Runsheng Pharmaceutical industry's first drug application
On December 12, 2019, Runsheng Pharmaceutical salmeterol-fluticasone Powder Inhaler received CDE approval for clinical development; the indications are:
(1) Asthma: This product is used in combination (bronchodilators and inhaled corticosteroids) for regular treatment of reversible obstructive airway diseases, including asthma in adults and children.
(2) Chronic obstructive pulmonary disease: This product is suitable for patients with chronic obstructive pulmonary disease, including conventional treatment of chronic bronchitis and emphysema.
Earlier in May 2019, Runsheng Pharmaceutical industry submitted its first application, Fluticasone Generic drug, with acceptance numbers (CYHS1900314, CYHS1900315, CYHS1900316). It took 7 months from submission of clinical application to approval of clinical application.
Brief introduction of Runsheng Pharmaceutical Co., Ltd.
It is Registered in 2014, the original Chongqing Runsheng Technology Co., Ltd. was changed to Runsheng Pharmaceutical Co., Ltd. in November 2018. Located in Shuitu Hi-tech Industrial Park, Beibei District, Chongqing, it is an international enterprise specializing in the development, production and sales of respiratory drugs.
Established tiotropium bromide dry powder inhaler, Salmeterol Xinafoate, fluticasone powder inhalation production line.
Original GSK of seretide
Seretide / Advair (LABA and ICS compound preparations) 2018 global sales performance is about 3.22 billion US dollars; 2017 and 2016 were 4.07 billion and 4.53 billion US dollars.
Seretide is a difficult combination of medicinal and mechanical products, consisting of medicines and equipment. The US composition patent expired in 2010, and the dry powder inhalation device patent expired in 2016. The US FDA issued a guideline for the development of Seretide generic drugs in 2013, which provided recommendations on bioequivalence, drug prescription, and inhalation devices.
As there is no generic drug on the market, the market of is entirely occupied by the original research pharmaceutical company GSK. According to the sample hospitals in Minei, salmeterol and fluticasone have sales of 1.42 billion yuan in 2017.
Seretide Generic drug application company
In addition to Runsheng, there are many companies reporting intensively
Global Respiratory Drug Market
According to IQVIA, global spending on respiratory medicines reached US $ 38.5 billion in 2017, with a compound growth rate of 4.80% from 2012 to 2017. Driven by the deterioration of the global environment, the increase in the prevalence of respiratory diseases, and the approval of new biologics and targeted therapies, the global respiratory drug market will maintain a steady growth.It is estimated that pharmaceutical spending in this area will reach 40-50 billion US dollars in 2022.
