Samsung Bioepis said on Jan. 10 that it has recently received approval from the China Drug Administration for a clinical trial application of Soliris biosimilar (SB12).
Soliris is a prescription medicine that is used to treat adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). It was developed by Alexion in the U.S. and is a typical expensive drug that costs hundreds of millions of won per patient in treatment.
Samsung Bioepis launched the SB12 global clinical test III in August last year, unveiling a plan to compare the validity, safety and immunological origin of the original drug for 50 patients.
The clinical approval allows the company to expand its global clinical trials to China, and plans to conduct clinical trials in China with the aim of visiting the first patient in the first half of the year.
"We will make efforts to expand the accessibility of patients to high-priced biologic drugs in the Chinese market through the development of SB12," a Samsung Bioepis official said.
In addition, the company plans to seek approval and commercialization of SB12 with AffaMed Therapeutics established by China's healthcare venture fund operator CBC Group.
Samsung Bioepis has teamed up with AffaMed Therapeutics to hold the clinical trial III in China of its breast cancer treatment Herceptin biosimilar. (SB3)