250803 Green Light for Global Drug Development Based on Korean Medicine

BICHEDAM’s Degenerative Disease Therapeutic Candidate
Receives MFDS Approval for Phase 1 Clinical Trial
Notable as First Case of Scientific Validation in Korean Medicine

BICHEDAM announced that its self-developed herbal-based degenerative disease therapeutic candidate, ‘BCD101,’ has received approval from the Ministry of Food and Drug Safety (MFDS) for its Phase 1 clinical trial (IND).

The Korean Institute of Oriental Medicine (KIOM) Herbal Medicine Innovation Technology Development Project, which drives innovation in the field of traditional Korean medicine, announced on the 3rd that the IND approval was achieved through support from the “Herbal Medicine Innovation Technology Development Project.” This achievement is recognized as one of the first cases in which a herbal medicine based on traditional prescriptions has secured scientific evidence meeting modern drug development standards and entered the formal pharmaceutical development framework.

Although traditional Korean medicine has extensive clinical experience and demonstrated therapeutic effects across various diseases, it has remained limited in scope due to a lack of scientific validation and standardized manufacturing infrastructure. The approval of the Phase 1 IND is expected to overcome these limitations, marking a significant turning point for the scientific advancement and global competitiveness of Korean medicine.

Before applying for Phase 1 clinical trials, ‘BCD101’ thoroughly secured essential data for drug development, including △raw material standardization △pharmaceutical quality specifications (CMC) △non-clinical safety and efficacy evaluations. It is explained that long-term research and inter-institutional collaboration were key factors behind obtaining this approval.

Ho-bin Moon, CEO of BICHEDAM, stated, “Through the Phase 1 clinical trial conducted at the Chungbuk National University Hospital Clinical Trial Center, we plan to establish the safety, tolerability, and pharmacokinetic properties of BCD101,” adding, “Based on this, we will focus on subsequent clinical trials and developing strategies for global market entry.”

Joon-hyuk Lee, Director of the Korean Medicine Innovative Technology Development Project Group, emphasized, “We will continue to actively support the ongoing accumulation of scientific evidence for Korean medicine to promote public health and drive entry into the global market.”

Source : https://www.idaegu.co.kr/news/articleView.html?idxno=518661