Korean drug pipeline regains life starting with Hanmi¡¯s renewed clinical development

2017.06.26 16:41:05 | 2017.06.26 16:41:34

À̹ÌÁö È®´ë
The Korean drug pipeline has picked up life after stalling last year after industry leader Hanmi Pharm delivered major disappointments. Hanmi said it will resume the clinical development program of a promising investigational drug to treat diabetes and obesity, seven months after being halted due to some production disruptions. Other Korean makers also have been making headway in their ventures.

Hanmi had sealed a 1 trillion won deal with Janssen covering the global development and commercialization of the drug. The deal was one of Hanmi¡¯s several multi-trillion-won license deals signed with global pharmaceutical companies in 2015, catalyzing the worldwide attention on research capabilities and pipelines in the Korean pharmaceutical industry. But the fever fizzled out over time after Hanmi dropped or downsized its license value and suspended a planned clinical study of its medicines licensed out to Janssen and Sanofi, respectively.

Hanmi will also resume a phase III trial of another novel diabetes drug efpeglenatide in the fourth quarter of this year. Hanmi¡¯s resumed study plan is bringing renewed attention to some pipelines that had lost trust. The drug maker is on its way to conducting clinical trials of poziotinib and eflapegrastim. Poziotinib is an investigational targeted cancer drug licensed out to U.S.-based Spectrum Pharmaceuticals and a phase II study began in the U.S. in March. Eflapegrastim is an investigational neutropenia drug whose phase III study is expected to be completed by September.

À̹ÌÁö È®´ë
Other Korean drug names also are making progress. Among the most anticipated candidates from the Korean pharmaceutical pipepline are SK Biopharm¡¯s sleep disorder drug and epilepsy drug. The sleep disorder drug SKL-N05 is on track for an FDA application at the end of this year with a goal of a market launch next year after a phase III study was recently completed.

A phase III study is underway for the company¡¯s epilepsy drug. The FDA said last year that previous data strongly supported the drug¡¯s efficacy and indicated its approval based on long-term safety data alone, making it the first among such drugs to treat epilepsy in the world. If launched, SK Biopharm could rake in more than 1 trillion won a year in the American market.

Invossa, the world¡¯s first cell-gene therapy developed by Kolon Life Science, is expected to be approved by Korean health authorities as early as this month. Invossa is directly injected into the joint requiring no need of knee resection in patients with degenerative arthritis.

Genexine is conducting phase II trials of a long-acting growth hormone (GX-H9) in Korea and 14 European countries. The Korean biotech company has developed proprietary hyFc technology to lower the frequency of dosing of growth hormones from once daily to twice monthly. The new hormonal therapy was given orphan drug designation by the FDA last year.

By Kim Hye-soon

[¨Ï Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]