Samjin Pharmaceutical Applies for Phase 1 IND for Immune and Inflammatory Drug Candidate "SJN314"

Non-clinical Studies Supported by the Korea Drug Development Fund

Samjin Pharmaceutical announced on the 4th that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety for a Phase 1 clinical trial of its new immune and inflammatory disease treatment candidate, "SJN314".

Exterior view of the Samjin Pharmaceutical Research Center. Samjin Pharmaceutical

SJN314 is an oral small-molecule MRGPRX2 inhibitor being developed for inflammatory diseases such as chronic spontaneous urticaria and atopic dermatitis. The non-clinical studies were conducted with support from the Korea Drug Development Fund (KDDF).

MRGPRX2 is a receptor involved in mast cell activation via a non-IgE pathway. It is being investigated as a new therapeutic target for patient groups who do not respond to existing antihistamines or IgE-based therapies. Recently, global pharmaceutical companies have been actively pursuing clinical development and technology transfer for related pipelines.

This Phase 1 clinical trial will evaluate safety, pharmacokinetic characteristics, and tolerability in healthy adults. The trial will be conducted by the clinical pharmacology research team at Seoul National University Hospital and will include comparative assessments between Korean and Caucasian participants. Based on the human data obtained in the early clinical stage, Samjin Pharmaceutical plans to review subsequent clinical development and global partnering opportunities.

Lee Sumin, Head of the Research Center at Samjin Pharmaceutical, said, "We have entered the clinical stage based on the data accumulated through non-clinical studies," adding, "We will proceed with development with a view toward global technology transfer and co-development."

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