HLB chairman directly clarified the suspicion of false disclosure… Stock price plunges

It revealed that it is being investigated by the financial authorities for suspicion that the domestic bio company HLB (HLB) has disclosed false clinical results. HLB chairman Jin Yang-gon appeared on YouTube on the afternoon of the 16th. He refuted, saying, “I am clarifying the fact that I have not made a false disclosure.”

The suspicion of false disclosure of clinical results is the content distributed by HLB to media outlets in September 2019. HLB, which is developing a new oral anticancer drug candidate (Riboceranib) that can be used for the treatment of gastric cancer, released a press release titled’HLB, Riboceranib Global Clinical Phase 3 Success Announcement’. At the European Oncology Association (ESMO) held in Barcelona, ​​Spain, a subsidiary of HLB (Eliva) officially announced the results of the third phase of the global clinical trial of Rivoceranib.

In a press release at the time, HLB said,’From February 2017 to October 2018, clinical trials were conducted on 460 patients who failed gastric cancer in 88 hospitals in 12 countries. Nip has proven its superior medicinal effect.’

Chairman Jin said on YouTube that day, “(Regarding this), the Financial Supervisory Service investigated, passed through the Financial Services Commission Capital Market Research Deliberation Committee, and the Securities and Futures Commission.”

However, Chairman Jin is in the position that “(whether it was a false disclosure) a conclusion was not made”. He directly refuted the report that a media company reported on the day that’even though the clinical trial results of riboseranib were close to failure, they arbitrarily interpreted them as if they were successful’.

Regarding the allegations that the US Food and Drug Administration (FDA) negatively evaluated the results of the clinical trial of Riboceranib, Chairman Jin said, “It was only from a pre-NDA meeting that took place before NDA “The pre-meeting is not the place to decide on new drug approval,” he explained.

HLB claims that it has already informed investors about the negative evaluation that emerged during the FDA’s pre-meeting process. HLB said, “At the company briefing session (IR) on June 27, 2019, it was revealed that the results of the global phase 3 test of Riboceranib did not reach the target value.”

At the time, HLB announced that the overall survival (OS) value of gastric cancer patients who participated in the clinical trial was lower than that of conventional gastric cancer treatments. In order to evaluate that a new drug is “effective,” patients who took the real drug (test group) had to live relatively longer than those who took the fake drug (control group) (survival rate). The difference in period was only 0.65 months.

Regarding this, HLB said, “As one of the efficacy indicators (OS) could not be proven clinically, it was self-disclosed that it may be difficult to approve a new drug for riboseranib.

Chairman Jin also said, “We are calling the financial authorities for such information,” and said, “I am terrible at the conclusion (from the outside) about a company that is developing (new drug) and commercializing it.”

Meanwhile, as it became known that the financial authorities were investigating, HLB’s stock price plummeted. HLB’s stock price, which had recorded the lower limit during the intraday, fell by 2,4900 won (-27.2%) from the closing price of the previous day, closing the transaction at 66,500 won. As the market capitalization decreased by 1.3 trillion won in one day, the KOSDAQ market capitalization ranking, which was 3rd the day before (4,853 trillion won), also fell to 8th place (3,531.3 billion won). Shares of affiliates HLB Life Science (-28.0%) and HLB Pharmaceutical (-22.8%) also plunged.

Reporter Moon Hee-cheol [email protected]