Dong-A Pharmaceutical (President and CEO Won-Bae Kim) is accelerating its efforts to develop next-
generation biomedicines following the US FDA’s approval in March of its Investigational New Drug (IND) plans
for three biomedicines now under development.
The global market for biomedicines is growing rapidly, and is expected to reach USD 117 billion by 2012,
according to market research firm Datamonitor. With total drug sales projected to reach USD 485 billion over the
same term, this means that biomedicines will eventually comprise one quarter of global drug sales. The current
domestic market for biomedicines is worth KRW 400 billion, and is expected to grow to KRW 1.4 trillion by 2012.
Dong-A is stocking its product pipeline with high-value biomedicines that will meet changing market conditions
and consumer demands. The company is preparing to develop nine new biomedicines to the clinical trial stage
by 2013, adding to the current five in its pipeline.
New drugs approved for domestic clinical trials include DA-3803 (hCG), an infertility treatment scheduled to
enter trials in January, 2008; DA-3003 (sr-hGH), a sustained release-type human growth hormone drug
scheduled for March, 2008; and DA-3031 (PEG-GCSF), a cyclic neutropenia treatment. DA-3021 (PEG-INFα), a
treatment for chronic persistent hepatitis B and C, is being studied for additional clinical trials. In the second
half of this year, clinical trials for DA-3501 (INF-β) multiple sclerosis treatment and DA-3601 brain tumor drug
were applied for approval to enter clinical trials. Dong-A Pharmaceutical has therefore brought six new
biomedicines to clinical trial readiness this year.
DA-3803 (hCG) is proposed for use in conjunction with Gonadopin®, a recombinant follicle-stimulating
hormone analog currently marketed by Dong-A as an infertility treatment, to boost the effectiveness of
Gonadopin®. DA-3003 (sr-hGH) and DA-3031 (PEG-GCSF) are designed to greatly relieve patients’
treatment burden by offering administration regimens of one injection per day for long-term treatment, reduced
terms of just one or two weeks for short-term treatment, and even single-injection treatment options.
Dong-A has been an active developer of protein therapies since the 1980s, including Eporon®,
Growtropin®, Leucostim®, Interferon-α and Gonadopin®. The company has adopted global-standard
R&D techniques using serum-free medium to culture animal cells, and focused on developing sustained
release-type and cyclical release-type next-generation protein pharmaceuticals. By meeting international
standards beginning from the early stages of R&D, Dong-A is targeting the penetration of advanced markets in
the US and Europe. With its early investments in biopharmaceutical R&D, Dong-A has secured early
technological advantages in animal cell culture, protein in vivo longevity, DNA pharmaceutical production and
biomedicine verification.
Dong-A Pharmaceutical is now actively pursuing the globalization of its biomedical sales. It has been exporting
to Southeast Asia, Latin America and India since the 1990s, recording KRW 45 billion in overseas sales of
biomedicines in 2007. In the past two years, Dong-A has signed export contracts valued at USD 800 million with
partner companies in Russia, Turkey, Thailand and China, covering Gonadopin® infertility treatment and
other biomedicines. Negotiations are now underway with potential partners in Eastern Europe and Latin
America, as well as other export destinations.
Dong-A Pharmaceutical President and CEO Won-Bae Kim said, “Zydena®, a new recombinant drug, and
Stillen®, a naturally-derived drug, represent Dong-A’s rising competitiveness in the area of high value-
added biomedicines. They are major assets in our over