Analysis on the Prospect of AstraZeneca Asthma Treatment Drug Xinbiko Imitation

Asthma, also known as bronchial asthma, is a chronic airway inflammatory disease involving many cells and cytokines. It is a chronic disease of global concern. The main features include: repeated symptoms, airflow obstruction, airway hyperresponsiveness and potential inflammatory response; symptoms are: paroxical cough, chest tightness and dyspnea, mostly at night and (or) in the early morning.

According to the WHOStatistics, there are 2.35 in the worldHundreds of millions of people suffer from asthma. And the number of patients is increasing year by year, especially in children. This kind of disease is a chronic disease with repeated symptoms, which requires long-term medication. Therefore, the research and development of corresponding drugs for the treatment of asthma is urgent.

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease characterized by incomplete reversible airflow limitation. Clinically, it often manifests as recurrent cough, expectoration, dyspnea and other symptoms, usually showing the characteristics of progressive progress, including the vast majority of chronic bronchitis and emphysema. As the disease progresses, it leads to airway remodeling, eventually progressing to irreversible airflow obstruction, or coexisting with asthma.

COPDIt is one of the diseases with the highest morbidity and mortality worldwide. 2015year, the world has 320Ten thousand people have died from chronic obstructive pulmonary disease, and the prevalence has increased by 14.7 percent since 1990. According to the data surveyed by the World Health Organization, it is estimated that COPD will become the third leading cause of death in the world after heart disease and cancer in 2030.

The domestic situation is not optimistic. According to the results of an epidemiological survey conducted by Academician Zhong Nanshan, the current COPD in ChinaThe overall prevalence was 8.2 percent.The prevalence was 12.4 per cent for men and 5.1 per cent for women. There are more than 40 million COPD patients in China, and more than 1 million people die from chronic obstructive pulmonary disease every year. It is estimated that 65 million people will die of COPD in China from 2003 to 2033, and the mortality rate of COPD in China also ranks first in all countries.

Asthma and COPDThe manufacturers of therapeutic drugs are concentrated in GlaxoSmithKline (GSK), AstraZeneca and Boehringer Ingelheim, of which AstraZeneca's patent on Xinbico (Symbicort) is about to expire. The drug is a compound drug for the treatment of asthma and COPD. It was initially approved for listing in 2006 and its sales in 2017 will be about US $2.8 billion.

Introduction to Xinbico

Name: Budesonide/福莫特罗(budesonide/formoterol)

Trade name: Xinbico (Symbicort®)

Time to market: 2006Year (FDA)

Original research company: AstraZeneca (AstraZeneca)

Primary indications: Asthma and chronic obstructive pulmonary disease (COPD)

Dosage form: powder inhaler

Chemical structure:

 

budesonide

 

Formoterol

The mechanism of action of the letter

Synbicol is a compound preparation consisting of formoterol and budesonide. where formoterol is a long-acting selective β2Receptor agonist, budesonide for adrenocorticosteroid. Formoterol has a strong and long-lasting bronchodilator effect in a dose-dependent manner, and it can increase the forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak expiratory flow rate (PER) increase, and can expand bronchi and reduce airway resistance minutes after inhalation.

 

Original research patent situation

It is important to note that AstraZeneca has successfully won the Symbicortof pediatric exclusivity, thereby deferring generic competition until 2019May of the year.

Inhalant matching device, difficult to imitate

In terms of dosage form, the powder mist released by the lungs is mainly a metered dose inhalation aerosol (MDI), solution atomizing inhaler, soluble dry powder inhaler (DPI) Three categories, which is the biggest difference between drugs in this field and products in other therapeutic fields. Due to the difficulty of imitating powder inhalants, it is expected that after the patent expires, it will not have a significant impact on the market in a short time. Local pulmonary administration, in addition to the study of compounds, but also need to cooperate with the relevant drug delivery device, in this regard, it also brings a certain degree of difficulty to imitation.

 

Domestic imitation situation

Except 2010.Several of the companies declared years ago are still waiting for a major policy change and a long way off for review and approval. 2010There was no declaration of imitation of this product years later, while budesonide formoterol powder inhalant (capsule type) declared by zhengda tianqing was not approved in 2015, which shows the difficulty of imitation of this product. The drug is currently imported only from Sweden.

 

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