GC Green Cross Wellbeing has announced positive topline results from a Phase 3 clinical trial of its chronic liver disease treatment Laennec Injection, demonstrating that the intravenous high-dose regimen statistically significantly improves liver damage markers compared to the existing subcutaneous injection. This development signals a potential shift in administration protocols for aesthetic and medical clinics that use placental extract-based injectables, offering a more efficient delivery method for liver support therapies.
Trial design and endpoints
The Phase 3 study enrolled 226 patients with chronic liver disease across 18 institutions in South Korea, including Severance Hospital, starting in April 2024. The primary endpoint was the change in alanine aminotransferase (ALT) levels from baseline at six weeks. The IV high-dose group showed a statistically significant improvement over the subcutaneous group (p=0.0098), meeting the targeted therapeutic effect.
Regulatory pathway and timeline
GC Green Cross Wellbeing plans to submit a variation application to the Ministry of Food and Drug Safety (MFDS) within this year after receiving the final clinical study report. The company will also present detailed results at domestic and international academic conferences. This regulatory step is critical for clinics and distributors seeking to offer the IV formulation as a new treatment option.
What buyers should watch
For overseas importers and clinic buyers, the IV high-dose regimen could expand the clinical utility of Laennec Injection, potentially increasing demand for placental extract-based injectables in liver health and aesthetic recovery protocols. Distributors should monitor MFDS approval timelines and prepare for potential supply chain adjustments once the new dosage form is authorized.
Sourcing context
GC Green Cross Wellbeing is a subsidiary of GC Green Cross, a major South Korean biopharmaceutical company. The company also co-markets Terazosin Injection with Alteogen Bio in South Korea. Buyers interested in placental extract products should evaluate the regulatory status of Laennec in their target markets and consider the implications of this new dosing option for clinical adoption.
Source: Read the original report | Published: June 16, 2026