REMEGEN (09995) surged over 7% today, rising 7.25% to HK$109.4 with trading volume reaching HK$357 million as of press time.

On the news front, the CDE website showed on September 28 that REMEGEN's telitacicept has been proposed for inclusion in the priority review category for treating adult patients with primary immunoglobulin A (IgA) nephropathy at risk of progression, significantly reducing proteinuria levels.

Previously, on August 27, REMEGEN announced that the domestic Phase III study of telitacicept for treating IgA nephropathy achieved its primary endpoint in Stage A. The study results demonstrated that compared to the placebo group, patients in the telitacicept group showed a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks of treatment.

Telitacicept is currently the only drug that can simultaneously inhibit both B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). These two cytokines are present at significantly higher levels in IgA nephropathy patients compared to the normal population and serve as key driving factors in disease development. By inhibiting these two factors, telitacicept can reduce B-cell proliferation, decrease plasma cell numbers and abnormal immunoglobulin production, thereby blocking immune complex deposition at the source and alleviating renal immune inflammatory responses.