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华东医药(000963.SZ)：用于治疗铂耐药卵巢癌的全球首创ADC药物ELAHERE™计划下半年向NMPA递交BLA申请

Huadong Pharmaceutical (000963.SZ): ELAHERE™, the world's first ADC drug for treating platinum-resistant ovarian cancer, plans to submit a BLA application to NMPA in the second half of the year

Gelonghui Finance ·  02/20 15:30

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.

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