[Edaily Reporter Hong Ju-yeon ] BukwangPharmaceutical(003000)is kicking off a revaluation of its corporate value, driven by the expanded indication for its key new drug “Latuda” for depression and the synergies from its acquisition of UNION KOREA PHARM CO.,Ltd. In addition, with news that its Danish subsidiary, Contra Pharma, plans to spin off its ribonucleic acid (RNA) business unit, industry observers are assessing that BukwangPharmaceutical has established a structure where its stable core business provides a floor, while its new drug pipeline and RNA platform open up upside potential.

IND Approval for Latuda’s Phase 3 Clinical Trial for Depression… Aims to Significantly Expand Patient Population

Last month, BukwangPharmaceutical received approval from the Ministry of Food and Drug Safety (MFDS)

for its Investigational New Drug (

IND)

application to conduct

a

Phase 3 clinical

trial of the new antipsychotic drug “Latuda Tablets” (active ingredient: lurasidone) as an adjunctive treatment for major depressive disorder (MDD). The trial will evaluate the efficacy and safety of Latuda as an adjunctive therapy compared to a placebo over an 8-week period in 364 adult patients with depression who have not responded to monotherapy with existing antidepressants. The company plans to conduct the clinical trial over two years to drive sales growth through the expansion of its indications.

There are expectations that if Latuda—currently used to treat schizophrenia and bipolar disorder—expands its indication to major depressive disorder, the patient population for which it is prescribed will increase significantly. Currently, treatment for major depressive disorder is dominated by first-line selective serotonin reuptake inhibitors (SSRIs) such as Lexapro, Zoloft, and Prozac; however, there are many patients whose symptoms do not improve sufficiently with these medications alone. Latuda targets this unmet need. Add-on therapy—combining antidepressants with atypical antipsychotics—is a strategy recommended in both domestic and international treatment guidelines for depressive disorders. Currently, the leading drugs in South Korea with approved indications for this add-on therapy are those in the aripiprazole class. If Latuda succeeds in clinical trials, it will enter this market as a direct competitor.

Latuda’s key differentiator is its tolerability. While it exerts antipsychotic effects through dopamine D2 and serotonin 5-HT2A/5-HT7 receptor antagonism, as well as 5-HT1A partial agonism, its key strength lies in the fact that it causes relatively fewer side effects—such as weight gain, elevated prolactin levels, and metabolic abnormalities—which are chronic concerns associated with existing atypical antipsychotics. Given the nature of psychiatric treatment, where long-term use is inevitable, this tolerability directly translates to patient adherence and quality of life.

Launched in August 2024, Latuda quickly established itself, with coding completed at over 90% of tertiary general hospitals nationwide in just over a year and prescriptions issued at the “Big 5” hospitals. Last year, it recorded sales of 10.9 billion won, marking growth of over 90% compared to the previous year. It also generated 3.3 billion won in the first quarter of this year. If the depression market is added to this, the growth curve could become even steeper. Driven by the combined growth of Latuda and the diabetic neuropathy treatments “Dexid” and “Chioctacid,” BukwangPharmaceutical surpassed 200.7 billion won in sales and 14.1 billion won in operating profit last year, marking the first time in its history that the company has exceeded 200 billion won in sales.

A BukwangPharmaceutical official stated, “We will be able to provide a wider range of treatment options for patients with major depressive disorder who do not respond adequately to existing treatments,” adding, “We expect that the addition of this indication will strengthen Latuda’s market dominance and position, expand our reach into the depression market, and contribute to our financial performance.”

Synergies from the Acquisition of UNION KOREA PHARM CO.,Ltd Expected to Be Reflected in the Second Half of the Year

BukwangPharmaceutical has effectively completed the acquisition

of UNION KOREA PHARM

CO

.

,

Ltd

and is now working to resolve its chronic shortage of production capacity. In May, BukwangPharmaceutical participated in UNION KOREA PHARM CO.,Ltd’s 30 billion won third-party private placement, securing a 75.14% stake and becoming the largest shareholder. Work to integrate the production systems is currently underway.

