HanAll Biopharma announced today that the company had achieved sales of 23.4 billion won, operating profit of 1.6 billion won, and net profit of 3.3 billion won in the second quarter of 2021.
In the first half of this year, cumulative sales were reported as 51.2 billion won, a 15% increase compared to the same period last year, and operating profit increased by 56% to 7 billion. In particular, with increased sales in major products such as Normix, an antibiotic for gastrointesinal infection; Eligard, a prostate cancer treatment; and Biotop, a probiotic product; operating margin was at 14%, indicating an increase of 362 basis-point in profitability compared to the first half of last year.
As of the end of the first half, HanAll Biopharma maintained a stable financial status with a debt ratio of 25% and assets of 201.9 billion won, equity of 161.2 billion won, and liabilities of 40.6 billion won.
About HanAll Biopharma Co., Ltd.
HanAll Biopharma (KRX: 009420.KS) is a global bio pharmaceuticals company founded in 1973 with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful therapies to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas of endocrine, circulatory, and urologic diseases for more than 47 years. HanAll is now focused on autoimmune disease, ophthalmology, oncology, and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its leading pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody drug, is in Phase 2 trials across the world for the treatment of rare autoimmune disorders. Another main asset, HL036 (INN: tanfanercept), an anti-TNF alpha protein drug, is in Phase 3 clinical trials in the US and China for the treatment of dry eye disease.
[R&D Pipeline]
- HL161 (a novel, fully human, subcutaneous anti-FcRn antibody therapeutic for autoimmune diseases)
HL161 (INN: batoclimab), an antibody-drug for autoimmune diseases caused by pathogenic antibodies, is currently undergoing clinical trials in the US, and China through its partners Immunovant and Harbor BioMed.
In early June, global partner Immunovant announced plans to resume clinical trials, which were put on hold in February this year due to an issue related to increased cholesterol. As a result of a detailed analysis of patients participating in the clinical trials, it said lipid elevations are predictable and manageable. It plans to return to the clinic and initiate a pivotal MG trial in late 2021 or early 2022 as well as resume its trial in WAIHA on a similar timeframe. In addition, the company has a plan to initiate at least two additional clinical studies over the next 12 months, including another pivotal trial in 2022.
Meanwhile, HanAll Biopharma is preparing a Phase 3 clinical trial for the treatment of myasthenia gravis in Japan in collaboration with Immunovant.
In China, Harbour BioMed is conducting clinical trials in myasthenia gravis, thrombocytopenia, and neuromyelitis optica. In July, it announced positive topline results from the Phase 2 clinical trial of batoclimab in myasthenia gravis.
Batoclimab demonstrated a statistically significant improvement (p=0.043) compared to placebo in patients with myasthenia gravis on MG-ADL (Myasthenia Gravis Activities of Daily Living), the primary endpoint of the study. In addition, the drug induced rapid, substantial and persistent clinical improvement over placebo as measured by all four predefined clinical efficacy scales - MG-ADL, QMG (Quantitative Myasthenia Gravis), MGC (Myasthenia Gravis Composite) and MG-QoL (Myasthenia Gravis Quality of Life).
Furthermore, batoclimab has shown to be overall safe and well-tolerated, with incidence of adverse events (AE) comparable to placebo, majority of AEs characterized as mild, no serious adverse events (SAE) and no discontinuation due to AEs. Harbor BioMed plans to enter Phase 3 clinical trial of HL161 in myasthenia gravis in China in the second half of this year.
- HL036 (a novel, topical anti-TNF biologic therapy for dry eye disease)
HL036 (INN: tanfanercept), jointly developed by HanAll Biopharma and ...
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