China’s approval of the first dual BAFF/APRIL-targeting therapy for IgA nephropathy marks a significant shift in a treatment landscape long constrained by limited disease-modifying options and reliance on corticosteroids. The milestone highlights the growing role of innovative biologics in addressing persistent unmet needs, while underscoring the increasing influence of Chinese biopharma innovation in a competitive and rapidly evolving global nephrology market, according to GlobalData, a leading intelligence and productivity platform.

The National Medical Products Administration (NMPA) has recently approved RemeGen’s Taiai (telitacicept) for adults with IgA nephropathy (IgAN). The new conditional approval makes it the first BAFF/APRIL-dual targeting therapy and the fourth drug approved in China dominated by western companies approvals.

Taiai’s NMPA approval is supported by robust Phase II and Phase III clinical trial data which demonstrated 58.9% reduction the urinary protein-to-creatinine ratio (UPCR) and a significant decline in eGFR when compared with the ACEI/ARB group.  Taiai joins Novartis’s Atrasentan Hydrochloride, Otsuka’s Izaike (sibeprenlimab-szsi) and Everest Medicines Ltd’s Nefecon (budesonide) as an approved option, while standing out for its dual-target mechanism and greater UPCR reduction versus existing treatments.

Abhishake Peyyeti, Pharma Analyst at GlobalData, comments: ”RemeGen strategically expands into the nephrology segment with the approval of Taiai. With its already strong presence in China, RemeGen also partnered with Vor Bio to further develop and market Taiai outside China. The move reflects broader efforts by Chinese biopharma companies to build drugs targeting multiple indications and pursue international partnerships to extend market reach beyond domestic approvals.”

According to GlobalData Pharma Intelligence Center, the number of diagnosed prevalent cases of IgAN in China were predicted to be 0.88 million cases in 2026.

IgAN current treatment options include corticosteroid treatments that lower proteinuria, but prolonged use often incurs serious risks. Meanwhile, most new therapeutics targeting single pathways achieve only modest proteinuria reductions and offer limited evidence on sustained renal outcomes. This highlights the country’s need for therapies that can meaningfully reduce proteinuria, a key marker associated with disease progression and long-term outcomes.

According to the GlobalData Pharma Intelligence Center, 19 Chinese companies are involved in the clinical development of IgAN drugs. There are five drugs in Phase III, nine drugs in Phase II and seven drugs Phase I studies.

Peyyeti concludes: “Telitacicept retains its early-mover advantage in the dual BAFF/APRIL class. However, povetacicept, currently being evaluated in Phase III trials, achieved approximately 56% reduction in UPCR from baseline in its Phase II studies and could lead to increased competition within the dual class following successful Phase III trials and regulatory approvals.”