格隆汇2月20日丨华东医药(000963.SZ)于2023年2月15日14:30-16:00;2月16日11:00-11:40、14:00-15:00接受机构现场调研时表示,2022年11月15日,华东医药美国合作方ImmunoGen对外宣布,其用于治疗铂耐药卵巢癌的全球首创(first-in-class)ADC药物ELAHERE™ (mirvetuximab soravtansine-gynx,研发代码:IMGN853、HDM2002)获得美国食品药品监督管理局(FDA)加速批准上市。
目前,该产品在中国的相关临床及注册工作正按计划积极推进,公司计划于2023年下半年向NMPA递交BLA申请。
Gelonghui February 20 丨On February 15, 2023, Huadong Pharmaceutical (000963.SZ) was surveyed on-site by the agency at 14:30-16:00 on February 15, 2023; 11:00-11:40 and 14:00-15:00 on February 16, it was stated that on November 15, 2022, ImmunoGen, an American partner of Huadong Pharmaceutical, announced to the outside world that its first-in-class (first-in-class) ADC drug for the treatment of platinum-resistant ovarian cancer ELAHERE™ (mirvetuximab soravtansine-gynx, R&D codes: IMGN853, HDM2002) received accelerated approval for listing from the US Food and Drug Administration (FDA).
Currently, clinical and registration work related to this product in China is progressing actively as planned, and the company plans to submit a BLA application to NMPA in the second half of 2023.