[단독] HLB suspects false disclosure of FDA clinical results… Gtree B&T’s late investigation

Input 2021.02.16 09:30

Arbitrary Interpretation of FDA’s Phase 3 Results in 2019
Last November, Financial Services Commission’s self-care deliberation Remaining decision

The financial authorities drew a knife over the announcement of the progress of a US clinical trial by a domestic bio-pharmaceutical company. HLB (028300)Has completed deliberation by the Financial Services Commission’s Capital Market Research Deliberation Committee (self-consideration) on the charges of arbitrarily interpreting the results of a phase 3 trial in the U.S. for its anticancer drug in 2019 and taking action by the Securities and Futures Commission (Jungseon Committee). Gtree B&T (115450)In the case of the case, the Jeungseon Committee in the first half of last year decided to accuse the prosecution, and an investigation is currently underway at the southern district prosecutor in Seoul.

According to inside and outside the financial authorities, in November last year, the Financial Services Commission completed a deliberation on the allegations that HLB falsely disclosed the results of a phase 3 trial of an anticancer drug in the United States. As a result of the deliberation, the Financial Services Commission’s self-care thought that HLB had arbitrarily interpreted the clinical trial result as if it had succeeded, even though it was close to failure.

An official said, “The US Food and Drug Administration (FDA) gave a negative evaluation in a fairly clear tone in response to the clinical trial results.” Explained.

The problem the financial authorities have posed is the results of a clinical trial of riboseranib, an anticancer drug, notified in June 2019. HLB Chairman Jin Yang-gon announced in June last year, “It is an internal judgment that this clinical trial has not reached the originally planned target and that it may be difficult to apply for FDA approval.”

However, in September, he said, “Riboceranib has passed the global phase 3 clinical trial” and said that he signed a contract with a law firm (law firm) to quickly go through the new drug approval process, such as application for prior approval (NDA), and said that preparation for raw material production is in progress. . The business report for the third quarter of the same year said, “The global phase 3 clinical trial has been completed,” and “Pre-NDA (Pre-NDA) meetings were held with the US FDA. Based on the results, an appropriate approval strategy was established, and new drug approval was obtained. I plan to apply.”

Earlier, on September 21 of last year, HLB’s stock price soared to 133,000 won during the market as the meaningful phase 3 clinical results of riboseranib were announced at the European Oncology Society 2020 Online Conference (ESMO).

The financial authorities are in the position that HLB arbitrarily interpreted the results based on the FDA’s evaluation of the results of the phase 3 test. It is known that the FDA’s documentation has been clearly negatively evaluated to the point of using the expression’failure’. Professor Lee Hyung-ki of Seoul National University College of Medicine explained that “communication with the FDA is important during the phase 3 examination in the United States, and a lot of documents come and go here.”

Sanctions against false disclosures are conducted in the form of an investigation by the Financial Supervisory Service, deliberation by the Financial Services Commission’s self-examination, and finally deciding on measures by the additional committee. They either impose a fine or file a complaint with the prosecution. This is a method in which factual relations are confirmed through investigation by the prosecution.

Usually, when self-examination deliberations are conducted, the decision of the Jeung-seon Committee is made the following week. An official explained, “There is also an effect of the novel coronavirus infection (Corona 19).” A former non-executive member of the Jeungseon Committee said, “It is rare that the results of self-care deliberation are overturned on the Jeungseon.”

HLB said about this, “There is nothing finalized about it.” HLB added, “We are steadily preparing for the call of the Jeungseon Committee.” It means that he will argue the facts about the allegations.

The financial authorities took a charge against the prosecutor’s office in June of last year on charges of false disclosure of the results of clinical trials against another bio company, GTRIBNT. It is said that the results of the US FDA phase 3 trial were arbitrarily interpreted, and the failed clinical trial was inflated as if it had succeeded.

Gtree B&T purchased a dry eye treatment treatment developed by Regenex in the United States in 2015, and is continuing clinical trials in the United States.

Currently, it is known that the case is being investigated at the Southern District Prosecutors’ Office in Seoul.

The reason why the financial authorities took a knife out of the announcement of overseas clinical results by domestic pharmaceutical companies was because there were many cases where the stock price plummeted due to poor clinical trial results, contrary to the forecasts made by pharmaceutical companies. The fact that the company made an announcement that was different from the actual result or concealed unfavorable facts for the purpose of boosting the stock price has returned to investors’ damage.

January last year Hanall Bio Pharma (009420)Hanall Biopharma’s stock price plunged 25.59% at the time as it was revealed that the Phase 3 clinical trial conducted in the United States failed to meet the ‘1st evaluation index’. On January 21 of last year, Hanall Biopharma announced, “Failure to meet the primary indicators in phase 3 clinical trials of the new drug candidate for dry eye syndrome (pipeline)’HL036′.” Failure to do so is considered clinical failure in fact. The primary indicator is to be set as an experimental indicator that judges success in clinical design submitted to FDA.

Earlier, Hanall Biopharma changed the word after announcing the results of its own evaluation that it had succeeded in phase 3 clinical trials without specific data. Five days before the announcement that it failed to meet the primary evaluation index, Hanall Biopharma released a press release and announced that it has confirmed excellent effects in both objective indicators measuring corneal improvement and subjective indicators felt by patients.

April 2019 Kolon Life Science (102940)Announced that it was manufactured using’GP2-293′ cells, which are kidney-derived cells, not cartilage-derived cells, which were originally known by Invossa for osteoarthritis while pursuing phase 3 clinical trials in the United States. Accordingly, the FDA notified the suspension of phase 3 clinical trials of Invossa in May of the same year, and the Ministry of Food and Drug Safety finalized the cancellation of the Invossa license in July of the same year. It was concluded that Kolon Life Science hid the fact of the ingredient change.

Accordingly, the Korea Exchange decided that Kolon TissueGene, who developed Invossa, had falsely entered or omitted important matters at the time of listing examination, and decided that the company was subject to the substantive examination of eligibility for listing. In December of last year, the Exchange KOSDAQ Market Committee discussed whether Kolon TissueGene would be canceled and decided to give it a year for improvement. Even now, Kolon TissueGene is in a state of suspension.