April 20, 2024

• 

South Korea’s Health Ministry said Oct. 30 that it is considering revoking Kolon Life Science’s innovative drug company certification for mislabeling and falsely reporting ingredients in its gene therapy drug, Invossa.

A key material used in Invossa came from a kidney cell instead of from cartilage as stated in the document submitted for approval, according to the ministry. 

Government regulators added that the company intentionally did not disclose additional data it discovered before submitting the joint cartilage treatment drug for approval.

The authorities have taken steps to retrieve the 8.2 billion won ($7 million) Kolon Life received from the government when it won the innovative pharmaceutical company designation in Oct. 2015.

The money was allocated to help the company conduct research and development.

Of the total, the government aims to get back 2.5 billion won from the company first, with the remainder to be decided following the ongoing investigations by prosecutors.

By Ram Garikipati and newswires (ram@heraldcorp.com)