10:43 AM EDT, 07/18/2024 (MT Newswires) -- Marinus Pharmaceuticals ( MRNS ) said Thursday that its ganaxolone oral suspension has been approved by the China National Medical Products Administration as treatment for epileptic seizures in patients two years old and older with CDKL5 deficiency disorder.
The approval is supported by Marinus' phase 3 trial data, the company said.
Marinus said it granted Tenacia Biotechnology in 2022 the right to develop and sell ganaxolone in mainland China, Hong Kong, Macau, and Taiwan, with Marinus receiving royalties and milestone payments.
Ganaxolone has also been approved in the US and European Union for patients with CDD, Marinus added.
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