Lee Woo-suk, 63, a Kolon Life Science, who was arrested for suspicions surrounding the osteoarthritis gene therapy Inbosakei (Inbosa), was prosecuted today.

The investigation ended just last eight months after the prosecution launched an investigation last June.

The Seoul Central Prosecutor's Division of Criminal Affairs, Deputy Prosecutor Lee Chang-su, arrested Lee on July 7 for alleged violations of the Pharmaceutical Affairs Act, the Capital Markets Act, and the Subsidy Management Act.

In accordance with the Punishment Regulation, Kolon Life Science and Kolon Tissuejin were also prosecuted.

The prosecution prosecuted three people in December, including the grandmother's director who oversaw the clinical development field, the chief executive officer of Kolon Tissuejin (CFO) and Kolon Life Science's Wool General Manager, who were involved in the listing of Kolon Tissuejin.

This has resulted in six law enforcement officials, including corporations.

Lee received a product license from the Ministry of Food and Drug Safety as a `` chondrocyte '' from November 2017 to March last year. I have been charged with manufacturing and selling (violation of the Pharmaceutical Affairs Law).

Inbosa is a osteoarthritis gene therapy injection consisting of 1 fluid containing human chondrocytes and 2 fluids containing transformed cells with chondrocyte growth factor (TGF-β1).

The injection was approved by the Korea Food and Drug Administration as the first gene therapy in Korea in 2017, but was approved last July after two transgenic cells were found to be renal cells that can cause tumors, not chondrocytes written in the data submitted at the time of approval. Canceled

The prosecution judged that Lee had submitted false data for hiding in order to obtain the approval of the KFDA even though he knew that July 17, 2017, the in bosa contained renal-derived cells, not chondrocytes. .

The prosecution believes that the representative was involved in the 'listed fraud' of Kolon Tissuejin.

Kolon Tissuejin, a subsidiary of Kolon Life Sciences, led the development of Inbosa, and was listed on the KOSDAQ market in 2017 thanks to Inbo's approval of the Food and Drug Administration.

The prosecution's judgment is that Kolon Tissuejin used the false data submitted at the time of approval of the KFDA for listing.

The prosecution said that the representative hid the fact that the U.S. clinical trial for Inbosa was suspended in November 2017, and that the main component of Inbosa 2 is a kidney-derived cell. I applied a charge of violating capital market law.

The subscription fee paid at that time was about 200 billion won.

Mr. Lee deceived into fraudulent cartilage cells even though Inbosa 2 is 'kidney-derived cells', and is also accused of fraudulent and exaggerated advertisements that he received about 7 billion won from patients.

The prosecution is a data created by Kolon Life Sciences from November 2015 to July 2018 and was selected for the government's global advanced biopharmaceutical technology development project. I have applied for a violation.

In addition, the company interrupted the auditing work of the accounting firm and the listing examination of the Korea Exchange by hiding the fact that US clinical trials were suspended for invoicing companies and disputes with Japanese pharmaceutical companies in March-July 2017. The charge was applied.

Mr. Lee is also charged with preparing and disclosing false financial statements of Kolon Life Science (a violation of the External Audit Act) as a way of recognizing 'prepaid fees' received as a temporary revenue under a technology export contract with a Japanese pharmaceutical company.

The prosecution filed an arrest warrant for the representative in December last year, but was dismissed by the court.

Since then, he has reinforced the arrest with a warrant issued through reinforcement investigation and continued the investigation.

The prosecution official said, "We will promptly investigate the rest of the group, including the group management." I'm doing it. "

The prosecution plans to review the disposal level of Kolon Life Science's Kim Mo, who has been denied a warrant for one arrest soon.

However, the legal observation is that the investigation into former Kolon Group chairman Lee Woong-yeol (63), who is considered as the final in charge of the invoicing incident, will not be extended.

(Photo = Yonhap News)