On July 29, 2022 HanAll Biopharma (KRX: 009420.KS), a global biopharmaceutical company focusing on delivering breakthrough therapies for patients, reported financial results for the second quarter 2022 as well as an update to its R&D progress (Press release, HanAll Biopharma, JUL 29, 2022, View Source [SID1234617150]).

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"The second quarter delivered strong momentum for HanAll Biopharma. Our operating income has turned to profit while we continued our investment in R&D" said Sean Jeong, M.D., CEO of HanAll Biopharma.

"Moving forward over the next few quarters, we expect to see topline results for the Phase 3 study in dry eye disease in the US, while enhancing our portfolio through open collaborations. HanAll will continue to invest in R&D to bring innovative therapeutics to patients" he added.

SECOND QUARTER 2022 BUSINESS UPDATE
Pipeline Development Highlights

A comprehensive update on HanAll’s pipeline development includes an overview of HanAll’s research and a list of compounds in development with targeted indication and the phase of development.

Batoclimab (Project Code: HL161)

A novel, fully human, anti-FcRn antibody being developed as a subcutaneous injection for the treatment of rare autoimmune diseases mediated by pathogenic IgG antibodies.

In March 2022, Harbour BioMed, a licensed partner of HanAll updated full clinical development progress in batoclimab. The company is progressing towards Biologics License Application (BLA) submission in the calendar year of 2022, after obtaining topline results from Phase 3 clinical trial for myasthenia gravis (MG). Harbour is developing batoclimab in a wide range of autoimmune indications in addition to MG, including immune thrombocytopenic purpura (ITP), neuromyelitis optica spectrum disorder (NMOSD) and thyroid eye disease (TED).
In June 2022, Immunovant, a global licensed partner of HanAll initiated a Phase 3 study to further evaluate the efficacy of batoclimab in MG. Immunovant expects to reveal two new indication programs by August 2022.
HanAll Biopharma plans to initiate a Phase 3 clinical trial in MG in collaboration with Immunovant in Japan, during the 2H 2022.
Tanfanercept (Project Code: HL036)

A novel, topical anti-TNF alpha biologic therapy for dry eye disease (DED) which aims to treat inflammatory eye diseases by inhibiting TNF alpha, which is critical in ocular inflammation.

HanAll Biopharma and Daewoong Pharmaceutical are continuing to conduct their second Phase 3 clinical study (Study name: VELOS-3) in DED to examine the safety and efficacy of the medication, at nine clinical sites located in the U.S. The study design was recently expanded to include a pharmacogenomics component that could deliver more value for patients and prescribers from this study.
Harbour BioMed is conducting its pivotal Phase 3 trial on tanfanercept in patients with DED.
HL187/ HL186

HanAll is advancing its development in immuno-oncology therapeutics, that respectively target TIM-3 and TIGIT with Daewoong Pharmaceutical.

HL187 is in pre-clinical development and antibody screening is ongoing to select the lead molecule in HL186.
Major Development Highlights

HanAll further advanced its partnerships with companies with promising technologies.

HanAll supported Neudive, a company developing digital therapeutic solutions to help neurodiverse children. Neudive’s platform is expected to deliver individually tailored therapy programs to children with neurodevelopmental disorders by using VR technology.
FINANCIAL HIGHLIGHTS (PROVISIONAL)
Key Highlights

Sales were 26.2 billion won in the second quarter, a 12% increase compared to the same period last year. Sales growth was mainly driven by continued strong performance from pharmaceuticals sold under the names of Normix, Eligard, Biotop and other major products.
R&D expenses showed 45.1 % increase compared to the same period last year, recording around 3.6 billion won.
Operating income was 682 million won, a 56.6% decrease, compared to the same period last year, mainly due to increased investment in R&D.