CSPC's Enyitan® receives approval for new indication

CSPC Pharmaceutical Group Limited (HKEX: 1093) announced that its subsidiary, CSPC Megalith Biopharmaceutical Co., Ltd., has obtained marketing approval in China for a new indication for Enyitan® (omalizumab for injection), its Class 3.3 therapeutic biological product. The approval, granted by the National Medical Products Administration of the People's Republic of China, expands the drug's use to treat moderate to severe persistent allergic asthma. Enyitan® is a humanised anti-immunoglobulin E (IgE) monoclonal antibody developed by the Group, and is a biosimilar version of Xolair®. According to the company, Enyitan® is the first omalizumab biosimilar in China approved under the Class 3.3 biological product registration category. The previously approved use was for treating chronic spontaneous urticaria in adults and adolescents symptomatic despite H1 antihistamine treatment.