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250808 ICHEDAM Secures Approval for Phase 1 Clinical Trial of Herbal Degenerative Disease Drug Candidate

Author
realhobin

Date
2025-12-22 05:26

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107

Achievements from the ‘Korean Medicine Innovative Technology Development Project’ Hosted by the Korea Institute of Oriental Medicine

 

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BICHEDAM, a domestic herbal medicine pharmaceutical company (CEO: Moon Ho-bin), announced that its self-developed degenerative disease drug candidate, ‘BCD101,’ has received IND approval for a Phase 1 clinical trial from the Ministry of Food and Drug Safety.

 

This achievement was the result of the “Korean Medicine Innovative Technology Development Project” led by the Korea Institute of Oriental Medicine, marking the first domestic case in which an herbal medicine based on traditional prescriptions officially secured scientific evidence meeting modern pharmaceutical development standards.

 

Despite extensive clinical experience and proven effects across various conditions, Korean medicine has faced challenges entering the formal pharmaceutical sector due to a lack of scientific validation and standardized manufacturing processes. This IND approval is highly significant as it overcomes these structural limitations and represents a first step toward elevating Korean medicine to global pharmaceutical standards through scientific validation and standardization.

 

Prior to the IND application, ‘BCD101’ fully secured essential requirements for drug development, including safety, efficacy, and quality specifications. Through comprehensive efforts such as raw material standardization, establishment of a CMC framework, and accumulation of non-clinical data, a solid foundation for clinical entry was established.

 

Going forward, BICHEDAM plans to verify the safety, tolerability, and pharmacokinetic characteristics of BCD101 through a Phase 1 clinical trial at the Chungbuk National University Hospital Clinical Trial Center, and will focus on subsequent clinical trials and strategies for global market entry.

 

Moon Ho-bin, CEO of BICHEDAM, stated, “This achievement marks a significant step forward in the scientific validation and credibility of Korean medicine,” adding, “We will continue to actively promote public health and global market entry through the verification of safety and efficacy of Korean medicine.”

 

BICHEDAM is an incubated company participating in the “2025 Agri-Food Technology Startup Accelerator Support Project,” hosted by the Ministry of Agriculture, Food and Rural Affairs and managed by the Korea Institute of Agricultural Technology. The company demonstrated its growth potential by securing approximately 100 million KRW in direct investment from the selected agri-food accelerator, Y&Archer.

 

Additionally, BICHEDAM has received support for various commercialization programs, including global IR, technology advancement consulting, and follow-up investment connections. In May 2025, the company also secured 1 billion KRW in Pre-A funding from the Korea Technology Finance Corporation, bringing its total cumulative investment to 2 billion KRW.

 

Source: https://www.medisobizanews.com/news/articleView.html?idxno=127905