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On September 4, Health Yuan issued a notice that the company received the State Drug Administration approved the issuance of the "Drug Registration Certificate."
In accordance with the Drug Administration Law of the People's Republic of China and the relevant provisions, after examination, the solution of isopropyl tobly bromide for inhalation of healthy yuan meets the relevant requirements of drug registration, approves registration and issues a drug registration certificate.
announcement, the first time health yuan submitted for inhalation with isopropyl bromide solution registration was accepted on March 12, 2019, acceptance number CYHS1900195, CYHS1900196.
this product can be used in β with inhalation-persetressor agitants to treat reversible gas vessel obstruction caused by acute or chronic asthma.
products for the company's independent research and development products.
Isopropropyl bromide is an anticholinel energy drug with strong bronchial smooth muscle relaxation, which can significantly improve lung function and exercise tolerance in patients with chronic obstructive pulmonary disease (COPD), relieve the symptoms of breathing difficulties, improve sleep and quality of life, and is one of the main drugs for COPD treatment.
isopropyl propylene bromide in β inhaled and imported chemicals, and is widely used to treat acute asthma attacks.
, the cumulative research and development cost of the health yuan directly invested in the inhalation of ammonium isopropyl bromide solution is about RMB11.8698 million.
it is understood that the solution of isopropyl tobly bromide for inhalation was first developed by Boehringer-Ingelheim, which was approved for listing in the UK in August 1986 and entered the Chinese market in 2004.
IQVIA sampling statistics estimate data, the domestic inhalation of ammonium isopropyl bromide solution in 2019 end-sales amount of about 501 million yuan.
According to the website of the Drug Review Center of the State Drug Administration and the Xianda database, up to now, a total of 6 domestic manufacturers (including the Company and 1 import registration) declared, Health Yuan is the first in China according to the new registration classification application and approved 4 classes of generic drugs manufacturers.
source: Health Meta Bulletin