Shanghai, China and Seoul, South Korea, July 27, 2018/ Shanghai HaiHe Biopharma Co., Ltd. (“HaiHe Biopharma”) and DAEHWA Pharmaceutical Co., Ltd. (“DAEHWA Pharma”) announced today, RMX3001, co-developed by both companies, has been granted the clinical trial approval (CTA) for gastric cancer by China National Drug Administration (CNDA). At the same time, IND filing for breast cancer phase III multi-regional clinical trial (MRCT) was also accepted by CNDA.

“We are very pleased that RMX3001 project has been granted CTA by CNDA in only 4 months. This approval is undoubtedly good news for Chinese cancer patients. We will immediately advance clinical trials for gastric cancer. As the world's first successfully developed oral paclitaxel, RMX3001 was developed under a unique and innovative oral formulation process. It needs no premedication before treatment, and is convenient to use with less adverse reactions such as peripheral neuropathy, contributes to high patient compliance. We look forward to the launch of RMX3001 as soon as possible to benefit cancer patients.”

“With the support and assistance of friends from HaiHe Pharma, RMX3001 (DHP1007/ Liporaxel®) project co-developed by both companies has progressed faster than expected, having obtained CTA for gastric cancer, and IND filing for breast cancer phase III MRCT accepted by CNDA. We are eagerly looking forward to the early initiations of clinical trials in China, and we hope that both companies will work together closely to write a new history of Chinese and global anticancer drugs."

Paclitaxel is one of the most widely used drug for chemotherapy. There are huge market needs in China, with Paclitaxel usage by 220,000 patients of gastric cancer, breast cancer, ovary cancer and lung cancer alone. Currently used Paclitaxel products are all injectable with a lot of side effects and is inconvenience to use. Therefore, the development of oral paclitaxel formulations has always been a hot area in industry. 

RMX3001 is originally developed by DAEHWA Pharma based on its innovative lipid self-emulsifying drug delivery technology. The product, with brand name Liporaxel®, was successfully approved for launch for the treatment of gastric cancer by Korean Drug Administration (MFDS) on September 9, 2016. To date, Liporaxel® is the world's first successfully developed and approved oral paclitaxel. HaiHe Biopharma licensed in the rights of China mainland, Taiwan, Hong Kong and Thailand from DAEHWA Pharma in September 2017. HaiHe Biopharma actively advanced the IND filing process in China, with IND submission for gastric cancer in March 2018, and CTA granted in July 2018. It took only 4 months for CNDA review.

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.