海南葫芦娃药业集团股份有限公司关于获得吸入用异丙托溴铵溶液药品注册证书的公告

Core Viewpoint - Hainan Huluwa Pharmaceutical Group Co., Ltd. has received the drug registration certificate for inhaled ipratropium bromide solution from the National Medical Products Administration, which is expected to enhance the company's product line and positively impact its development [1][4]. Drug Information - The drug is named inhaled ipratropium bromide solution, classified as a Class 4 chemical drug, with specifications of 2ml:0.25mg and 2ml:0.5mg [1][2]. - The 2ml:0.25mg formulation is indicated for the treatment of reversible airway obstruction caused by acute or chronic asthma when used in conjunction with inhaled β-agonists [2]. - The 2ml:0.5mg formulation serves as a bronchodilator for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and can also be used with inhaled β-agonists for acute bronchospasm [2]. - The original manufacturer of the drug is Boehringer Ingelheim Pharma GmbH & Co. KG, which first received approval in the UK in 1986 and was launched in China in 2004 [2]. R&D Investment - The company has invested a total of RMB 5.9089 million in the research and development of this product to date (unaudited) [3]. Market Context - As of the date of this announcement, there are 29 other domestic companies that have received approval to market inhaled ipratropium bromide solution [2].