Quansin Bio: New drug Rucerituzumab monoclonal antibody application for listing accepted

LightningPacketLoss · 2026-03-10T11:37:40+00:00

Quansin Bio's Lucechita monoclonal antibody injection has been accepted by the National Medical Products Administration and is planned for the treatment of adult active ankylosing spondylitis. Based on Phase III clinical trials, the drug has shown significant improvement in patients and has a good safety profile, marking a progress in the company's R&D efforts.

LightningPacketLoss

2026-03-10 11:37:40

Abstract generation in progress

Recently, Quansin Biotech announced that the new drug application (NDA) for their self-developed Ruceqita monoclonal antibody injection (anti-IL-17A monoclonal antibody, development code: QX002N) has been accepted by the National Medical Products Administration on March 9, 2026. The registration category for this drug is Class 1 biological product for therapeutic use, with acceptance number CXSS2600039, and the proposed indication is adult active ankylosing spondylitis (AS).

This submission is based on a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. The results show that Ruceqita monoclonal antibody significantly and sustainably improves disease activity, signs, and symptoms in patients with active AS who have inadequate response or contraindications to NSAIDs. It also demonstrated good safety and tolerability during 52 weeks of treatment and follow-up. Ruceqita monoclonal antibody is the company’s first innovative drug to receive NDA acceptance, marking a step forward in the company’s R&D pipeline.

(Quansin Biotech Announcement)

(Edited by: Yang Yan, Lin Chen)

Keywords: Healthcare

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