REMEGEN(688331) Ge Long Hui A P P·2025-05-27 08:39Core Viewpoint - Rongchang Biologics' drug Tai'taxip has received approval from the NMPA for the treatment of adult generalized myasthenia gravis (gMG) patients with AChR antibody positivity in China [1][2]. Group 1: Drug Approval and Clinical Data - Tai'taxip has shown significant clinical benefits and good safety in gMG patients, with 98.1% of patients in the treatment group improving their MG-ADL score by ≥3 points after 24 weeks, compared to 12.0% in the placebo group [1]. - The treatment group saw a reduction in MG-ADL scores by 5.74 points from baseline, while the placebo group saw a reduction of only 0.91 points [1]. - In terms of the quantitative myasthenia gravis score (QMG), 87.0% of patients in the Tai'taxip group improved by ≥5 points, compared to 16.0% in the placebo group, with a reduction of 8.66 points from baseline in the treatment group versus 2.27 points in the placebo group [1]. Group 2: Market Potential and Patient Demographics - Approximately 80%-85% of myasthenia gravis patients are AChR antibody positive, with over 85% of these patients developing gMG within 24 months of onset [2]. - There are about 1.2 million myasthenia gravis patients globally, with around 220,000 in China, indicating a significant unmet clinical need [2]. - The approval of Tai'taxip in China is expected to benefit more domestic myasthenia gravis patients and achieve better treatment outcomes in long-term disease management [2]. Group 3: Additional Indications - Besides gMG, Tai'taxip has also been approved for the treatment of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) in China [3].