RemeGen’s telitacicept at 104 weeks: kidney function protection persists, while commercial use still depends on payment
A Chinese phase III study showed that kidney function declined more slowly over two years in the telitacicept group than in the placebo group, while improvements in proteinuria persisted. J.P. Morgan considers it competitive for high-risk IgA nephropathy patients, but treatment choices and long-term costs will affect actual use.
Original source：J.P. MorganFirst published on Unhidea：Original source date：
Key takeaway
The 104-week telitacicept data strengthen the evidence for long-term kidney protection, but the extent of its use in China also depends on treatment pathways and the burden on patients.
What changed with the 104-week data?
In the Chinese phase III TELIGAN study involving 318 participants, the annualized change in estimated glomerular filtration rate (eGFR) at 104 weeks was a decline of 0.6 mL/min/1.73m² per year in the telitacicept group, versus a decline of 5.7 in the placebo group, a treatment difference of 5.1 per year. This means kidney function declined significantly more slowly in the treatment group.
Compared with placebo, the telitacicept group had an 89% lower risk of a confirmed eGFR decline of at least 30% and an 81% lower risk of a decline of at least 40%; no prespecified composite kidney failure endpoint events occurred in the treatment group.
How does improvement in proteinuria support long-term protection?
At 104 weeks, 44.0% of patients in the telitacicept group had a 24-hour urine protein-to-creatinine ratio (UPCR) below 0.5 g/g, compared with 8.2% in the placebo group. UPCR fell 60.3% from baseline in the treatment group and rose 0.9% in the placebo group.
Gd-IgA1 fell 47.79% from baseline in the treatment group and rose 19.06% in the placebo group. J.P. Morgan believes this change supports telitacicept’s dual-target BLyS/APRIL mechanism of action.
How does it compare with the reference drug in the Chinese market?
J.P. Morgan uses the mainland China subgroup of the Nefecon phase III study as the closest local reference: the subgroup included 62 patients and showed a two-year time-weighted average eGFR benefit of 9.6 mL/min/1.73m² versus placebo; UPCR fell 43% at 24 months.
The bank believes telitacicept’s long-term kidney function and proteinuria data are competitive, and that its randomized Chinese study had a larger sample. The eGFR measures in the two studies differ: the former is the difference in annualized rates of change, while the latter is the difference in two-year time-weighted averages.
How might clinical data translate into market use?
J.P. Morgan believes the data support telitacicept as an immunomodulatory treatment option for high-risk IgA nephropathy patients in China. But physician feedback indicates that treatment pathways are not yet consistent; proteinuria levels, biopsy practices, physician preferences, insurance reimbursement and patients’ ability to pay all affect drug selection.
Patients with lower proteinuria may continue conservative treatment; those with proteinuria above approximately 0.5 grams per day or higher-risk characteristics may use newer drugs such as Nefecon and telitacicept.
Long-term cost is an important factor in near-term adoption. Nefecon appears to be used more widely in regions where medical insurance reduces out-of-pocket costs; whether telitacicept can expand its use depends partly on how much long-term treatment costs fall after its IgA nephropathy indication potentially gains medical insurance coverage in 2027.
J.P. Morgan maintains its Overweight rating on RemeGen’s A-shares, with a target price of 151 yuan for December 2027, based on a discounted cash flow model.
