Domestic drugmaker Bukwang Pharmaceutical(003000) surpassed 100 billion won in half-year sales for the first time since its founding in the first half of this year. Multiple factors aligned, including improved results at subsidiaries, but growth in its core prescription drug business also supported the expansion in scale. The total out-of-hospital prescription amount for strategic prescription drug (ETC) items rose 7% from a year earlier, and among them, central nervous system (CNS) strategic items increased 32%.
At the center is Latuda (ingredient lurasidone), a treatment for schizophrenia and bipolar disorder launched in 2024. Latuda's sales, which fell short of 1.9 billion won in its first year on the market, topped 10.9 billion won last year, and surpassed 7 billion won in the first half alone this year, rising to the company's No. 3 product by sales. The year-over-year growth rate reached 112%.
However, expansion in scale and recovery in profitability are different stories. Bukwang Pharmaceutical's operating profit for the first half was 2.5 billion won, down 49.9% from a year earlier. The impact stemmed from cost pressures due to a stronger exchange rate, outsourcing expenses during the production automation process at the Ansan plant, and initial marketing expenses for new product launches.
Bukwang Pharmaceutical's strategy is to broaden Latuda's indications and develop the CNS business into a new growth pillar. A CNS Business Division was also placed directly under CEO Lee Jae-young. As existing CNS powerhouses such as Whan In Pharm(016580) and Myung In Pharm(317450) prepare the ground for generic entry, signaling competition, attention is on whether Latuda can sustain its sales growth and translate it into the company's profitability recovery.
◇ No. 3 in sales two years after launch… Latuda targets the larger depression market
Bukwang Pharmaceutical posted 104.8 billion won in sales on a consolidation basis in the first half of this year. That figure is up 15.9% from a year earlier.
In particular, Latuda's growth stood out. Latuda generated 7.04 billion won in first-half sales, following diabetes peripheral neuropathy treatment Dexid (9.961 billion won) and anemia treatment Ferobu (8.03 billion won). It accounted for about 7% of total sales.
Its prescription base is also expanding quickly. In March, Latuda was recommended as a first-line therapy in the Korean Medication Algorithm Project for Bipolar Disorder 2026 (KMAP-BP 2026) released by the Korean College of Neuropsychopharmacology and the Korean Society for Affective Disorders. Prescribing sites increased from 139 general hospitals, 120 psychiatric hospitals, and 1,034 psychiatric clinics in March to 158, 134, and 1,154, respectively, by the end of June.
It has entered all of the so-called "big five," including Seoul National University Hospital, Severance Hospital, Samsung Medical Center, Seoul St. Mary's Hospital, and Asan Medical Center. According to the industry, Latuda ranked sixth in the domestic market for treatments for schizophrenia and bipolar disorder in the first half.
Bukwang Pharmaceutical plans to sustain growth by expanding Latuda's indications. In June, the company received approval from the Ministery of Food and Drug Safety for a domestic phase 3 clinical trial to expand the indication to adjunctive therapy for major depressive disorder (MDD). It aims to start the trial at the end of Sep. and finish in Oct. next year.
If the trial succeeds and the adjunctive MDD indication is obtained, the patient group eligible for Latuda prescriptions could expand significantly. According to the Ministry of Health and Welfare, as of 2023, there were 2,189 MDD patients per 100,000 people receiving treatment, about 2.7 times the combined figure for schizophrenia (502) and bipolar disorder (315).
◇ Latuda with reduced weight burden… Could it become a new option for adjunctive MDD therapy?
The key question is whether Latuda can establish itself as a new adjunctive option in the MDD market.
Currently, selective serotonin reuptake inhibitor (SSRI) antidepressants are mainly used to treat MDD. However, there are many patients who do not achieve sufficient efficacy with antidepressants alone. In such cases, guidelines in Korea and abroad recommend adjunctive therapy adding an atypical antipsychotic to an antidepressant.
However, existing atypical antipsychotics carry concerns about side effects such as weight gain and metabolic abnormalities. For depression patients who require long-term treatment, these factors can reduce treatment adherence.
Latuda emphasizes that its ingredient, lurasidone, is relatively less burdensome for weight gain and metabolism. According to a study published in 2014 in the American Journal of Psychiatry, in a 6-week trial of patients with bipolar I depression, both monotherapy and combination therapy showed no significant differences from placebo in changes in metabolic indicators such as weight, lipids, and glucose.
A real-world evidence (RWE) analysis published in 2017 in the Annals of General Psychiatry also confirmed a trend toward weight loss. Patients receiving lurasidone showed an average weight reduction of 0.77 kilograms over one year, and those who switched from existing treatments to lurasidone lost an average of 1.68 kilograms.
Similar results were found in Korea. According to a retrospective observational study released in Feb. by Professor Kim Young-chan's team at Catholic University St. Vincent's Hospital, bipolar disorder patients who switched from existing treatments to Latuda showed an average weight loss of 2.06 kilograms over 16 weeks.
◇ Despite Latuda's growth… expense burden and generic competition are "variables"
However, there are not a few challenges Latuda must overcome to sustain its growth.
First is the exchange-rate burden from sourcing raw materials. Bukwang Pharmaceutical imports Latuda raw materials from the developer, Japan's Sumitomo Pharma. As prescriptions expand, the larger the scale of raw material purchases, the greater the impact exchange-rate volatility could have on profitability.
The burden of research and development is also a variable. In the first half of this year, Bukwang Pharmaceutical's recurring research and development expense was 11.6 billion won, up 31.5% from a year earlier. The increase reflects higher spending on new drug development at subsidiary Contera Pharma.
On top of this, once phase 3 for expanding Latuda's MDD indication gets into full swing, additional expenses will occur. Bukwang Pharmaceutical did not disclose the expense, but given it is a large-scale trial involving 364 patients across 18 institutions, a significant expense is likely to be invested. Even after successfully securing the indication, sales and marketing expenses are expected to follow to expand prescriptions in the new market.
A bigger variable is how long it can leverage the MDD indication as a competitive edge after securing it. Bukwang Pharmaceutical is targeting a related marketing authorization application and reimbursement listing in 2029.
Around that time, generic competition in the existing indication market is expected to intensify. Chong Kun Dang pharmaceutical(185750), Whan In Pharm, Myung In Pharm, Yungjin Pharm(003520), and 유니메드제약 filed scope confirmation trials seeking negative confirmation on two formulation patents, and some have won. It cannot be ruled out that these companies may later avoid the MDD indication patent.
A Bukwang Pharmaceutical official said, "We are currently preparing a patent strategy related to the MDD indication," and added, "We are a latecomer in the CNS market, but we plan to expand the business by making MDD a new growth driver."