On 8 June 2026, RemeGen Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted a Drug Registration Certificate for a new indication of Telitacicept for Injection (RC18, brand name 泰愛®). The biologic is now approved for use, in combination with conventional therapy, to treat adult patients with active Sjögren’s disease (ESSDAI ≥ 5).
Telitacicept is the first-in-class dual-target inhibitor of BLyS (B-lymphocyte stimulator) and APRIL (a proliferation-inducing ligand), cytokines that drive B-cell survival and maturation. Elevated levels of these cytokines are characteristic of Sjögren’s disease; Telitacicept blocks their interaction with B-cell receptors, aiming to curb abnormal B-cell activity and restore immune balance.
The new indication is backed by a nationwide, multi-centre, randomised, double-blind, placebo-controlled Phase III study—the first global dual-target biologic program for Sjögren’s disease to reach and successfully complete Phase III. Both the 160 mg and 80 mg dosing arms achieved statistically significant reductions in ESSDAI scores versus placebo at week 24, with sustained efficacy observed through week 48.
Sjögren’s disease, recently re-designated from Sjögren’s syndrome, affects 0.3%–0.7% of China’s population, equating to an estimated 4.20–9.80 million patients. The new approval is expected to enhance Telitacicept’s competitive position within China’s autoimmune therapeutics market.
Management noted that commercial outcomes will depend on policy conditions, market demand and competitive dynamics, and committed to timely disclosure of further developments. RemeGen’s Board is chaired by Mr Wang Weidong; the company’s shares trade in Hong Kong under the stock name REMEGEN.
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