250804 “First Case of Korean Medicine Scientific Validation”… BICHEDAM’s Therapeutic Candidate Approved by MFDS

Korean Medicine Advancement Institute Support Achieves Results…Scientific Evidence Secured for Traditional Prescription-Based Therapeutic Clinical Trials at Chungbuk National University Hospital Planned…Safety, Tolerability, and Pharmacokinetic Properties to Be Evaluated

Korean herbal medicine specialist BICHEDAM Co., Ltd. (CEO Ho-bin Moon) has received Phase 1 clinical trial approval (IND) from the Ministry of Food and Drug Safety for its self-developed degenerative disease drug candidate, ‘BCD101’.

On the 31st, the Korea Institute of Oriental Medicine’s Herbal Medicine Innovation Technology Development Project Group (Director Jun-hyuk Lee) stated, “This achievement is one of the first officially recognized cases in which a traditional prescription-based herbal medicine has secured scientific evidence meeting modern pharmaceutical development standards.”

Until now, herbal medicine has faced limitations as a formal pharmaceutical due to a lack of scientific data and standardized manufacturing, despite extensive clinical experience and proven therapeutic effects for various diseases. Experts view this Phase 1 IND approval as an important turning point, overcoming these limitations and enabling herbal medicine to advance to global standards through scientific validation and standardization.

‘BCD101’ secured essential pharmaceutical development data prior to the IND application, including safety, stability, efficacy, and quality specifications. Processes such as raw material standardization, establishment of a CMC (Chemistry, Manufacturing, and Controls) framework, institutional collaboration, and accumulation of non-clinical data were key factors behind this achievement.

BICHEDAM plans to conduct a Phase 1 clinical trial at the Chungbuk National University Hospital Clinical Trial Center to assess safety, tolerability, and pharmacokinetic characteristics. Based on these results, the company intends to accelerate subsequent clinical trials and the development of strategies for global market entry.

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

Lee Jun-hyeok, Director of the Korean Medicine Innovative Technology Development Project, stated, “This achievement marks another step forward in the scientific validation and reliability of Korean medicine. Moving forward, we will continue to demonstrate safety and efficacy to promote public health and drive global market expansion.”

Source : https://www.yeongnam.com/web/view.php?key=20250804023176853