Helixmith Successfully Re-Certified as an Innovative Pharmaceutical Company

Ministry of Health and Welfare Announces 2021 Innovative Pharmaceutical Company Certification Results
Successful Certification Renewal Every 3 Years Since 2012
Re-certified This Year to Maintain Status Until 2024

[Asia Economy Reporter Jang Hyowon] Helixmith announced on the 24th that it has successfully been re-certified as an ‘Innovative Pharmaceutical Company’ certified by the Ministry of Health and Welfare. After receiving the first certification in June 2012, the certification was extended every three years in 2015 and 2018. This year as well, it passed the review and will maintain the status for three years until 2024.

The selection as an Innovative Pharmaceutical Company means that the company has been recognized by the government for its outstanding research and development investment performance and achievements, contributing to enhancing the global competitiveness of the domestic pharmaceutical industry. Companies selected as Innovative Pharmaceutical Companies receive benefits such as ▲preferential drug pricing ▲R&D advantages ▲tax support ▲regulatory relaxation ▲policy fund loans ▲personnel support. New certification reviews are conducted every two years, and companies that pass the review maintain the certification status for three years.

On the 23rd, the Ministry of Health and Welfare announced 45 companies certified as Innovative Pharmaceutical Companies. Among the 45, 40 companies including Helixmith were re-certified. Helixmith was positively evaluated for its development technology of various pipelines including Enzencis (VM202), advanced clinical trial know-how in developed countries, global network, and licensing-out potential.

Yoo Seung-shin, CEO of Helixmith, said, “This re-certification as an Innovative Pharmaceutical Company is a good opportunity to objectively reaffirm Helixmith’s excellent technological capabilities,” and added, “Based on the steadily accumulated research and development capabilities, we will do our best to show results in our pipelines including Enzencis.”

Meanwhile, Helixmith’s gene therapy drug ‘Enzencis (VM202)’ is a drug composed of plasmid DNA expressing hepatocyte growth factor (HGF) protein. Through 15 years of research and clinical trials, it has been revealed that a simple muscle injection can produce HGF protein in vivo, showing effects such as nerve regeneration, angiogenesis, and prevention of muscle atrophy.

The U.S. FDA recognized the scientific and clinical results of Enzencis and designated it as a Regenerative Medicine Advanced Therapy (RMAT) in 2018. It is the first gene therapy to receive RMAT designation in the U.S. for a widespread disease affecting millions of patients.