Gowell Pharma's application for a generic version of Spinraza (nusinersen) has been rejected by China's National Medical Products Administration (NMPA), marking the third such rejection in the past eight months. The drug, used to treat spinal muscular atrophy (SMA), remains protected in China despite the expiration of its core patent in other markets. Previous generic drug filings by YaoPharma and Qilu Pharmaceutical were also unsuccessful.

The original product, developed by Biogen and Ionis Pharmaceuticals, was the first SMA therapy approved in the US (2016) and China (2019). Despite competition from Novartis' gene therapy Zolgensma and Roche's oral therapy Evrysdi, Spinraza continues to generate significant revenue, with USD 1.5 billion in sales in 2025.

Its price has been a focal point of discussion; after negotiations, the cost per vial in China was reduced from nearly RMB 700,000 to approximately RMB 33,000.

PharmCube's NextBiopharm® database lists five SMA therapies approved in the Chinese market. Click here to request a free trial for NextBiopharm®.