China Expands Liporaxel Approval to HER2-Negative Breast Cancer
Dae Hwa Pharmaceutical said China’s NMPA approved its oral paclitaxel drug Liporaxel for recurrent or metastatic HER2-negative breast cancer.
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Dae Hwa Pharmaceutical announced on October 8, 2026, that Liporaxel, also identified as DHP107/RMX3001, received an additional breast cancer indication in China. The approval expands the drug’s authorized use in China beyond its existing stomach cancer indication.
Who is covered by the approval
China’s NMPA authorized Liporaxel for patients with recurrent or metastatic HER2-negative breast cancer. The Chinese approval covers first-line treatment as well as later treatment lines, including second- and third-line use.
The authorized treatment range differs by country. Liporaxel is licensed for first-line breast cancer treatment in South Korea, while the new Chinese indication extends across first-line and subsequent treatment settings.
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