GC녹십자웰빙's Renehanc Inj. Shows Success in IV Clinical Trial, Seeks Approval by Year-End

GC녹십자웰빙 has achieved a significant milestone with its chronic liver disease treatment, 'Renehanc inj.,' announcing positive top-line results from a Phase 3 clinical trial for an intravenous (IV) formulation. This development marks a crucial step towards expanding treatment options beyond the existing subcutaneous (SC) and intramuscular (IM) injections.

The trial, conducted across 18 domestic institutions with 226 chronic liver disease patients, directly compared the efficacy and safety of high-dose IV Renehanc with the SC method. The results showed a statistically significant improvement in alanine aminotransferase (ALT) levels, a key indicator of liver damage, at the six-week mark. This outcome successfully validated the treatment's therapeutic effect, with a P-value of 0.0098, well within the scientifically accepted threshold of 0.05.

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The successful clinical results scientifically prove the clinical value of Renehanc's intravenous administration.

This advancement promises to revolutionize clinical practice by offering greater flexibility and convenience. While SC and IM injections can be cumbersome for multiple ampoule administrations, the IV route allows for easier administration of up to 10mL, tailored to the patient's condition and clinical judgment. This is expected to improve patient compliance and overall treatment experience.

GC녹십자웰빙 anticipates that the expanded usage of Renehanc, which has already surpassed 100 million doses since its 2005 launch, will generate an additional 20 billion won (approximately $14.5 million USD) in annual revenue. "The successful clinical results scientifically prove the clinical value of Renehanc's intravenous administration," stated Jeong Si-young, head of GC녹십자웰빙's R&D division. "Based on the data obtained, we will promptly proceed with the filing for product approval with the Ministry of Food and Drug Safety within the year, and do our best to provide more effective and safer treatment options to medical professionals and patients."

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Based on the data obtained, we will promptly proceed with the filing for product approval with the Ministry of Food and Drug Safety within the year, and do our best to provide more effective and safer treatment options to medical professionals and patients.