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A domestic leader emerges in a 6 billion market! Healthy Yuan's inhaled budesonide is approved
Published Time：
2020-07-24
On July 22, 2020, Joincare Pharmaceutical Group Industry Co., Ltd. (hereinafter referred to as "Health Yuan") launched a new inhaled preparation product—
Wu Shu (Budesonide Suspension for Inhalation) was approved for marketing through the new Class 4 registration, becoming the first domestically produced small-specification budesonide to pass the consistency evaluation! (Approval number: National Drug Standard Z H20203343)
It is understood that budesonide is an anti-inflammatory corticosteroid drug with potent glucocorticoid activity and weak mineralocorticoid activity, which treats asthma through anti-inflammatory effects. Inhalation therapy is the preferred treatment for asthma and other respiratory diseases, as the inhaled drug directly reaches the respiratory tract and lungs, with advantages such as rapid onset, small dosage, and minimal side effects.
Currently, the most common inhaled corticosteroids (ICS) in domestic clinical practice is budesonide suspension for inhalation, administered via nebulization inhalation. The original research is AstraZeneca's Pulmicort. Since its approval for import in China in 2001, Pulmicort has long occupied the ICS blue ocean. According to IMS data, Pulmicort's total domestic sales in 2019 were approximately 5.6 billion yuan, a year-on-year increase of 15.37%, making it the largest-selling inhaled preparation in China. This is also related to chronic respiratory diseases becoming the third leading cause of death from chronic diseases among Chinese residents. The large patient base and severe clinical situation mean that ICS, as the most effective drug for controlling airway inflammation, is widely used in the treatment of asthma and COPD and other wheezing diseases. This time, Health Yuan's launch of the generic version of budesonide suspension for inhalation—Wu Shu—strongly penetrates the 6 billion yuan ICS market of the original research product, with broad prospects and promising returns!
With China's aging population and accelerating urbanization, the incidence of respiratory diseases is on the rise. Inhalation administration, with its advantages of rapid onset and fewer side effects, is rapidly emerging, and the domestic market for respiratory inhalation preparations has broad prospects. However, due to the high R&D barriers of respiratory inhalation preparations, the vast majority of the Chinese market share has long been occupied by foreign pharmaceutical companies.
Relevant information shows that Health Yuan began to deploy inhaled preparations as early as 2012, and is one of the few companies in China to include inhaled preparations in its core business. Health Yuan executives told investors at this year's shareholders' meeting that its inhaled preparation-related business will be accelerated. To build a leading brand of respiratory inhalation preparations, Health Yuan has recently joined hands with top domestic R&D teams to conduct in-depth research on respiratory drugs and invested a large amount of funds in R&D of respiratory drugs, with cumulative R&D investment exceeding 100 million yuan.
In April 2019, Health Yuan's first respiratory product, Shutanlin (Compound Ipratropium Bromide Solution for Inhalation), was approved for marketing, becoming the first respiratory inhalation preparation in China to pass the consistency evaluation, marking a milestone in the development of high-end inhaled preparations in China. In September of the same year, Lishu Tong (Levosalbutamol Hydrochloride Nebulization Inhalation Solution) was approved for registration under the new Class 3 registration, becoming a unique nebulization product in China. This time, Wu Shu (Budesonide Suspension for Inhalation) was approved for marketing through the new Class 4 registration. Both the in-vitro drug quality comparison and the in-vivo bioequivalence study showed results comparable to the original research, making it the first domestically produced small-specification budesonide to pass the consistency evaluation.
With unwavering dedication, the successful launch of Health Yuan's major product, Wu Shu (Budesonide Suspension for Inhalation), strongly penetrates the 6 billion yuan ICS market of the original research product, which is of great significance to Health Yuan's development in the field of respiratory inhalation preparations. It is believed that its future innovation and R&D will closely focus on inhaled preparations and overall market demand, providing Chinese doctors with more and better choices, and allowing more asthma and chronic obstructive pulmonary disease patients to receive better treatment.
Source: China Economic News Network
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