On October 11, multinational pharmaceutical company UCB announced that the China National Medical Products Administration (NMPA) has approved the marketing authorization of Zelukeblen sodium (trade name: Zobequel), which can be used in combination with conventional treatment drugs to treat adult patients with generalized myasthenia gravis (GMG) who are positive for anti-acetylcholine receptor (AChR) antibodies.
　　According to the information, Zelukeblen sodium is the world's first and only new generation C5 complement inhibitor that can be injected subcutaneously, self-administered and has dual inhibitory effects. It can effectively block complement-mediated neuromuscular junction damage. Patients can complete the subcutaneous injection at home in only 5 to 8 seconds, reducing the burden of traveling to and from the hospital.
　　Generalized myasthenia gravis is a rare, chronic, and heterogeneous autoimmune disease with approximately 220,000 patients in China. Common pathogenic antibodies include AChR antibodies and muscle-specific receptor tyrosine kinase (MuSK) antibodies. Among them, AChR antibodies are the most common, detected in approximately 80% to 90% of patients.
　　A reporter from the National Business Daily noted that several systemic myasthenia gravis drugs have entered China in recent years. In March of this year, another systemic myasthenia gravis drug from UCB, rozelixizumab injection (trade name: Udige), was approved in China. This drug covers both AChR-positive and MuSK-positive adult patients with systemic myasthenia gravis.
　　In April, AstraZeneca's long-acting C5 complement inhibitor reslizumab injection (trade name: Vilirui) was approved in China. The drug can be used in combination with conventional treatment drugs to treat adult patients with generalized myasthenia gravis who are positive for AChR antibodies.
　　In May, Chinese pharmaceutical company Rongchang BiopharmaThe drug developed by the company, Taitasip (trade name: Tai'ai), has also been approved by the China National Drug Administration. The drug is used to treat adult patients with generalized myasthenia gravis who are positive for AChR antibodies.
　　However, most of these drugs are in the form of intravenous infusion, and the number of subcutaneous injections is relatively small. In July last year, Zai Lab and Argenx announced that the China National Medical Products Administration approved the subcutaneous injection of agamod (trade name: Weilijia) as a biological product.Marketing authorization application, this drug can be used in combination with conventional treatment drugs to treat adult patients with generalized myasthenia gravis who are AChR antibody positive.
　　In terms of injection time, the subcutaneous administration of agamod is longer than that of zelucaben sodium, taking 30 to 90 seconds. Due to its earlier launch, the drug is eligible for submission to this year's national medical insurance negotiations. According to the National Medical Insurance Administration's official website, both agamod α injection (subcutaneous) and agamod α injection have passed preliminary formal review.
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