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[이데일리 김재은 기자] Amid suspicion of false disclosures related to the phase 3 clinical trial of riboseranib, an oral gastric cancer treatment drug, bio stocks showed a sharp decline for the second day.
HLB also started on a rebound on the 17th, but ended the deal at 62,500 won, down 6.02% (4,000 won) from the previous day.
Amid growing controversy over the suspicion of HLB’s false disclosure from the financial authorities, the Securities and Futures Committee of the HLB related Financial Services Commission is scheduled to open on the 24th.
Controversy 1. A failure, but a success?
What is the core of the controversy over this false disclosure? The financial authorities are questioning the fact that in June 2019, the phase 3 clinical trial of riboceranib was recognized as a failure, and at the end of September, it overturned it with success. There is a suspicion that a false disclosure was made to raise the stock price.
On June 27, 2019, Chairman Jin Yang-gon said at a press conference, “As a result of statistical significance analysis, it is judged that the final clinical goal has not been reached.” Although the premise was that it was not all data for phase 3 clinical trials, this suggested that it would be difficult to apply for a new drug due to this clinical result, and the market accepted it as a clinical failure.
On August 5th, a paper was submitted to the European Cancer Society (ESMO) by synthesizing the opinions and opinions of experts related to the phase 3 clinical data, and at the end of September, it was announced that the entire phase 3 clinical data would be released.
Chairman Jin said through a YouTube broadcast on the day, “As a result of confirming and analyzing the entire data, we have identified a number of indicators that are clinically significant.” “With the advice of experts, we decided to proceed with the preliminary procedure aiming at applying for a new drug license. ”
The first index, total survival (OS), failed to secure statistical significance, but the second index, progression-free survival (PFS), was an analysis that showed superior efficacy compared to other competing drugs.
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At that time, the company held a pre-NDA meeting with the US Food and Drug Administration (FDA) for NDA application in mid-October, and the full data related to the third phase of Riboceranib was published in the European Cancer Center at the end of September. It was announced that it will be released at the conference (ESMO). It was because of a guarantee clause with ESMO that the data will not be disclosed in advance.
A HLB official said, “As a result of the final analysis of the entire data, we confirmed that the direction was confirmed not by clinical delay but by applying for new drug approval by confirming a number of clinically meaningful indicators.” Will be gathered.”
On September 29, it announced the success of the global phase 3 clinical trial of riboseranib, a gastric cancer treatment. The paper related to the phase 3 clinical trial of riboseranib was selected as the best paper in ESMO, and the stock price was on the rise. Particularly, it is known that the momentum of the stock price increase at that time increased the amount of short-selling and short-covering products.
Controversy 2. Arbitrary interpretation? “It reflects the opinions of experts”
What the financial authorities have troubled is the document data for the pre-NDA meeting with the US FDA in October after September 29th. As stated by Chairman Yang-gon Jin in June of the same year, this data mentions that’the primary indicator failed to secure statistical significance’.
It is stated as’Fail’, but I doubt whether it was misleading as if it was successful. In response, Chairman Jin Yang-gon refuted in three ways.
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He said, “I submit the documents in the first time and hold the face-to-face meeting in the second time,” he said. So I asked for a meeting again.” If a clinical failure is the case, it is explained that there is no need for instructions to request or supplement additional data.
Secondly, if the phase 3 clinical failure is correct as the financial authorities judge, it is unreasonable that the paper containing the results of the phase 3 clinical trial was selected as the best paper by the European Cancer Society (ESMO).
Lastly, Riboceranib has been sold in China as a gastric cancer treatment drug named’aitan’ since 2015, and it is reported that it has generated sales of 500 billion won last year alone. In addition, riboseranib was observed in Korea and Israel in October last year, and its use was approved for the purpose of treating patients.
Chairman Jin asked, “If the opinions of such experts are gathered and presented in an arbitrary interpretation, which one is objective?”
High probability of notifying the prosecution… Concerns about continued uncertainty
Investment sentiment for bio stocks is freezing amid controversy over HLB’s false disclosures, but it is unclear whether the Securities and Futures Committee will be held on the 24th. This is because the agenda related to HLB has already been postponed several times. Sanctions against Corona and Lyme were the reasons, but they are delaying at least three months.
Regarding the controversy over the HLB false disclosure, a financial authority official who was in charge of an unfair investigation in the past determined that there was room for contention. However, as the Jeungseon Committee’s customary practice, there is hardly any precedent of acquitting the sanctions agenda from self-consideration, and the view that the judgment on this will be passed to the prosecution is dominant.
An official from the financial authorities said, “Nothing has been decided yet.” “It is a very bad case to influence the market in this way.”
Chairman Jin Yang-gon said, “No matter where the final stage goes, I am confident in the vocation of the relevant facts.” “As there is a lot of damage to the company and shareholders due to the current uncertainty, I would like to make the judgment as soon as possible.”