Brand dynamics

Group Real-Time Dynamics And Cutting-Edge Information In The Field Of One Health

【Major Breakthrough】HealthGen Targets Inhaled Drug Market Again! 4 out of 14 Investigational Products are New Drugs

Published Time:

2021-04-08

On April 3, the clinical trial application for the Class 2 new drug, ipratropium bromide inhalation powder, submitted by Healthspring, was accepted. Currently, there are no similar inhalation products on the market. Earlier (March 2021), AstraZeneca submitted a Class 5.1 imported clinical application for ipratropium bromide powder inhaler, which is currently under review and approval. Whether the original research drug will be approved for import first or the domestic new drug will seize the opportunity is worth further attention.

 

Data from MiNet shows that Healthspring and its subsidiaries have previously submitted 13 inhalation products for listing, of which 4 have been approved for production and deemed to have passed the review, with inhalation compound ipratropium bromide solution and levalbuterol hydrochloride inhalation solution being the first domestic generic drugs. Healthspring's inhalation product line is becoming increasingly rich, and currently, there are 4 more products under review and approval, which are expected to be approved for listing successively in 2021 and beyond.

 

Among the 9 inhalation products that have been approved for clinical trials, 4 are registered as new drugs. Among them, the pharmacokinetic test for tiotropium bromide powder is underway, and the Phase III clinical trial for tobramycin inhalation solution is also underway. For the 5 generic drugs, the Phase III clinical trial for formoterol fumarate inhalation solution is underway, the bioequivalence test for indacaterol maleate powder inhaler has been completed, the BE pre-test for salmeterol fluticasone powder inhaler is underway, and the bioequivalence test for ipratropium bromide aerosol has been completed.
 
In addition, the Class 3 generic clinical application for mometasone furoate/formoterol inhalation aerosol is under review and approval.
 
Currently, Healthspring's inhalation product line continuously has new products entering the clinical and listing stages. With the successive listing of new products, the company is becoming increasingly stable on its strategic path of "leading domestic inhalation preparation enterprise".
 
Source: CDE website, MiNet database
Review data statistics are as of April 6. Please point out any errors or omissions.