HL161(batoclimab) Demonstrated Positive Top-line Results in ..
- HanAll Biopharma achieved both stability
and innovativeness
[Sales Performance and Financial
Conditions]
HanAll Biopharma(KRX: 009420.KS) announced
today that it recorded 22.6 billion KRW, 1.6 billion KRW, and 2.8 billion KRW
in sales, operating profit, and net profit, respectively, for the second
quarter of 2020.
With the Phase 2 clinical trials for HL161,
a novel antibody drug for autoimmune diseases, beginning in China in the second
quarter, a milestone payment has been secured, which led to an increase of 2.3%
in the company’s sales from the previous quarter despite the difficult business
environment in Korea. Operating profit decreased by 1.2 billion KRW from the
previous quarter to 1.6 billion KRW due to a temporary cost increase resulting
from the requirement of inventory assets and recall of Glucodown, a drug for diabetes,
due to the NDMA issue.
The company’s total sales and operating
profit in the first half of 2020 were 44.7 billion KRW and 4.5 billion KRW,
respectively. Despite the decrease in the number of patients due to the
COVID-19 pandemic, which led to a drop in drug sales, HanAll Biopharma’s
profitability has improved as a result of the continuously increasing
royalties. Accordingly, the company maintained its operating profit rate at
approximately 10%.
HanAll Biopharma is maintaining a stable
financial condition with assets, capital, and liabilities of 196.8 billion KRW,
156.8 billion KRW, and 40.1 billion KRW, respectively, as of the end of the
second quarter. The company’s quick assets(cash, cash equivalents, short-term
financial assets) total 91.3 billion KRW as of the end of the second quarter.
[Status of New Drug Pipeline]
HP161, a novel antibody drug for treatment
of autoimmune diseases, is differentiated as a subcutaneous injection product
with a pre-filled syringe that can be administered by patients. Immunovant,
HanAll Biopharma’s global partner, is conducting Phase 2 clinical trials on
HL161 in a number of countries including the U.S. in relation to three types of
rare autoimmune diseases. It is expected that the Phase 2 clinical trial
top-line results for myasthenia gravis(MG), the results for warm antibody autoimmune
hemolytic anemia(WAIHA), and the Phase 2b clinical trial results for thyroid
eye disease(TED) will be available by the end of the third quarter or early
fourth quarter of this year, the end of this year, and the first half of next
year, respectively.
In China, Harbour BioMed, HanAll
Biopharma’s Chinese partner, is conducting Phase 2 clinical trials on HL161 for
patients with neuromyelitis optica spectrum disorder (NMOSD), idiopathic
thrombocytopenic purpura (ITP), and MG, which are rare autoimmune diseases.
Additionally, it is preparing for clinical trials in relation to TED with
approval on the seamless Phase 2/3 trial IND from the China Food and Drug
Administration.
For HL036, a novel, topical anti-TNF
biologic dry eye disease, which is being jointly developed by HanAll Biopharma
and Daewoong Pharmaceutical, the follow-up Phase 3-2 clinical trial plan is
being established by the global advisory board on the basis of the Phase 3-1
clinical result secured in the U.S. during the first half of the year. The
clinical development strategy will be finalized through the Type C meeting with
the FDA. Separately, in China, Harbour BioMed will prepare for and commence
Phase 3 clinical trials in the second half of this year to obtain the permit
for HL036.
Over the past two to three years, HanAll
Biopharma has been implementing HL186 and HL187, the immunotherapeutic antibody
projects with new targets other than PD-1 and PD-L1, jointly with Daewoong
Pharmaceutical, and has recently begun efficacy evaluation using an animal
model. HanAll Biopharma also implemented the HL189 project, which treats
non-infectious uveitis through intraocular injection of tanfanercept, the
principal component of the HL036 eye drop, thus verifying the drug effect
through animal testing, and is preparing to commence clinical trials for the
drug.
Successfully transforming from a “small
pharmaceutical company in Korea” into a “global innovative new drug developer”
by pursuing “corporate innovation through R&D” over the last decade, HanAll
Biopharma is drawing attention as a biopharmaceutical company that is recording
a surplus and is consistently maintaining and developing innovativeness and
stability.