Third Rejection! No Generic Nusinersen Sodium Approved for Market Launch Yet

On May 25, the website of the National Medical Products Administration (NMPA) showed that Guowei Biotech'sNusinersen Sodium Injection Receives Drug Notification, Fails to Obtain Approval for Marketing.This is the third one that has not passed the review.Nusinersen仿制药。此前，Yaopharma andQilu Pharmaceutical's Nusinersen Sodium Injection received approvals in November 2025 and April 2026, respectively.Drug Notification.

The original research drug Nusinersen (trade name: Spinraza) is an antisense therapy targeting survival motor neuron 2 (SMN2) that Biogen licensed from Ionis Pharmaceuticals. In December 2016, Nusinersen Sodium Injection was first approved for marketing in the United States, becoming the first FDA-approved drug for the treatment of Spinal Muscular Atrophy (SMA). In February 2019, Nusinersen Sodium Injection was approved for marketing in China.

Since its launch, the global sales of Nusinersen Sodium Injection have been on the rise, peaking in 2019 at $2.097 billion. In May 2019, Nusinersen Sodium Injection faced its first competitor — the SMN1 gene therapy Onasemnogene Abeparvovec (brand name: Zolgensma, Novartis) — which was approved for marketing in the United States. In 2020, Roche launched Risdiplam (brand name: Evrysdi), creating a three-way competition in the SMA field. To date, these remain the only three targeted therapeutic drugs available in the SMA field.

Although the launch of Zolgensma and Evrysdi has weakened Spinraza's market position, this drug still generated $1.547 billion in revenue for Biogen in 2025.

The price of Spinraza was once a hot topic in the industry. At its launch, Biogen set the U.S. price at $125,000 per vial, and its initial pricing upon entering the Chinese market was 699,700 yuan per vial, earning it the label of an "astronomically priced" rare disease drug. After negotiations for inclusion in China's medical insurance system, the price of Spinraza in China dropped to 33,000 yuan per vial, significantly reducing the financial burden of treatment for patients.

According to the registration information, the core patent of Nusinersen in China will expire in 2030.