China's Domestic Firms Vie for First Generic of Nusinersen, Once Priced at ¥700,000 per Dose

On January 3, the official website of the Center for Drug Evaluation under the National Medical Products Administration showed that Qilu Pharmaceutical's Nusinersen Sodium Injection had applied for market approval. This is the second company to apply for the market launch of this drug after Yaoyou Pharmaceutical, marking the beginning of the race for the first generic version of Nusinersen Sodium Injection. Once priced at approximately 700,000 yuan per injection, Nusinersen Sodium was reduced to around 30,000 yuan after being included in China’s national medical insurance. With the entry of domestically produced generics, the price of Nusinersen Sodium is expected to become even more affordable.

Nusinersen is the world's first precision-targeted treatment for the rare disease Spinal Muscular Atrophy (SMA). In December 2016, the nusinersen injection developed by Biogen was approved for marketing in the United States, becoming the first specific drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of SMA. In April 2019, the nusinersen injection was approved for marketing in China.

At the time of its launch in China, nusinersen sodium injection garnered significant market and public attention due to its high selling price of 700,000 RMB per dose. In December 2021, after undergoing a rigorous "soul-cutting" negotiation during the national medical insurance talks, nusinersen sodium was included in the National Medical Insurance Drug List at a new price of 33,000 RMB per dose, benefiting more patients. According to a previous report by *China Medical Insurance*, from January to May 2022, the total number of patients using nusinersen sodium increased fivefold compared to before it was included in the medical insurance, and the total sales of the drug also approached the cumulative sales volume since its launch in China over two years prior.

In September 2024, Chongqing Pharma Yaoke submitted a market application for the generic version of Nusinersen Injection. This is also the first generic drug application in China under Category 4 for Nusinersen Injection. With Qilu Pharmaceutical's generic version of Nusinersen Injection approved for marketing, there are now two generic drugs approved in China. However, the core Chinese patent for Nusinersen does not expire until 2030, and generic drugs can only be marketed after the patent expires. It is foreseeable, however, that with the availability of generics, the burden on patients will be further reduced.

Reporters from the People's Daily Health Client found that, as of January 8, there are three drugs for the treatment of SMA approved for marketing worldwide: Biogen's Nusinersen, Novartis' Zolgensma, and Roche's Evrysdi. Among them, the relevant drugs from Biogen and Roche have been approved for marketing in China, and the clinical trial application for Novartis' AAV gene therapy drug Zolgensma submitted in China has received tacit approval for clinical trials.

Source: People's Daily Health Client