) business for pharmaceuticals.
During its Q3 earnings conference call on the 23rd, Bukwang Pharm announced that its cumulative consolidated revenue for the third quarter of this year reached 162.7 billion won, representing an 17.8% increase compared to the same period last year. Operating profit recorded 4.7 billion won, continuing a profitable trend.
Due to increased investments in research and development, operating profit decreased by 22.2% year-on-year. Cumulative ordinary R&D expenses for the third quarter rose by 29.5% to 16.9 billion won.
The existing pharmaceutical business is maintaining a steady growth trend. Outpatient prescriptions for prescription drug (ETC) strategic items increased by 9%, while CNS strategic items grew by 20%. The CNS sector significantly outperformed the market growth rate of 9%.
'Latuda (lurasidone),' a treatment for schizophrenia and bipolar depression, surpassed a cumulative revenue of 20 billion won last July, marking its second anniversary since launch.
Currently, it is being prescribed across 177 general hospitals, 151 psychiatric hospitals, and 1,280 neuropsychiatric clinics nationwide. As of the third quarter, it ranked 6th in the domestic schizophrenia and bipolar disorder treatment market.
Bukwang Pharm has also initiated domestic Phase 3 clinical trials to expand the indications of Latuda to include major depressive disorder (MDD). The strategy is to solidify its position within the CNS therapeutics market through expanded indications.
CP-012 Confirms Sustained-Release Properties in Phase 1; Global Phase 2 Enters Full Swing
In the new drug development sector, 'CP-012,' a treatment for Parkinson's disease morning akinesia developed by its subsidiary Contera Pharma, stands out as a core pipeline asset.
In the Phase 1b clinical trials presented this month at the International Congress of Parkinson's Disease and Movement Disorders (MDS 2026), the drug demonstrated delayed drug absorption characteristics compared to conventional immediate-release formulations in 14 Parkinson's disease patients.
Notably, the levodopa detection rate 16 hours after administration was 92.9% to 100%, which is higher than that of the immediate-release single-administration group (42.9%). No clinically significant safety-related findings were observed.
Having received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), the company is preparing for global Phase 2 clinical trials under the name 'DAWN-PD.'
The goal is to begin dosing the first patient in the U.S. during the fourth quarter of this year and secure key results by the first quarter of 2028.
"We expect CP-012 clinical trials to cost approximately 20 billion won over two years," said Lee Je-young, CEO of Bukwang Pharm. "This investment was decided through joint discussions between Contera Pharma, Bukwang Pharm, and OCI Holdings, and we have high expectations for the clinical results."
Establishing an Independent RNA New Drug Development System: Joint Research with Lundbeck and Expansion of CMO Business
In the RNA therapeutics business, the company is improving R&D efficiency through a separate, specialized legal entity.
Contera Pharma has completed the spin-off procedures for 'THREEPOINT Therapeutics' in Denmark and is preparing for its official launch in November.
The newly established corporation plans to expand its pipeline by leveraging artificial intelligence (AI)-based target discovery technology and an RNA therapeutics platform.
Bukwang Pharm plans to unveil the technological competitiveness of its RNA platform, current status of joint research, and the mid-to-long-term development strategy of the new subsidiary at its R&D Day on November 24.
In the manufacturing sector, the company changed the corporate name of Korea Union Pharm, which it acquired this year, to 'Bukwang UniPharm' and is fostering it as a specialized manufacturing enterprise.
Building on its production capabilities for antibiotics and injectables, the company aims to expand its CMO business targeting external pharmaceutical companies, securing additional revenue and profit bases.
CEO Lee Je-young stated, "Based on three growth engines—solid growth in our core business, visible R&D results, and synergies from manufacturing subsidiaries—we will continue to achieve unshakeable growth through the fourth quarter and into next year and beyond."
[ⓒ Global Economic Times. 무단전재-재배포 금지]
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