Daehwa's Oral Paclitaxel Wins Breast Cancer Indication

Daehwa Pharmaceutical's Liporaxel Solution. Photo by Daehwa Pharmaceutical

Daehwa Pharmaceutical has secured a first-line breast cancer indication in Korea for Liporaxel Solution, an oral anticancer drug that had long remained an “unfortunate” reformulated new drug after receiving domestic approval for gastric cancer in 2016 but failing to clear the reimbursement hurdle.

Daehwa Pharmaceutical announced on May 13 that the Ministry of Food and Drug Safety approved the additional indication for Liporaxel Solution as a “first-line treatment for recurrent or metastatic HER2-negative breast cancer.”

According to the company, the approval was based on the multinational, multicenter, randomized, open-label Phase 3 OPTIMAL study, which enrolled 549 patients across 51 institutions in Korea, China, and Europe.

In the study, Liporaxel Solution demonstrated non-inferiority to IV paclitaxel, recording a median progression-free survival of 10.0 months, overall survival of 32.6 months, and an objective response rate of 43.3%. The OPTIMAL study was also selected for an oral presentation at the 2025 American Society of Clinical Oncology Annual Meeting.

HER2-negative breast cancer accounts for about 80% of all breast cancer cases. Unlike conventional IV paclitaxel, Liporaxel Solution can be taken orally, reducing the burden of intravenous infusion lasting more than three hours and eliminating the need for steroid and antihistamine premedication. The company said this gives the drug significant clinical value.

Liporaxel Solution is an oral paclitaxel formulation based on Daehwa Pharmaceutical’s lipid-based self-emulsifying drug delivery technology, DHLASED. It was approved in Korea for gastric cancer in 2016, but reimbursement-based launch was blocked after its value as a reformulated new drug was not recognized during pricing negotiations.

Daehwa Pharmaceutical said it plans to strengthen Liporaxel Solution’s competitiveness by expanding additional indications through extrapolation strategies, pursuing approval strategies based on global partnerships, and accumulating real-world evidence.