Chinese biotech company RemeGen Co Ltd (SH:688331) (HK:09995) announced on Tuesday that telitacicept (RC18) has received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for the treatment of myasthenia gravis (MG).

With this designation, telitacicept becomes the first dual-target biologic drug for MG with ODD from both FDA and EMA worldwide.

The decision, granted based on telitacicept's significant benefits in treating MG, a life-threatening rare disease, will provide advantages on protocol assistance, regulatory fee reductions/waivers and up to 10 years of market exclusivity, thereby accelerating the clinical development, registration and drug approval process in Europe and its availability among MG patients.

Telitacicept is the world's first approved innovative BLyS/APRIL dual-targeting fusion protein drug for MG. It was approved for marketing in China in May this year.

RemeGen says that it is proceeding the global multi-centre phase III clinical trial of telitacicept in patients with MG to bring the breakthrough treatment option to more patients globally.