By Fineline Cube South Korea’s Daehwa Pharmaceutical (KOSDAQ: 067080) has announced the filing of a New Drug Application (NDA) in China for Liporaxel/RMX3001, its innovative oral paclitaxel formulation. The application seeks approval for Liporaxel as a secondary treatment option for patients with advanced gastric cancer.
Liporaxel: An Innovative Oral Formulation
Liporaxel is an oral paclitaxel formulation composed of edible lipids and a US FDA-approved emulsifier. This unique composition aims to provide the same efficacy as the patented drug delivery technology while avoiding the toxicity and adverse effects commonly associated with intravenous injections. Additionally, Liporaxel offers the convenience of oral administration, making it a more patient-friendly option.
Phase III Clinical Trial and Regulatory Submission
The NDA for Liporaxel in China is based on the results of a Phase III clinical trial conducted by Daehwa and its Chinese partner, Haihe Biopharma. The trial demonstrated the drug’s potential as a secondary treatment for advanced gastric cancer. The submission to China’s regulatory authorities marks a significant step in making this innovative treatment available to patients in the region.
Previous Approval in South Korea
Liporaxel was previously approved in South Korea in September 2016 as a secondary treatment for advanced or metastatic stomach cancer or locally recurrent stomach cancer. The drug’s successful track record in South Korea, combined with the positive results from the Phase III trial, underscores its potential to address the unmet needs of patients with advanced gastric cancer.-Fineline Info & Tech