Humanwell Healthcare (600079.SH): Lisdexamfetamine Dimesylate Capsule Marketing Authorization Application Accepted

Stock News11-21

Humanwell Healthcare (600079.SH) announced that its subsidiary Yichang Humanwell Pharmaceutical Co., Ltd. (holding an 80% stake) recently received the acceptance notice from the National Medical Products Administration for the marketing authorization application of Lisdexamfetamine Dimesylate Capsules.

The original drug was first approved in the U.S. for treating attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 and above, as well as moderate-to-severe binge eating disorder (BED) in adults. Yichang Humanwell's application covers ADHD treatment for the same patient groups.

Currently, no domestic or imported Lisdexamfetamine Dimesylate Capsules are available in China according to regulatory records. The cumulative R&D investment in this project has reached approximately RMB 90 million.

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