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Shanghai, China and Seoul, South Korea, October 27, 2018--Shanghai HaiHe Biopharma Co., Ltd. (hereinafter referred to as “HaiHe Biopharma”) and DAE HWA PHARMACEUTICAL CO., LTD. (hereinafter referred as “DAE HWA Pharmaceutical”) announced today that the oral paclitaxel (RMX3001) (DHP1007/Liporaxel®) jointly developed by the both parties has recently obtained CTA from CNDA for first-line treatment of breast cancer in an international multi-center phase III clinical trial, only 3 months since the approval of the clinical trial for gastric cancer. The international multi-center clinical trial is aimed at evaluating the efficacy and safety of RMX3001 (paclitaxel oral solution) as a first-line treatment in patients with recurrent or metastatic breast cancer compared with Taxol® (paclitaxel injection), which shall be conducted under the leadership of both Prof. Sung Bae Kim of Asan Medical Center in Seoul, South Korea and Prof. Xu Binghe of the Cancer Hospital Chinese Academy of Medical Science.

“It took only 4 months to obtainthe CTA of the clinical trial for gastric cancer for the RMX3001 project, and recently only 3 months to obtain the CTAfor the international multi-center phase III trial for breast cancer. We wish to express our thanks and admiration for the efficiency of the CNDA. We shall exert all our efforts to boost these two clinical trials, so as to enable the oral paclitaxel product, which is first approved in the world, to be marketed in the Greater China Region as soon as possible to benefit the tumor patients with its remarkable clinical efficacy, safety and convenience,” said Dr. Dong Ruiping, CEO of HaiHe Biopharma.

“Very excited to learn about the good news. This is another key milestone in our important project of the oral paclitaxel product co-developed with HaiHe Biopharma and it all happened in just three months. We will continue to work closely with HaiHe Biopharma to carry out these two clinical trials stably and efficiently and strive to complete them as early as possible to make joint contribution to the new history of anti-cancer drugs in China and even in the world,” commented Mr. Eun-Seok Kim, President and CEO of DAE HWA Pharmaceutical.

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