RemeGen's telitacicept approved in China for myasthenia gravis

RemeGen Co., Ltd. (HKEX:9995) announced that the National Medical Products Administration (NMPA) in China has granted marketing approval for Telitacicept (brand name: 泰爱®) for the treatment of adult patients with anti-acetylcholine receptor ("AChR") antibody-positive generalized myasthenia gravis ("gMG"). Phase III trial data, presented in April 2025, showed 98.1% of patients in the Telitacicept group demonstrated a ≥ 3-point improvement in Myasthenia Gravis Activities of Daily Living (“MG-ADL”) score, compared to 12.0% in the placebo group. Additionally, 87.0% of the Telitacicept group showed a ≥ 5-point improvement in Quantitative Myasthenia Gravis (“QMG”) score, exceeding the 16.0% improvement in the placebo group. RemeGen is also advancing a global multi-center phase III trial of Telitacicept for Myasthenia Gravis to further validate its efficacy and safety. The approval will provide a new treatment option for the approximately 220,000 patients in China with Myasthenia Gravis.