On June 9, the NMPA website showed that Tianguangshi MIL62 (generic name: Oxtuzumab β injection ) has been approved for a new indication: the treatment of primary membranous nephropathy (PMN) , becoming the world's first drug approved for this indication.
MIL62 is an innovative third-generation CD20 antibody drug independently developed by Tianguangshi . It was approved for marketing in China in February 2026 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) . It is the world's first CD20 antibody for the treatment of this disease and also the first domestically produced drug in China in this field.
On June 4, 2026, Tianguangshi and Everest Medicines reached a commercialization licensing agreement for the drug and signed a relevant agreement, authorizing the clinical development and commercialization rights of MIL62 in the Asia-Pacific region (Southeast Asia, India, South Korea, Australia, New Zealand, Hong Kong, Macau and Taiwan) .
According to the relevant agreement, Tianguangshi will receive an initial payment and sales milestone payments of up to RMB 209 million , and will also receive a share of the gross profit from the sales of its products in the Asia-Pacific region.
The NMPA has approved a new indication for MIL62, namely the treatment of PMN.
The clinical trial of MIL62 for the treatment of PMN received the drug clinical trial approval notice issued by CDE in May 2021. It entered Phase III clinical trial in June 2023 and was included in the CDE's "breakthrough therapy" drug list in the same month. It is the first domestically produced "breakthrough therapy" nephropathy drug.
The Phase III trial completed its primary endpoint analysis in July 2025, becoming the first global registrational clinical study of PMN to reach its clinical endpoint. The specific results were presented at the American Society of Nephrology (ASN) annual meeting that year .
Regarding the primary endpoint, the complete clinical response rate at 76 weeks , significantly superior to the 3.9% in the control group (P<0.0001) . Furthermore, 84.4% of patients treated with MIL62 monotherapy achieved clinical response at 76 weeks.
In terms of immunological complete remission based on the PLA2R antibody marker, the MIL62 monotherapy group achieved an immunological complete remission rate of 90.6% at week 52. Across all endpoints of clinical complete remission, immunological complete remission, and clinical remission, MIL62 monotherapy demonstrated superior depth and sustained remission compared to existing guideline-recommended drugs and other investigational drugs with published data . Not only did it achieve statistically significant superiority in the primary endpoint of clinical complete remission at week 76, but it also possesses groundbreaking clinical value.
In terms of rapid disease control, MIL62 monotherapy also showed outstanding performance, with a median immunological remission time of only 5 weeks and a median clinical remission time of 16 weeks , both significantly better than the control group, demonstrating the characteristics of rapid onset of action.
Regarding the improvement of renal function, the MIL62 monotherapy group showed significantly better results than the control group in terms of mean glomerular filtration rate (eGFR) at week 2, and began to show an upward trend . At week 76, the mean eGFR changes in the MIL62 monotherapy group and the control group were +3.9 vs. -10.4 ml/min/1.73m², demonstrating the ability of MIL62 to protect and improve renal function .
In terms of safety, the overall safety profile of the MIL62 monotherapy group was not significantly different from that of the cyclosporine group, demonstrating good safety and tolerability. No new safety signals emerged with MIL62 monotherapy, and the number of treatment-related adverse events (TRAEs) leading to treatment discontinuation was significantly lower in the MIL62 monotherapy group than in the cyclosporine group.China has one of the highest rates of PMN in the world. PMN is a primary glomerulonephropathy with a gradually increasing incidence in recent years. It is one of the main causes of end-stage renal disease. About 30%-40% of PMN patients will progress to end-stage renal disease within 5-15 years, causing a serious economic and social burden .
For a long time, no specific drugs for treating primary membranous nephropathy (PMN) have been approved globally , and traditional treatments such as glucocorticoids and calcineurin inhibitors are still needed, resulting in a significant unmet clinical need. The successful approval of MIL62 for this new indication makes it the world's first specific drug for treating primary membranous nephropathy .

https://mp.weixin.qq.com/s/DXYXJMZZ6FdwM8S27Qq35A