Enyitan (omalizumab biosimilar) / CSPC Pharma - LARVOL DELTA

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