Novartis Announces NMPA Approval of Xolair® (Omalizumab) Prefilled Autoinjector in China
On March 19, 2026, Novartis announced that its innovative biologic agent Xolair®(Omalizumab) pre-filled auto-injector pen has been approved by the National Medical Products Administration for the treatment of adult and adolescent (aged 12 years and older) patients with chronic spontaneous urticaria (CSU) who remain symptomatic after H1 antihistamine therapy, as well as patients diagnosed with IgE (immunoglobulin E)-mediated asthma (this product is indicated for adult and adolescent (aged 12 years and older) patients, for use following inhaled corticosteroids and long-acting inhaled β2- Moderate to severe persistent allergic asthma in which symptoms remain inadequately controlled despite treatment with adrenergic receptor agonists).
It is reported that Xolair has been marketed globally for over 20 years, with multiple dosage forms and indications, and is widely used in more than 90 countries and regions, including China.