Gongwinbiopharm granted for MUMS sponsor fee waiver by US FDA

Gongwin Biopharm's product GWA301 passed US FDA MUMS

In September, US FDA-CVM (Center for Veterinary Medicine) replied officially, indicating that Gongwin’s animal oncology medicine GWA301 has passed MUMS inspection.

In order to provide incentives to for new animal drug sponsors, Office of Minor Uses and for Minor Species (OMUMS) were organized to support the approval process. Drugs for use in minor species or for use in major species afflicted with uncommon diseases or conditions takes enormous drug development efforts while being less profitable. MUMS were hence here to assist and accelerate the process.

GWA301 passed US FDA MUMS, falling in specific criteria, is eligible to proceed to conditional approval process. Similar to orphan drug for humans, the conditional approval would accelerate the progress for drug availability. While there are few drugs made for animal cancers, Gongwin’s animal oncology medicine made for canine cancers would definitely benefit the animal patients in the near future.