Shanghai, China, December 8, 2018--Shanghai HaiHe Biopharma Co., Ltd. (hereinafter referred to as “HaiHe Biopharma”) and DAE HWA PHARMACEUTICAL CO., LTD. (hereinafter referred to as “DAE HWA Pharmaceutical”) announced today that the national investigator meeting on the pivotal phase III clinical trial of oral paclitaxel RMX3001，which is developed through joint efforts by the both companies, for treatment of breast cancer was successfully convened in Guangzhou. Prof. Xu Binghe of the Cancer Hospital Chinese Academy of Medical Science acts as the PI.

“The investigators and experts from 13 sites nationwide gather together in Guangzhou and attend the national investigator meeting on the pivotal phase III clinical trial of oral paclitaxel RMX3001 for treatment of breast cancer, which marks the official launch of the pivotal phase III clinical trial of RMX3001 for treatment of breast cancer. As the first oral paclitaxel chemotherapeutic drug approved abroad, RMX3001 has the milestone significance. In order to benefit the cancer patients in China as early as possible, we will work hard together with the experts from a number of research centers nationwide to commercializeRMX3001in China as soon as possible,” said Dr. Dong Ruiping, CEO of HaiHe Biopharma.

“Very happy to be able to act as the PI of the multi-center clinical trial of the first oral paclitaxel in the world and thanks to the unique and innovative process in RMX3001, the oral dosage form of paclitaxel has been developed, which needs no pre-medication and minimizes the adverse reactions. We will work in collaboration with a number of research centers nationwide to jointly advance the pivotal phase III clinical trial of RMX3001 for treatment of breast cancer and ensure the soonest and high-quality accomplishment of the trial. If successfully approved, a safe, effective and convenient oral dosage form of paclitaxel will be made available to the tumor patients in China,” said Professor Xu Binhe from the Cancer Hospital Chinese Academy of Medical Sciences.

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. 

DAEHWA Pharmaceutical Co., Ltd., was established in the spirit of “providing society a more human-centered pharmaceutical business.” Its main goal is to improve National health and people’s life. Since its foundation in 1984, DAEHWA continuously seeks new paths for its business development with a consistent progress-oriented core-target.   With its own platform technologies, DAEHWA produces APIs and finished products. Liporaxel Solution, which is the result of DAEHWA’s 17-year study. The completed clinical studies proved its efficacy, safety and convenience. DAEHWA invests more than 10% of its sales into R&D, is a global company specialized in pharmaceutical products.

Please visit the company website for more information: http://www.dhpharm.co.kr