[단독] Exchange, loose KOSPI bio disclosure guidelines… “Only investors are harmed”

[이데일리 김유림 기자] It was revealed that the Korea Exchange is applying only the results of phase 3 clinical trials to the KOSPI bio company as a subject of mandatory disclosure. As the COVID-19 treatment and vaccine can receive conditional approval as early clinical results, it is pointed out that phases 1 and 2 clinical trials should also be included in the disclosure so that investors can accurately grasp the progress.

KOSPI Bio Disclosure Guidelines. [자료=거래소]

According to the Korea Exchange on the 19th, the exchange created the KOSPI bio-disclosure guidelines in November of last year, and introduced them to companies from early December and implemented them immediately. However, unlike the KOSDAQ disclosure guidelines, the distribution of press releases through the media did not proceed, and was posted on the exchange website last month.

Earlier in February 2020, the Exchange announced the’KOSDAQ Bio Disclosure Guidelines’ as a series of controversy over the act of distributing data indiscriminately with arbitrary interpretations of pharmaceutical and bio companies without disclosing clinical results.

According to the KOSDAQ Bio Disclosure Guidelines, the facts and results of clinical trials are subject to mandatory disclosure because they correspond to important information of management activities of pharmaceutical and bio companies. All clinical results should be objectively disclosed as to whether the primary evaluation index (main evaluation index) is statistically significant or not. The company’s own judgment should not be disclosed without disclosing topline data.

On the other hand, there are frequent cases in which investors are not clearly aware of the investment risk, while KOSPI bio companies are subject to mandatory disclosure only for phase 3 clinical trials.

In January, Napabeltan (ingredient name napamostatmesylate), the second clinical trial in Russia for Corona 19, was ended, but according to regulations, there was no public announcement. Instead, only the press release of the results of the phase 2 clinical trial of Nafeveltan containing the company’s own interpretation was distributed. Chong Kun Dang said, “As a result of the phase 2 clinical trial in Russia, which was conducted on 100 severely ill patients with Corona 19, statistical significance was secured as a result of evaluating various clinical indicators.”

On the 17th, the Ministry of Food and Drug Safety concluded that Nafebeltan had not proven effective in treating Corona 19, and that additional clinical trials were needed. Failure to prove the effectiveness of the primary indicator, clinical improvement time, and the time for the transition of the additionally evaluated virus test results from positive to negative (virus negative time required) also had no effect.

The additional analysis showed statistical significance in the’patient group with an early warning score of 7 or more’, but it was judged that the design of the clinical trial was’open-label’ and that objectivity and reliability were limited. The open test is a method in which both the subject and the investigator know whether they have used a fake drug or a drug. In the double blind method, both the patient and the medical staff do not know whether they have been given either a fake drug or a drug until the end of the clinical trial. Clinical trial data rely more on double blinding.

Also, in December of last year, it only announced that it applied for conditional permission based on the results of phase 2 clinical trials for Corona 19 antibody treatment, Rekirona, and the contents of the primary indicator were omitted. At that time, the market raised doubts about the clinical results, and in January Celltrion released the clinical design and data for investors. Since then, a conditional approval was obtained from the Ministry of Food and Drug Safety in February, and phase 3 clinical trials are currently in progress.

The exchange clarified that it did not include it in the subject of mandatory disclosure because phases 1 and 2 clinical trials do not hurt performance significantly for KOSPI companies. An official of the exchange said, “If it is an important management matter that is judged by the public announcement, it is the factors that may affect the business’s business or finance.” In fact, it is a license agreement of 5% or more of capital,” he said.

Corona 19 treatment can be delivered directly with conditional approval only with early clinical results. Even for a KOSPI company, the results of phase 1 and 2 clinical trials are important management issues that have a big impact on earnings and stock prices. In this regard, the exchange said, “Because the KOSDAQ bio company has a large impact on performance due to the failure and success of the pipeline, all clinical trials are subject to mandatory disclosure.” There is no” he added.

Currently, KOSPI-listed companies, such as,,, are undergoing phase 1 to 2 clinical trials for COVID-19 treatment, and the stock price is recurring, regardless of performance. However, unless these companies voluntarily disclose primary and secondary indicators, investors are likely to still not be provided with proper information, as in the previous case.