On October 28, 2021 HanAll Biopharma (KRX: 009420.KS) reported that the company had achieved sales of 25.5 billion won, an operating profit of 2.2 billion won, and a net profit of 2.1 billion won in the third quarter of 2021 (Press release, HanAll Biopharma, OCT 28, 2021, View Source [SID1234592154]).
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In the first nine months of the year, net sales were 76.7 billion won, a 15% increase compared to the same period last year, and the operating profit increased by 67% to 9.2 billion won. Increased sales were largely due to strong revenues with double digit growth from major products such as Normix, an antibiotic for gastrointesinal infection; Eligard, a prostate cancer treatment; and Biotop, a probiotic product.
As of the end of the third quarter, HanAll Biopharma maintained a stable financial status with net cash of 87.6 billion won and reported assets of 203.0 billion won, an equity of 163.9 billion won, and liabilities of 39.1 billion won.
[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 HanAll’s partners, Immunovant and Harbor BioMed.
The licensed partner in the US and Europe, Immunovant, is preparing to resume clinical trials, which were put on hold in February of this year due to an issue related to increased cholesterol. Program-wide data review suggests that HL161 has a broader therapeutic window than previously anticipated and that lipid elevations are predictable, manageable, and appear to be driven by reductions in albumin. Immunovant announced its plan
1) to return to the clinic and initiate a pivotal Phase 3 myasthenia gravis (MG) trial and Phase 2 in warm autoimmune hemolytic anemia (WAIHA) in the first half of 2022 following meetings with regulators including the FDA,
2) to communicate with the FDA and other authorities to discuss future plans for Phase 2 trials for thyroid eye disease or other thyroid related disease and
3) to initiate new studies in two additional indications in 2022.
The licensed partner in greater China, Harbour BioMed, is currently conducting clinical trials in myasthenia gravis (MG), immune thrombocytopenia (ITP), neuromyelitis optica (NMO), and thyroid eye disease (TED) in China. In September, Harbour BioMed released that the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to initiate a Phase 2 trial of batoclimab in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Harbor BioMed reported the first dosing of the first patient in registrational Phase 3 trial of batoclimab in myasthenia gravis in China in September and expects BLA submission for the disease next year.
In Japan, HanAll Biopharma is preparing a Phase 3 trial for myasthenia gravis (MG) 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. The first Phase 3 clinical trial (VELOS-2) for dry eye disease was completed last year.
HanAll submitted the IND for the second Phase 3 clinical trial (study name: VELOS-3) to the US FDA on July 22, and is expected to begin clinical trials in the fourth quarter this year and have topline results next year. Due to the recent COVID related delays of global transportation, there was a delay in the investigational drug transportation. Accordingly clinical study initiation was rescheduled from the third quarter to the fourth quarter.
The VELOS-3 study is a Phase 3, multicenter, randomized, double-blind, and placebo-controlled study evaluating the efficacy and safety of tanfanercept ophthalmic solution 0.25% compared to placebo in subjects with dry eye disease.
Harbor BioMed, the license holder for the Chinese market, started a pivotal Phase 3 trial in dry eye disease in the first half of the year, and plans to file a biologics license application (BLA) with NMPA in 2022 after the study ends.
– HL189 (tanfanercept)
HanAll Biopharma is exploring the options to expand the indications of tanfanercept to new inflammatory eye disorders including uveitis. Preclinical studies on uveitis have been conducted. The company will decide on new indications development plan in 2022.
– HL186/HL187 (novel immune-oncology therapies)
HL186 and HL187 projects are novel immuno-oncology antibodies that target TIM-3 and TIGIT, respectively, developed in collaboration with Daewoong Pharmaceutical. Both programs are at preclinical stage. The companies aim to develop differentiated immune checkpoint inhibitors with better efficacy and higher response rates for patients with cancer.