RemeGen will apply for telitacicept’s approval in China for the treatment of immunoglobulin-A nephropathy (IgAN) after the drug met its primary endpoint in a Phase III trial, according to partner Vor Bio.
During the clinical study conducted in China(NCT05799287), the subcutaneous B-cell-targeting fusion protein triggered a 55% reduction in proteinuria during Stage A of the clinical study when administered once per week.
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This was measured by the 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks – a key biomarker of disease activity in IgAN – compared with placebo. Vor, the exclusive licence holder to telitacicept outside of China, also stated that the subcutaneous drug demonstrated a favourable safety profile in patients with IgAN.
The trial enrolled patients with IgAN who were at risk of progressing to end-stage renal disease and had tried previous treatment with renin-angiotensin system blockers.
Though neither Vor nor RemeGen has yet publicised the safety or secondary endpoint data from this study, the former noted that the results “underscore the strength of the telitacicept dataset and its comparability to global benchmarks”. RemeGen plans to share the findings of the Phase III trial at an undisclosed upcoming medical conference.
The results of the IgAN study closely follow a positive trial readout in Sjögren’s disease for RemeGen from this month, which saw telitacicept meet its primary endpoint. This prompted the Chinese pharma to apply for the drug’s approval to its compatriot regulator.
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By GlobalDataAs RemeGen has chosen to apply for marketing authorisation in IgAN, the company will now shortly submit two biologics license applications to the National Medical Products Administration (NMPA), potentially widening its use to five indications.
Otherwise known as Berger’s disease, IgAN is a chronic autoimmune condition characterised by the aggregation of abnormal IgA protein within the kidney’s filtration system, causing progressive damage and inflammation. It is the most common glomerulopathy worldwide and has an estimated global incidence of 2.5 cases per 100,000 people per year.
Expanding indications
Telitacicept has already been approved in China for three autoimmune conditions, including generalised myasthenia gravis (gMG), systemic lupus erythematosus (SLE) and rheumatoid arthritis. By applying for approval in both Sjögren’s disease and IgAN, the company will expand its market reach significantly within the region.
Though RemeGen is making steps to broaden the commercial potential of telitacicept in China, the company is also looking to obtain approval for the drug further afield, as it is currently running a global Phase III trial in gMG. This could support the drug’s approval in the US, Europe and Japan.
However, telitacicept would likely face stiff competition in this indication, as there are currently five FDA-approved disease-modifying therapies (DMTs) for gMG available to US patients. This includes Johnson & Johnson’s neonatal Fc receptor (FcRn) blocker Imaavy (nipocalimab), which analysts at GlobalData predict will bring in $3.5bn for the big pharma by 2031.
It is not yet clear if RemeGen or Vor will pursue late-stage trials for telitacicept in IgAN on the global stage, but a US-based Phase II study concluded in 2023 within the indication.
There are currently three approved treatments available on the US market for IgAN, including Calliditas Therapeutics’ Tarpeyo (budesonide), Travere Therapeutics’ Filspari (sparsentan) and Novartis’ Fabhalta (iptacopan).
