Helixmith’s Plasmid DNA Therapeutic Moves Forward With New Formulation
Non-Viral Gene Therapy Set For Mass Production
Executive Summary
South Korea's Helixmith reaches a milestone with a US FDA nod to use a new in-house developed formulation for its plasmid DNA therapeutic Engensis, said to be more suited to mass production, in its upcoming Phase III trials for diabetic peripheral neuropathy.
You may also be interested in...
The Race Is On. When Will Korea Have Its Own Approved Gene Therapy?
Scrip takes a look at the landscape of the South Korean gene and cell therapy sector, which is under the spotlight with the implementation of a new cutting-edge biologics law.
Helixmith Mods Engensis Trial Plans As Probe Unravels PK Anomalies
After probing pharmacokinetic data flaws in the first US Phase III study for its gene therapy Engensis, Korea's Helixmith concludes that these stemmed from clinical operation issues. As a result, it admits a failure to meet the primary endpoint but is still moving forward with new trials given signals of efficacy and safety in an extended study.
New Data Position Lazertinib As Strong Contender In 1L NSCLC
Yuhan’s oncology drug lazertinib is set to expand its indications in Korea to the first-line treatment of EGFR mutation-positive advanced NSCLC, based on new top-line Phase III data showing clinical benefits for all patient sub-groups.