13^th September, 2022, Shanghai, China--- Haihe Biopharma Co., Ltd. ( “Haihe Biopharma” or the “Company”) and DAEHWA PHARMACEUTICAL CO., LTD. (“DAEHWA Pharmaceutical”) announced that the Marketing Authorization Application (“MAA”) for Paclitaxel Oral Solution (RMX3001) in gastric cancer (GC) has been accepted for review by the National Medical Products Administration-Center for Drug Evaluation (NMPA-CDE). The acceptance No. is: JXHS2200082, JXHS2200083, JXHS2200084.

The MAA in China is mainly supported by the data from the successful RMX3001/DHP107C2301 study, a randomized, open-label, parallel-group, non-inferiority design, multi-center phase III clinical trial to compare the efficacy and safety of paclitaxel oral solution (RMX3001) with paclitaxel injection (Taxol^®) in patients with advanced gastric cancer who failed previous treatment. Professor Jin Li from Shanghai East Hospital and Professor Shukui Qin from Nanjing Jinling Hospital, the leading principal investigators of this study, commented, “paclitaxel oral solution (RMX3001) utilizes lipid-based self-emulsifying drug delivery technology, which has demostrated efficacy and avoids the side effects from the paclitaxel injection solvent (Cremophor EL^®) and it is convenient for use. RMX3001 is the first oral formulation of paclitaxel approved in the world. We look forward to having an early approval to benefit patients with advanced gastric cancer in China.”

Gastric cancer is one most common malignancy worldwide with high incidence and poor prognosis which seriously threatens people’s health. Frost & Sullivan report 2021 showed that the number of new cases of gastric cancer ranked sixth and second among different types of cancers globally and in China, respectively. The number of death caused by gastric cancer ranked the fourth and the third among different types of cancers globally and in China, respectively. In 2021, there were about 1.1 million new cases of gastric cancer globally with 483.9 thousand cases in China, accounting for 43.2% of the global number. There are about 790.3 thousand deaths of gastric cancer globally with around 352.6 thousand in China, accounting for 44.6% or nearly half of the global number. At the time of diagnosis, nearly 80% of gastric cancer patients in China are at an advanced stage¹, more often metastatic or causing ascites, severe emaciation, hematemesis or other symptoms. Patients experience a very poor quality of life. Paclitaxel monotherapy is the stand of care according to the National Comprehensive Cancer Network (NCCN) guideline and category 1A recommendation according to CSCO guideline for the second-line treatment of gastric cancer.

Paclitaxel is one of the most extensively used chemotherapy drugs with huge market demands. Currently, the marketed formulation of paclitaxel in most parts of the world is injection, which should be administrated intravenously in the hospital. As a result, patients need to visit hospital frequently and may suffer from infusion-related side effects. Therefore, the development of oral paclitaxel formulation has been a research focus in the pharmaceutical industry. Liporaxel^® is an oral paclitaxel formulation developed by DAEHWA Pharmaceutical based on its innovative technology of lipid self-emulsifying drug delivery, which has been approved for the second-line treatment of advanced and metastatic or local recurrent 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 successfully developed and approved in the world. In September 2017, HaiHe Biopharma obtained an exclusive right from DAEHWA Pharmaceutical to develop, manufacture and commercialize RMX3001 in mainland China, Taiwan, Hong Kong, and Thailand.

Haihe Biopharma is a leading innovation-driven biotechnology company in China focusing on the discovery, development, production and commercialization of innovative anti-tumor drugs. Haihe aims to bring life-saving therapies to cancer patients worldwide. As a new drug R&D company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed to the path of independent innovation. Haihe Biopharma also has a research and management team with a global perspective and is proactively mapping out the international development of its innovative drugs. The Company currently has thirteen drug candidates. As of today, Haihe Biopharma has received 33 IND or clinical trial approvals in four countries.

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 many finished products. Liporaxel^® Oral 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 DAEHWA’s website for more information: http://www.dhpharm.co.kr.

Reference:
1. Wang FH, Zhang XT, Li YF, et al. The Chinese Society of Clinical Oncology (CSCO): Clinical guidelines for the diagnosis and treatment of gastric cancer, 2021. Cancer Commun (Lond) 2021; 41:747-95.