Daehwa Pharmaceutical announced that Liporaxel 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. This approval marks a significant milestone for Daehwa Pharm, allowing it to enter the world's second-largest pharmaceutical market.
Liporaxel 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 treatment. The European Medicines Agency (EMA) also granted Liporaxel orphan drug designation (ODD) for gastric cancer in February.
Clinical Advantages of Oral Paclitaxel
Liporaxel 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 patients, notably reducing hair loss and peripheral neuropathy compared to IV therapy. According to Daehwa Pharm, this innovation is expected to significantly enhance patient convenience and safety.
Commercial Strategy in China
In September 2017, Daehwa Pharm 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 patients in China, Daehwa Pharm submitted Liporaxel for Chinese marketing authorization in September 2022.
Daehwa Pharm 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 stated, “With the approval of Liporaxel for gastric cancer 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 anticipates that Liporaxel's improved ease of administration will allow it to capture a substantial portion of the market.
Ongoing Clinical Trials
Daehwa Pharm 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.
