北京市首个试点品种获批 罕见病创新药 “跨境分段生产” 全球同步上市

Recently, Johnson & Johnson's Nicarbazin injection cross-border segmented production pilot has been approved by the National Medical Products Administration. This is an innovative product launched simultaneously worldwide and is the first biological product in the country for treating the rare disease "generalized myasthenia gravis" in adolescents aged 12 and older and adult patients. According to the city's drug regulatory bureau, the raw liquid of this product is produced domestically, while the formulation and packaging are produced overseas, making it the first approved segmented production pilot for biological products in this city