Samyang Biopharm Selected for National New Drug Development Project to Develop SENS-Based Idiopathic Pulmonary Fibrosis Therapeutic Candidate

Samyang Biopharm announced on December 22 that it will develop a candidate mRNA therapeutic for idiopathic pulmonary fibrosis (IPF) using its proprietary gene delivery system, SENS (Selectivity Enabling Nano Shell).

Samyang Biopharm, a pharmaceutical and biotech affiliate of Samyang Group, also stated on December 22 that it has recently been selected for the research project to establish a new drug R&D ecosystem under the "2025 Second National New Drug Development Project," led by the National New Drug Development Project Group. The company has signed an agreement to jointly develop a candidate therapeutic for idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis is a chronic progressive lung disease in which soft lung tissue is excessively replaced by fibrous tissue such as collagen, leading to fibrosis that hardens the lungs and impairs respiratory function. With approximately 3 million patients worldwide, demand for effective treatments is increasing. The global market for idiopathic pulmonary fibrosis therapeutics reached about $3.29 billion last year and is projected to grow to approximately $6.07 billion by 2034.

Currently approved treatments are oral medications that inhibit the fibrotic pathway (TGF-β) of pulmonary fibrosis and slow disease progression. However, these drugs must be taken three times a day and may cause side effects such as gastrointestinal discomfort and liver dysfunction with long-term use.

To overcome the limitations of existing therapies, Samyang Biopharm plans to utilize its proprietary SENS gene delivery system to enhance both dosing safety and therapeutic efficacy. SENS is a technology that selectively delivers next-generation RNA-based therapeutics, such as siRNA (small interfering RNA) and mRNA (messenger RNA), to specific organs including the liver, lungs, and spleen.

Through this project, Samyang Biopharm will develop a nonclinical candidate by formulating a modulator that inhibits the fibrotic pathway of pulmonary fibrosis in mRNA form and loading it onto SENS for selective delivery to lung tissue. The Korea Drug Development Fund (KDDF) will provide research and development funding for the candidate's development over the next two years.

A representative from Samyang Biopharm stated, "The candidate derived from this project will leverage the advantages of the SENS platform, which enables selective delivery to specific tissues, to enhance the duration of efficacy and safety, ultimately focusing on improving therapeutic efficiency. We expect this opportunity to demonstrate Samyang Biopharm's global technological competitiveness in the field of gene therapeutics."

Meanwhile, the National New Drug Development Project is a cross-ministerial national R&D initiative launched to strengthen the global competitiveness of Korea's pharmaceutical and biotech industries. Since 2021, it has supported all stages of new drug development over a ten-year period, with goals to reinforce the domestic new drug R&D ecosystem, achieve global commercialization, and generate public health outcomes.