Joincare Health issued an announcement stating that it recently received the Drug Registration Certificate for Inhalation Budesonide Suspension approved and issued by the National Medical Products Administration (NMPA).
The initial submission and acceptance date of the Company's registration application for Inhalation Budesonide Suspension (2 ml:1 mg) wasAugust 22, 2017, with the acceptance number CYHS1700291 Yue. The product is mainly indicated for the treatment of bronchial asthma and can be used as an alternative to or to reduce oral steroids.
This product is independently developed by Joincare Health. Budesonide is a glucocorticoid that exerts an anti-asthmatic effect through local anti-inflammatory action. Inhalation therapy is the first-line therapy for the prevention and treatment of respiratory diseases such as asthma. As inhaled drugs act directly on the respiratory tract and lungs, they feature rapid onset, low dosage, and mild toxic and side effects.
As of the date of this announcement, the Company's aggregate direct R&D investment in Inhalation Budesonide Suspension (2 ml:1 mg) has amounted to approximatelyRMB 30,672,800.
Budesonide Inhalation Suspension was originally developed and manufactured by AstraZeneca, first launched in the United Kingdom in 1991 and introduced into the Chinese market in 2001.According to sampling statistics and estimates from IQVIA, the domestic terminal sales value of Budesonide Inhalation Suspension in China was approximatelyRMB 5.632 billion in 2019.
As shown on the website of the Center for Drug Evaluation (CDE) of NMPA and the Xenda Database, up to the present, there are 2 domestic manufacturers (including the Company) with the product approved for marketing, and another 3 domestic manufacturers have submitted applications.
