AstraZeneca’s Long-Acting C5 Complement Inhibitor Ravulizumab (Ultomiris®) Approved in China for Generalized Myasthenia Gravis

Apr 22, 2025 16:02 CST Updated 16:02

AstraZeneca

Biopharmaceutical Manufacturer

4Month22Recently, AstraZeneca announced the long-actingC5Complement Inhibitor Vilree^®(English Product Name:Ultomiris^®, Generic Name: Relizumab Injection) has been officially approved in China for use in combination with conventional therapeutic drugs to treat anti-acetylcholine receptor (AChR) Antibody-positive adult generalized myasthenia gravis (gMG) Patient.

The approval by the National Medical Products Administration (NMPA) was based on the positive results of the CHAMPION-MG Phase III study, which were published in NEJM Evidence. The study demonstrated that rozanolixizumab was superior to placebo in the primary efficacy endpoint, showing improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline at Week 26. MG-ADL is a patient-reported scale used to assess the ability to perform daily activities.

Moreover, long-term follow-up during the open-label extension period showed that the clinical benefits of Relizumab persisted up to 60 weeks. The study also observed a 71.1% reduction in the annual rate of disease exacerbations per 100 patients treated with Relizumab compared to placebo.

Final results from the CHAMPION-MG Phase III trial, published by the American Academy of Neurology (AAN) and in the European Journal of Neurology, indicate that rozanolixizumab provided clinically meaningful improvement in myasthenia gravis (MG) symptoms sustained for up to 164 weeks.

gMG is a rare, debilitating chronic autoimmune neuromuscular disorder that can lead to loss of muscle function and severe weakness. There are approximately 113,000 diagnosed gMG patients in China.

Dr. He Jing, Senior Vice President of AstraZeneca Global and Head of Global R&D in China, stated: "We are very pleased to bring the long-acting C5 complement inhibitor to patients in China. The results of the CHAMPION-MG study fully demonstrate the clinical benefits and convenience that Rejalizumab offers to gMG patients. In the future, we will continue to leverage AstraZeneca's strong R&D capabilities, strengthen external collaborations, and bring more innovative therapies with breakthrough significance to benefit patients with rare diseases."

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