On November 8,Jiangsu Hengrui Pharmaceutical Co., Ltd. announced that it has recently received the "Clinical Trial Notice" approved by the State Drug Administration. The drug Hengrui Medicine is the application for declaration and production, and the National Bureau finally approved the clinical trial.
It seems that it is necessary to continue to do clinical trial follow-up production.
1. Name of the drug:Intravenous inhalation powder for Indacaterol Maleate
Dosage form: inhalation powder
Specification: 150μg (calculated according to C24H28N2O3)
Application: Declaration of production
Applicant: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Reception number: CYHS1900067
2. Other conditions of the drug
Indacaterol Maleate inhalation powder is a novel long-acting β2-receptor agonist intended for maintenance therapy in adults with chronic obstructive pulmonary disease (COPD).Inhaled Powder Indacaterol Maleate was first approved by Novartis Pharmaceuticals in November 2009,Specifications are 150μg and 300μg.In July 2011,
it was approved by the US FDA and Japan PMDA, and the approved specifications were 75μg and 150μg respectively. Up to now, this product has been approved for
listing in more than 50 countries around the world.Upon enquiry, in June 2012, Novartis's inhaled powder of Indacaterol Maleate was approved for import in China. The product
name is Anrun, and the specification is 150μg.In January 2019, the company's first inhaled powder of Indacaterol Maleate was invented in the fourth category of chemical
registration.
After inquiring about the IMS database, global sales of Indacaterol Maleate in 2018 were approximately $111 million, with domestic sales of approximately $307,500.
Up to now, the product project has invested R&D expenses of approximately RMB 22.4 million.After inquiring, the drug was reported to be produced for the first time in 2015. It is expected that clinical trials will also be required. Hengrui Pharmaceutical declares production in 6 categories of generic drugs in 2016 and is not expected to be approved.The clinical trial found that Hengrui Medicine completed the human
bioequivalence study of the drug for the first time, and the second of Shenzhen Haibin Pharmaceutical completed the BE pre-test and the formal BE test.Inhalation
preparations are declared for production, and it is not enough to complete the BE test. It may be necessary to conduct a confirmatory clinical trial.