迈博药业-B(02181.HK):国家药品监督管理局批准核心产品CMAB007(注射用奥马珠单抗α)的上市注册申请(NDA)
格隆汇5月23日丨迈博药业-B(02181.HK)公吿,近日,公司核心产品之一,CMAB007(注射用奥马珠单抗α)的上市注册申请(NDA)获中国国家药品监督管理局批准,用于治疗确诊为免疫球蛋白E("IgE")介导的哮喘患者,为中国首个获国家药监局批准的国产过敏性哮喘治疗性抗体新药。
CMAB007为一种重组人源化抗IgE单克隆抗体,用于治疗确诊为IgE介导的哮喘患者的单克隆抗体新药。CMAB007与游离IgE相结合,形成抗IgE复合物,能抑制高亲和力IgE受体,从而防止过敏反应。CMAB007的安全性及疗效已经由共4项临床试验,合共824名受试者接受CMAB007给药的结果所证实,该等试验为中国规模最大的治疗哮喘的单克隆抗体("mAb")临床试验。公司的临床试验结果显示,CMAB007能以较低剂量的吸入糖皮质激素改善哮喘病人的病情及降低急性哮喘发病的概率。CMAB007未来预计拓展适应症到慢性特发性荨麻疹、季节性过敏性鼻炎以及食物过敏。
公司旗下泰州迈博太科药业有限公司位于江苏泰州中国医药城之抗体药物生产基地亦已顺利通过江苏省药品监督管理局对于CMAB007的GMP符合性检查。
于公吿日期,CMAB007为首个由中国国内公司开发并在中国上市的mAb哮喘疗法。CMAB007上市后将有望为超过2000万中国过敏性疾病患者提供疗效更佳的可负担的生物特效治疗药物。
CMAB007(注射用奥马珠单抗α)为迈博药业第二个获批上市的药物,亦为首个由中国国内公司开发并在中国上市的mAb哮喘疗法,疗效显著,安全便捷,将大大提升中国超过2,000万过敏性疾病患者福祉。
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