Bioneer Subsidiary SunaGen Signs Validation Testing Contract for New Drug Candidates with Overseas Pharmaceutical Company

SAMiRNA-AREG Plans to Submit Phase 1 Application to MFDS Within This Year

[Asia Economy Reporter Kim Ji-hee] Bioneer’s subsidiary Sernagen Therapeutics announced on the 19th that it has signed a contract allowing an overseas pharmaceutical company to conduct validation tests on the new drug candidate 'SAMiRNA-AREG.'

Under this contract, the contracting party receiving the candidate substance from Sernagen must entrust the experiments to a specialized company to verify the therapeutic effects and then submit a final report. Validation tests or material transfer agreements are typically part of the new drug technology transfer process.

Ownership and intellectual property rights of all research outputs, including validation test data and the final report, belong to Sernagen. Sernagen plans to apply for a Phase 1 clinical trial with the Ministry of Food and Drug Safety within this year for this candidate substance.

A company official stated, “Since the modeling of the candidate substance is simple, we expect the period until the validation test results are derived will not be long,” adding, “Due to confidentiality clauses, we cannot disclose detailed contract contents, but the test results will serve as a stepping stone for the candidate substance to enter the global market.”

According to the company, SAMiRNA-AREG has demonstrated efficacy and safety in suppressing inflammation and fibrosis in various disease model animal experiments and primate toxicity tests conducted domestically, including chronic kidney disease, idiopathic pulmonary fibrosis of unknown cause, and non-alcoholic steatohepatitis (NASH). It also showed anti-obesity effects by reducing visceral white adipose tissue by about 70% and lowering triglycerides. No side effects such as innate immune responses were observed. Bioneer and Sernagen hold approximately 190 intellectual property rights related to this, including global foundational patents and candidate substance patents.

This content was produced with the assistance of AI translation services.