Gene And Cell Therapies In Asia: New Korean Law To Change Landscape Of Cutting Edge Biologics
Invossa Affair Still Hangs Heavy
South Korea will undergo many changes as it gears up for a new law on cutting edge regenerative medicine and biologics, which will be implemented next year. Until then, further discussions will be needed to set details of the rules that can step up the industry’s competitiveness and bring the country more in line with global standards.
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Helixmith delays making conclusions on disappointing first top-line data from lead US Phase III study of plasmid DNA therapeutic Engensis, citing unexpected pharmacokinetic results in the placebo and treatment groups. The South Korean biotech vows to improve strategy for upcoming trials, but much may hinge on their success.
Kolon TissueGene is facing delisting in South Korea after the recent revocation of approval of gene therapy Invossa, which could fuel legal action from shareholders. The company still hopes to resume Invossa trials in the US by submitting additional data demanded by the FDA.