[Edaily Reporter KIM JI-WAN ] Daehwa Pharmaceutical ( DAE HWA PHARM CO., LTD(067080)) announced on the 8th that its oral anticancer drug “Liporaxel” (Liporaxel, active ingredient DHP107/RMX3001) has received approval from China’s National Medical Products Administration (NMPA) for an additional indication for the treatment of breast cancer.

The newly approved indication is recurrent or metastatic HER2-negative breast cancer. Consequently, Liporaxel can now be used in China as a treatment for breast cancer, in addition to its existing use for stomach cancer.

Notably, the scope of approval secured in China is broader than that in South Korea. While its use in South Korea is limited to first-line treatment for breast cancer, in China, the approval covers not only first-line treatment but also subsequent lines of treatment, including second- and third-line therapies.

The clinical trials that formed the basis for this approval include the multinational Phase 3 “OPTIMAL” trial, conducted in South Korea, China, and three Eastern European countries, as well as the Phase 2 “OPERA” trial, conducted in the United States and the Czech Republic.

Through these studies, DAE HWA PHARM CO., LTD evaluated the therapeutic efficacy and safety of Liporacel Solution in breast cancer patients. The results confirmed its non-inferiority compared to “Taxol,” an existing paclitaxel formulation administered via weekly intravenous injection.

Liporacel Solution is a product developed by DAE HWA PHARM CO., LTD using its proprietary lipid-based drug delivery technology to formulate paclitaxel as an oral medication.

While conventional paclitaxel must be administered via intravenous injection, Liporacel Solution can be taken orally. This reduces the time required for patients to establish an intravenous line or receive the infusion.

Furthermore, it does not contain “Cremophor EL,” a solubilizing agent used in conventional intravenous paclitaxel. According to ENCell Co., Ltd., this eliminates the need for premedication to prevent hypersensitivity reactions to that ingredient.

DAE HWA PHARM CO., LTD is also focusing on the growth potential of China’s breast cancer treatment market. According to global cancer statistics from the International Agency for Research on Cancer (IARC) and the World Health Organization (WHO), as well as data from China’s National Cancer Center, the number of new breast cancer cases in China is estimated at approximately 360,000 annually.

The company plans to emphasize the convenience of oral anticancer drugs for patients with HER2-negative breast cancer while accelerating the establishment of supply and distribution networks in collaboration with local partners.

Furthermore, the company plans to expand investigator-initiated trials (IITs) with its Chinese partners to secure additional clinical evidence and solidify its entry into the local market.

An official from DAE HWA PHARM CO., LTD stated, “Securing an additional indication for breast cancer treatment in China has expanded the clinical scope of Liporacel and opened up new overseas business opportunities,” adding, “We will strengthen cooperation with local partners to ensure product supply and establish a firm foothold in the market.” The official further noted, “We also plan to continuously explore the possibility of securing additional indications for Liporacel through researcher-initiated clinical trials both domestically and internationally.”