Once BukwangPharmaceutical secures the antibiotic and liquid injection production facilities owned by UNION KOREA PHARM CO.,Ltd, its total production capacity is expected to increase by approximately 30%. In fact, BukwangPharmaceutical’s Ansan plant was operating at an average capacity utilization rate of 122% between 2024 and 2025, indicating it was overloaded, and the company had to rely on outsourced production for about 20% of its sales last year. The company reportedly plans to gradually transfer its existing outsourced production items to strengthen cost competitiveness and to enter the contract development and manufacturing organization (CDMO) business for synthetic pharmaceuticals by utilizing the surplus production capacity resulting from production efficiency improvements.

Collaboration between the two companies is already taking shape. Last month, BukwangPharmaceutical shipped “Complex Pajaim Tablets,” an over-the-counter medication and the first contract manufacturing (CMO) product it outsourced to UNION KOREA PHARM CO.,Ltd. Shipments of additional products, such as “Hard-Chewable Tablets,” are scheduled to begin this coming August. Industry observers expect the benefits of the UNION KOREA PHARM CO.,Ltd acquisition to be gradually reflected starting in the second half of the year. Even considering that it will take some time to supplement and restart production lines, analysts note that sales of cephalosporin antibiotics—which can be produced and sold without additional construction—could contribute to initial revenue growth. However, BukwangPharmaceutical remained tight-lipped about the detailed schedule for the integration process and future plans, as court approval has not yet been granted.
Plans

to Spin Off and List the RNA Business Unit… Securities Analysts: “High Potential for Revaluation”

Contra Pharma, a key driver of future growth, is also facing a major milestone. Founded in 2010 by researchers from Novo Nordisk, Contra Pharma is a biotech venture specializing in the central nervous system (CNS); BukwangPharmaceutical acquired a stake in the company in 2014, making it a wholly-owned subsidiary. Last year, it attracted market attention by securing two key milestones: the successful completion of a Phase 1b clinical trial for “CP-012,” a treatment for morning akinesia in Parkinson’s disease, and a joint research agreement for a new RNA drug with Lundbeck, a global CNS pharmaceutical company.

BukwangPharmaceutical is currently pursuing a plan to spin off Contra Pharma’s RNA platform business unit into a separate entity (NewCo). In the first quarter of this year, the company applied to the Danish tax authorities for preliminary approval of the spin-off. The core objective of the spin-off is to independently highlight the value of the RNA platform, which is not yet fully reflected in the company’s current market valuation. The plan is for the new entity to expand its research scope beyond the CNS to all areas where RNA technology can be applied, such as oncology and metabolic diseases, and to operate independently by attracting external venture capital (VC) investment and forming additional partnerships with global pharmaceutical companies. A BukwangPharmaceutical official stated, “We are currently in the planning stage for the spin-off,” adding, “We are also planning an IPO alongside the spin-off and expect investment to proceed smoothly.”

Based on this structural transformation, the securities industry views BukwangPharmaceutical as undervalued. While the platform’s value is difficult to reflect in the valuation when the RNA business is buried within consolidated earnings, spinning it off into a separate entity will allow the company to directly receive a premium as a specialized RNA firm. Kim Seung-jun, an analyst at the Corporate Research Center of the Korea IR Association, analyzed, “BukwangPharmaceutical has established a structure where its specialized pharmaceutical business provides a stable floor, while CP-012 and the value of its RNA platform open up upside potential,” adding, “It is difficult to view the current price-to-book ratio (PBR) of 1.5 as fully reflecting the value of the RNA platform.” This suggests the company is relatively undervalued compared to the premiums enjoyed by RNA-based new drug development firms such as Rznomics Inc. (2025 PBR of 37.98x) and Olix Pharmaceuticals, Inc. (2026 PBR of 59.82x).

However, in the short term, increased R&D expenses for “CP-012,” a treatment for morning akinesia in Parkinson’s disease, and costs associated with the normalization of operations at UNION KOREA PHARM CO.,Ltd may weigh on earnings. Analyst Kim stated, “These measures are largely preemptive investments aimed at expanding production capacity and enhancing the value of the mid- to long-term pipeline,” adding, “It is highly likely that the company’s value will be reevaluated once momentum—such as growth in the core business centered on Latuda, the normalization of production efficiency following the acquisition of Union Pharmaceutical, and the entry of CP-012 into Phase 2 clinical trials—begins to materialize sequentially.”