Wanbangde drug gains FDA orphan drug status

Wanbangde Pharmaceutical Holding Group [SZSE:002082] announced that its subsidiary, Wanbangde Pharmaceutical Group, has received orphan drug designation from the U.S. FDA for mecobalamin in the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The FDA's decision, following an application submitted in November 2024, offers incentives for developing treatments for rare diseases. These incentives may include tax credits for clinical trial costs, waivers for new drug application fees, and a potential seven-year period of market exclusivity upon approval. ALS is a rare and fatal neurodegenerative disease. While a mecobalamin injection has been approved in Japan for ALS treatment, it is not yet available in the U.S.. The company cautioned that clinical trials and regulatory approvals are subject to uncertainty.