Liporaxel® is the commercial brand name of Paclitaxel Oral Solution, an orally administered paclitaxel formulation developed by Daehwa Pharmaceutical of Korea with lipid self-emulsifying drug delivery technology. It exerts antitumor effects by promoting microtubule polymerization and inhibiting mitosis of tumor cells.
Main Indications
Treatment of adult patients with advanced gastric cancer whose disease has progressed during or after first-line fluoropyrimidine-based chemotherapy.
Clinical Research
A multicenter, randomized, open-label, non-inferiority Phase III trial was conducted in China, comparing oral paclitaxel solution versus intravenous paclitaxel injection as second-line therapy for advanced gastric cancer;
The primary non-inferiority endpoint was achieved, with the oral formulation demonstrating comparable antitumor efficacy and lower incidences of peripheral neuropathy, alopecia and fatigue;
No hypersensitivity reactions occurred in the oral group without routine premedication, and long-term follow-up confirmed a manageable safety profile.
Common Side Effects
Severe but important risks: Severe neutropenia, febrile neutropenia, gastrointestinal perforation and severe diarrhea;
Common mild adverse reactions: Peripheral sensory neuropathy, alopecia, nausea, diarrhea, vomiting, fatigue, myalgia, arthralgia, decreased appetite and abnormal liver function. Severe hypersensitivity reactions frequently seen with intravenous paclitaxel were not observed.
Approval Status in China
Original drug Liporaxel® (Paclitaxel Oral Solution, specification: 30ml:300mg) was officially approved for marketing in China in September 2024. It is currently a prescription anti-tumor drug jointly commercialized by Haihe Biopharma and 3SBio Inc.
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