Approval Notification for Supplementary Application of Sodium Oligosialic Acid Tetrahexosyl Ganglioside Injection

October 26, 2024  Source: drugdu 35

"/On October 23, Sai Sheng Pharmaceutical (300485) announced that it recently received an Approval Notification for the Supplementary Application of Sodium Oligosialic Acid Tetrahexosyl Ganglioside Injection issued by the National Medical Products Administration (NMPA).

According to company regulations, the firm completed confirmatory clinical trials meeting current requirements within three years and submitted a supplementary application to the NMPA Center for Drug Evaluation, successfully obtaining the approval. The product's labeling has been updated, indicating that the revised indication is for patients with acute ischemic stroke.

The announcement stated that the Sodium Oligosialic Acid Tetrahexosyl Ganglioside Injection, available in specifications of 2ml:20mg, 2ml:40mg, and 5ml:100mg, has received the approval notification for the supplementary application. This will enhance the drug's potential market sales and competitiveness in the future. However, due to the high-tech and high-risk nature of pharmaceutical products, sales performance may be influenced by national policies, changes in the market environment, and other factors, leading to significant uncertainties.

In the first half of 2024, the company reported an operating income of 215 million yuan, a year-on-year decrease of 21.03%. The net profit attributable to the parent company was a loss of 105 million yuan, compared to a profit of 252 million yuan during the same period last year.

Sai Sheng Pharmaceutical: Approval Notification for Supplementary Application of Sodium Oligosialic Acid Tetrahexosyl Ganglioside Injection

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