Chinese biopharmaceutical company RemeGen Co., Ltd. (SHA:688331; HKG:09995) announced on Tuesday that Telitacicept has received marketing approval in China from the National Medical Products Administration for use in adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalised myasthenia gravis, in combination with conventional therapies.

Telitacicept is the world's first biologic drug targeting both B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL) for myasthenia gravis and marks a significant addition to China's domestic treatment options in this field. The drug had previously received breakthrough therapy and priority review status from Chinese regulators, along with orphan drug and fast track designations from the US Food and Drug Administration.

According to phase III trial data, 98.1% of patients treated with Telitacicept achieved at least a 3-point improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores, compared to 12.0% in the placebo group. Safety profiles were comparable across both groups.

The drug's approval addresses a substantial unmet need, with approximately 220,000 patients affected by myasthenia gravis in China alone.

Telitacicept is also approved in China for systemic lupus erythematosus and rheumatoid arthritis. RemeGen is conducting a global Phase III trial to evaluate the drug's potential in broader myasthenia gravis populations.