▷ HanAll Biopharma announces results for the third quarter of 2021


30.10.2021 – 02:10

HanAll Biopharma

Seoul, South Korea, Jan. 28 / PRNewswire /

  • Revenue in the 3rd quarter of 2021 of KRW 25.5 billion increases by 15% compared to the same period of the previous year
  • Operating profit in Q3 2021 of KRW 2.2 billion is up 120% compared to Q3 2020
  • Nine-month sales of KRW 76.7 billion and operating profit of KRW 9.2 billion are up 15% and 67%, respectively, year over year

[Geschäftsentwicklung und finanzielle Lage]

HanAll Biopharma (KRX: 009420.KS) announced today that the company had sales of won 25.5 billion, operating income of won 2.2 billion and net income of won 2.1 billion in the third quarter of 2021 .

For the first nine months of the year net sales were 76.7 billion won, an increase of 15% over the same period last year, and operating income rose 67% to 9.2 billion won. The sales increases resulted mainly from strong sales growth with double-digit growth rates for important products such as Normix, an antibiotic for gastrointestinal infections, Eligard, a prostate cancer treatment and Biotop, a probiotic product.

At the end of the third quarter, HanAll Biopharma held stable financial status with net liquidity of 87.6 billion won, reported assets of 203.0 billion won, equity of 163.9 billion won, and liabilities of 39.1 billion won.

[FuE-Pipeline]

– HL161 (a novel, fully human anti-FcRn antibody therapeutic for the subcutaneous treatment of autoimmune diseases)

HL161 (INN: Batoclimab), an antibody drug against autoimmune diseases caused by pathogenic antibodies, is currently being tested in clinical trials in the USA and China by HanAll partners Immunovant and Harbor BioMed.

Licensed partner in the US and Europe, Immunovant, is preparing to resume clinical trials that were suspended in February this year due to a problem related to high cholesterol. A program-wide data review suggests that HL161 has a broader therapeutic window than previously thought and that lipid elevations are predictable and controllable, and likely driven by reductions in albumin. Immunovant announced the following steps:

1) Rückkehr in die Klinik und Einleitung einer zulassungsrelevanten Phase-III-Studie zu Myasthenia gravis (MG) und Phase II bei warmer autoimmuner hämolytischer Anämie (WAIHA) in der ersten Hälfte des Jahres 2022 nach Treffen mit Aufsichtsbehörden, einschließlich der FDA,
2) Kommunikation mit der FDA und anderen Behörden, um zukünftige Pläne für Phase-II-Studien für Schilddrüsen-Augenerkrankungen oder andere Schilddrüsen-Erkrankungen zu besprechen und 
3) Aufnahme neuer Studien in zwei weiteren Indikationen im Jahr 2022.

The licensed partner in Greater China, Harbor BioMed, is currently conducting clinical studies in China on myasthenia gravis (MG), immune thrombocytopenia (ITP), neuromyelitis optica (NMO) and thyroid eye disease (TED). In September Harbor BioMed announced that the China National Medical Products Administration (NMPA) had approved a new drug investigation (IND) application for a Phase II study of batoclimab in patients with chronic inflammatory demyelinating polyneuropathy (CIDP ) to initiate.

Harbor BioMed announced the first dosage of the first patient in the Phase III pivotal trial of Batoclimab in Myasthenia Gravis in China in September and expects to initiate the Biologics License Application (“BLA”) in the coming year.

In Japan, HanAll Biopharma is working with Immunovant to prepare a phase III study for myasthenia gravis (MG). The study is expected to start in 2022.

HL036 (a novel, topical anti-TNF biological therapy for dry eye) HL036 (INN: Tanfanercept), jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, is a novel biological drug under development to treat inflammatory eye diseases by inhibiting TNF, which is involved in eye inflammation. The first phase III clinical trial (VELOS-2) for the treatment of dry eye was completed last year.

HanAll submitted the IND application for the second phase III clinical trial (trial name: VELOS-3) to the US FDA on July 22nd and is expected to begin clinical trials in the fourth quarter of this year and the first next year Submit results. Due to the recent COVID-related delays in global transport, there has been a delay in the transport of investigational drugs. Accordingly, the start of the clinical trial has been postponed from the third quarter to the fourth.

The VELOS-3 study is a multicenter, randomized, double-blind and placebo-controlled phase III study to evaluate the efficacy and safety of Tanfanercept eye drops 0.25% compared to placebo in patients with dry eye.

Harbor BioMed, the licensee for the Chinese market, started a central phase III study on dry eye in the first half of the year and plans to apply for approval for biologics (BLA) to the NMPA after the study is over in 2022.

-HL189 (tanfanercept)HanAll Biopharma is exploring the possibility of expanding Tanfanercept’s indications to include new inflammatory eye diseases such as uveitis. Preclinical studies on uveitis have already been carried out. The company will decide on a new indication development plan in 2022.

– HL186 / HL187 (novel immuno-oncological therapies)The HL186 and HL187 projects are novel immuno-oncological antibodies that target TIM-3 and TIGIT and were developed in collaboration with Daewoong Pharmaceutical. Both programs are in the preclinical stage. The companies aim to develop differentiated immune checkpoint inhibitors with better efficacy and higher response rates for cancer patients.

Financial highlights in the third quarter of 2021 (consolidated, KRW billion)

3Q 2021 3Q 2020 %Change 9M 2021 9M 2020 %Change
sales 25,5 22,1 +15% 76,7 66,8 +15%
Gross profit 14,8 12,1 +22% 46,3 38,4 +21%
Gross margin 58% 55% 60% 50%
Operating profit 2,2 1,0 +120% 9,2 5,5 +67%
Operating margin 9% 5% 12% 7%
Net result 2,1 3,7 -43% 9,8 13,5 -27%
Net margin 8% 17% 13% 18%

About HanAll Biopharma Co., Ltd.

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company founded in 1973 with the aim of making an important contribution to the lives of patients and meeting serious unmet medical needs through innovative, effective therapies. HanAll has operated a portfolio of pharmaceutical products in the areas of endocrine, circulatory and urological diseases for more than 48 years. HanAll is currently focusing on autoimmune diseases, ophthalmology, oncology and neurology to research and develop innovative drugs for patients with diseases for which there are no effective treatments. Its lead compound in the pipeline, HL161 (INN: batoclimab), an anti-FcRn antibody drug, is in Phase III and Phase II trials worldwide for the treatment of rare autoimmune diseases. Another key compound, HL036 (INN: Tanfanercept), an anti-TNF-alpha protein drug, is in Phase III clinical trials in the United States and China for the treatment of dry eye.

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Press contact:

HanAll IR-Team
[email protected]

Daewoong IR-Team
[email protected]

Jang Jun-seok (IR-Manager at HanAll Biopharma)
+82-2-2204-1901
[email protected]

Original content by: HanAll Biopharma, transmitted by news aktuell


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