[Market Focus] BioSolution Plunges Despite Announcement of U.S. Phase 2 Clinical Trial Results

As of 9:30 a.m. on May 8, BioSolution's share price on the KOSDAQ market was trading at 26,850 won, down 10.5% from the previous day's closing price. This appears to be due to a wave of profit-taking following the announcement of the results of a key pipeline's Phase 2 clinical trial in the United States the previous day.

On May 7, BioSolution announced that it had received the final Clinical Study Report (CSR) for the U.S. Phase 2 clinical trial of its knee cartilage regeneration cell therapy 'CartiLife.' A BioSolution representative explained, "We have demonstrated structural cartilage regeneration and maintenance ability, as well as enhanced improvement effects," and added, "It is significant that we confirmed not only meaningful improvements in pain and function compared to baseline in osteoarthritis patients?who accounted for about 37% of all subjects?but also cartilage regeneration effects."

CartiLife received formal product approval from the Ministry of Food and Drug Safety in Korea on April 30. For entry into the U.S. market, BioSolution obtained Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) in November 2019 and conducted a Phase 2 clinical trial at five clinical sites in the United States, targeting a total of 20 patients with knee cartilage defects.

According to the company, the main evaluation index of this clinical trial?the 'cartilage defect filling score' at 48 weeks post-surgery?achieved 14.2 out of a possible 20 points, demonstrating a clear ability for cartilage regeneration. This is a higher figure compared to the average cartilage filling score of around 9 points for microfracture procedures up to Phase 3 clinical trials in Korea.

BioSolution's share price had been steadily rising since early April, reaching 30,000 won on May 7. However, due to the surge in profit-taking following the announcement, the share price weakened on May 8.