Explained the facts related to the’False Disclosure’ controversy on the company’s bulletin board… Emphasis on willingness to overcome
▲ HLB chairman Jin Yang-gon is explaining about’Riboceranib’ in a YouTube video on the 16th. (yunhap news)
HLB’s chairman Jin Yang-gon, who was caught in controversy over false disclosures, reiterated his determination to successfully develop the target anticancer drug’Riboceranib’.
On the morning of the 18th, Chairman Jin posted a long article explaining the facts of the controversy on the HLB’s internal bulletin board.
The controversy this time is the result of the global phase 3 clinical trial of Riboceranib, which HLB released in 2019. At the time, HLB announced on June 27 that riboseranib did not achieve the first evaluation index in the global phase 3 clinical trial. However, the final data released on September 29 reversed this and announced that the clinical trial was successful as a third- and fourth-line gastric cancer treatment. Financial authorities believe that the company has arbitrarily interpreted clinical results and made false disclosures in this process.
Chairman Jin refuted the suspicion of the financial authorities that the clinical results were arbitrarily interpreted as “the clinical results were determined based on the final judgments of internal and external bio experts and consulting companies, and were judged by experts, not arbitrary.” “It’s like several doctors claiming to read X-ray images as arbitrary readings,” he said.
At that time, it also clarified the point that it announced contradicting results in June and September. Chairman Jin said, “At the time of the announcement of the results in June, the entire data has not been confirmed, and if any of the topline results come out, it was released to keep the promise to announce.” · The data analysis that classified the 4th patient was finished.”
The global phase 3 clinical trial of riboseranib was conducted in 460 patients with gastric cancer of 3rd or higher. According to HLB, experts and consulting companies at the time concluded that “it is enough to apply for a new drug license” based on the analysis result of 275 tertiary patients. In addition, 185 patients with 4th or higher grades satisfied the first efficacy index and satisfied the conditions for new drug approval. Therefore, the company’s position is that it can be determined that the global phase 3 clinical trial of riboseranib was successful. Currently, the company is preparing a new drug license application (NDA) for riboseranib with the US Food and Drug Administration (FDA).
Chairman Jin argued, “As if not all new drug approvals were successful in clinical trials, new drug approval and success in Imseong are separate,” he argued.
On this day, Chairman Jin explained in detail the suspicions surrounding riboseranib, and encouraged executives and employees who had fallen into morale due to the recent controversy. “Our new drug will surely succeed, and the goal of launching 5 anticancer drugs within 5 years will surely be achieved,” he said. “As the group chairman, we will overcome the current difficulties well.”
Earlier, Chairman Jin revealed that the controversy was investigated by the Financial Supervisory Service through a YouTube video on the 16th, and that the situation is ahead of the Securities and Futures Committee after passing through the Financial Services Commission Capital Market Research Deliberation Committee.