Samsung Bioepis Begins Clinical Trial of Rare Disease Treatment SB12 in China

[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis recently announced on the 10th that it has received approval for the clinical trial application (CTA) of the rare disease treatment SB12 from the National Medical Products Administration (NMPA) of China.

SB12 is a biosimilar of Soliris, a treatment for paroxysmal nocturnal hemoglobinuria. Soliris, developed by the U.S. company Alexion, has annual global sales of approximately 4 trillion KRW.

Samsung Bioepis expects to expand its global clinical trials to China through this clinical approval. Clinical trials are planned to be conducted in China, aiming for the first patient visit in the first half of this year.

Soliris is a representative high-cost drug with an annual treatment cost per patient reaching several hundred million KRW. A Samsung Bioepis official stated, "Through the development of SB12, we will expand patient access to high-cost biopharmaceuticals in the Chinese market as well."

Samsung Bioepis plans to promote the approval and commercialization of SB12 in China together with Ephermed Therapeutics, a subsidiary of CBC Group, a Chinese venture fund management company.

This content was produced with the assistance of AI translation services.