Jin Yang-gon, CEO of HLB.
HLB(66,500 -27.24%)On the 16th, explained the controversy that it had falsely disclosed the results of the global clinical phase 3 of the anticancer drug’Riboceranib’.
He expressed his position in the media reports that HLB has arbitrarily interpreted the clinical results notified by the US Food and Drug Administration (FDA) and made false disclosures.
According to the company, the document in question by the financial authorities is the minutes of the pre-NDA meeting before applying for a new drug license. It was negatively evaluated that there was an expression of’fail’ in the minutes of the meeting, but HLB was suspicious of arbitrarily interpreting it.
HLB CEO Jin Yang-gon (photo) said, “It is true that there is a sentence with the word’fail’ in the document screening opinion during the pre-NDA process.” The content has been released steadily,” he said.
According to Jin, the FDA expressed in pre-NDA, “Because the primary efficacy indicator has not been reached, it is not appropriate to proceed with the new drug approval process.” However, it is a position that it has been announced without hiding it.
He said, “In June 2019, we directly announced the results through YouTube in the situation that only the entire survival organ (OS) and progression free survival (PFS) data were available out of the three-phase riboseranib data. “Since the OS could not reveal the statistical significance, he expressed that the approval of new drugs could be delayed or difficult.”
The company announced that it can apply for a new drug license in August 2019. Although it was not able to secure statistical significance, it was concluded that it was possible to apply for a new drug because it secured clinical significance. In the process, CEO Jin explained that the opinions of not only internal but also external experts such as foreign consulting groups were consulted.
President Jin stressed that the pre-NDA minutes in question did not mean the failure of the new drug.
CEO Jin added, “The pre-NDA is not a place to decide whether to approve a new drug, but it is part of the process of discussing supplementary matters based on previously submitted data.”
The company is currently preparing a document that has received a request for supplementation from the FDA. “However, due to the corona 19 pandemic, preparations are being delayed,” said Jin. “This is also what was revealed through a stock report.”
He admitted to the fact that it is under investigation by the Financial Services Commission and is currently calling. The company is currently facing the Securities and Futures Committee after completing the deliberation by the Financial Services Commission’s Capital Market Research Deliberation Committee.
CEO Jin said, “It is natural for the financial authorities to strictly pay attention to prevent risks that may occur in the market,” he said. “It will be an opportunity to be proud of being properly verified and fulfilling our responsibilities.”
Reporter Park In-hyuk [email protected]
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