As the inhalation formulation market is developing in China, the Chinese government has gradually introduced favorable policies to offer support, for example, the medical insurance policy continues to promote the Chinese-produced pharmaceutical products to substitute imported ones, and China has also provided a series of policy support for Chinese-produced pharmaceutical product innovation and medical device domestication. As a result, Chinese pharmaceutical enterprises that develop and produce inhalation formulations are rising. Chinese enterprises represented by Chiatai Tianqing, Joincare, CF PharmTech, and Hengrui Medicine, etc. are actively developing formulation varieties and compound formulation varieties such as budesonide, salmeterol and fluticasone, and tiotropium bromide; wherein, the first generics of many inhalation products have been approved, such as Joincare’s Compound Ipratropium Bromide Solution for Inhalation, and Chiatai Tianqing’s Budesonide Suspension for Inhalation. As Chinese-produced generic varieties are successively marketed, the share of respiratory system inhalation formulations of Chinese enterprises will continue to increase in the future, to gradually break the domination of imported pharmaceutical products.
Layout of Chinese enterprises
Inhalation formulations in China are mainly single formulations and nebulizer solutions (NEBs) (such as Budesonide Suspension for Inhalation), while compound formulations and aerosols/dry powder inhalers (DPIs) are used far more than NEBs in overseas markets. Take the respiratory system drugs, for instance, products commonly used in the current inhalation formulation market of China include Budesonide Suspension for Inhalation, Budesonide and Formoterol Fumarate Powder for Inhalation, Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation (Seretide), Tiotropium Bromide Powder for Inhalation, Terbutaline Sulphate Solution for Nebulization, Salbutamol Sulphate Aerosol, Ipratropium Bromide Solution for Inhalation, Compound Ipratropium Bromide Solution for Inhalation, betamethasone, and fluticasone, etc. (see Table 1 for the details)
Table 1 Common Inhalation Formulations for Respiratory System and Registration Situation in China
Most of the inhalation formulations approved in China years ago were applied for registration according to the old Class 6 registration. Approved for production, they still need to go through again the generic drug consistency evaluations or confirmatory clinical trials as required by the latest policy. Inhalation formulations produced by Chinese enterprises have rapidly risen in the market in recent one year, with multiple first generics approved for marketing, for example, the first generic “Compound Ipratropium Bromide Solution for Inhalation” of Joincare was marketed on Apr. 9, 2019, which started a new pattern of the Chinese inhalation formulation market; it is the first inhalation formulation approved according to the new Class 4 registration, the second inhalation formulation passing the generic drug consistency evaluation, and the first drug passing the generic drug consistency evaluation among all respiratory inhalation formulations in China. Following this, there has been continuous good news of Chinese enterprises, for example, Joincare’s Levosalbutamol Hydrochloride Nebuliser Solution was approved for marketing on Sep. 29, 2019; Hebei Renhe Yikang’s Salbutamol Sulfate Solution for Inhalation was approved for marketing on Feb. 5, 2020; Budesonide Suspension for Inhalation, the first generic of the original drug with the biggest sales in the respiratory system field in China, was ...
(All Rights Reserved)