Chairman Jin Yang-gon turned off the lights, but… HLB stock price plunge issue

HLB(66,500 -27.24%) Stock prices ended plunging.

As HLB received a deliberation by the Financial Services Commission’s Capital Market Research Committee (self-consideration) by arbitrarily interpreting the results of a phase 3 clinical trial in the U.S. for the anticancer drug’Riboceranib’, and a report that the Securities and Futures Commission (Jungseon Committee) is about to take action. All.

HLB Chairman Jin Yang-gon said, “It is true that the financial committee has been deliberated,” and “We will do our best to explain the facts, as long as we can prove it through clinical results or thesis.” It was not enough.

On the 16th, in the KOSDAQ market, HLB closed the deal at 66,000 won, down 25,900 won (27.24%) from the previous day. HLB Life Science(16,750 -27.96%)(27.96%) HLB Pharmaceutical(13,200 -22.81%)(-22.81%) HLB Power(1,005 -14.83%)(-14.83%) and others also ended a double-digit plunge.

On that day, a media reported that HLB’s arbitrarily interpreted the results of a phase 3 trial in the U.S. for an anticancer drug in 2019 and made a false disclosure.After deliberation by the Financial Services Commission’s Capital Market Research Deliberation Committee (self-consideration), the Securities and Futures Commission (Jungseon Committee) took action. Reported that it is ahead.

According to reports, the problem the financial authorities are facing is the results of a clinical trial of riboseranib, an anticancer drug notified in June 2019. The financial authorities are in a position that HLB arbitrarily interpreted the results based on the document that the US Food and Drug Administration (FDA) evaluated 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’.

Nevertheless, HLB signed a contract with a law firm (law firm) in September of last year, saying, “Riboceranib has passed the global clinical phase 3,” and said that it is in the process of preparing for the production of raw materials. did. The business report for the third quarter of the same year said, “We have completed a global phase 3 clinical trial,” and said, “We had a pre-NDA (Pre-NDA) meeting with the US FDA. Based on the results, we established an appropriate approval strategy and then applied for a new drug license. Plan”.

Chairman Jin Yang-gon personally explained

As the situation worsened, such as a plunge in the stock price, HLB Chairman Jin Yang-gon set out to turn off the fire.

Chairman Jin said through a live YouTube video that afternoon, “It is true that the Financial Supervisory Service investigated it, passed the Capital Market Research Deliberation Committee of the Financial Services Commission, and is ahead of the Securities and Futures Committee,” and “the situation has not been concluded and is calling the financial authorities.” .

Chairman Jin said that the clinical results of riboseranib can be sufficiently proven through the results or thesis.

In addition,’In order to reduce market misunderstandings while directly disclosing clinical results in 2019, it was directly revealed that statistical significance was not secured in one of the two data’s efficacy indicators.” “These matters are reflected in the consultation process with the FDA. It’s done,” he explained.

He also said, “It is true that a sentence in which the word’Fail’ is used during the NDA meeting with the FDA is in the minutes, but this does not mean a clinical failure, but a’statistical significance could not be secured’. “I explained.

Lastly, he said, “It is not a clinical failure, but the process of supplementing documents remains, so the actual application stage for new drug approval may be delayed, but it is different from a simple failure.” Through this, we will make every effort to present accurate information and faithfully express the facts so that we can take responsibility for various institutional investigations:

Lee Song-ryul, reporter of Hankyung.com [email protected]