阿斯利康(AZN.US)双抗1类新药在中国获批临床

Core Insights - AstraZeneca's new drug AZD1163 has been approved for clinical trials in China, targeting rheumatoid arthritis treatment [1] - AZD1163 is a novel bispecific antibody that inhibits the activity of PAD2 and PAD4 enzymes, which are responsible for protein citrullination in rheumatoid arthritis patients [1] Group 1: Drug Approval and Mechanism - The approval of AZD1163 by the China National Medical Products Administration (NMPA) marks a significant step in developing a treatment for rheumatoid arthritis [1] - The drug targets the citrullination process that activates T cells and leads to the production of pathogenic anti-citrullinated protein antibodies (ACPAs), which are associated with worse prognosis in rheumatoid arthritis patients [1] Group 2: Clinical Trial Data - The 2025 ACR annual meeting presented pharmacokinetic data showing that AZD1163 has a dose-proportional increase in exposure, with a maximum concentration observed on day 10 after subcutaneous administration [2] - The estimated bioavailability of AZD1163 via subcutaneous injection is 65%, with an average systemic clearance rate of 0.15 L/day and a half-life of 38 days [2] - The drug demonstrated significant and dose-dependent inhibition of PAD2/4 activity, with a maximum inhibition rate exceeding 95%, confirming target engagement [2] - A low incidence of anti-drug antibodies (ADA) at 6.7% and few adverse events indicate good tolerability of AZD1163 in healthy volunteers [2] - AstraZeneca is conducting a Phase 2 clinical trial for AZD1163 in rheumatoid arthritis patients, following its approval for clinical research in China [2]