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健民药业集团股份有限公司 关于获得《药物临床试验批准通知书》的公告

Group 1 - The company has received the clinical trial approval notice for the nasal congestion granules from the National Medical Products Administration [1] - The nasal congestion granules are indicated for the treatment of acute sinusitis and have shown good efficacy and safety in clinical applications [1][2] - The market for nasal medication is significant, with 26% of the adult population in China suffering from nasal inflammation or sinusitis, and the market demand for nasal medication is expected to grow [2] Group 2 - The sales revenue for nasal medication (traditional Chinese medicine) is projected to be 2.757 billion yuan in 2023 and 3.061 billion yuan in 2024, with the nasal congestion granules expected to generate sales of 409 million yuan in 2023 and 475 million yuan in 2024 [2] - There are several traditional Chinese medicine products approved for the treatment of acute sinusitis, including nasal congestion granules, with one approval number for the nasal congestion granules [3] - The company must complete clinical trials and submit a marketing authorization application to the National Medical Products Administration before the product can be marketed [4]