PharmaEngine and Haihe Biopharma enter into exclusive distribution agreement for LIPORAXEL®

2024-11-04

PharmaEngine, Inc. (TWO:4162) and Shanghai RMX Biopharma Co. Ltd. (Shanghai RMX Biopharma), a subsidiary of Haihe Biopharma Co., Ltd., have entered into a distribution agreement for LIPORAXEL® (paclitaxel oral solution) today. PharmaEngine will be solely responsible for applying new drug application (NDA), sales, and marketing of LIPORAXEL® in the Taiwan market.

 

LIPORAXEL® is a paclitaxel oral solution developed and manufactured by South Korea’s Daehwa Pharmaceutical Co., Ltd. (Daehwa). In September 2017, Shanghai RMX Biopharma in-licensed the rights for development, manufacturing, and commercialization of LIPORAXEL® for the territory of Mainland China, Taiwan, Hong Kong, and Thailand from DaeHwa.

 

Hong-Ren Wang, Ph.D., President and CEO of PharmanEngine stated “LIPORAXEL® was developed by using innovative drug delivery technology to transform intravenous (IV) paclitaxel solution that is normally seen in the market into an oral solution. LIPORAXEL® was designed to enhance administration convenience for patients in hope to improve quality of life. PharmaEngine is not only focusing on the R&D of oncology new drugs, we also hope to fulfill unmet medical needs in Taiwan by providing more treatment options to benefit patients.”  

 

Ruiping Dong, Ph.D., CEO of Haihe Biopharma noted “LIPORAXEL® is the first paclitaxel oral solution in the world to be approved for market and it has showcased significant survival benefit and high tolerance. Through mutual efforts of Haihe and PharmaEngine, we hope to benefit more oncology patients.”

 

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LIPORAXEL®

Paclitaxel is one of the most widely used chemotherapy drugs. Currently, the drug needs to be prepared and administrated intravenously in the hospital. Paclitaxel has been approved for the treatment of many cancers, including breast cancer, ovarian cancer, non-small cell lung cancer and Kaposi's sarcoma. LIPORAXEL® is an oral solution of paclitaxel developed by South Korea's Daehwa Pharmaceutical Co., Ltd using innovative lipid self-emulsified drug delivery technology (DH-LASED Platform).

 

LIPORAXEL® was approved by South Korea’s Ministry of Food and Drug Safety (MFDS) for the treatment of patients with advanced, metastatic, and recurrent gastric cancers in September 2016. In September 2024, LIPORAXEL® also obtained approval from Mainland China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced gastric cancers. Currently, LIPORAXEL is the first oral paclitaxel product that has been successfully developed and approved in the world.

 

About PharmaEngine, Inc.

PharmaEngine, Inc., was established in 2003. Adopting the virtual pharmaceutical company business model and international collaboration strategy, PharmaEngine has been focusing on the R&D of new drugs in the oncology field. ONIVYDE®, PharmaEngine’s commercial product for the treatment of adult patients with metastatic pancreatic adenocarcinoma, has been approved in most major markets including the US, Europe, and Asia. PharmaEngine also has many new anti-cancer drug development projects on the pipeline. For more information, please visit www.pharmaengine.com

 

About Haihe Biopharma Co., Ltd.

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,(INN) in China and Japan and paclitaxel oral solution (RMX3001DHP107) in China and several drug candidates.