Haihe Pharmaceuticals' Paclitaxel Oral Solution China Marketing Authorization Application Officially Accepted
On September 13, 2022, Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. and South Korea's Daehwa Pharmaceutical Co., Ltd. jointly announced that the paclitaxel oral solution jointly developed by the two parties has officially been accepted by the Center for Drug Evaluation of the State Drug Administration. The Chinese marketing application for this indication is mainly based on a randomized, open-label, parallel-controlled, non-inferiority design, multi-center phase III clinical trial of RMX3001/DHP107C2301, which aims to compare paclitaxel oral solution and paclitaxel injection in the second-line treatment of patients with advanced gastric cancer efficacy and safety. Professor Li Jin from Shanghai Oriental Hospital and Professor Qin Shukui from Nanjing Jinling Hospital jointly served as the principal investigators of the study. They said: "Paclitaxel oral solution adopts the patented self-emulsifying drug delivery technology, which has a precise curative effect and avoids the common injection solvent Cremophor EL. some toxic and side effects, and easy to use.