Bejescin® (MIL62)

Bejescin® (MIL62, Obinutuzumab beta Injection) is a novel 3rd-generation anti-CD20 monoclonal antibody with a unique competitive position in the market, and has been approved by NMPA for marketing in China for the treatment of Neuromyelitis Optica Spectrum Disorders (NMOSD).

Autoimmune Diseases

Neuromyelitis Optica Spectrum Disorders (NMOSD) is a debilitating autoimmune disorder targeting the central nervous system, often causing irreversible damage to vision and mobility. With an estimated 50,000 patients in China by 2024, NMOSD represents a critical unmet medical need.

Bejescin® has approved as the first Chinese-innovated therapy for NMOSD. Comparative Phase III trial analyses highlight its monotherapy regimen's superior efficacy in reducing relapse rates—a key metric in NMOSD management—positioning Bejescin® as a leading therapeutic option.

Primary membranous nephropathy (PMN) is the most common type of adult kidney disease and one of the leading causes of end-stage renal disease (ESRD). Currently, there are nearly 2 million end - stage kidney disease (ESKD) patients in China. Hemodialysis is the main treatment for relieving the condition, with high associated costs, and younger aged people account for a significant percentage of the patient population. The number of moderate to severe PMN patients in China eligible for treatment with Bejescin® (MIL62) reached 1.45 million in 2024 and is expected to increase to 1.76 million by 2032.

Globally, there are no approved targeted therapies for Primary Membranous Nephropathy (PMN). Bejescin®'s New Drug Application (NDA) for this indication is currently undergoing NMPA’s priority review procedure, positioning it to become China’s first approved targeted therapy for PMN.

Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease that primarily affects young women and is one of the most common autoimmune diseases in China and globally. Among its complications, lupus nephritis (LN) is one of the most severe organ-related complications and a major cause of mortality in SLE patients. There are approximately 1 million SLE patients in China in 2024, with the prevalence stabilizing, making it the second-highest in the world.

Currently, there are two biologics approved for the treatment of SLE, both of which require administration every week or every 2 to 4 weeks. Bejescin® is in the Phase II/III clinical trial and offers the potential for administration every 24 to 28 weeks, meeting the market demand for long-acting therapies and providing a high-quality solution for SLE patients.

Hematology

Follicular lymphoma (FL) is one of the most common types of non-Hodgkin lymphoma (NHL). The estimated FL patients in China is approximately 31,000 in 2024, and this number is expected to reach 40,000 by 2032.

Compared to 1st-generation CD20 antibodies, Bejescin®, as a 3rd-generation CD20 antibody, offers better clinical benefits for patients who are resistant, have relapsed, or have experienced disease progression or treatment-related adverse reactions.