[Featured Stock] Ubio Anticipates Domestic COVID-19 Development... Preparing to Produce Hundreds of Millions of Doses

[Asia Economy Reporter Yoo Hyun-seok] Yu Biologics is showing strong performance. The expectation of approval for the phase 1/2 clinical trial plan (IND) of the novel coronavirus disease (COVID-19) vaccine 'Yucovac-19' appears to be influencing the stock price.

As of 9:35 AM on the 5th, Yu Biologics was trading at 24,600 KRW, up 10.07% (2,250 KRW) compared to the previous trading day.

The previous day, a media outlet reported that the Ministry of Food and Drug Safety (MFDS) had begun reviewing the phase 1/2 IND application for Yu Biologics' COVID-19 vaccine 'Yucovac-19'. The MFDS has established a 'High-Intensity Rapid Productization Promotion Program' to shorten the IND approval period for COVID-19 pharmaceuticals to expedite product development.

Yu Biologics submitted the phase 1/2 IND for Yucovac-19 to the MFDS on December 11 last year.

Yucovac-19 is a vaccine developed by combining an antigen directly produced through genetic recombination of a portion of the coronavirus spike protein with an immune adjuvant. It is developed in a liquid injectable form that can be refrigerated, allowing use of the general distribution system.

Yu Biologics is confident in the efficacy of Yucovac-19. It is known to encourage its employees to participate in the clinical trials. The total clinical trial subjects for Yucovac-19 are designed as 30 for phase 1 and 230 for phase 2. The company has about 200 employees. Yucovac-19 delivers a small, precise amount of antigen necessary for immunity directly into the human body to induce a rapid immune response, and safety has been secured through similar vaccines.

Yu Biologics expects to enter phase 3 clinical trials in the second half of this year. Through expansion of existing animal cell culture facilities and immune adjuvant manufacturing facilities, it plans to have the capacity to produce hundreds of millions of doses annually. In animal experiments, Yucovac-19 showed an antibody formation rate approximately 1,000 times higher than existing drugs. It is explained that immune antibodies can be formed even when diluted over 1,000 times.

In February this year, Yu Biologics expanded its existing animal cell culture facility from 450L to 2000L, and plans to produce phase 3 clinical trial samples and commercial products by the second quarter of next year. Designed to use only 10㎍ or 20㎍ per dose, the 2000L facility can produce over hundreds of millions of doses of its own vaccine annually.

This content was produced with the assistance of AI translation services.