Daehwa Pharmaceutical's Liporaxel aims for listing in China

Obtained local marketing approval in 2024… began a launch in Shanghai around March

Priced at approximately KRW 940,000 per 30 mg as a non-reimbursable drug… the anticipated reimbursement price will likely range from KRW 400,000 to 450,000

China's market for paclixatel injectable worth KRW 2 trillion…considered as a global battleground

Haihe Biopharma holds sales rights in the markets of China, Taiwan, Hong Kong, and Thailand

The world's first oral paclitaxel, Liporaxel, for gastric cancer, is expected to enter the first negotiation step with the Chinese health authority in June for health insurance listing.

 

The negotiation outcome gains attention.

 

Daehwa Pharmaceutical's Liporaxel is sold in local Chinese hospitals at approximately KRW 940,000 per 30 mg.

 

Sources said that this drug's anticipated reimbursement price will likely range KRW 400,000-450,000.

 

The global market for paclitaxel injectables is valued at roughly KRW 5 trillion, of which China accounts for approximately 40–50%, making it a critical battleground for drug launches.

 

Liporaxel obtained marketing approval in September 2024 from the China National Medical Products Administration (NMPA) for the indication of gastric cancer and began a full-scale launch centered in Shanghai around March.

 

Until the development of Liporaxel solution in 2016, paclitaxel formulations had been prescribed only in injectable form.

 

The oral liquid formulation of Liporaxel, a gastric cancer treatment, secured the status of the world's first improved drug converted from an injectable to a liquid formulation, and if reimbursement is achieved in China, its ease of administration is expected to drive rapid growth.

 

Conventional paclitaxel intravenous (IV) treatments typically require more than three hours of infusion time, including pre-treatment, so launching a formulation-changed product has been a long-awaited goal for academia and patient groups.

 

The mechanism of action of Daehwa Pharmaceutical

Furthermore, in clinical trials for gastric cancer, the new formulation showed improved outcomes compared to IV therapy, particularly in terms of side effects such as hair loss and peripheral neuropathy, which is expected to enhance patient convenience and safety greatly.

 

Notably, by reducing the treatment time, this drug is expected to provide more patients with the opportunity to receive treatment, thereby improving the overall efficiency of cancer care.

 

Liporaxel demonstrated equivalent safety and efficacy compared to a control drug in a Phase 3 trial conducted in approximately 550 gastric cancer patients in China.

 

Meanwhile, Liporaxel was licensed in September 2017 to China's RMX Biopharma under a contract that included a licensing fee of USD 25 million (approximately KRW 33.2 billion) along with separate sales royalties, and the rights for Liporaxel as a second-line treatment for advanced, metastatic, or locally recurrent gastric cancer in the markets of China, Taiwan, Hong Kong, and Thailand are held by Haihe Biopharma.