[Featured Stock] BioSolution, KatiLife's US FDA Phase 2 Anticipation... Undervalued Compared to Kolon TissueGene Increased

Biosolution is showing strong performance. As the results of the Phase 2 clinical trial of Cartilife, a knee osteoarthritis treatment, in the United States and the approval issue from the Korean Ministry of Food and Drug Safety (MFDS) approach, the undervalued stock price is being highlighted.

As of 2:05 PM on the 14th, Biosolution is trading at 24,750 KRW, up 5.32% from the previous day.

According to industry sources, Biosolution's Cartilife completed Phase 2 clinical trials in the U.S., finished follow-up observation in December last year, and is currently undergoing statistical analysis. Cartilife was designated as an RMAT (Regenerative Medicine Advanced Therapy) drug by the U.S. FDA in 2023.

Byungyong Oh, a researcher at Hanyang Securities, stated, “The Phase 2 clinical trial results are scheduled to be disclosed at the American Academy of Orthopaedic Surgeons (AAOS) in March and the Osteoarthritis Research Society International (OARSI) in April.”

He also said, “Biosolution announced the interim results of the domestic Phase 3 clinical trial last April and has applied for product approval from the MFDS based on those results,” adding, “The MFDS’s new drug approval is expected in March this year.”

He continued, “Additionally, the final follow-up observation of the domestic Phase 3 clinical trial ended in November last year,” and “The final results of Phase 3 will also be disclosed at AAOS.”

Researcher Oh pointed out that although there are many developers of arthritis treatments, Biosolution is significantly undervalued. He cited comparable companies including Kolon TissueGene (2.3 trillion KRW), which is in Phase 3 in the U.S., Naturecell (1.3 trillion KRW, knee osteoarthritis RMAT designated), L&C Bio (605.7 billion KRW), Medipost (378.8 billion KRW), and Samil Pharmaceutical (304.6 billion KRW).

He emphasized, “Biosolution’s market capitalization is still less than 200 billion KRW,” and “Expectations for stock price increases are likely to rise depending on domestic MFDS approval and U.S. clinical trial announcements.”