Press time:2021-06-04From:CR Pharma [Font:BigMediumSmall]
On June 1, China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. (“CR Sanjiu”; Stock Code: 000999.SZ), a subsidiary of China Resources Pharmaceutical Group Limited (“CR Pharmaceutical” or “the Group”; Stock Code: 3320.HK), and Runsheng Pharmaceutical Co., Ltd., (“Runsheng” or “the Company”), a company jointly invested in by CR Sanjiu and CR Pharmaceutical Industrial Investment Fund, submitted an ANDA application to FDA for its Advair Diskus generic drug. The application has been admitted by FDA and is currently in the vetting process. As a product type that had not more than three similar counterparts, the application was given the status of priority review by FDA.
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation, the first core product of Runsheng, is a high-end generic drug for Advair？ Diskus？ of GSK used for maintenance therapy of asthma and airflow blocking and reducing acute exacerbation of chronic obstructive pulmonary disease (COPD) for patients aged four or above.
Based on the tiered treatment and control strategies for asthma and COPD, Runsheng has been developing multiple product pipelines. The company filed a clinical application with Chinese authorities for its first product in 2019, and filed applications with the drug authority in the European Union and the FDA prior to its marketing in use in 2021. At the same time, product pipelines of the company under research are advancing steadily, and some of its products have entered the clinical research stage. The company has become a new player in the research and development and production of inhalation preparations.
Founded on October 8, 2014, Runsheng is a high-end complex preparation pharmaceutical company focusing on the core technology of the platform of inhalation drug delivery devices. The company’s current main products are drugs for the treatment of respiratory diseases, serving patients with asthma and chronic obstructive pulmonary diseases in countries and regions such as the United States, China, Europe, etc.
Runsheng is the strategic agency partner of Lannett Company (NYSE: LCI). CR Sanjiu and CR Pharmaceutical Industrial Investment Fund jointly hold 15.15% of the shares in Runsheng Pharmaceutical. CR Sanjiu obtained the China region dealership for Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation after its launch, which will help to fill up CR Sanjiu’s void in the inhaler segment.
