Enyitan (omalizumab biosimilar) / CSPC Pharma - LARVOL DELTA

Omalizumab for Injection (Enyitan®) in Elderly Patients with Chronic Spontaneous Urticaria: Maintenance of Treatment Goals - A Six-Month Retrospective Follow-Up of Real-World Evidence. (PubMed, Int Arch Allergy Immunol) - "Domestic omalizumab (Enyitan®) demonstrated rapid, sustained effectiveness and a favorable safety profile in elderly patients with H1-antihistamine-resistant CSU, supporting its use as a first-line biologic therapy in this vulnerable population."

HEOR • Journal • Real-world evidence • Retrospective data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pain • Urticaria

NEW INDICATION FOR ENYITAN (OMALIZUMAB FOR INJECTION) OBTAINS MARKETING APPROVAL (CSPC Press Release) - "The board of directors (the 'Board') of CSPC Pharmaceutical Group Limited...is pleased to announce that the new indication for omalizumab for Injection (brand name: Enyitan ) (the Product'), a Class 3.3 therapeutic biological product developed by CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary of the Company, for the treatment of moderate to severe persistent allergic asthma has obtained marketing approval granted by the National Medical Products Administration of the People’s Republic of China. It is the second approved indication for Enyitan in China...Enyitan is the first omalizumab biosimilar in China approved for marketing under the registration category of Class 3.3 biological product."

China approval • Asthma