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Date: 2016-05-18

Type of information: Granting of a patent

Product name: ZW25 - anti-HER2 bispecific antibody

Compound: anti-HER2 bispecific antibody

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism:

bispecific antibody. This bispecific antibody targets two different epitopes of the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on the surface of many tumor types, including a subset of breast, gastric, lung, and ovarian cancers. 

Company: Zymeworks (Canada)

Disease:

ovarian cancer

Latest news:

* On May 18, 2016, the FDA has granted orphan drug designation for anti-HER2 bispecific antibody ZW25 for treatment of ovarian cancer.  ZW25 is currently in development in preparation for an IND filing in early 2017.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes