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诺华(NVS.US)“潜在重磅”口服新药新适应症在华申报上市

Novartis (NVS.US) has applied for a market approval in China for a potential blockbuster oral new drug and new indication.

Zhitong Finance ·  Sep 5 21:20

The latest announcement on the official website of China's National Medical Products Administration Drug Evaluation Center (CDE) reveals that the application for market approval of Novartis' ipatropium hydrochloride capsules for a new indication has been accepted.

According to the latest announcement on the official website of China's National Medical Products Administration Drug Evaluation Center (CDE), Novartis' ipatropium hydrochloride capsules for a new indication have been accepted. The specific indication has not been disclosed. Ipatropium is a specific oral inhibitor of complement factor B and was approved for the first indication in China in April this year for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adult patients. This is the third market approval application for the product in China, and public information speculates that the indication may be C3 glomerulopathy.

Public information shows that Ipatropium capsules (iptacopan, LNP023) are an oral specific alternative complement pathway factor B inhibitor, which can efficiently inhibit factor B in the alternative complement pathway. It may simultaneously treat diseases caused by abnormalities in various alternative pathway functions without affecting the immune response to microbial invasion mediated by other complement pathways, reducing the risk of infection for patients. This product has been listed as one of the 10 potential blockbuster therapies worth paying attention to by industry media Evaluate.

The translation is provided by third-party software.


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