CSPC PHARMA (01093): Batoclimab Injection (Subcutaneous Injection) Receives Drug Registration Certificate Issued by the National Medical Products Administration

CSPC PHARMA (01093) announces that the batoclimab injection (subcutaneous injection) (trade name: Enlida) (the "Product"), licensed by the Company's subsidiary CSPC NBP Pharmaceutical Co., Ltd. from Harbour BioMed (Shanghai) Co., Ltd., has obtained the drug registration certificate issued by the National Medical Products Administration (NMPA) of China, for use in combination with conventional drugs for the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG). gMG is a rare chronic autoimmune neuromuscular disease mediated by autoantibodies that impair neuromuscular junction transmission, thereby causing skeletal muscle weakness. The disease can significantly affect patients' ability to work and quality of life, and in severe cases can trigger potentially life-threatening myasthenic crises. Existing treatment options include cholinesterase inhibitors, glucocorticoids and other immunosuppressive drugs, but there remain unmet clinical needs in terms of efficacy, safety, accessibility and cost. The Product is a fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn). By blocking FcRn-mediated recycling of immunoglobulin G (IgG) antibodies, it accelerates the degradation of pathogenic IgG autoantibodies. It is also the first anti-FcRn therapy to complete full clinical development in gMG patients in China. This approval is primarily based on the positive results of a pivotal Phase III clinical study conducted at 27 research centers in China. The primary study population was adult gMG patients who were positive for AChR antibodies or muscle-specific tyrosine kinase (MuSK) antibodies. The primary endpoint was the proportion of patients achieving sustained improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) score during the first treatment cycle. Sustained improvement was defined as a reduction of at least 3 points from baseline in MG-ADL score lasting for at least four weeks. The study results showed that 58.2% of patients in the batoclimab subcutaneous injection group achieved the primary endpoint, compared with 31.3% in the placebo group (P=0.001); clinical efficacy was observed as early as the second week of treatment. Compared with the placebo group, the batoclimab subcutaneous injection group also showed statistically significant improvements in secondary endpoints, including sustained improvement in Quantitative Myasthenia Gravis (QMG) score, duration of MG-ADL score improvement of at least 3 points, and the proportion achieving minimal symptom expression (defined as MG-ADL score of 0 or 1) at any visit, among others, and was generally well tolerated.