Livzon：Lecankitug approved for marketing in China
On June 3, Livzon Pharmaceutical announced that the New Drug Application (NDA) for its Category 1 innovative biologic drug Laikangqita Monoclonal Antibody for the treatment of ankylosing spondylitis (AS) has been formally accepted by the National Medical Products Administration (NMPA). This is the second indication for which the drug has received NDA acceptance, following the acceptance and priority review designation of its NDA for the treatment of psoriasis. (Source: Livzon Pharmaceutical official WeChat account)
The NDA submission for Laikangqita Monoclonal Antibody in the treatment of ankylosing spondylitis is based on a pivotal registrational Phase III clinical study. The study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial that enrolled 323 subjects with moderate-to-severe active AS. The study consisted of a 0-16 week double-blind controlled period and a 16-44 week maintenance treatment period, with follow-up through Week 52. The placebo group was switched to Laikangqita Monoclonal Antibody treatment after Week 16. The primary endpoint was the ASAS40 response rate at Week 16, and the key secondary endpoint was the ASAS20 response rate at Week 16.
The study results demonstrated that Laikangqita Monoclonal Antibody exhibited clear, robust, and clinically meaningful efficacy in patients with moderate-to-severe active AS, with multiple advantages including rapid onset of action, deep remission, long-term maintenance, convenient dosing, and a favorable safety profile.
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