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Jiankang Yuan Yi inhalation solution drug obtained registration approval

Published Time:

2019-05-29

HealthGen announced on the evening of April 9 that its research drug, inhaled combined ipratropium bromide solution, has recently received the Drug Registration Certificate issued by the National Medical Products Administration.

The drug, through the combined administration of ipratropium bromide and salbutamol sulfate, can simultaneously act on the muscarinic and β2-adrenergic receptors in the lungs, relaxing the smooth muscles of the main bronchi to the terminal bronchioles. It is suitable for patients who need the combined use of multiple bronchodilators, used to treat reversible bronchospasm related to airway obstructive diseases. Its efficacy is superior to single-drug administration, making it a clinical drug for moderate to severe asthma and COPD patients.

According to the announcement, as of that day, the cumulative direct research and development costs for this drug were approximately 6.2384 million yuan.

The announcement stated that currently, the only inhaled combined ipratropium bromide solution on the market in China is Boehringer Ingelheim's "Combivent®". According to IQVIA data, the product's domestic sales in 2018 were approximately 343.44 million yuan.

According to the website of the Center for Drug Evaluation of the National Medical Products Administration and the Salda database, as of the announcement date, apart from the original research product, only the company has obtained the registration certificate for this product. Another company has submitted a registration application for this product, which is currently under review and approval. (Huang Shu)

Reprinted from: China Securities Journal