Kolon "Regret Prosecutor's Action... Will Do Our Best in Invossa US Phase 3 Clinical Trial"

[Asia Economy Reporter Hyungsoo Park] The prosecution, investigating allegations of false reporting of the components of the osteoarthritis gene therapy drug Invossa K Injection (Invossa), has filed an arrest warrant for former Kolon Group Chairman Lee Woong-yeol, prompting Kolon Group to express regret.

Kolon stated on the 25th, "We regret the prosecution's actions at a time when a new turning point is being established in new drug development following the recent decision by the U.S. Food and Drug Administration (FDA) to resume Phase 3 clinical trials of Invossa."

They added, "The company will do its best to ensure the success of Invossa's Phase 3 clinical trials in the U.S., the world's first osteoarthritis cell and gene therapy."

On the afternoon of the same day, the Criminal Division 2 of the Seoul Central District Prosecutors' Office (Chief Prosecutor Lee Chang-soo) filed an arrest warrant against former Chairman Lee on charges including violations of the Capital Markets and Financial Investment Business Act (fraudulent transactions, market manipulation, etc.) and breach of trust and mediation.

The pre-arrest detention hearing (warrant substantive examination) for former Chairman Lee is expected to be held at the Seoul Central District Court as early as the afternoon of the 26th or by the morning of the 29th at the latest.

Former Chairman Lee is suspected of manufacturing and selling Invossa with a component different from the approved one, 'kidney-derived cells (GP2-293),' despite having received product approval from the Ministry of Food and Drug Safety from November 2017 to March last year for the Invossa component 2 as 'cartilage cells.'

This content was produced with the assistance of AI translation services.