Daewoong Pharmaceutical group said on the 14th that bio new drug development corporations HANALL BIOPHARMA is expected to achieve its highest-ever results this year.
HANALL BIOPHARMA's sales for the first through third quarters this year came to 117.6 billion won, up 14.7% from a year earlier. Last year's annual sales were 138.9 billion won. A company official said, "There has been a long-held industry stereotype that bio corporations inevitably run losses until they succeed in developing a new drug, but HANALL BIOPHARMA has been turning a profit and steadily growing its results."
What stands out is that it has continued to post operating profit despite increased investment in research and development expenses. HANALL BIOPHARMA saw meaningful progress in succession with the development of the new autoimmune disease treatments "batoclimab" and "imerofrubat," pushing the ratio of research and development expenses to last year's sales up to 26.3% (36.4 billion won). That was more than a 50% increase compared with 21.5 billion won, or 19.5% of sales, in 2022.
The secret to staying in the black lies in rising sales of key medicines. The company said sales of the probiotic intestinal regulator Biotop are on the verge of surpassing the 20 billion won mark.
According to the company, first-half sales surpassed 10 billion won, and in Aug. it ranked No. 1 in out-of-hospital prescriptions in the probiotics intestinal regulator category. The company explained that Biotop is an over-the-counter medicine available at pharmacies and, with effects in improving intestinal health, constipation, diarrhea, and abdominal bloating, it has been performing well in the prescription market and rapidly increasing its market share.
Eligard, a treatment for prostate cancer and precocious puberty, reached 10 billion won in sales early. The company said the hair loss treatment "Hair Grow" set a record monthly sales high in Sept. with 2.5 million tablets sold and is maintaining the No. 1 spot in the prescription dispensing market for finasteride 1 mg generics.
The company said research on bio new drugs is also proceeding smoothly.
"Batoclimab (HL161BKN)," under development as a treatment for autoimmune diseases, suggested the potential to be a fundamental therapy for patients who did not respond to existing treatments through six-month maintenance-effect data after stopping treatment in phase 2 for Graves' disease (GD) in Sept. In the trial results, about 80% of patients maintained normal thyroid hormone levels for six months after stopping batoclimab, and half of them remained stable even without antithyroid drugs.
Research and development of "imerofrubat (HL161ANS)" is also proceeding as scheduled. Based on clinical data for batoclimab, it is also being developed for a total of six autoimmune diseases: myasthenia gravis (MG), Graves' disease (GD), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA), Sjögren's disease (SjD), and cutaneous lupus erythematosus (CLE).
Clinical trials for the dry eye disease candidate "tanfanercept" are also underway with the goal of announcing key topline results next year. The Parkinson's disease candidate "HL192" is aiming to enter subsequent clinical trials next year. The company said it is continuing research on an mRNA lipid nanoparticle (LNP)-based anti-aging therapy introduced last year and is strengthening its immunology-based research and development capabilities.
A HANALL BIOPHARMA official said, "A virtuous cycle is taking hold in which revenue generated by steady growth in the prescription market is reinvested in new drug development to deliver results," adding, "We plan to keep growing our key medicine portfolio and focus our capabilities on delivering results in bio new drug development."