250731 BICHEDAM Secures Clinical Approval for Herbal Degenerative Disease Drug Candidate

【Health Welfare Times】 The Korea Institute of Oriental Medicine’s Herbal Medicine Innovative Technology Development Project Group (Director: Junhyuk Lee) announced on the 31st that BICHEDAM Co., Ltd. (CEO: Hobin Moon), a domestic pharmaceutical company specializing in herbal treatments, has obtained approval from the Ministry of Food and Drug Safety (MFDS) for the Phase 1 clinical trial plan (IND) of its self-developed degenerative disease drug candidate, ‘BCD101’.

This achievement was realized through the “Herbal Medicine Innovative Technology Development Project” and represents one of the first cases in which a traditional herbal formulation has been officially recognized for meeting the scientific standards required for modern drug development.

Despite its long-standing clinical experience and demonstrated therapeutic effects across various conditions, traditional Korean medicine has faced limitations as a formal pharmaceutical due to a lack of scientific data and standardized manufacturing foundations. The approval of the Phase 1 IND represents a significant milestone, overcoming these limitations and marking an important first step toward advancing herbal medicine into globally recognized, standardized, and scientifically validated pharmaceuticals.

Prior to submitting the Phase 1 IND, ‘BCD101’ thoroughly secured essential data for drug development, including safety, stability, efficacy, and quality specifications. Continuous research, collaboration with institutions, and accumulation of non-clinical data for raw material standardization and CMC (Chemistry, Manufacturing, and Controls) foundation were key factors underpinning this achievement.

Going forward, BICHEDAM plans to secure safety, tolerability, and pharmacokinetic profiles through the Phase 1 clinical trial conducted at the Chungbuk National University Hospital Clinical Trial Center, and based on these results, focus on advancing to subsequent clinical trials and formulating strategies for global market entry.

Meanwhile, BICHEDAM began with a seed investment in the first half of 2024 and, in May of this year, secured an additional Pre-A investment of 1 billion KRW from the Korea Technology Finance Corporation, bringing its total accumulated investment to 2 billion KRW to date.

Lee Jun-hyuk, Director of the Korean Medicine Innovative Technology Development Project Group, stated, “This achievement represents a step forward in the scientific validation and credibility of Korean medicine. Moving forward, we will continue our efforts to promote public health and drive global market expansion by demonstrating the safety and efficacy of Korean medicine.”

 Source : https://www.whosaeng.com/162906