250731 Korea Institute of Oriental Medicine Grants Clinical Approval for BICHEDAM’s Herbal Degenerative Disease Candidate

“Achievements of the Oriental Medicine Innovative Technology Development Project”

The Korea Institute of Oriental Medicine (KIOM) Oriental Medicine Innovative Technology Development Project Team announced on the 31st that BICHEDAM Co., Ltd. (CEO Ho-bin Moon), a domestic pharmaceutical company specializing in traditional Korean medicine (TKM) therapeutics, has obtained approval from the Ministry of Food and Drug Safety (MFDS) for the Phase 1 clinical trial application (IND) of its degenerative disease drug candidate, “BCD101.”

This achievement was derived from the “Oriental Medicine Innovative Technology Development Project” and represents one of the first officially recognized cases where a TKM formulation based on traditional prescriptions secured scientific evidence meeting modern pharmaceutical development standards.

According to KIOM, despite TKM’s long-standing clinical experience and therapeutic effectiveness for various diseases, its integration into the formal pharmaceutical system has been limited due to a lack of scientific data and standardized manufacturing processes.

The Phase 1 IND approval is therefore highly significant, marking an important first step toward overcoming these limitations and advancing TKM into a globally recognized pharmaceutical through scientific validation and standardization.

Prior to the Phase 1 IND application, BICHEDAM thoroughly secured essential data for drug development, including safety, stability, efficacy, and quality specifications. Continuous research, collaboration with institutions, and the accumulation of non-clinical data to standardize raw materials and establish a CMC framework were key factors behind this achievement.

Going forward, BICHEDAM plans to focus on assessing the safety, tolerability, and pharmacokinetic properties of BCD101 through the Phase 1 clinical trial conducted at Chungbuk National University Hospital Clinical Trial Center, and will leverage the results to advance subsequent clinical trials and develop a strategy for global market entry.

Meanwhile, BICHEDAM began with seed investment in the first half of last year and secured an additional 1 billion KRW Pre-A investment from the Korea Technology Finance Corporation in May this year, bringing the total cumulative funding to 2 billion KRW.

Jun-hyuk Lee, Director of the Oriental Medicine Innovative Technology Development Project Team, stated, “This achievement represents a step closer to the scientific validation and credibility of TKM. We will continue to promote public health and drive global market entry by demonstrating the safety and efficacy of TKM products.”

Source : newsfreezone(https://www.newsfreezone.co.kr/news/articleView.html?idxno=639218)