The world’s first paclitaxel oral solution was accepted in China

On September 13, 2022, Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. and Daehwa Pharmaceutical Co., Ltd. jointly announced that the paclitaxel oral solution (RMX3001) jointly developed by the two parties has been officially approved by the Center for Drug Evaluation (CDE) of the State Drug Administration. (Acceptance number: JXHS2200082 country, JXHS2200083 country, JXHS2200084 country).

Administration

Image source: State Drug Administration

Paclitaxel is widely used in the treatment of various malignant tumors such as lung cancer, breast cancer, ovarian cancer, head and neck cancer, and gastric cancer. Protein polymerization, microtubule assembly, preventing depolymerization, thereby stabilizing microtubules and inhibiting the mitosis of cancer cells and triggering apoptosis, thereby effectively preventing the proliferation of cancer cells and playing an anti-cancer effect.

At present, most parts of the world use paclitaxel in the form of injection, which needs to be formulated and administered by intravenous drip in the hospital. Patients need to return to the hospital frequently, and there will be adverse reactions at the injection site. Therefore, the development of oral paclitaxel preparations has always been a hot spot in industry research. .

RMX3001 is an oral formulation of paclitaxel developed by Dahua Pharmaceutical based on its innovative lipid self-emulsifying drug delivery technology. It has been approved by the Korean Food and Drug Administration in September 2016 (trade name Liporaxel), and the indication is advanced or second-line treatment of metastatic gastric cancer or locally recurrent gastric cancer. According to a press release from Haihe Pharmaceuticals, Liporaxel is the first oral paclitaxel product that has been successfully developed and approved for marketing in the world so far. In September 2017, Haihe Pharmaceutical obtained the R&D, production and sales rights of the product in mainland China, Hong Kong, Taiwan and Thailand from Dahua Pharmaceuticals.

The listing application of RMX3001 in China is mainly based on a randomized, open-label, parallel-controlled, non-inferiority design, multi-center Phase 3 clinical trial, which aims to compare the second-line treatment of paclitaxel oral solution RMX3001 and paclitaxel injection (Taxol) Efficacy and safety in patients with advanced gastric cancer. The study was jointly conducted by Professor Li Jin from Shanghai Oriental Hospital and Professor Qin Shukui from Nanjing Jinling Hospital as the principal investigators.

Dr. Ruiping Dong, Chief Executive Officer of Haihe Pharmaceuticals, said: “The acceptance of the application for paclitaxel oral solution (RMX3001) is another important milestone for Haihe Pharmaceuticals, and I am very grateful to the clinical investigators and patients who participated in our trial. Advanced gastric cancer There is still a huge unmet clinical need for treatment, and we hope to bring the world’s most cutting-edge innovative and convenient treatments to patients in China and around the world as soon as possible.”

Yunnan Hande Biotechnology Co., Ltd. has been focusing on the production of paclitaxel for 28 years. It is the world’s first independent manufacturer of the plant-derived anticancer drug paclitaxel that has been approved by the US FDA, European EDQM, Australian TGA, China CFDA, India, Japan and other national regulatory agencies. enterprise. If you want to buy Paclitaxel API, please contact us online.


Post time: Sep-14-2022