荣昌生物: H股公告

Core Viewpoint - RemeGen Co., Ltd. has received approval from the National Medical Products Administration (NMPA) in China for the marketing of Taitizumab (brand name: Tai'ai®) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are positive for acetylcholine receptor (AChR) antibodies [1][2]. Group 1: Product Approval and Clinical Benefits - Taitizumab has shown significant clinical benefits in gMG patients, with 98.1% of patients in the Taitizumab group improving their Myasthenia Gravis Activities of Daily Living (MG-ADL) score by at least 3 points after 24 weeks, compared to only 12.0% in the placebo group [2]. - The Taitizumab group experienced a reduction in MG-ADL scores by 5.74 points from baseline, while the placebo group saw a reduction of only 0.91 points [2]. - In terms of Quantitative Myasthenia Gravis (QMG) scores, 87.0% of patients in the Taitizumab group improved by at least 5 points, compared to 16.0% in the placebo group, with a reduction of 8.66 points from baseline in the Taitizumab group versus 2.27 points in the placebo group [2]. Group 2: Market Potential and Unmet Needs - There is a significant unmet clinical need for gMG treatments, with approximately 120 million patients globally, including around 220,000 patients in China, of which 80%-85% are AChR antibody positive [3]. - The approval of Taitizumab in China is expected to benefit a larger population of gMG patients and help achieve better treatment outcomes in long-term disease management [2][3]. - Taitizumab is also being investigated in global multicenter Phase III trials for its efficacy and safety in a broader patient population [2]. Group 3: Mechanism of Action - Taitizumab targets the pathogenic antibody production at the source by simultaneously acting on B-cell activating factor (BLyS) and proliferation-inducing ligand (APRIL), which are crucial in the activation of B cells and plasma cells [3]. - In addition to gMG, Taitizumab has also been approved for the treatment of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) in China [3].