UPDATE : Wednesday, September 26, 2018
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How are Korean drugmakers faring in US?
  • By So Jae-hyeon
  • Published 2018.05.09 15:55
  • Updated 2018.05.09 15:55
  • comments 0

Major Korean drugmakers such as Daewoong Pharmaceutical, Huons, Hanmi Pharmaceutical, and Chong Kun Dang are accelerating efforts to secure a larger share in the U.S., the world’s largest pharmaceutical market.

Daewoong is seeking a greater impact in the U.S., announcing the latest clinical results of botulinum toxin Nabota and liver drug Ursa.

The company recently revealed results of a clinical study that compared Nabota with Botox at the meeting of the American Society for Aesthetic Plastic Surgery in New York.

Nabota proved non-inferiority of efficacy compared to Allergan’s Botox in 520 participants in the EVB-003 study in Europe and Canada. In the EVB-004 trials in the U.S., Nabota proved its safety and efficacy through a 12-month repeated dose.

Daewoong is emphasizing that Nabota has equivalent efficacy and safety compared to Botox, citing the clinical results.

The Korean firm also plans to apply for approval of the U.S. Food and Drug Administration for ursodeoxycholic acid (UDCA)-containing Ursa as early as this year, as the company has completed a bioequivalence test on the hepatic protector in Canada.

If Nabota and Ursa win FDA approval, Daewoong will be able to sell three drugs in the U.S., including antibiotics Meropenem.

Huons shipped 300,000 amples of Lidocaine injections to the U.S. on Wednesday.

The shipping follows the company’s deal with Spectra Medical to supply 89.3 billion won worth of 1-percent Lidocaine 5mL amp. for 20 years.

Huons is also preparing to apply for a phase-2 U.S. clinical trial on Thymosin β4, the endogenous proteins that have the proliferation and anti-inflammatory action of goblet cells. The company also aims to introduce its botulinum toxin Hutox in the U.S.

Hanmi Pharmaceutical is taking steps to enter the U.S., too.

The FDA designated Hanmi's oral treatment for cancer Oraxol as an orphan drug to treat angiosarcoma on April 20. The Korean drugmaker had signed a licensing-out deal with U.S. firm Athenex Inc.

Hanmi’s Glucagon Analog (HM15136), a congenital hyperinsulinemia drug, also won the rare drug status in the U.S. in February.

The Korean firm is developing Poziotinib, which Hanmi licensed out to Spectrum, to target non-small cell lung cancer, a rare disease.

As the first Korean drugmaker, Hanmi obtained FDA approval for Hyalrheuma, a hyaluronic acid product, to treat arthritis. With the FDA’s nod, Hanmi and its partner company Teva plan to sell the treatment across the U.S.

Chong Kun Dang has patented CKD-11101, a biosimilar referencing Nesp for the treatment anemia, in the U.S.

The company is testing CKD504, a therapy for Huntington disease, a progressive brain disorder, in the U.S.

As Huntington disease is a rare disease with an incidence rate of 3-10 patients per 100,000 people, the company is hoping to have an early license-out deal if clinical results turn out well.

sjh@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>

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