Jinyang Gon HL Bi Chairman "Investigation by the Korea Securities and Futures Commission is Correct but Fully Explainable"

[Asia Economy Reporter Hyunseok Yoo] Jin Yang-gon, chairman of HL Biopharma, stated at 2 p.m. on the 16th via YouTube that regarding the suspicions about the anticancer drug 'Rivoceranib,' "It is true that it has undergone review by financial authorities, but it can be sufficiently explained and proven."

On the same day, a media outlet reported that HL Biopharma is facing measures from the Securities and Futures Commission (SFC) for allegedly making false disclosures by arbitrarily interpreting the results of the Phase 3 clinical trial of the anticancer drug 'Rivoceranib' in the United States in 2019.

Chairman Jin said, "It is true that the Financial Supervisory Service (FSS) investigated, that it passed the Capital Market Investigation Review Committee (CMIRC), and that it is now before the SFC," adding, "This is a matter where opposing claims exist and no conclusion has been reached yet, but it has become known."

Regarding the use of the word 'Fail' during the meeting with the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA), he emphasized that it was mentioned in a pre-NDA meeting, not during the new drug approval process.

He explained, "'Fail' appearing in the document review comments means that statistical significance was not achieved in the primary efficacy endpoint, OS (Overall Survival), which could delay or hinder new drug approval, but it does not mean failure," and stressed, "The important point is that after document submission and review, during the subsequent face-to-face meeting, the FDA said that if supplementary materials for the NDA are prepared, they would review it again, as seen in the meeting minutes."

He added, "Although statistical significance was not achieved, clinical significance was sufficiently secured, so the conclusion was that the new drug application could be submitted," and said, "Not only internally but also external expert groups concluded that it is worth attempting, and we also referred to opinions from foreign consulting firms that NDA is fully possible."

Chairman Jin explained that the efficacy of Rivoceranib has already been sufficiently proven, thus adequately addressing concerns about new drug failure. He said, "For the past six years, it has recorded annual sales exceeding 300 billion KRW in China and has been prescribed to tens of thousands of patients," and added, "Over the past five years, we have submitted more than 500 international clinical research papers proving efficacy against 25 types of cancer, including stomach, colorectal, liver, lung, and breast cancers."

Finally, he emphasized that he will sufficiently explain the matter through the SFC to protect the company's value. He stated, "As HL Biopharma's market capitalization has grown, corresponding responsibilities will follow, and verification by financial authorities is inevitable in that process," and concluded, "If new drug development is a process of confirmation, verification, and assurance, then the financial authorities' raising of issues is also a process of confirmation and verification. Therefore, we will undergo proper verification to protect the honor of our executives and employees."

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