Daehwa Pharm's Oral Paclitaxel (Liporaxel) Approved in China for Gastric Cancer Treatment
Key Insights
Daehwa Pharm (search)'s Liporaxel (search), an oral formulation of paclitaxel, has received marketing approval from China's NMPA for treating gastric cancer (search).
Liporaxel (search) utilizes Daehwa's DHLASED technology, offering improved convenience and safety compared to traditional intravenous paclitaxel.
Clinical trials demonstrated improved outcomes, particularly regarding hair loss and peripheral neuropathy, enhancing patient comfort.
Daehwa Pharmaceutical announced that Liporaxel (search) Sol. (Liporaxel), its oral paclitaxel formulation, has been granted marketing authorization by China's National Medical Products Administration (NMPA) for the treatment of gastric cancer (search). This approval marks a significant milestone for Daehwa Pharm (search), allowing it to enter the world's second-largest pharmaceutical market.
Liporaxel (search) is the first oral formulation of paclitaxel, a drug traditionally administered intravenously. It was developed using Daehwa’s Lipid-based Self-Emulsifying Drug Delivery System (DHLASED) platform technology. In September 2016, the Ministry of Food and Drug Safety (MFDS) in Korea approved Liporaxel as an incrementally modified drug (IMD) for gastric cancer (search) treatment. The European Medicines Agency (EMA) also granted Liporaxel orphan drug designation (ODD) for gastric cancer in February.
Clinical Advantages of Oral Paclitaxel
Liporaxel (search) offers several advantages over conventional intravenous (IV) paclitaxel therapy. It eliminates the need for pre-treatment and the typical three-hour dosing time associated with IV administration. Clinical trials have indicated that Liporaxel improves outcomes for gastric cancer (search) patients, notably reducing hair loss and peripheral neuropathy compared to IV therapy. According to Daehwa Pharm (search), this innovation is expected to significantly enhance patient convenience and safety.
Commercial Strategy in China
In September 2017, Daehwa Pharm (search) entered into a technology transfer agreement with RMX Biopharma in China, securing a $25 million technology transfer fee along with sales royalties. Following a phase 3 clinical trial involving 550 gastric cancer (search) patients in China, Daehwa Pharm submitted Liporaxel (search) for Chinese marketing authorization in September 2022.
Daehwa Pharm (search) plans to leverage its partnership with Haihe to drive sales in China. Haihe's marketing and distribution expertise will be crucial for expanding the business into neighboring Asian countries, Central and Eastern Europe, Western Europe, and the Americas.
Executive Perspective
An official at Daehwa Pharm (search) stated, “With the approval of Liporaxel (search) for gastric cancer (search) in China, we are thrilled to overcome the setback of not being able to market in Korea due to domestic drug price negotiation issues and to demonstrate our innovation and potential in the Chinese market.”
While Lvye currently holds a significant share of the paclitaxel formulation market in China with its lipid-based paclitaxel injection, Lipusu, Daehwa Pharm (search) anticipates that Liporaxel (search)'s improved ease of administration will allow it to capture a substantial portion of the market.
Ongoing Clinical Trials
Daehwa Pharm (search) is conducting a phase 3 breast cancer MRCT study in Korea, China, and several Eastern European countries, expected to be completed by the end of 2024. The company plans to submit additional indication applications in Korea and China in 2025.