Zhitong Finance App News, Shiyao Group (01093) announced that the Bartolizumab injection (subcutaneous injection) (product name: Enlida®) (product) authorized by the company's subsidiary, Shiyao Group Enbipu Pharmaceutical Co., Ltd., has obtained a drug registration certificate issued by the China National Drug Administration (NDRA) to treat adult systemic myasthenia gravis (GmG) patients with positive anti-acetylcholine receptor (AChR) antibodies.
gMG is a rare chronic autoimmune neuromuscular disease mediated by autoantibodies that impair neuromuscular junction transmission, leading to skeletal muscle weakness. The disease can significantly affect the patient's ability to work and quality of life. In severe cases, it can cause a crisis of muscle weakness that may be life-threatening. Current treatment options include cholinesterase inhibitors, glucocorticoids, and other immunosuppressive drugs, but there are still unmet clinical needs in terms of efficacy, safety, accessibility, and cost.
This product is an all-human monoclonal antibody targeting neonatal Fc receptor (FcRn). It accelerates the degradation of pathogenic IgG autoantibodies by blocking FcRN-mediated immunoglobulin G (IgG) antibody recycling. It is also the first anti-FcRN therapy to complete complete clinical development for GMG patients in China.
The approval was mainly based on the positive results of a critical phase III clinical study conducted at 27 research centers in China. The main study population was adult GMG patients positive for AChR antibodies or muscle-specific tyrosine kinase (MuSK) antibodies. The primary endpoint was the proportion of patients who achieved continuous improvement in myasthenia gravis daily activity scale (MG-ADL) scores within the first treatment cycle. Continuous improvement is defined as a reduction in the MG-ADL score of at least 3 points from the baseline and continued for at least 4 weeks.
The study results showed that 58.2% of patients in the bartolizumab subcutaneous injection group reached the primary endpoint, while 31.3% (P=0.001) in the placebo group; clinical efficacy was observed as early as the second week of treatment. Compared to the placebo group, the bartolizumab subcutaneous injection group also showed statistically significant improvements in secondary endpoints, including continuous improvement in quantitative myasthenia gravis (QMG) score, improvement of MG-ADL score by at least 3 points, ratio of minimal symptom expression (defined as an MG-ADL score of 0 or 1) during any visit, etc., and overall tolerability was good.