Vor Biopharma Inc. 8K

Vor Bio reported that China’s NMPA has granted conditional approval to collaborator RemeGen’s telitacicept for treating adult IgA nephropathy, supported by positive Phase 2 and Phase 3 clinical trial results.

Vor Bio, a clinical-stage biotechnology company, announced that its collaborator RemeGen Co., Ltd. has received conditional approval from China’s National Medical Products Administration (NMPA) for telitacicept as a treatment for adult patients with IgA nephropathy (IgAN), making it the first BAFF/APRIL-targeting therapy approved for this indication. The decision is based on positive efficacy and safety data from RemeGen’s completed Phase 2 trial and the Phase 3 TELIGAN trial, which met its primary endpoint by demonstrating a substantial reduction in urinary protein-to-creatinine ratio and a favorable safety profile, along with preservation of kidney function. RemeGen retains responsibility for development, regulatory activities, and commercialization of telitacicept in China, while Vor Bio holds exclusive rights outside Greater China and is advancing telitacicept in global Phase 3 trials for other autoimmune indications, including generalized myasthenia gravis and Sjögren’s disease, to support potential approvals in the U.S., Europe, and Japan.

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CIK

1817229

Ticker

VOR

Form

8K

Source Type

sec

Accession

0001193125-26-261661

Alert Tier

6