Zhengda Tianqing Budesonide Suspension First Imitation Officially Approved

2Month26day,NMPAOfficial website announced2020Year02Month26The Japanese drug approval document issued a notice, Zhengda Tianqing acceptance number isCYHS1700633Sue'sInhalation with budesonide suspension to get the drug approval, officially approved.

At present, two important varieties of budesonide inhalation budesonide suspension (trade name: Pulmicort Respules) and budesonide powder inhalation (trade name: Pulmicort Turbuhaler) are from AstraZeneca, accordingPDB sample hospital data show that budesonide2018AstraZeneca's share of domestic sales in98.93%You can see its leading position. Among the other varieties on the market, aerosol domestic products of Shanghai Xinyi Bailuda and Lunanbeite, powder mist agent has Shanghai Xinyi Bailuda products, but the share is smaller.Domestic listed budesonide inhalation products

(Source: Medicine Intelligence Network)

Budesonide is an anti-inflammatory corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity.

Anti-inflammatory treatment of asthma. Inhalation therapy is the first choice for the prevention and treatment of respiratory diseases such as asthma. The inhaled drugs can directly reach the respiratory tract and lungs, and have the advantages of fast onset, small dose, and low side effects.

Budesonide suspension for inhalation belongs to inhaled corticosteroids, administered through a nebulizer,Indications for the treatment of bronchial asthmamay replace or reduce oral steroid therapy. The original research is AstraZeneca's Pulmicort Respules,1991First listed in the UK,2000Year8Monthly acquisitionFDAapproved for listing,2001Year11Monthly approval to enter the domestic market, specifications.2 ml:0.5 mgand2 ml:1 mg.

According to the intranet data,Sales of budesonide suspension for inhalation in sample hospitals in 201812.46Billion yuan, corresponding to the actual market size of about50Billion yuan, year-on-year growth11.17%,2012-2018YearCAGRup19.29%. Expected2019Annual Domestic Sales Breakthrough60Billions of yuan, for AstraZeneca in the country's largest variety.

In terms of imitations, the research and development progress of Zhengda Tianqing and Kangkang Yuan was originally in a leading position.20183Monthly submission of listing applications. while in2018Year11Month20On the same day, Health Yuan announced that its subsidiary, Mrs. Pharmaceuticals, had received a "drug clinical trial notice" of budesonide suspension, which was re-launched.BEtest, in2019Year2Monthly re-submission of listing applications. And Changfeng Pharmaceutical in2018Year5Monthly declaration of listing, time on the curve overtaking health yuan.

Zhengda Tianqing20183Monthly chemical medicine4Class submitted a generic version of budesonide suspension for inhalation (acceptance number:CYHS1700633,CYHS1700634, respectively representing2 ml:1 mgand2 ml:0.5 mg), this time approved for large specifications, namelyCYHS1700633.This time Zhengda Tianqing successfully won the first imitation of budesonide suspension, and will divide the country with the original research.6 billion market.

In recent years, Zhengda Tianqing's performance in the first imitation medicine has attracted much attention.various signs show that,“Grab the first imitation”It is the strategic planning that Zhengda Tianqing Pharmaceutical has always adhered to, and it is also the company's huge competitive advantage in the market.