[Business Performance and Financial Status]
HanAll Biopharma (KRX: 009420.KS) announced today that it achieved 101.6 billion won in sales in 2021, a 15% increase from the previous year. It had 10.1 billion won in operating profit, a 70% increase year-on-year, for the 19th consecutive quarter in the black, and the net profit in 2021 was 10 billion won. Both growth and profitability were thus secured.
Strong financial performance was largely due to increasing revenues from R&D activities and double digit percentage sales growth of major products such as Normix, an antibiotic for gastrointesinal infection; Eligard, a prostate cancer treatment; and Biotop, a probiotic product.
HanAll has been generating stable profits since the licensing agreements with Roivant Sciences and Harbour Biomed in 2017. HanAll has thus established a virtuous investment cycle in which new R&D programs are funded by its own profits.
"While transforming into a global, innovative biopharmaceutical company with a promising pipeline and continuous investments, HanAll continues to produce stable profits. Milestone payments are expected to increase more this year. We will be carrying out more proactive R&D activities in 2022 to develop novel drugs for patients with high unmet medical needs," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma.
HanAll's financial status as of the end of 2021 includes 199.7 billion won in assets, 164.7 billion won in equity, and 35 billion won in liabilities, maintaining a stable financial structure.
[R&D Pipeline development status]
- HL161 (a novel, fully human, subcutaneous anti-FcRn antibody therapeutic for autoimmune diseases)
HL161 (INN: batoclimab) is a new antibody drug for the treatment of rare autoimmune diseases caused by pathogenic autoantibodies. It is being developed in the US/Europe and China respectively by global license partners Immunovant and Harbour Biomed.
Immunovant recently announced plans for a Phase 3 trial in myasthenia gravis (MG) as well as for other clinical trial plans for this year. The Phase 3 in MG is planned to be initiated in the first half of the year, and two additional pivotal clinical trials are expected to start in 2022. Moreover, with the addition of two new indication programs, HL161 is planned to be developed in five autoimmune diseases in the US and Europe by Immunovant.
Harbour Biomed, HanAll's partner in China, is developing batoclimab in six autoimmune indications: myasthenia gravis (MG), immune thrombocytopenia (ITP), neuromyelitis optica spectrum disorder (NMOSD), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and pemphigus vulgaris (PV). MG is in Phase 3 and ITP, NMOSD, and TED are in Phase 2. Harbour is planning to submitt a biologics license application (BLA) to the National Medical Products Administration (NMPA) for approval in MG this year.
HanAll Biopharma is preparing a Phase 3 trial for myasthenia gravis (MG) in Japan in collaboration with Immunovant. The study is expected to start in 2022.
- HL036 (a novel, topical anti-TNF biologic therapy for dry eye disease)
HL036 (INN: tanfanercept), jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, is a novel biologic treatment under development to treat inflammatory eye diseases by inhibiting TNF, which is involved in ocular inflammation.
In November 2021, the first patient first dose in the second Phase 3 clinical trial (study name: VELOS-3) has started in the US and the trial is currently ongoing. The clinical trial's topline results are expected in the second half of 2022. The VELOS-3 clinical trial aims to replicate the efficacy seen in VELOS-2 (the first Phase 3 trial), and is proceeding at 9 clinical sites in the US with patients who have moderate to severe dry eye disease.
Harbour Biomed, who has the rights to develop tanfanercept in China, is ...
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