MIL62

MIL62 is a novel 3rd-generation anti-CD20 antibody with a unique competitive position in the market, and various indications for the product are currently in Phase III clinical trials. It is developed based on our innovated ADCC-enhanced antibody platform and has been granted patents in China, the United States, and Europe.

The ongoing clinical trials for MIL62 include primary membranous nephropathy (PMN), systemic lupus erythematosus (SLE), neuromyelitis optica spectrum disorders (NMOSD) and follicular lymphoma (FL). Additionally, the product has the potential to expand into other autoimmune diseases and oncology, offering a broad range of application prospects.

MIL62 has been granted “Breakthrough Therapy Designation” by the National Medical Products Administration (NMPA) in China for the treatment of primary membranous nephropathy (PMN) as the first kidney drug produced by the Chinese pharma, fully recognizing its characteristics for treating "serious life-threatening conditions or diseases that significantly impact quality of life" and its "more significant or important therapeutic effects compared to existing treatment options." The product is currently in the late stage of Phase III clinical trials and is expected to become the first approved targeted therapy for PMN.

Autoimmune Diseases

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). Without effective treatment, 40% to 50% of patients with moderate to severe PMN will ultimately progress to ESRD, with a significant proportion being younger adults. The number of moderate to severe PMN patients in China eligible for treatment with MIL62 reached 1.41 million in 2023 and is expected to increase to 1.76 million by 2032.

The 2021 KDIGO recommend rituximab (the 1st-generation anti-CD20 antibody), calcineurin inhibitors and corticosteroids, either alone or in combination with cyclophosphamide, for treating PMN. Currently, no targeted therapies for PMN have been approved in the market.

Globally, there are no approved targeted therapies for PMN, and only two drugs are in Phase III clinical trials. MIL62 is expected to become the first approved targeted therapy for PMN in China and globally.

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, 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. MIL62 is in the Phase II/III clinical trial and offers the potential for administration every 24 weeks, meeting the market demand for long-acting therapies and providing a high-quality solution for SLE patients.

Neuromyelitis optica spectrum disorders (NMOSD) is a rare autoimmune disease of the central nervous system, where the immune system attacks the optic nerves and spinal cord, potentially leading to severe vision loss and paralysis. The estimated NMOSD patients in China is around 49,000 in 2023.

Currently, there are no approved CD20 antibody treatments for NMOSD, and MIL62 is leading in this area.

Hematology

Follicular lymphoma (FL) is one of the most common types of non-Hodgkin lymphoma (NHL). The estimated FL patients in China is approximately 30,000 in 2023, and this number is expected to reach 40,000 by 2032.

Compared to 1st-generation CD20 antibodies, MIL62, 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.