The heated race to develop a cure or a vaccine against COVID-19 amid global spotlight on Korean drug makers requires discretion as some are suspected to have overhyped their progress to inflate their stock prices.

On Feb. 26, Kosdaq-listed Komipharm announced it filed for urgent clinical trial approval with the Ministry of Food and Drug Safety (MFDS) for its cytokine storm inhibitor Panaphix to treat COVID-19. After the announcement, Komipharm shares skyrocketed 56 percent for the following three days.

But the company has not gained approval for the clinical trial although more than 40 days have passed since then. An MFDS official said it twice requested supplementary documents from Komipharm and is still waiting for the company’s additional data.

Komipharm responds it is conducting efficacy tests in animals and needs two more months to obtain data. The company also used the term ‘urgent clinical trial’ in its February announcement, but the term per se does not exist in the ministry’s protocol. Critics point out that the company intentionally hyped the progress.

If the data are sufficient, clinical trial approval is given two to three days after application, the MFDS official said.

Another Kosdaq-listed firm NKMAX announced on Mar. 26 that it will conduct an emergency clinical trial of an immune cell therapy called ‘Super NK’ in cooperation with a Korea University Medical Center team. The emergency clinical trial program was introduced to allow the use of a medicine prior to marketing authorization at the discretion of a doctor for a disease without currently available treatment. Although its name was changed to `approval for treatment purposes` in November 2017, the company willfully used the old phrase to give away the impression that it has making headway.

NKMAX did not even set a date of when to apply for approval with Korea University. A market watcher said it is common not to make announcements during the actual application stage because the stock price can rise only by the news of clinical trial application itself.

According to the MFDS, a total of 12 applications were received for COVID-19 clinical trials, of which six applications have been approved as of Apr. 6. In addition, all approved clinical trials are aimed at confirming whether commercially available treatments such as Ebola treatment Remdesivir, AIDS treatment Kaletra, and malaria drug chloroquine can be used as treatments for COVID-19.

Market watchers are also casting a suspicious glance at Sillajen after the liver cancer drug developer announced a plan to develop a COVID-19 vaccine. The company’s stock price had plunged after its clinical trial of Pexa-Vec discontinued in August last year. But the stock price soared on the vaccine development plan released on Mar. 26.

Shares of CHA Biotech gained over 10 percent on news it announced that its partner Pluristem Therapeutics, an Israeli startup, is developing a COVID-19 treatment using placental-derived mesenchymal stromal cells (PLX). CHA Biotech signed a marketing rights agreement with Pluristem Therapeutics in the past, but its PLX application is for intermittent claudication, not for COVID-19.

By Kim Byung-ho and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]