Daehwa Pharmaceutical’s Liporaxel Expands Beyond Gastric Cancer to Breast Cancer, Broadening the Reach of an Oral Anticancer Drug

Daehwa Pharmaceutical’s oral anticancer drug Liporaxel has successfully expanded its indications from gastric cancer to breast cancer.

In its semiannual report disclosed on the 7th, Daehwa Pharmaceutical said it received approval in May from the Ministry of Food and Drug Safety (MFDS) for a change to the marketing authorization covering a new breast cancer indication for the oral paclitaxel anticancer drug Liporaxel (Liporaxel®). The approval was based on the results of a multinational phase 3 clinical trial conducted in South Korea, China and Europe in patients with recurrent or metastatic breast cancer.

The company previously presented the clinical results orally at the American Society of Clinical Oncology (ASCO) meeting in May 2025, demonstrating the drug’s efficacy and safety. Liporaxel is an improved drug developed as the world’s first oral formulation of paclitaxel, an anticancer ingredient previously available only as an injectable.

Daehwa Pharmaceutical applied its proprietary drug delivery system (DDS) technology, the DH-LASED platform, eliminating the premedication process required for injectable administration and the lengthy administration time. The drug is also characterized by improved major adverse effects, including peripheral neuropathy and hair loss, substantially enhancing patients’ convenience and quality of life.

The domestic approval also signals potential expansion of Liporaxel in global markets. Daehwa Pharmaceutical’s Chinese partner, Haihe Biopharma, filed an application in June 2025 with China’s National Medical Products Administration (NMPA) to add the breast cancer indication.

Liporaxel previously received marketing approval in China as a gastric cancer treatment in September 2024. It was subsequently added to China’s National Reimbursement Drug List (NRDL) in January 2026 and became eligible for reimbursement there, raising expectations that the addition of the breast cancer indication could accelerate sales growth.

Meanwhile, Daehwa Pharmaceutical is also accelerating development of next-generation pipeline products in addition to Liporaxel. The company said it is conducting formulation research on DHP3301, an obesity treatment being developed as an oral glucagon-like peptide-1 (GLP-1) analog. The strategy is interpreted as an effort to differentiate the product with an oral formulation in the GLP-1 market, where most existing products are injectable.