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2024
Today, Shanghai, China--- Haihe Biopharma Co., Ltd. ( "Haihe Biopharma" or the “Company”) and DAEHWA PHARMACEUTICAL CO., LTD. (“DAEHWA Pharmaceutical”) announced that the Paclitaxel Oral Solution (RMX3001) in gastric cancer (GC) has been approved by the National Medical Products Administration- (NMPA).
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As the world's first successfully developed oral paclitaxel, RMX3001 has been verified for efficacy in the Phase III DREAM study and has been approved in South Korea for second-line treatment of gastric cancer. The NPMA approval is based on positive results from an open-label, randomized, multi-center phase III study (CTR20190050) led by leading PI Professor Jin Li's team and Professor Shukui Qin's team in China, which was conducted at 53 centers in China and confirmed the efficacy of RMX3001 once again.
Between April 22, 2019, and January 31, 2022 (data cut-off date), 536 patients with unresectable or recurrent or metastatic gastric cancer progressed after fluoropyrimidine- or fluoropyrimidine plus platinum-based first-line therapy were randomly allocated to paclitaxel oral solution (n=268) or paclitaxel injection (n=268) group with median follow-up of 13.4 months and 12.6 months respectively.
Median progression-free survival assessed by BIRC was 3.02 months (95% confidence interval [CI]: 2.69, 3.71) in the oral group and 2.89 months (95% CI: 2.53, 3.48) in the injection group, demonstrating non-inferiority conclusion (HR 0.894, 95% CI: 0.719, 1.112, p=0.311). Median overall survival (as of February 15, 2023) was 9.13 months (95% CI: 7.72, 10.97) in the oral group and 6.54 months (95% CI: 5.75, 7.26) in the injection group, showing superiority with an absolute 2.59-month survival improvement (HR 0.770, 95.5% CI: 0.635, 0.934, p=0.006). Paclitaxel oral solution was clinically manageable. The most common grade 3 or higher treatment-related adverse events were neutrophil count decreased, white blood cell count decreased and anemia. Paclitaxel oral solution displayed improved safety profile with lower incidence in alopecia, neuropathy peripheral, fatigue, musculoskeletal and connective tissue disorders, hypersensitivity reactions than paclitaxel injection.
Gastric cancer is the fifth most common malignancy worldwide with high incidence and poor prognosis which seriously threatens people's health. It was estimated with 968,784 new cases and 660,175 deaths in 2022. The new cases ranked fifth and deaths ranked third in China with estimated 358,672 new cases and 260,372 deaths, accounting for 40% of worldwide 1-3. It is more often metastatic, or with ascites, severe emaciation, hematemesis, or other symptoms when at the advanced stage, resulting in poor quality of life for patients 4. Paclitaxel monotherapy is category 1 preferred regimen in the second-line therapy of gastric cancer per the National Comprehensive Cancer Network (NCCN) and CSCO guidelines 4, 5.
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.RMX3001 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, RMX3001 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 Co., Ltd is a global, values-based, R&D driven biopharmaceutical leader headquartered in China with operation centers in the US and Japan, and mainly focuses on innovative anti-tumor therapies. The company has the fully capability of drug discovery, development, manufacturing and commercialization and delivers life-saving therapies to cancer patients in China, even the world widely. As an R&D focused company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed in-house innovator with global perspective management and R&D team. Currently Haihe Biopharma has one approved product (Gumarontinib, Haiyitan®) in China and Japan，including several drug candidates.
Haihe Biopharma Co., Ltd is a global, values-based, R&D driven biopharmaceutical leader headquartered in China with operation centers in the US and Japan, and mainly focuses on innovative anti-tumor therapies. The company has the fully capability of drug discovery, development, manufacturing and commercialization and delivers life-saving therapies to cancer patients in China, even the world widely. As an R&D focused company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed in-house innovator with global perspective management and R&D team. Currently Haihe Biopharma has two approved products (Gumarontinib, Haiyitan®; Paclitaxel Oral Solution)，including several drug candidates.
Please visit DAEHWA's website for more information: http://www.dhpharm.co.kr.
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