On 1 June 2026, Livzon Pharmaceutical Group Inc. (Livzon Pharma, HKEX: 01513) reported that its controlling subsidiary Livzon MABPharm Inc. received Acceptance Notice CXSS2600087 from the National Medical Products Administration (NMPA) for the marketing authorization application of Lecankitug Injection (160 mg/1.6 mL per vial). The biologic is intended for adult patients with active ankylosing spondylitis who have shown inadequate response or intolerance to conventional therapy.

The submission, classified as a Class 1 therapeutic biological product, is supported by a pivotal multicenter, randomized, double-blind, placebo-controlled Phase III trial. Key readouts showed: • Onset of efficacy as early as Week 1 with rapid improvement in inflammatory markers. • Significantly higher clinical response at Week 16 versus placebo, with durable benefits maintained through Week 52. • Comparable safety and tolerability to placebo with no new safety signals. • Consistent efficacy in both TNF inhibitor-naïve and TNF inhibitor-experienced patients. • Convenient subcutaneous administration once every four weeks, aiding treatment adherence.

This is the second regulatory filing for Lecankitug, following its psoriasis indication already under Priority Review. Cumulative R&D investment in the asset has reached approximately RMB 216.90 million.

Market data cited in the filing indicate about 4 million ankylosing spondylitis patients in China and only one IL-17A/F dual-target therapy—imported bimekizumab—currently approved for this indication, leaving domestically developed options absent.

Post-acceptance, Lecankitug enters the Center for Drug Evaluation review process. Livzon Pharma noted that review timelines and final approval remain uncertain and the acceptance is not expected to have a material near-term impact on financial results. The company will disclose further progress as required.