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2019
May 1, 2019, Shanghai, China -- HaiHe Biopharma, a biopharmaceutical company focusing on discovery, development and commercialization of innovative anti-tumor drugs, and Daehwa Pharmaceutical Co., Ltd. (hereinafter referred to as "Daehwa") announced today that the phase III clinical trial of paclitaxel oral solution RMX3001 jointly developed by the two companies for the treatment of advanced gastric cancer has recently completed the first subject administration. This clinical trial was led by Professor Li Jin of Shanghai East Hospital and Professor Qin Shukui of the 81 Hospital of Chinese People's Liberation Army.
RMX3001-301 is a multicenter, randomized, open-label, phase III clinical study to compare the efficacy and safety of paclitaxel oral solution (RMX3001/DHP107) and paclitaxel injection (Taxol®) in the second-line treatment of patients with advanced gastric cancer.
Paclitaxel is one of the most extensively used chemotherapy drugs with huge market demands. Currently, the marketed dosage form of the drug is injection, which is inconvenient to use and has many side effects. Therefore, the development of oral paclitaxel dosage forms has been a research focus in the pharmaceutical industry. With the trade name of Liporaxel®, this product is an oral paclitaxel dosage form developed by DAE HWA Pharmaceutical based on its innovative technology of lipid self-emulsifying drug delivery, which has been approved for the indication of gastric cancer by the South Korean Ministry of Food and Drug Safety (MFDS) on September 9, 2016. To date, Liporaxel® is the first oral paclitaxel product that has been successful developed and approved in the world. In September 2017, HaiHe Biopharma obtained the rights of the product in mainland China, Taiwan, Hong Kong, and Thailand from DAE HWA Pharmaceutical.
Haihe Biopharma is an innovation-driven biotechnology company in China focusing on the discovery, development, production and commercialization of innovative anti-tumor drugs. Haihe brings life-saving therapies to cancer patients worldwide. It also has a research and management team with a global perspective, and is proactively mapping out the international development of innovative drugs. The Company currently has thirteen key drug candidates. As of today, Haihe Biopharma has received 21 IND or clinical trial approvals in four countries and regions.
